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1. Effect of the Factor XIa Inhibitor Asundexian According to Baseline Infarct Pattern and on MRI Covert Infarct Outcomes

Author

Smith, Eric E., Shoamanesh, Ashkan, Xu, Lizhen, Heenan, Laura, Saad, Feryal, Colorado, Pablo, Chen, Chih-Hao, Lemmens, Robin, De Marchis, Gian Marco, Caso, Valeria, Masjuan, Jaime, Hirano, Teruyuki, Milanov, Ivan, Campbell, Bruce C.V., Mas, Jean-Louis, Connolly, Stuart J., Mundl, Hardi, Hart, Robert G., Bailey, P., Kleinig, T., Cordato, D., Choi, P., Garcia-Esperon, C., Chew, A., Cloud, G., Stanislaus, V., Krause, M., Priglinger, M., Grimley, R., Ghia, D., Sahathevan, R., Brown, H., Kwan, C., Devlin, M., Greisenegger, S., Bonelli-Nauer, S., Rath, J., Langer, A., Marko, M., Ferrari, J., Bernegger, A., Baumgartinger, M., Vigl, M., Krebs, S., Lang, W., Knoflach, M., Dejakum, B., Kiechl, S., Töll, T., Domig, L., Mutzenbach, J.S., Ganser, B., Hecker, C., Rösler, C., Bubel, N., Pikija, S., Zellner, T., Leitner, U., Berger, O., Surböck, B., Beirer, S., Staykov, D., Schrammel, D., Halilovic, A., Frattner, M., Barmherzigen, D., Lampl, C., Höfer, C., Nagl, S., Bocksrucker, C., Demeestere, J., Desfontaines, P., Ciobanu, C., De Pauw, A., Terwecoren, A., Hasenbroekx, M.C., Clement, F., De Klippel, N., Soors, P., Hermans, S., De Raedt, S., Vandervorst, F., Seynaeve, L., Fockaert, N., Smet, S., Rutgers, M., Del Gaudio, N., Paindeville, P., Staikov, I., Simeonova, A., Stoyanova, I., Cholakova, M., Mihnev, N., Petrova, T., Koralova, A., Dimov, D., Kuzev, Y., Danovska, M., Marinova, D., Marinova-Trifonova, D., Ovcharova, E., Mladenovski, I., Yanakieva, M., Stoev, P., Dimitrova, M., Todorova-Georgieva, S., Haralanov, L., Milkov, B., Solakov, D., Petkova, N., Ignatova-Valkova, V., Karabinov, V., Marinova, V., Miteva, Y., Andonova, V., Kasabova, D., Kostadinova, E., Shopova-Vrabcheva, Y., Gatev, D., Semova, D., Halil, E., Kaprelyan, A., Ivanov, B., Panov, G., Grudkova, M., Syuleyman, N., Kalpachki, R., Alexiev, F., Ivanova, I., Kancheva, K., Sakelarova, T., Maslarov, D., Drenska, D., Georgiev, V., Petrova, K., Petrova, N., Ivanova, I., Semerdjieva, N., Zhelyazkov, P., Spasova-Markova, S., Dong, X., Wang, D., Wang, S., Huang, W., Zhao, H., Wang, C., Jie, L., Xinyang, Y., Ping, Z., Dong, Q., Wang, Y., Fuling, Y., Yue, W., Liu, R., Yang, Y., Stetkarova, I., Mikulenka, P., Vasko, P., Peisker, T., Bar, M., Roubec, M., Mikulik, R., Cabukova, M., Vinklarek, J., Kovar, M., Pansky, M., Mencl, P., Skoda, O., Carek, M., Pernicka, M., Skodova, M., Geier, P., Cepkova, J., Drlik, J., Prax, T., Herzig, R., Krajickova, D., Vitkova, E., Haluskova, S., Vaclavik, D., Martinkova, J., Blejcharova, K., Tkacova, M., Pavlik, O., Nevšímalová, M., Rosol, J., Nevsimalova, M., Hruby, R., Iversen, H., Andersen, A.V., Rahimi, D., Christensen, H., Grundtvig, J., Hjort, N., Andersen, G., Sandal, B., Stilund, M., Modrau, B., Strade, A., Porobic, M., Andersen, S.D., Kruuse, C., Ölmestig, J., Kolmos, M., Parvez, A., Christensen, T., Stokholm, J., Jensen, H.B., Putaala, J., Strbian, D., Sibolt, G., Tiainen, M., Martinez-Majander, N., Curtze, S., Raty, S., Kraemer, Y., Roine, R., Aivo, J., Ruuskanen, J., Ylikotila, P., Roine, S., Hallikainen, M., Jakala, P., Kurl, S., Julkunen, V., Sibon, I., Olindo, S., Richard, S., Larrue, V., Gollion, C., Catala, H., Henon, H., Lucie, D.S., Nelly, D., Calvet, D., Malbranque, A., Mazé, B., Barbieux-Ghitu, C., Rosso, C., Samson, Y., Vannier, S., Moulin, T., Bonnet, L., Reiner, P., Buffon, F., Denier, C., Amri, K., Legris, N., Chassin, O., Selli, N., Mariana, S., Berrouschot, J., Stoll, A., Klunk, D., Keilitz, J., Neustadt, M., Zerrenner, S., Veltkamp, R., Hajjar, K., Heeger, A., Winezki, E., Apel, L., Pompsch, M., Mueller, P., Rappard, P., Auer, R., Ringleb, P.A., Berberich, A., Heyse, M., Mundiyanapurath, S., Reiff, T., Poli, S., Gomez-Exposito, A., Mengel, A., Tünnerhoff, J., Adeyemi, K., Poli, K., Kusch, V., Pelz, J., Michalski, D., Wartenberg, K., Althaus, K., Tavares, F., Mueller, S., Soda, H., Rascher, A., Hiermann, E., Weinhardt, R., Weissenborn, K., Leotescu, A., Grosse, G., Worthmann, H., Ernst, J., Gabriel, M., Schuppner, R., Schäfer, J.H., Charisse, D., Gruber, K., Kurka, N., Reitz, S.C., Pfeilschifter, W., Lee, J.I., Gliem, M., Moll, M., Steiner, T., Segura, L., Szegedi, N., Barandi, D., Uhrinakova, L., Czencz, M., Pasztor, M., Gyuker, N., Bartha, N.E., May, Z., Simony, Z., Szasz, G., Kakuk, I., Pető, N., Panczel, G.F., Olah, A., Racz, O., Balla, T., Horvath, B., Tuba, K., Czinderi, V., Klivenyi, P., Annus, A., Hertelendy, P., Szapary, L., Bosnyak, E., Kalmar, P., Karadi, Z., Cziba, L., Olah, L., Berki, A., Hudak, L., Kozák, M., Babel, S., Nemeth, L., Molnár, B., Simon, Z., Roveri, L., Cerri, F., Giacalone, G., Zini, A., Mauro, G., Asioli, G.M., Forlivesi, S., Arnone, G., Fiaccadori, A., Maria Fontana Francesca, E., Allegra, G., Mosconi, M.G., Longoni, M., Terlizzi, R., Paolucci, M., Tassi, R., Franci, B., Lucani, B., Domenichelli, C., Paoletti, D., Acampa, M., Zedde, M.L., Pezzella, F.R., Mangiardi, M., Galizia, P., Anticoli, S., Scalise, S., Lattanzi, S., Norata, D., Cannuccia, M., Cavallini, A., Federica, F., Denaro, M.F., Tosi, P., Sonoda, K., Kawajiri, M., Kusano, Y., Haraguchi, K., Kawano, H., Terasaki, T., Kaneko, C., Murase, S., Kumagai, M., Murai, N., Miyazaki, Y., Mori, T., Hatano, T., Kawanishi, M., Ochiai, J., Ishihara, S., Uehara, T., Yasaka, M., Nakagawa, H., Makino, M., Yonehara, T., Fukushima, Y., Hirotsune, N., Sakai, N., Yamasaki, M., Coutinho, J., Wouters, A., den Hertog, H., Zwartbol, R., Beumer, D., Kerklaan, J., Hilkens, P., Schreuder, T., Propper, D., Slowik, A., Wlodarczyk, E., Wrona, P., Pulyk, R., Lasek-Bal, A., Kosarz-Lanczek, K., Puz, P., Bilik, M., Magielska, A., Zamiela – Żółciak, A., Ochocinska, L., Bahdasaryan, S., Stępień, A., Dębiec, A., Joanna, K., Pawel, M., Jacek, S., Daniel, P., Marta, S., Rejdak, K., Wojczal, J., Luchowski, P., Fryze, W., Wisniewska, A., Krzyzanowska, M., Skowron, P., Wolosz, A., Galan, A., Grzymala, K., Krajewska, M., Nowak, R., Kłos, M., Cruz, V., Castro, P., Ferro, J., Canhão, P., Gouveia, R., Inácio, N., Rodrigues, M., Rachão, A., Ionel, C., Pereira, L., Viana-Baptista, M., Machado, C., Fernandes, C., Sargento, J., Inácio, N., Timchenko, L., Mironova, J., Zhadan, O., Torgashova, A., Bazhenova, O., Barashenkova, M., Kireeva, M., Romadina, N., Stepanova, I., Lenskaya, L., Lukinykh, L., Vorontsova, T., Agafina, A., Fedorova, A., Yashina, A., Alasheev, A., Smolkin, A., Prazdnichkova, E., Lutskovich, O., Gonysheva, Y., Mordvintseva, E., Nechaev, A., Martynova, E., Fedoraeva, N., Vishnyakova, T., Popov, D., Merzliakova, A., Margarita, K., Rechkalova, L., Ilyina, A., Kurenkova, N., Barbarash, O., Bazdyrev, E., Zvereva, T., Hromova, A., Morkvenas, A., Postnikova, E., Kovalenko, G., Taran, I., Pavlov, L., Ott, M., Chernitsova, N., Vodopyanova, N., Drozdova, E., Korebo, E., Lobanova, M., Lazareva, N., Snegova, N., Nikolaeva, O., Kolesnikov, Y., Kosheleva, Y., Krastev, G., Tomasova, K., Danis, M., Mako, M., Jankovicova, Z., Stevkova, Z., Kovacik, M., Kubikova, T., Jarosova, A., Serdahely, V., Cilingova, I., Pribulova, I., Sedlak, J., Slebodova, K., Paldaufova, M., Risnovsky, R., Berndtova, B., Urbanova, I., Junas, R., Karapetian, S., Gurcik, L., Vantrobova, A., Verbovsky, F., Vanacka, K., Ferenc, M., Galik, P., Bucakova, S., Ferencova, M., Kubalova, P., Boksanska, Z., Zacharova, E., Mahundi, E., Judita, H., Bachnak, M., Turcani, P., Kvasnicova Kamenska, A., Jurik, M., Vestenicka, V., Kycina, M., Sagatova, E., Dvorak, M., Hlubekova, A., Kucera, C., Gernath, L., Ferenc, M., Frimmelova, P., Slebodnikova, J., Aksteinerova, N., Horny, V., Gregova, Z., Segura, T., Romero, C., Ayo, O., Masjuan Vallejo, J., Cruz, A., De felipe, A, Matute, M.C., Garcia, S., Tembl Ferrairo, J., Vielba, I., Morales Caba, L., Molina, C., Garcia-Tornel García-Camba, Á., Requena Ruiz, M., Noelia, R., Rodriguez-Yañez, M., Rodriguez Castro, E., Lopez, I., Santamaria, M., Arias, S., Purroy García, F., Vázquez Justes, D., Mauri Capdevila, G., Vicente Pascual, M., Martí Fabregas, J., Camps Renom, P., Rodríguez Campello, A., Giralt, E., Krupinski, J., Molina, J., Trillo Senin, C. Ramos Martin, S., De La Fuente Sanz, E., Moniche, F., Manuel, M.R., Pardo, B., Martínez, I., Hernández Pérez, M., Arenillas Lara, J.F., De Lera, M., Egido, J.A., Gomez Escalonilla, C., Guillan, M., Martinez, J., Lindgren, A., Andsberg, G., Wictor, L., Leonidou, M., Stenman, M., Dalberg, N., Laska, A.C., Grünfeldt, A., Lundström, A., Nadzjafov, E., Rooth, E., Dalenbring, I., Sandén, P., Johansson, E., Thomas, G., Zietz, A.V., Rudin, S., Dittrich, T.D., Lilian, K., Kägi, G., Vehoff, J., Arnold, M., Scutelnic, A., Clénin, L., Beyeler, M., Madlaine, M., Maamari, B., Siepen, B., Vynckier, J., Tarnutzer, A., Bertschi, D., Luciani, M., Cereda, C., Maulucci, F., Bianco, G., Shairin, S., Pihan, H.A., Salmen, S., Quinn, T., McAlpine, C., Wright, F., Kalladka, D., Taylor, E., Sohaa, J., Brown, Z., Dawson, J., Cameron, A., Muir, S., Dima, S., Khan, U., Zhang, L., Warburton, E., Chatterjee, K., Nallasivan, A., Curran, D., Haider, S., Ghani, U., Kenton, A., Dallol, B., Mirza, M., Menezes, B., Davies, R., Robinson, T.G., Manning, L., Sztriha, L., Phinney, T., Sethi, P., Altafullah, I., Sharaf, A., Ostrander, M., Renati, S., Burgin, W.S., Olds, K., Delio, P., Malek, A., Dissin, J., Khatri, P., Flaherty, M., Demel, S., and Dofitas, S.

Published
2024
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3. Economic Evaluation of Endovascular Treatment for Acute Ischemic Stroke

Author

Berg, Lauri M.M. van den, Berkhemer, O.A., Fransen, P.S., Beumer, D., Lingsma, H., Majoie, C.B.L.M., Dippel, D.W., Lugt, A. van der, Oostenbrugge, R.J. van, Zwam, W.H. van, Jenniskens, S.F.M., Roos, Y.B.W.E.M., Dijkgraaf, M.G.W., Berg, Lauri M.M. van den, Berkhemer, O.A., Fransen, P.S., Beumer, D., Lingsma, H., Majoie, C.B.L.M., Dippel, D.W., Lugt, A. van der, Oostenbrugge, R.J. van, Zwam, W.H. van, Jenniskens, S.F.M., Roos, Y.B.W.E.M., and Dijkgraaf, M.G.W.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: Endovascular treatment for acute ischemic stroke has been proven clinically effective, but evidence of the cost-effectiveness based on real-world data is scarce. The aim of this study was to assess whether endovascular therapy plus usual care is cost-effective in comparison to usual care alone in acute ischemic stroke patients. METHODS: An economic evaluation was performed from a societal perspective with a 2-year time horizon. Empirical data on health outcomes and the use of resources following endovascular treatment were gathered parallel to the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) and its 2-year follow-up study. Incremental cost-effectiveness ratios were calculated as the extra costs per additional patient with functional independence (modified Rankin Scale score 0-2) and the extra cost per quality-adjusted life year gained. RESULTS: The mean costs per patient in the intervention group were $126 494 versus $143 331 in the control group (mean difference, -$16 839 [95% CI, -$38 113 to $5456]). Compared with patients in the control group, more patients in the intervention group achieved functional independence, 37.2% versus 23.9% (absolute difference, 13.3% [95% CI, 4.0%-22.0%]) and they generated more quality-adjusted life years, 0.99 versus 0.83 (mean difference of 0.16 [95% CI, 0.04-0.29]). Endovascular treatment dominated standard treatment with $18 233 saved per extra patient with a good outcome and $105 869 saved per additional quality-adjusted life year. CONCLUSIONS: Endovascular treatment added to usual care is clinically effective, and cost saving in comparison to usual care alone in patients with acute ischemic stroke. Registration: URL: https://www.trialregister.nl/trial/695; Unique identifier: NL695. URL: https://www.isrctn.com; Unique identifier: ISRCTN10888758.

Published
2022

4. Clinical and Imaging Markers Associated With Hemorrhagic Transformation in Patients With Acute Ischemic Stroke

Author

Kranendonk, K.R. van, Treumiet, K.M., Boers, A.M.M., Berkhemer, O.A., Berg, L.A. van den, Chalos, V., Lingsma, H.F., Zwam, W.H. van, Lugt, A. van der, Oostenbrugge, R.J. van, Dippel, D.W.J., Roos, Y.B.W.E.M., Marquering, H.A., Majoie, C.B.L.M., Fransen, P.S.S., Beumer, D., Yoo, A.J., Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wenner, M.J.H., Walderveen, M.A.A. van, Staals, J., Hofmeijer, J., Oostayen, J.A. van, Nijeholt, G.J.L.A., Boiten, J., Brouwer, P.A., Emmet, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., R.H. lo, Dijk, E.J. van, Vries, J. de, Kort, P.L.M. de, Rooij, W.J.J. van, Berg, J.S.P. van den, Hassell, B.A.A.M. van, Aerden, L.A.M., Dallinga, R.J., Visser, M.C., Bot, J.C.J., Vroomen, P.C., Eshghi, O., Schreuder, T.H.C.M.L., Heijboer, R.J.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Steyerberg, E.W., Flach, H.Z., Sprengers, M.E.S., Jenniskens, S.F.M., Beenen, L.F.M., Berg, R. van den, Koudstaal, P.J., MR CLEAN Investigators, RS: Carim - B05 Cerebral small vessel disease, RS: CARIM - R3.03 - Cerebral small vessel disease, RS: Carim - B06 Imaging, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CARIM - R3.11 - Imaging, MUMC+: MA Neurologie (3), Klinische Neurowetenschappen, MUMC+: MA AIOS Neurologie (9), MUMC+: MA Med Staf Spec Neurologie (9), Graduate School, Radiology and Nuclear Medicine, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ANS - Neurovascular Disorders, Neurology, Radiology and nuclear medicine, VU University medical center, Amsterdam Neuroscience - Neurovascular Disorders, Radiology & Nuclear Medicine, Orthopedics and Sports Medicine, and Public Health

Subjects
medicine.medical_specialty, Population, infarction, intracranial hemorrhages, Infarction, BLOOD-PRESSURE, Tissue plasminogen activator, All institutes and research themes of the Radboud University Medical Center, Hematoma, Internal medicine, medicine, risk factors, atrial fibrillation, education, Stroke, TISSUE-PLASMINOGEN ACTIVATOR, Advanced and Specialized Nursing, HEALTH-CARE PROFESSIONALS, education.field_of_study, business.industry, INTRAVENOUS ALTEPLASE, Other Research Radboud Institute for Health Sciences [Radboudumc 0], blood pressure, Atrial fibrillation, SYMPTOMATIC INTRACRANIAL HEMORRHAGE, Odds ratio, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], medicine.disease, stroke, n/a OA procedure, reperfusion, Blood pressure, THROMBOLYTIC THERAPY, ENDOVASCULAR TREATMENT, Cardiology, RISK-FACTORS, TRIAL, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, medicine.drug, INTRAARTERIAL TREATMENT
Abstract

Background and Purpose— Hemorrhagic transformation (HT) after acute ischemic stroke may cause severe neurological deterioration and affects functional outcome. Identifying patients most likely to suffer from this complication could potentially be used for future treatment selection. Reperfusion after endovascular therapy could be associated with different risk factors for HT than intravenous thrombolytics as these treatments largely differ. In this study, we aimed to identify clinical and imaging markers that are associated with HT subtypes in the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) population. Methods— In this post hoc analysis, all patients with follow-up imaging were included. HT was classified according to ECASS II (European Cooperative Acute Stroke Study). Variables with an association of P Results— Of the 478 out of 500 included patients in this subanalysis, 46% had HT (n=222). Of these, 66% had hemorrhagic infarction (n=147) and 34% PH (n=75). Symptomatic intracranial hemorrhage was observed in 7.3% (n=35) of all patients. Baseline National Institutes of Health Stroke Scale (odds ratio [OR], 1.05,95% CI, 1.01–1.09 per point) and absent/poor collaterals (OR, 1.90; 95% CI, 1.05–3.42) were significantly associated with hemorrhagic infarction. Increased systolic blood pressure (OR, 1.17; 95% CI, 1.05–1.31 per 10 mm Hg) and atrial fibrillation (OR, 1.94; 95% CI, 1.08–3.48) were associated with PH. Increased systolic blood pressure (OR, 1.28; 95% CI, 1.12–1.48) and antiplatelet use (OR, 2.6; 95% CI, 1.08–6.3) were associated with symptomatic intracranial hemorrhage. Conclusions— Clinical and imaging stroke severity parameters were associated with HT, both in hemorrhagic infarction and PH, whereas baseline patients characteristics like systolic blood pressure, atrial fibrillation, and antiplatelet use were only associated with PH or symptomatic intracranial hemorrhage. Clinical Trial Registration— URL: http://www.controlled-trials.com . Unique identifier: ISRCTN10888758.

Published
2019
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7. Intracranial Carotid Artery Calcification and Effect of Endovascular Stroke Treatment MR CLEAN Subgroup Analysis

Author

Compagne, K.C.J., Clephas, P.R.D., Majoie, C.B.L.M., Roos, Y.B.W.E.M., Berkhemer, O.A., Oostenbrugge, R.J. van, Zwam, W.H. van, Es, A.C.G.M. van, Dippel, D.W.J., Lugt, A. van der, Bos, D., Fransen, P.S.S., Beumer, D., Berg, L.A. van den, Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wermer, M.J.H., Walderveen, M.A.A. van, Staals, J., Hofmeijer, E., Oostayen, J.A. van, Nijeholt, G.J.L.A., Boiten, J., Brouwer, P.A., Emmer, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., R.H. lo, Dijk, E.J. van, Vries, J. de, Kort, P.L.M. de, Berg, J.S.P. van den, Rooij, W.J.J. van, Hasselt, B.A.A.M. van, Aerden, L.A.M., Dallinga, R.J., Visser, M.C., Bot, J.C.J., Vroomen, P.C., Eshghi, O., Schreuder, T.H.C.M.L., Heijboer, R.J.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Marquering, H.A., Beenen, L.F., Sprengers, M.E.S., Jenniskens, S.F.M., Berg, R. van den, Yoo, A.J., Koudstaal, P.J., Flach, H.Z., Steyerberg, E.W., Lingsma, H.F., MR CLEAN Investigators, Radiology and nuclear medicine, VU University medical center, Neurology, Amsterdam Neuroscience - Neurovascular Disorders, ACS - Atherosclerosis & ischemic syndromes, MUMC+: MA Neurologie (3), Klinische Neurowetenschappen, RS: CARIM - R3.03 - Cerebral small vessel disease, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CARIM - R3.11 - Imaging, Beeldvorming, MUMC+: MA AIOS Neurologie (9), and MUMC+: MA Med Staf Spec Neurologie (9)

Subjects
Tunica media, medicine.medical_specialty, IMPACT, medicine.medical_treatment, RECANALIZATION, Subgroup analysis, 030204 cardiovascular system & hematology, tomography, Revascularization, DISEASE, 03 medical and health sciences, 0302 clinical medicine, carotid arteries, Modified Rankin Scale, Internal medicine, medicine, ACUTE ISCHEMIC-STROKE, Stroke, Advanced and Specialized Nursing, business.industry, MECHANICAL THROMBECTOMY, Odds ratio, medicine.disease, Tunica intima, stroke, medicine.anatomical_structure, thrombectomy, tunica media, Cardiology, REVASCULARIZATION, TRIAL, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery, Calcification
Abstract

Background and Purpose— Previous studies suggest that intracranial carotid artery calcification (ICAC) volume might influence the clinical outcome of patients after endovascular treatment (EVT) for acute ischemic stroke. Importantly, ICAC can be subtyped into a medial or intimal pattern that may differentially influence the effect of EVT in patients with acute ischemic stroke. Methods— All 500 patients included in the MR CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for acute ischemic stroke in the Netherlands) were evaluated. Volume (mm 3 ) and location pattern (tunica intima or tunica media) of ICAC could be determined on baseline noncontrast computed tomography in 344 patients. Functional outcome at 90 days was assessed with the modified Rankin Scale. Next, we investigated the association of ICAC volume and pattern with functional outcome using adjusted ordinal logistic regression models. Effect modification by EVT was assessed with an interaction term between treatment allocation and ICAC aspect. Results— We found evidence for treatment effect modification by ICAC pattern ( P interaction=0.04). Patients with predominantly medial calcification had better functional outcome with EVT than without this treatment (adjusted common odds ratio, 2.32; 95% CI, 1.23–4.39), but we observed no effect of EVT in patients with predominantly intimal calcifications (adjusted common odds ratio, 0.82; 95% CI, 0.40–1.68). We did not find an association of ICAC volume with functional outcome (adjusted common odds ratio per unit increase ICAC volume 1.01 (95% CI, 0.89–1.13). Moreover, we found no evidence for effect modification by ICAC volume ( P interaction=0.61). Conclusions— The benefit of EVT in acute ischemic stroke patients with a medial calcification pattern is larger than the benefit in patients with an intimal calcification pattern. Clinical Trial Registration— URL: http://www.trialregister.nl . Unique identifier: NTR1804. URL: http://www.isrctn.com . Unique identifier: ISRCTN10888758.

Published
2018
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8. Early effect of intra-arterial treatment in ischemic stroke on aphasia recovery in MR CLEAN

Author

Crijnen, Y.S., Nouwens, F., Lau, L.M. de, Visch-Brink, E.G., Sandt-Koenderman, M.W. van de, Berkhemer, O.A., Fransen, P.S., Beumer, D., Berg, L.A. van den, Lingsma, H.F., Roos, Y.B., Lugt, A. van der, Oostenbrugge, R.J. van, Zwam, W.H. van, Majoie, C.B., Dippel, D.W., Dijk, E.J. van, Radiology and Nuclear Medicine, ANS - Neurovascular Disorders, Other departments, Neurology, Biomedical Engineering and Physics, Rehabilitation Medicine, Radiology & Nuclear Medicine, Public Health, MUMC+: MA AIOS Neurologie (9), RS: CARIM - R3.03 - Cerebral small vessel disease, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: CARIM - R3.11 - Imaging, Beeldvorming, and MUMC+: DA BV Medisch Specialisten Radiologie (9)

Subjects
Male, medicine.medical_specialty, Movement disorders, Severity of Illness Index, law.invention, Brain Ischemia, Brain ischemia, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Aphasia, Internal medicine, Severity of illness, medicine, Journal Article, Humans, 030212 general & internal medicine, Stroke, Aged, Netherlands, Movement Disorders, Endovascular Procedures, Recovery of Function, Middle Aged, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], medicine.disease, Confidence interval, Treatment Outcome, Cardiology, Physical therapy, Arm, Female, Neurology (clinical), medicine.symptom, Motor Deficit, Psychology, 030217 neurology & neurosurgery
Abstract

OBJECTIVE: To investigate the effect of intra-arterial treatment (IAT) on early recovery from aphasia in acute ischemic stroke. We hypothesized that the early effect of IAT on aphasia is smaller than the effect on motor deficits.METHODS: We included patients with aphasia from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN), in which 500 patients with a proximal anterior circulation stroke were randomized to usual care plus IAT (RESULTS: Of the 288 patients with aphasia, 126 were assigned to IAT and 162 to usual care alone. The acOR for improvement of language score at 24 hours was 1.65 (95% confidence interval [CI] 1.05-2.60), and at 1 week 1.86 (95% CI 1.18-2.94). The acOR for improvement of motor deficit at 24 hours was 2.44 (95% CI 1.54-3.88), and at 1 week 2.32 (95% CI 1.43-3.77). The effect of IAT on language deficits was significantly different from the effect on motor deficits at 24 hours and 1 week (p = 0.005 and p = 0.011).CONCLUSIONS: IAT results in better early recovery from aphasia than usual care alone. The early effect of IAT on aphasia is smaller than the effect on motor deficits.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with acute ischemic stroke IAT increases early recovery from aphasia and that the early effect on aphasia, as measured by the NIHSS, is smaller than the effect on motor deficits.

Published
2016
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9. Penumbral imaging and functional outcome in patients with anterior circulation ischaemic stroke treated with endovascular thrombectomy versus medical therapy: a meta-analysis of individual patient-level data

Author

Campbell, B.C., Majoie, C., Albers, G.W., Menon, B.K., Yassi, N., Sharma, G., Zwam, W.H. van, Oostenbrugge, R.J. van, Demchuk, A.M., Guillemin, F., White, P., Davalos, A., Lugt, A. van der, Butcher, K.S., Cherifi, A., Marquering, H.A., Cloud, G., Fernandez, J.M., Madigan, J., Oppenheim, C., Donnan, G.A., Roos, Y., Shankar, J., Lingsma, H., Bonafe, A., Raoult, H., Hernandez-Perez, M., Bharatha, A., Jahan, R., Jansen, O., Richard, S., Levy, E.I., Berkhemer, O.A., Soudant, M., Aja, L., Davis, S.M., Krings, T., Tisserand, M., Roman, L., Tomasello, A., Beumer, D., Brown, S., Liebeskind, D.S., Bracard, S., Muir, K.W., Dippel, D.W., Goyal, M., Saver, J.L., Jovin, T.G., Vries, J. de, Hill, M.D., Mitchell, P.J., Campbell, B.C., Majoie, C., Albers, G.W., Menon, B.K., Yassi, N., Sharma, G., Zwam, W.H. van, Oostenbrugge, R.J. van, Demchuk, A.M., Guillemin, F., White, P., Davalos, A., Lugt, A. van der, Butcher, K.S., Cherifi, A., Marquering, H.A., Cloud, G., Fernandez, J.M., Madigan, J., Oppenheim, C., Donnan, G.A., Roos, Y., Shankar, J., Lingsma, H., Bonafe, A., Raoult, H., Hernandez-Perez, M., Bharatha, A., Jahan, R., Jansen, O., Richard, S., Levy, E.I., Berkhemer, O.A., Soudant, M., Aja, L., Davis, S.M., Krings, T., Tisserand, M., Roman, L., Tomasello, A., Beumer, D., Brown, S., Liebeskind, D.S., Bracard, S., Muir, K.W., Dippel, D.W., Goyal, M., Saver, J.L., Jovin, T.G., Vries, J. de, Hill, M.D., and Mitchell, P.J.

Abstract

Item does not contain fulltext, BACKGROUND: CT perfusion (CTP) and diffusion or perfusion MRI might assist patient selection for endovascular thrombectomy. We aimed to establish whether imaging assessments of irreversibly injured ischaemic core and potentially salvageable penumbra volumes were associated with functional outcome and whether they interacted with the treatment effect of endovascular thrombectomy on functional outcome. METHODS: In this systematic review and meta-analysis, the HERMES collaboration pooled patient-level data from all randomised controlled trials that compared endovascular thrombectomy (predominantly using stent retrievers) with standard medical therapy in patients with anterior circulation ischaemic stroke, published in PubMed from Jan 1, 2010, to May 31, 2017. The primary endpoint was functional outcome, assessed by the modified Rankin Scale (mRS) at 90 days after stroke. Ischaemic core was estimated, before treatment with either endovascular thrombectomy or standard medical therapy, by CTP as relative cerebral blood flow less than 30% of normal brain blood flow or by MRI as an apparent diffusion coefficient less than 620 mum(2)/s. Critically hypoperfused tissue was estimated as the volume of tissue with a CTP time to maximum longer than 6 s. Mismatch volume (ie, the estimated penumbral volume) was calculated as critically hypoperfused tissue volume minus ischaemic core volume. The association of ischaemic core and penumbral volumes with 90-day mRS score was analysed with multivariable logistic regression (functional independence, defined as mRS score 0-2) and ordinal logistic regression (functional improvement by at least one mRS category) in all patients and in a subset of those with more than 50% endovascular reperfusion, adjusted for baseline prognostic variables. The meta-analysis was prospectively designed by the HERMES executive committee, but not registered. FINDINGS: We identified seven studies with 1764 patients, all of which were included in the meta-analysis

Published
2019

10. A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

Author

Berkhemer, O.A., Fransen, P.S.S., Beumer, D., Berg, L.A. van den, Lingsma, H.F., Yoo, A.J., Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wermer, M.J.H., Walderveen, M.A.A. van, Staals, J., Hofmeijer, J., Oostayen, J.A. van, Nijeholt, G.J.L.A., Boiten, J., Brouwer, P.A., Emmer, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., R.H. lo, Dijk, E.J. van, Vries, J. de, Kort, P.L.M. de, Rooij, W.J.J. van, Berg, J.S.P. van den, Hasselt, B.A.A.M. van, Aerden, L.A.M., Dallinga, R.J., Visser, M.C., Bot, J.C.J., Vroomen, P.C., Eshghi, O., Schreuder, T.H.C.M.L., Heijboer, R.J.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Steyerberg, E.W., Flach, H.Z., Marquering, H.A., Sprengers, M.E.S., Jenniskens, S.F.M., Beenen, L.F.M., Berg, R. van den, Koudstaal, P.J., Zwam, W.H. van, Roos, Y.B.W.E.M., Lugt, A. van der, Oostenbrugge, R.J. van, Majoie, C.B.L.M., Dippel, D.W.J., MR CLEAN Investigators, Clinical Neurophysiology, Faculty of Science and Technology, ACS - Amsterdam Cardiovascular Sciences, ANS - Amsterdam Neuroscience, Radiology and Nuclear Medicine, Graduate School, Neurology, Biomedical Engineering and Physics, Other Research, Other departments, Radiology and nuclear medicine, NCA - neurodegeneration, Public Health, Radiology & Nuclear Medicine, RS: CARIM - R3 - Vascular biology, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA AIOS Neurologie (9), Interne Geneeskunde, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), MUMC+: MA Arts Assistenten Obstetrie Gynaecologie (9), Huisartsgeneeskunde, NUTRIM, and MUMC+: DA BV Medisch Specialisten Radiologie (9)

Subjects
medicine.medical_specialty, Solitaire Cryptographic Algorithm, Randomization, RECANALIZATION, THERAPY, law.invention, Randomized controlled trial, Modified Rankin Scale, law, SCORE, medicine, OCCLUSIONS, IR-98132, Intracerebral hemorrhage, business.industry, Other Research Radboud Institute for Health Sciences [Radboudumc 0], General Medicine, Odds ratio, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], medicine.disease, Confidence interval, Surgery, Clinical trial, Anesthesia, ENDOVASCULAR TREATMENT, METIS-313119, CEREBRAL INFARCT, business
Abstract

Contains fulltext : 153000.pdf (Publisher’s version ) (Open Access) BACKGROUND: In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. METHODS: We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). RESULTS: We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. CONCLUSIONS: In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).

Published
2015
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11. Two-Year Outcome after Endovascular Treatment for Acute Ischemic Stroke

Author

Berg, L.A. van den, Dijkgraaf, M.G., Berkhemer, O.A., Fransen, P.S., Beumer, D., Lingsma, H.F., Majoie, C.B., Dippel, D.W., Lugt, A. van der, Oostenbrugge, R.J. van, Dijk, E.J. van, Zwam, W.H. van, Roos, Y.B., Neurology, Radiology & Nuclear Medicine, Public Health, Graduate School, APH - Methodology, Clinical Research Unit, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Biomedical Engineering and Physics, Other Research, ARD - Amsterdam Reproduction and Development, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Microcirculation, ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, MUMC+: MA AIOS Neurologie (9), MUMC+: MA Neurologie (3), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, RS: CARIM - R3.03 - Cerebral small vessel disease, Klinische Neurowetenschappen, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CARIM - R3.11 - Imaging, and Beeldvorming

Subjects
Male, medicine.medical_specialty, Activities of daily living, Randomization, MEDLINE, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, THERAPY, law.invention, Brain Ischemia, Brain ischemia, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Randomized controlled trial, Quality of life, MODIFIED RANKIN SCALE, Modified Rankin Scale, law, Internal medicine, Activities of Daily Living, Medicine, Humans, Mortality, Stroke, Aged, business.industry, Endovascular Procedures, General Medicine, THROMBECTOMY, Middle Aged, medicine.disease, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], INTRAVENOUS T-PA, Treatment Outcome, Physical therapy, Quality of Life, TRIAL, Female, business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Item does not contain fulltext BACKGROUND: Several trials involving patients with acute ischemic stroke have shown better functional outcomes with endovascular treatment than with conventional treatment at 90 days after initiation of treatment. However, results on long-term clinical outcomes are lacking. METHODS: We assessed clinical outcomes 2 years after patients were randomly assigned to receive either endovascular treatment (intervention group) or conventional treatment (control group) for acute ischemic stroke. The primary outcome was the score on the modified Rankin scale at 2 years; this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). Secondary outcomes included all-cause mortality and the quality of life at 2 years, as measured by means of a health utility index that is based on the European Quality of Life-5 Dimensions questionnaire (scores range from -0.329 to 1, with higher scores indicating better health). RESULTS: Of the 500 patients who underwent randomization in the original trial, 2-year data for this extended follow-up trial were available for 391 patients (78.2%) and information on death was available for 459 patients (91.8%). The distribution of outcomes on the modified Rankin scale favored endovascular treatment over conventional treatment (adjusted common odds ratio, 1.68; 95% confidence interval [CI], 1.15 to 2.45; P=0.007). There was no significant difference between the treatment groups in the percentage of patients who had an excellent outcome (i.e., a modified Rankin scale score of 0 or 1). The mean quality-of-life score was 0.48 among patients randomly assigned to endovascular treatment as compared with 0.38 among patients randomly assigned to conventional treatment (mean difference, 0.10; 95% CI, 0.03 to 0.16; P=0.006). The cumulative 2-year mortality rate was 26.0% in the intervention group and 31.0% in the control group (adjusted hazard ratio, 0.9; 95% CI, 0.6 to 1.2; P=0.46). CONCLUSIONS: In this extended follow-up trial, the beneficial effect of endovascular treatment on functional outcome at 2 years in patients with acute ischemic stroke was similar to that reported at 90 days in the original trial. (Funded by the Netherlands Organization for Health Research and Development and others; MR CLEAN Current Controlled Trials number, ISRCTN10888758 , and Netherlands Trial Register number, NTR1804 , and MR CLEAN extended follow-up trial Netherlands Trial Register number, NTR5073 .).

Published
2017

12. Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study

Author

van den Berg, LA, Dijkgraaf, MGW, Berkhemer, Olvert, Fransen, Puck, Beumer, D, Lingsma, Hester, Majoie, C B M, Dippel, Diederik, van der Lugt, Aad, van Oostenbrugge, RJ, Zwam, WH, Roos, YBWEM, Invesigators, Mr Clean, MUMC+: MA AIOS Neurologie (9), MUMC+: MA Neurologie (3), Klinische Neurowetenschappen, RS: CARIM - R3.03 - Cerebral small vessel disease, RS: CARIM - R3.11 - Imaging, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), ANS - Neurovascular Disorders, Graduate School, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, APH - Amsterdam Public Health, Clinical Research Unit, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, Neurology, Public Health, Radiology & Nuclear Medicine, Radiology and nuclear medicine, and Amsterdam Neuroscience - Neurovascular Disorders

Subjects
Male, Research design, Time Factors, Medicine (miscellaneous), Kaplan-Meier Estimate, Brain Ischemia, law.invention, Brain ischemia, Disability Evaluation, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, Risk Factors, law, Modified Rankin Scale, Thrombolytic Therapy, Pharmacology (medical), 030212 general & internal medicine, Stroke, Netherlands, Thrombectomy, Aged, 80 and over, Endovascular Procedures, Treatment Outcome, Research Design, Cerebrovascular Circulation, Data Interpretation, Statistical, Female, Stents, medicine.medical_specialty, Acute ischemic stroke, Update, Intravenous thrombolysis, 03 medical and health sciences, medicine, Humans, Endovascular treatment, cardiovascular diseases, Artery occlusion, Aged, Proportional Hazards Models, Proportional hazards model, business.industry, Recovery of Function, medicine.disease, Surgery, Clinical trial, Logistic Models, Multivariate Analysis, Mechanical thrombectomy, business, 030217 neurology & neurosurgery
Abstract

MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves clinical outcome at three months. However, limited data are available on long-term clinical outcome. We aimed to estimate the effect of endovascular treatment on functional outcome at two-year follow-up in patients with acute ischemic stroke. Secondly, we aimed to assess the effect of endovascular treatment on major vascular events and mortality during two years of follow-up. MR CLEAN is a multicenter clinical trial with randomized treatment allocation, open-label treatment, and blinded endpoint evaluation. Patients included were 18 years or older with acute ischemic stroke caused by a proven anterior proximal artery occlusion who could be treated within six hours after stroke onset. The intervention contrast was endovascular treatment and usual care versus no endovascular treatment and usual care. The current study extended the follow-up duration from three months to two years. The primary outcome is the score on the modified Rankin scale at two years. Secondary outcomes include all-cause mortality and the occurrence of major vascular events within two years of follow-up. The results of our study provide information on the long-term clinical effectiveness of endovascular treatment, which may have implications for individual treatment decisions and estimates of cost-effectiveness. NTR1804 . Registered on 7 May 2009; ISRCTN10888758 . Registered on 24 July 2012 (main MR CLEAN trial); NTR5073 . Registered on 26 February 2015 (extended follow-up study).

Published
2016
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14. Is Intra-Arterial Treatment for Acute Ischemic Stroke Less Effective in Women than in Men?

Author

Ridder, I.R. de, Fransen, P.S.S., Beumer, D., Berkhemer, O.A., Berg, L.A. van den, Wermer, M.J., Lingsma, H., Zwam, W.H. van, Roos, Y.B., Oostenbrugge, R.J. van, Majoie, C.B., Lugt, A. van der, Dippel, D.W.J., MR CLEAN Investigators, Radiology and Nuclear Medicine, Amsterdam Cardiovascular Sciences, Amsterdam Neuroscience - Neurovascular Disorders, Graduate School, Neurology, Public Health, Radiology & Nuclear Medicine, MUMC+: MA AIOS Neurologie (9), RS: CARIM - R3.11 - Imaging, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CARIM - R3.03 - Cerebral small vessel disease, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Klinische Neurowetenschappen, and MUMC+: MA Med Staf Spec Neurologie (9)

Subjects
medicine.medical_specialty, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Modified Rankin Scale, law, Internal medicine, medicine, Endovascular treatment, 030212 general & internal medicine, Adverse effect, Acute ischemic stroke, Outcome, Original Paper, Cerebral infarction, business.industry, Odds ratio, medicine.disease, Confidence interval, Physical therapy, Surgery, Sex, Neurology (clinical), Ordered logit, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract

Introduction: Stroke etiology and outcome after ischemic stroke differ between men and women. We examined if sex modifies the effect of intra-arterial treatment (IAT) in a randomized clinical trial of IAT for acute ischemic stroke in the Netherlands (MR CLEAN). Patients and Methods: The primary outcome was the score on the modified Rankin scale at 90 days. We tested for interaction between sex and treatment and estimated the treatment effect by sex with multiple ordinal logistic regression with adjustment for prognostic factors. Results: All 500 patients were included in the analysis; 292 (58.4%) were men. The treatment effect (adjusted common odds ratio) was 2.39 [95% confidence interval (CI) 1.55-3.68] in men and 0.99 (95% CI 0.60-1.66) in women (pinteraction = 0.016). In women, mortality was higher in the intervention group than in the control group (24 vs. 15%, p = 0.07). Serious adverse events occurred more often in women than in men undergoing intervention. There were no differences in neuro-imaging outcomes. Discussion and Conclusion: Contrary to other studies, we found a significant interaction between sex and treatment effect in the MR CLEAN trial. Pooled analyses of all published thrombectomy trials did not confirm this finding. In MR CLEAN, women seem to have a slightly more unfavorable profile, causing higher mortality and more serious adverse events, but insufficient to explain the absence of an overall effect. This suggests a play of chance and makes it clear that IAT should not be withheld in women.

Published
2016

15. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke A Randomized Clinical Trial

Author

Fransen, P.S.S., Berkhemer, O.A., Lingsma, H.F., Beumer, D., Berg, L.A. van den, Yoo, A.J., Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wermer, M.J.H., Walderveen, M.A.A. van, Staals, J., Hofmeijer, J., Oostayen, J.A. van, Nijeholt, G.J.L.A., Boiten, J., Brouwer, P.A., Emmer, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., R.H. lo, Dijk, E.J. van, Vries, J. de, Kort, P.L.M. de, Berg, J.S.P. van den, Hasselt, B.A.A.M. van, Aerden, L.A.M., Dallinga, R.J., Visser, M.C., Bot, J.C.J., Vroomen, P.C., Eshghi, O., Schreuder, T.H.C.M.L., Heijboer, R.J.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Steyerberg, E.W., Flach, H.Z., Marquering, H.A., Sprengers, M.E.S., Jenniskens, S.F.M., Beenen, L.F.M., Berg, R. van den, Koudstaal, P.J., Zwam, W.H. van, Roos, Y.B.W.E.M., Oostenbrugge, R.J. van, Majoie, C.B.L.M., Lugt, A. van der, Dippel, D.W.J., Multictr Randomized Clin Trial End, Other departments, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Graduate School, Neurology, Biomedical Engineering and Physics, Other Research, MUMC+: MA AIOS Neurologie (9), RS: CARIM - R3.03 - Cerebral small vessel disease, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: CARIM - R3.11 - Imaging, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Clinical Neurophysiology, Faculty of Science and Technology, Radiology and nuclear medicine, Amsterdam Neuroscience - Neurovascular Disorders, Radiology & Nuclear Medicine, and Public Health

Subjects
Male, Time Factors, ANGIOGRAPHIC REPERFUSION, 030204 cardiovascular system & hematology, THERAPY, law.invention, Brain Ischemia, 0302 clinical medicine, Randomized controlled trial, Modified Rankin Scale, law, Interquartile range, Non-U.S. Gov't, 610 Medicine & health, Stroke, OUTCOMES, Research Support, Non-U.S. Gov't, Endovascular Procedures, Atrial fibrillation, Middle Aged, THROMBECTOMY, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], Multicenter Study, Treatment Outcome, Anesthesia, Tissue Plasminogen Activator, Randomized Controlled Trial, Female, IMAGING SELECTION, INTERVENTION, medicine.medical_specialty, Research Support, METIS-320854, 03 medical and health sciences, Reperfusion therapy, Fibrinolytic Agents, SDG 3 - Good Health and Well-being, medicine, Journal Article, Humans, Aged, Intention-to-treat analysis, COMPLEXITY, business.industry, Other Research Radboud Institute for Health Sciences [Radboudumc 0], medicine.disease, Surgery, INTRAVENOUS T-PA, IR-103531, ENDOVASCULAR TREATMENT, Reperfusion, Neurology (clinical), business, 030217 neurology & neurosurgery, Fibrinolytic agent
Abstract

Item does not contain fulltext IMPORTANCE: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. OBJECTIVE: To evaluate the influence of time from stroke onset to the start of treatment and from stroke onset to reperfusion on the effect of IAT. DESIGN, SETTING, AND PARTICIPANTS: The Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) was a multicenter, randomized clinical open-label trial of IAT vs no IAT in 500 patients. The time to the start of treatment was defined as the time from onset of symptoms to groin puncture (TOG). The time from onset of treatment to reperfusion (TOR) was defined as the time to reopening the vessel occlusion or the end of the procedure in cases for which reperfusion was not achieved. Data were collected from December 3, 2010, to June 3, 2014, and analyzed (intention to treat) from July 1, 2014, to September 19, 2015. MAIN OUTCOMES AND MEASURES: Main outcome was the modified Rankin Scale (mRS) score for functional outcome (range, 0 [no symptoms] to 6 [death]). Multiple ordinal logistic regression analysis estimated the effect of treatment and tested for the interaction of time to randomization, TOG, and TOR with treatment. The effect of treatment as a risk difference on reaching independence (mRS score, 0-2) was computed as a function of TOG and TOR. Calculations were adjusted for age, National Institutes of Health Stroke Scale score, previous stroke, atrial fibrillation, diabetes mellitus, and intracranial arterial terminus occlusion. RESULTS: Among 500 patients (58% male; median age, 67 years), the median TOG was 260 (interquartile range [IQR], 210-311) minutes; median TOR, 340 (IQR, 274-395) minutes. An interaction between TOR and treatment (P = .04) existed, but not between TOG and treatment (P = .26). The adjusted risk difference (95% CI) was 25.9% (8.3%-44.4%) when reperfusion was reached at 3 hours, 18.8% (6.6%-32.6%) at 4 hours, and 6.7% (0.4%-14.5%) at 6 hours. CONCLUSION AND RELEVANCE: For every hour of reperfusion delay, the initially large benefit of IAT decreases; the absolute risk difference for a good outcome is reduced by 6% per hour of delay. Patients with acute ischemic stroke require immediate diagnostic workup and IAT in case of intracranial arterial vessel occlusion. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1804.

Published
2016
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16. The effect of anesthetic management during intra-arterial therapy for acute stroke in MR CLEAN

Author

Berkhemer, Olvert, van den Berg, LA, Fransen, Puck, Beumer, D, Yoo, AJ, Lingsma, Hester, Schonewille, WJ, van den Berg, R, Wermer, MJH, Boiten, J, Nijeholt, GJL, Nederkoorn, PJ, Hollmann, MW, Zwam, WH, van der Lugt, Aad, van Oostenbrugge, RJ, Majoie, CBLM, Dippel, Diederik, Roos, YBWEM, Neurology, Public Health, and Radiology & Nuclear Medicine

Abstract

Background: The aim of the current study was to assess the influence of anesthetic management on the effect of treatment in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN). Methods: MR CLEAN was amulticenter, randomized, open-label trial of intra-arterial therapy (IAT) vs no IAT. The intended anesthetic management at the start of the procedure was used for this post hoc analysis. The primary effect parameter was the adjusted common odds ratio (acOR) for a shift in direction of a better outcome on the modified Rankin Scale (mRS) at 90 days, estimated with multivariable ordinal logistic regression analysis, which included a term for general anesthesia (GA). Results: GA was associated with significant (p=0.011) effect modification, resulting in estimated decrease of 51%(95% confidence interval [CI] 31%-86%) in treatment effect compared to non-GA. We found a shift in the distribution on the mRS in favor of non-GA compared to control group (acOR 2.18 [95% CI 1.49-3.20]). The shift in distribution between GA and control group was in a similar direction (acOR 1.12 [95% CI 0.71-1.78]) with loss of statistical significance. Conclusions: In this post hoc analysis, we found that the type of anesthetic management influences outcome following IAT. Only treatment without general anesthesia was associated with a significant treatment benefit in MR CLEAN. Classification of evidence: This study provides Class II evidence that for patients with acute ischemic stroke undergoing IAT, mRS scores at 90 days improve only in patients treated without GA.

Published
2016

18. The relationship between interventionists' experience and clinical and radiological outcome in intra-arterial treatment for acute ischemic stroke. A MR CLEAN pretrial survey

Author

Beumer, D., Boxtel, T.H. van, Schipperen, S., Zwam, W.H. van, Lycklama, A.N.G.J., Brouwer, P.A., Jenniskens, S.F.M., Schonewille, W.J., Vos, J.A., Lugt, A. van der, Roos, Y.B., Majoie, C.B., Oostenbrugge, R.J. van, Dippel, D.W., Investigators, M.C.P., Beumer, D., Boxtel, T.H. van, Schipperen, S., Zwam, W.H. van, Lycklama, A.N.G.J., Brouwer, P.A., Jenniskens, S.F.M., Schonewille, W.J., Vos, J.A., Lugt, A. van der, Roos, Y.B., Majoie, C.B., Oostenbrugge, R.J. van, Dippel, D.W., and Investigators, M.C.P.

Abstract

Item does not contain fulltext, BACKGROUND: Intra-arterial treatment in acute ischemic stroke is safe and effective as recently shown in several randomized clinical trials. The level of experience of the interventionist performing the IAT procedure has not been studied. The present study investigates effects of interventionists' experience on technical aspects of the procedure and clinical outcome of the patient. METHODS: In this study of 313 patients with a proximal intracranial arterial anterior circulation occlusion, treated in the Netherlands from 2002 until participation in the Multicenter Randomized Clinical trial of Endovascular treatment for acute ischemic stroke (MR CLEAN), data were collected retrospectively. The association of the senior interventionists' experience with duration of the procedure, adverse events, recanalization, neurological outcome, and functional outcome at discharge was analyzed. Multiple regression models adjusted for age, sex, stroke severity, carotid terminus occlusion, use of a retrievable stent and onset to door time were used. RESULTS: No association between interventionists' experience and recanalization, neurological outcome, or functional outcome was observed in a strict selection of patients. This strict selection include a start of intra-arterial treatment within 6h, no coagulation disturbances, systolic blood pressure<185mmHg and diastolic blood pressure<110mmHg), blood glucose level between 2.7 and 22.2mmol/L and the existence of a proximal intracranial occlusion. However, significant shorter procedure times were found with more experienced interventionists' [adjusted beta coefficient -0.67, 95% CI: -1.24 to -0.11], when using less strict inclusion criteria. CONCLUSION: No significant relation between the level of experience and either serious neurologic adverse events or poor outcomes was observed in this study of treatments by interventionists with experience of <50 previous procedures. We need further research to explore the relation of much higher le

Published
2017

19. Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands).

Author

Mulder, M.J.H.L., Ergezen, S., Lingsma, H.F., Berkhemer, O.A., Fransen, P.S., Beumer, D., Berg, L.A. van den, Lycklama a Nijeholt, G.J., Emmer, B.J., Worp, H.B. van der, Nederkoorn, P.J., Roos, Y.B., Oostenbrugge, R.J. van, Zwam, W.H. van, Majoie, C.B., Lugt, A. van der, Dippel, D.W., Wermer, M.J., Dijk, E.J. van, Vries, J. de, Jenniskens, S.F.M., et al., Mulder, M.J.H.L., Ergezen, S., Lingsma, H.F., Berkhemer, O.A., Fransen, P.S., Beumer, D., Berg, L.A. van den, Lycklama a Nijeholt, G.J., Emmer, B.J., Worp, H.B. van der, Nederkoorn, P.J., Roos, Y.B., Oostenbrugge, R.J. van, Zwam, W.H. van, Majoie, C.B., Lugt, A. van der, Dippel, D.W., Wermer, M.J., Dijk, E.J. van, Vries, J. de, Jenniskens, S.F.M., and et al.

Abstract

01 juli 2017, Item does not contain fulltext, BACKGROUND AND PURPOSE: High blood pressure (BP) is associated with poor outcome and the occurrence of symptomatic intracranial hemorrhage in acute ischemic stroke. Whether BP influences the benefit or safety of intra-arterial treatment (IAT) is not known. We aimed to assess the relation of BP with functional outcome, occurrence of symptomatic intracranial hemorrhage and effect of IAT. METHODS: This is a post hoc analysis of the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands). BP was measured at baseline, before IAT or stroke unit admission. We estimated the association of baseline BP with the score on the modified Rankin Scale at 90 days and safety parameters with ordinal and logistic regression analysis. Effect of BP on the effect of IAT was tested with multiplicative interaction terms. RESULTS: Systolic BP (SBP) had the best correlation with functional outcome. This correlation was U-shaped; both low and high baseline SBP were associated with poor functional outcome. Higher SBP was associated with symptomatic intracranial hemorrhage (adjusted odds ratio, 1.25 for every 10 mm Hg higher SBP [95% confidence interval, 1.09-1.44]). Between SBP and IAT, there was no interaction for functional outcome, symptomatic intracranial hemorrhage, or other safety parameters; the absolute benefit of IAT was evident for the whole SBP range. The same was found for diastolic BP. CONCLUSIONS: BP does not affect the benefit or safety of IAT in patients with acute ischemic stroke caused by proximal intracranial vessel occlusion. Our data provide no arguments to withhold or delay IAT based on BP. CLINICAL TRIAL REGISTRATION: URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758.

Published
2017

20. Quality of life after intra-arterial treatment for acute ischemic stroke in the MR CLEAN trial—Update

Author

Schreuders, J. (Jennifer), Van Den Berg, L.A. (Lucie A.), Fransen, P.S.S. (Puck), Berkhemer, O.A. (Olvert), Beumer, D. (Debbie), Lingsma, H.F. (Hester), Oostenbrugge, R.J. (Robert) van, Zwam, W.H. (Wim) van, Majoie, C.B. (Charles), Lugt, A. (Aad) van der, Kort, P.L.M. (Paul) de, Roos, Y.B.W.E.M. (Yvo), Dippel, D.W.J. (Diederik), Schreuders, J. (Jennifer), Van Den Berg, L.A. (Lucie A.), Fransen, P.S.S. (Puck), Berkhemer, O.A. (Olvert), Beumer, D. (Debbie), Lingsma, H.F. (Hester), Oostenbrugge, R.J. (Robert) van, Zwam, W.H. (Wim) van, Majoie, C.B. (Charles), Lugt, A. (Aad) van der, Kort, P.L.M. (Paul) de, Roos, Y.B.W.E.M. (Yvo), and Dippel, D.W.J. (Diederik)

Abstract

Background: Health-related quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire was one of the secondary outcomes in the Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (MR CLEAN). We reported no statistically significant difference in EuroQol Group 5-Dimension Self-Report Questionnaire score between the intervention and control groups, but deaths were not included. Aims: Reanalyze the effect of intra-arterial treatment for large vessel occlusion in acute ischemic stroke patients on health-related quality of life in more detail. We now include patients who died during follow-up. Methods: The EuroQol Group 5-Dimension Self-Report Questionnaire questionnaires were obtained 90 days after treatment. We used the Dutch tariff to derive a utility index from the EuroQol Group 5-Dimension Self-Report Questionnaire score. Treatment effect was estimated with the Mann–Whitney U test and linear regression. The effect of treatment on the distribution of EuroQol Group 5-Dimension Self-Report Questionnaire dimension scores was assessed with ordinal logistic regression. Results: We obtained EuroQol Group 5-Dimension Self-Report Questionnaire scores from 457 (91.7%) of the 500 patients, including 108 who died before follow-up. Median EuroQol Group 5-Dimension Self-Report Questionnaire score in the intervention group was 0.57, and 0.39 in the control group (p = 0.03). Treatment effect estimated with linear regression was 0.07 (95%CI: −0.001 to 0.143). Treatment specifically affected EuroQol Group 5-Dimension Self-Report Questionnaire dimensions “mobility” (OR: 0.43, 95%CI: 0.29–0.66), “self-care” (OR: 0.60, 95%CI: 0.41–0.89), and “usual activities” (OR: 0.53, 95%CI: 0.36–0.79). Conclusion: Treatment had a limited effect on quality of life, as measured with the EuroQol Group 5-Dimension Self-Report Questionnaire. Nevertheless, patients with acute ischemic stroke caused by an intracranial occlu

Published
2017
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21. Collateral Status on Baseline Computed Tomographic Angiography and Intra-Arterial Treatment Effect in Patients With Proximal Anterior Circulation Stroke

Author

Berkhemer, O.A., Jansen, I.G., Beumer, D., Fransen, P.S., Berg, L.A. van den, Yoo, A.J., Lingsma, H.F., Sprengers, M.E., Jenniskens, S.F.M., Lycklama-a-Nijeholt, G.J., Walderveen, M.A. van, Berg, R. van den, Bot, J.C., Beenen, L.F., Boers, A.M., Slump, C.H., Roos, Y.B., Oostenbrugge, R.J. van, Dippel, D.W., Lugt, A. van der, Zwam, W.H. van, Marquering, H.A., Majoie, C.B., Dijk, E.J. van, et al., Berkhemer, O.A., Jansen, I.G., Beumer, D., Fransen, P.S., Berg, L.A. van den, Yoo, A.J., Lingsma, H.F., Sprengers, M.E., Jenniskens, S.F.M., Lycklama-a-Nijeholt, G.J., Walderveen, M.A. van, Berg, R. van den, Bot, J.C., Beenen, L.F., Boers, A.M., Slump, C.H., Roos, Y.B., Oostenbrugge, R.J. van, Dippel, D.W., Lugt, A. van der, Zwam, W.H. van, Marquering, H.A., Majoie, C.B., Dijk, E.J. van, and et al.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: Recent randomized trials have proven the benefit of intra-arterial treatment (IAT) with retrievable stents in acute ischemic stroke. Patients with poor or absent collaterals (preexistent anastomoses to maintain blood flow in case of a primary vessel occlusion) may gain less clinical benefit from IAT. In this post hoc analysis, we aimed to assess whether the effect of IAT was modified by collateral status on baseline computed tomographic angiography in the Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN). METHODS: MR CLEAN was a multicenter, randomized trial of IAT versus no IAT. Primary outcome was the modified Rankin Scale at 90 days. The primary effect parameter was the adjusted common odds ratio for a shift in direction of a better outcome on the modified Rankin Scale. Collaterals were graded from 0 (absent) to 3 (good). We used multivariable ordinal logistic regression analysis with interaction terms to estimate treatment effect modification by collateral status. RESULTS: We found a significant modification of treatment effect by collaterals (P=0.038). The strongest benefit (adjusted common odds ratio 3.2 [95% confidence intervals 1.7-6.2]) was found in patients with good collaterals (grade 3). The adjusted common odds ratio was 1.6 [95% confidence intervals 1.0-2.7] for moderate collaterals (grade 2), 1.2 [95% confidence intervals 0.7-2.3] for poor collaterals (grade 1), and 1.0 [95% confidence intervals 0.1-8.7] for patients with absent collaterals (grade 0). CONCLUSIONS: In MR CLEAN, baseline computed tomographic angiography collateral status modified the treatment effect. The benefit of IAT was greatest in patients with good collaterals on baseline computed tomographic angiography. Treatment benefit appeared less and may be absent in patients with absent or poor collaterals. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl and http://www.controlled-tria

Published
2016

22. Clot Burden Score on Baseline Computerized Tomographic Angiography and Intra-Arterial Treatment Effect in Acute Ischemic Stroke

Author

Treurniet, K.M., Yoo, A.J., Berkhemer, O.A., Lingsma, H.F., Boers, A.M., Fransen, P.S., Beumer, D., Berg, L.A. van den, Sprengers, M.E., Jenniskens, S.F.M., Lycklama, A.N.G.J., Walderveen, M.A. van, Bot, J.C., Beenen, L.F., Berg, R. van den, Zwam, W.H. van, Lugt, A. van der, Oostenbrugge, R.J. van, Dippel, D.W., Roos, Y.B., Marquering, H.A., Majoie, C.B., Dijk, E.J. van, Vries, J. de, et al., Treurniet, K.M., Yoo, A.J., Berkhemer, O.A., Lingsma, H.F., Boers, A.M., Fransen, P.S., Beumer, D., Berg, L.A. van den, Sprengers, M.E., Jenniskens, S.F.M., Lycklama, A.N.G.J., Walderveen, M.A. van, Bot, J.C., Beenen, L.F., Berg, R. van den, Zwam, W.H. van, Lugt, A. van der, Oostenbrugge, R.J. van, Dippel, D.W., Roos, Y.B., Marquering, H.A., Majoie, C.B., Dijk, E.J. van, Vries, J. de, and et al.

Abstract

Item does not contain fulltext, BACKGROUND AND PURPOSE: A high clot burden score (CBS) is associated with favorable outcome after intravenous treatment for acute ischemic stroke. The added benefit of intra-arterial treatment might be less in these patients. The aim of this exploratory post hoc analysis was to assess the relation of CBS with neurological improvement and endovascular treatment effect. METHODS: For 499 of 500 patients in the MR CLEAN study (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), the CBS was determined. Ordinal logistic regression models with and without main baseline prognostic variables were used to assess the association between CBS (continuous or dichotomized at CBS of 6) and a shift toward better outcome on the modified Rankin Scale. The model without main baseline prognostic variables only included treatment allocation and CBS. Models with and without a multiplicative interaction term of CBS and treatment were compared using the chi2 test to assess treatment effect modification by CBS. RESULTS: Higher CBS was associated with a shift toward better outcome on the modified Rankin Scale; adjusted common odds ratio per point CBS was 1.12 (95% confidence interval, 1.04-1.20]. Dichotomized CBS had an adjusted common odds ratio of 1.67 (95% confidence interval, 1.12-2.51). Both effect estimates were slightly attenuated by adding baseline prognostic variables. The addition of the interaction terms did not significantly improve the fit of the models. There was a small and insignificant increase of intra-arterial treatment efficacy in the high CBS group. CONCLUSIONS: A higher CBS is associated with improved outcome and may be used as a prognostic marker. We found no evidence that CBS modifies the effect of intra-arterial treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR1804. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758.

Published
2016

23. The effect of age on outcome after intra-arterial treatment in acute ischemic stroke: a MR CLEAN pretrial study

Author

Beumer, D., Rozeman, A.D., Lycklama, A.N.G.J., Brouwer, P.A., Jenniskens, S.F.M., Algra, A., Boiten, J., Schonewille, W., Oostenbrugge, R.J. van, Dippel, D.W., Zwam, W.H. van, et al., Beumer, D., Rozeman, A.D., Lycklama, A.N.G.J., Brouwer, P.A., Jenniskens, S.F.M., Algra, A., Boiten, J., Schonewille, W., Oostenbrugge, R.J. van, Dippel, D.W., Zwam, W.H. van, and et al.

Abstract

Contains fulltext : 171716.pdf (publisher's version ) (Open Access), BACKGROUND: In recent randomized controlled trials (RCTs) intra-arterial treatment (IAT) has been proven effective and safe for patients with acute ischemic stroke (AIS). So far, there seemed to be no interaction between older age (>80) and main treatment effect. We studied the association of older age with outcome and adverse events after IAT in a cohort of intra arterially treated patients. METHODS AND FINDINGS: Data from all AIS patients with proven proximal anterior circulation cerebral artery occlusion who were intra arterially treated between 2002 until the start of the MR CLEAN trial were studied retrospectively. Duration of the procedure, recanalization (Thrombolysis In Cerebral Infarction score (TICI)), early neurological recovery (i.e. decrease on NIHSS of >/= 8 points) after one week or at discharge, good functional outcome at discharge by modified Rankin Scale (mRS

Published
2016

24. Effect of baseline Alberta Stroke Program Early CT Score on safety and efficacy of intra-arterial treatment: a subgroup analysis of a randomised phase 3 trial (MR CLEAN)

Author

Yoo, A.J., Berkhemer, O.A., Fransen, P.S., Berg, L.A. van den, Beumer, D., Lingsma, H.F., Schonewille, W.J., Sprengers, M.E., Berg, R. van den, Walderveen, M.A. van, Beenen, L.F., Wermer, M.J., Nijeholt, G.J., Boiten, J., Jenniskens, S.F.M., Bot, J.C., Boers, A.M., Marquering, H.A., Roos, Y.B., Oostenbrugge, R.J. van, Dippel, D.W., Lugt, A. van der, Zwam, W.H. van, Majoie, C.B., et al., Yoo, A.J., Berkhemer, O.A., Fransen, P.S., Berg, L.A. van den, Beumer, D., Lingsma, H.F., Schonewille, W.J., Sprengers, M.E., Berg, R. van den, Walderveen, M.A. van, Beenen, L.F., Wermer, M.J., Nijeholt, G.J., Boiten, J., Jenniskens, S.F.M., Bot, J.C., Boers, A.M., Marquering, H.A., Roos, Y.B., Oostenbrugge, R.J. van, Dippel, D.W., Lugt, A. van der, Zwam, W.H. van, Majoie, C.B., and et al.

Abstract

Item does not contain fulltext, BACKGROUND: Whether infarct size modifies intra-arterial treatment effect is not certain, particularly in patients with large infarcts. We examined the effect of the baseline Alberta Stroke Program Early CT Score (ASPECTS) on the safety and efficacy of intra-arterial treatment in a subgroup analysis of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN). METHODS: MR CLEAN was a randomised, controlled, open-label, phase 3 trial of intra-arterial treatment in patients (aged >/=18 years from the Netherlands) with proximal arterial occlusion of the anterior circulation, given intra-arterial treatment within 6 h of stroke onset. The primary outcome was 90 day modified Rankin Scale (mRS) score. We estimated the intra-arterial treatment effect for all patients in MR CLEAN who had ASPECTS graded by using multivariable ordinal logistic regression analysis (a proportional odds model) to calculate the adjusted common odds ratio for a shift towards a better functional outcome according to the mRS for intra-arterial treatment and usual care than for usual care alone. We entered an interaction term into the model to test for interaction with prespecified ASPECTS subgroups: 0-4 (large infarct) versus 5-7 (moderate infarct) versus 8-10 (small infarct). MR CLEAN is registered with the Netherlands Trial Registry, number NTR1804, and the ISRCTN Registry, number ISRCTN10888758. FINDINGS: 496 patients-232 (47%) in the intra-arterial treatment and usual care group and 264 (53%) in the usual care alone group-were included in the analysis. We noted no significant difference in intra-arterial treatment effect between the ASPECTS subgroups according to 90 day ordinal mRS (adjusted common odds ratio interaction term relative to ASPECTS 8-10: ASPECTS 0-4: 0.79 [95% CI 0.20-3.19], p=0.740; and ASPECTS 5-7: 1.02 [0.44-2.35], p=0.966). Intra-arterial treatment did not cause a significant increase in the proportion of patients

Published
2016

25. Automated entire thrombus density measurements for robust and comprehensive thrombus characterization in patients with acute ischemic stroke

Author

Santos, E.M.M. (Emilie M.), Niessen, W.J. (Wiro), Yoo, A.J. (Albert J.), Berkhemer, O.A. (Olvert), Beenen, L.F.M. (Ludo), Majoie, C.B. (Charles), Marquering, H. (Henk), Fransen, P.S.S. (Puck), Beumer, D. (Debbie), Van Den Berg, L.A. (Lucie A.), Lingsma, H.F. (Hester), Schonewille, W.J. (Wouter), Vos, J.A. (Jan Albert), Nederkoorn, P.J. (Paul), Wermer, M.J.H. (Marieke), Walderveen, M.A.A. (Marianne) van, Staals, J. (Julie), Hofmeijer, J., Oostayen, J.A. (Jacques) van, Lycklama à Nijeholt, G.J. (Geert), Boiten, J. (Jelis), Brouwer, P.A. (Patrick A.), Emmer, B.J. (Bart J.), Bruijn, S.F. (S.) de, Dijk, L.C. (Lukas) van, Kappelle, L.J., Lo, R.H. (Rob H.), Dijk, E.J. (Ewoud) van, De Vries, J. (Joost), Kort, P.L.M. (Paul) de, Berg, J.S.P. (Jan) van den, Van Hasselt, B.A.A.M. (Boudewijn A. A. M.), Aerden, L.A.M. (Leo), Dallinga, R.J. (René J.), Visser, M.C. (Marieke), Bot, J. (Joseph), Vroomen, P.C. (Patrick C.), Eshghi, O.S. (Omid S.), Schreuder, T.H.C.M.L. (Tobien H. C. M. L.), Heijboer, M.P. (Rien), Keizer, K. (Koos), Tielbeek, A.V. (Alexander), Hertog, H.M. (Heleen) den, Gerrits, D.G. (Dick G.), Berg-Vos, R.M. (R.) van den, Karas, G. (Giorgos), Steyerberg, E.W. (Ewout), Flach, H.Z. (Zwenneke), Sprengers, M.E.S. (Marieke), Jenniskens, S. (Sjoerd), Van Den Berg, R., Koudstaal, P.J. (Peter), Zwam, W.H. (Wim) van, Roos, Y.B.W.E.M. (Yvo), Lugt, A. (Aad) van der, Oostenbrugge, R.J. (Robert Jan) van, Dippel, D.W.J. (Diederik), Santos, E.M.M. (Emilie M.), Niessen, W.J. (Wiro), Yoo, A.J. (Albert J.), Berkhemer, O.A. (Olvert), Beenen, L.F.M. (Ludo), Majoie, C.B. (Charles), Marquering, H. (Henk), Fransen, P.S.S. (Puck), Beumer, D. (Debbie), Van Den Berg, L.A. (Lucie A.), Lingsma, H.F. (Hester), Schonewille, W.J. (Wouter), Vos, J.A. (Jan Albert), Nederkoorn, P.J. (Paul), Wermer, M.J.H. (Marieke), Walderveen, M.A.A. (Marianne) van, Staals, J. (Julie), Hofmeijer, J., Oostayen, J.A. (Jacques) van, Lycklama à Nijeholt, G.J. (Geert), Boiten, J. (Jelis), Brouwer, P.A. (Patrick A.), Emmer, B.J. (Bart J.), Bruijn, S.F. (S.) de, Dijk, L.C. (Lukas) van, Kappelle, L.J., Lo, R.H. (Rob H.), Dijk, E.J. (Ewoud) van, De Vries, J. (Joost), Kort, P.L.M. (Paul) de, Berg, J.S.P. (Jan) van den, Van Hasselt, B.A.A.M. (Boudewijn A. A. M.), Aerden, L.A.M. (Leo), Dallinga, R.J. (René J.), Visser, M.C. (Marieke), Bot, J. (Joseph), Vroomen, P.C. (Patrick C.), Eshghi, O.S. (Omid S.), Schreuder, T.H.C.M.L. (Tobien H. C. M. L.), Heijboer, M.P. (Rien), Keizer, K. (Koos), Tielbeek, A.V. (Alexander), Hertog, H.M. (Heleen) den, Gerrits, D.G. (Dick G.), Berg-Vos, R.M. (R.) van den, Karas, G. (Giorgos), Steyerberg, E.W. (Ewout), Flach, H.Z. (Zwenneke), Sprengers, M.E.S. (Marieke), Jenniskens, S. (Sjoerd), Van Den Berg, R., Koudstaal, P.J. (Peter), Zwam, W.H. (Wim) van, Roos, Y.B.W.E.M. (Yvo), Lugt, A. (Aad) van der, Oostenbrugge, R.J. (Robert Jan) van, and Dippel, D.W.J. (Diederik)

Abstract

Background and Purpose: In acute ischemic stroke (AIS) management, CT-based thrombus density has been associated with treatment success. However, currently used thrombus measurements are prone to inter-observer variability and oversimplify the heterogeneous thrombus composition. Our aim was first to introduce an automated method to assess the entire thrombus density and then to compare the measured entire thrombus density with respect to current standard manual measurements. Materials and Method: In 135 AIS patients, the density distribution of the entire thrombus was determined. Density distributions were described usingmedians, interquartile ranges (IQR), kurtosis, and skewedness. Differences between themedian of entire thrombusmeasurements and commonly applied manualmeasurements using 3 regions of interest were determined using linear regression. Results: Density distributions varied considerably with medians ranging from 20.0 to 62.8 HU and IQRs ranging from 9.3 to 55.8 HU. The average median of the thrombus density distributions (43.5 ± 10.2 HU) was lower than the manual assessment (49.6 ± 8.0 HU) (p<0.05). The difference between manual measurements and median density of entire thrombus decreased with increasing density (r = 0.64; p<0.05), revealing relatively higher manual measurements for low density thrombi such that manual density measurement tend overestimates the

Published
2016
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26. Supplementary Material for: Is Intra-Arterial Treatment for Acute Ischemic Stroke Less Effective in Women than in Men?

Author

de Ridder I.R., Fransen P.S.S., Beumer D., Berkhemer O.A., van den Berg L.A., Wermer M.J., Lingsma H., van Zwam W.H., Roos Y.B., van Oostenbrugge R.J., Majoie C.B., van der Lugt A., Dippel D.W.J., for the MR CLEAN Investigators, de Ridder I.R., Fransen P.S.S., Beumer D., Berkhemer O.A., van den Berg L.A., Wermer M.J., Lingsma H., van Zwam W.H., Roos Y.B., van Oostenbrugge R.J., Majoie C.B., van der Lugt A., Dippel D.W.J., and for the MR CLEAN Investigators

Abstract

Introduction: Stroke etiology and outcome after ischemic stroke differ between men and women. We examined if sex modifies the effect of intra-arterial treatment (IAT) in a randomized clinical trial of IAT for acute ischemic stroke in the Netherlands (MR CLEAN). Patients and Methods: The primary outcome was the score on the modified Rankin scale at 90 days. We tested for interaction between sex and treatment and estimated the treatment effect by sex with multiple ordinal logistic regression with adjustment for prognostic factors. Results: All 500 patients were included in the analysis; 292 (58.4%) were men. The treatment effect (adjusted common odds ratio) was 2.39 [95% confidence interval (CI) 1.55-3.68] in men and 0.99 (95% CI 0.60-1.66) in women (pinteraction = 0.016). In women, mortality was higher in the intervention group than in the control group (24 vs. 15%, p = 0.07). Serious adverse events occurred more often in women than in men undergoing intervention. There were no differences in neuro-imaging outcomes. Discussion and Conclusion: Contrary to other studies, we found a significant interaction between sex and treatment effect in the MR CLEAN trial. Pooled analyses of all published thrombectomy trials did not confirm this finding. In MR CLEAN, women seem to have a slightly more unfavorable profile, causing higher mortality and more serious adverse events, but insufficient to explain the absence of an overall effect. This suggests a play of chance and makes it clear that IAT should not be withheld in women.

Published
2016
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27. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke: A Randomized Clinical Trial

Author

Fransen, P.S., Berkhemer, O.A., Lingsma, H.F., Beumer, D., Berg, L.A. van den, Yoo, A.J., Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wermer, M.J., Walderveen, M.A. van, Staals, J., Hofmeijer, J., Oostayen, J.A., Lycklama, A.N.G.J., Boiten, J., Brouwer, P.A., Emmer, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., Lo, R.H., Dijk, E.J. van, Vries, J. de, Kort, P.L. de, Berg, J.S., Hasselt, B.A. van, Aerden, L.A., Dallinga, R.J., Visser, M.C, Bot, J.C., Vroomen, P.C., Eshghi, O., Schreuder, T.H., Heijboer, R.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Steyerberg, E.W., Flach, H.Z., Marquering, H.A., Sprengers, M.E., Jenniskens, S.F., Beenen, L.F., Berg, R. van den, Koudstaal, P.J., Zwam, W.H. van, Roos, Y.B., Oostenbrugge, R.J. van, Majoie, C.B., Lugt, A. van der, Dippel, D.W., Fransen, P.S., Berkhemer, O.A., Lingsma, H.F., Beumer, D., Berg, L.A. van den, Yoo, A.J., Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wermer, M.J., Walderveen, M.A. van, Staals, J., Hofmeijer, J., Oostayen, J.A., Lycklama, A.N.G.J., Boiten, J., Brouwer, P.A., Emmer, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., Lo, R.H., Dijk, E.J. van, Vries, J. de, Kort, P.L. de, Berg, J.S., Hasselt, B.A. van, Aerden, L.A., Dallinga, R.J., Visser, M.C, Bot, J.C., Vroomen, P.C., Eshghi, O., Schreuder, T.H., Heijboer, R.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Steyerberg, E.W., Flach, H.Z., Marquering, H.A., Sprengers, M.E., Jenniskens, S.F., Beenen, L.F., Berg, R. van den, Koudstaal, P.J., Zwam, W.H. van, Roos, Y.B., Oostenbrugge, R.J. van, Majoie, C.B., Lugt, A. van der, and Dippel, D.W.

Abstract

Item does not contain fulltext, IMPORTANCE: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. OBJECTIVE: To evaluate the influence of time from stroke onset to the start of treatment and from stroke onset to reperfusion on the effect of IAT. DESIGN, SETTING, AND PARTICIPANTS: The Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) was a multicenter, randomized clinical open-label trial of IAT vs no IAT in 500 patients. The time to the start of treatment was defined as the time from onset of symptoms to groin puncture (TOG). The time from onset of treatment to reperfusion (TOR) was defined as the time to reopening the vessel occlusion or the end of the procedure in cases for which reperfusion was not achieved. Data were collected from December 3, 2010, to June 3, 2014, and analyzed (intention to treat) from July 1, 2014, to September 19, 2015. MAIN OUTCOMES AND MEASURES: Main outcome was the modified Rankin Scale (mRS) score for functional outcome (range, 0 [no symptoms] to 6 [death]). Multiple ordinal logistic regression analysis estimated the effect of treatment and tested for the interaction of time to randomization, TOG, and TOR with treatment. The effect of treatment as a risk difference on reaching independence (mRS score, 0-2) was computed as a function of TOG and TOR. Calculations were adjusted for age, National Institutes of Health Stroke Scale score, previous stroke, atrial fibrillation, diabetes mellitus, and intracranial arterial terminus occlusion. RESULTS: Among 500 patients (58% male; median age, 67 years), the median TOG was 260 (interquartile range [IQR], 210-311) minutes; median TOR, 340 (IQR, 274-395) minutes. An interaction between TOR and treatment (P = .04) existed, but not between TOG and treatment (P = .26).

Published
2016

28. MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial

Author

Fransen, P.S., Beumer, D., Berkhemer, O.A., Berg, L.A. van den, Lingsma, H., Lugt, A. van der, Zwam, W.H. van, Oostenbrugge, R.J. van, Roos, Y.B., Majoie, C.B., Dippel, D.W., Dijk, E.J. van, Neurology, Public Health, Radiology & Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Amsterdam Neuroscience, Radiology and Nuclear Medicine, Graduate School, Biomedical Engineering and Physics, Other Research, RS: CARIM - R3 - Vascular biology, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA AIOS Neurologie (9), MUMC+: DA BV Medisch Specialisten Radiologie (9), Klinische Neurowetenschappen, and MUMC+: MA Med Staf Spec Neurologie (9)

Subjects
medicine.medical_specialty, medicine.medical_treatment, Acute ischemic stroke, Medicine (miscellaneous), Alteplase, Brain Ischemia, law.invention, Brain ischemia, Study Protocol, Clinical Protocols, Randomized controlled trial, Modified Rankin Scale, law, Journal Article, medicine, Stent, Humans, Pharmacology (medical), Endovascular treatment, cardiovascular diseases, Urokinase, Stroke, Thrombectomy, business.industry, Endovascular Procedures, Thrombolysis, medicine.disease, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], Arterial occlusion, Surgery, Multicenter Study, Sample Size, Anesthesia, business, medicine.drug
Abstract

Background Endovascular or intra-arterial treatment (IAT) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion. However, a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven. The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke. Additionally, we aim to assess the safety of IAT, and the effect on recanalization of different mechanical treatment modalities. Methods/design A multicenter randomized clinical trial with blinded outcome assessment. The active comparison is IAT versus no IAT. IAT may consist of intra-arterial thrombolysis with alteplase or urokinase, mechanical treatment or both. Mechanical treatment refers to retraction, aspiration, sonolysis, or use of a retrievable stent (stent-retriever). Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation, who can be treated within 6 hours after stroke onset, are eligible. Treatment effect will be estimated with ordinal logistic regression (shift analysis); 500 patients will be included in the trial for a power of 80% to detect a shift leading to a decrease in dependency in 10% of treated patients. The primary outcome is the score on the modified Rankin scale at 90 days. Secondary outcomes are the National Institutes of Health stroke scale score at 24 hours, vessel patency at 24 hours, infarct size on day 5, and the occurrence of major bleeding during the first 5 days. Discussion If IAT leads to a 10% absolute reduction in poor outcome after stroke, careful implementation of the intervention could save approximately 1% of all new stroke cases from death or disability annually. Trial registration NTR1804 (7 May 2009)/ISRCTN10888758 (24 July 2012). Electronic supplementary material The online version of this article (doi:10.1186/1745-6215-15-343) contains supplementary material, which is available to authorized users.

Published
2014
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29. Type of Anesthesia and Differences in Clinical Outcome After Intra-Arterial Treatment for Ischemic Stroke

Author

Berg, L.A. van den, Koelman, D.L., Berkhemer, O.A., Rozeman, A.D., Fransen, P.S., Beumer, D., Dippel, D.W., Lugt, A. van der, Oostenbrugge, R.J. van, Zwam, W.H. van, Brouwer, P.A., Jenniskens, S.F., Boiten, J., Lycklama a Nijeholt, G.J., Vos, J.A., Schonewille, W.J., Majoie, C.B., Roos, Y., Berg, L.A. van den, Koelman, D.L., Berkhemer, O.A., Rozeman, A.D., Fransen, P.S., Beumer, D., Dippel, D.W., Lugt, A. van der, Oostenbrugge, R.J. van, Zwam, W.H. van, Brouwer, P.A., Jenniskens, S.F., Boiten, J., Lycklama a Nijeholt, G.J., Vos, J.A., Schonewille, W.J., Majoie, C.B., and Roos, Y.

Abstract

Item does not contain fulltext

Published
2015

30. MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: Study protocol for a randomized controlled trial

Author

Fransen, P.S.S. (Puck), Beumer, D. (Debbie), Berkhemer, O.A. (Olvert), Van Den Berg, L.A. (Lucie A.), Lingsma, H.F. (Hester), Lugt, A. (Aad) van der, Zwam, W.H. (Wim) van, Oostenbrugge, R.J. (Robert Jan) van, Roos, Y.B.W.E.M. (Yvo), Majoie, C.B. (Charles B.), Dippel, D.W.J. (Diederik), Fransen, P.S.S. (Puck), Beumer, D. (Debbie), Berkhemer, O.A. (Olvert), Van Den Berg, L.A. (Lucie A.), Lingsma, H.F. (Hester), Lugt, A. (Aad) van der, Zwam, W.H. (Wim) van, Oostenbrugge, R.J. (Robert Jan) van, Roos, Y.B.W.E.M. (Yvo), Majoie, C.B. (Charles B.), and Dippel, D.W.J. (Diederik)

Abstract

Background: Endovascular or intra-arterial treatment (IAT) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion. However, a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven. The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke. Additionally, we aim to assess the safety of IAT, and the effect on recanalization of different mechanical treatment modalities. Methods/design: A multicenter randomized clinical trial with blinded outcome assessment. The active comparison is IAT versus no IAT. IAT may consist of intra-arterial thrombolysis with alteplase or urokinase, mechanical treatment or both. Mechanical treatment refers to retraction, aspiration, sonolysis, or use of a retrievable stent (stent-retriever). Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation, who can be treated within 6 hours after stroke onset, are eligible. Treatment effect will be estimated w

Published
2014
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35. Budget impact of endovascular treatment for acute ischaemic stroke patients in the Netherlands for 2015-2021.

Author

van den Berg LA, Berkhemer OA, Fransen PSS, Beumer D, Majoie CBL, Dippel DWJ, van der Lugt A, van Oostenbrugge RJ, van Zwam WH, Roos YB, and Dijkgraaf MGW

Abstract

Introduction: Endovascular treatment (EVT) has been proven to be both effective and cost-effective for patients with acute ischaemic stroke. We investigated the budget impact of large-scale implementation of EVT for acute ischaemic stroke patients in the Netherlands for 2015-2021., Methods: An analysis was performed from a healthcare perspective as a preplanned substudy of the Multicenter Randomized Clinical trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN). Estimated yearly costs during follow-up after stroke for patients who had or had not been treated with EVT as add-on to usual care were linked to numbers of new patients retrieved from 2 Dutch registries of EVT that started after the last inclusion in MR CLEAN (2014). Aggregated costs and costs per care sector were calculated based on prevalence using a population dynamic tool., Results: From 2015, the yearly number of new acute ischaemic stroke patients receiving EVT increased almost threefold, from 812 in 2015 to 2,370 in 2021. The introduction of EVT plus usual care resulted in estimated net annual savings that increased from € 2.9 million in 2015 to € 58 million in 2021., Conclusion: Offering EVT as add-on to usual care for acute ischaemic stroke patients was increasingly cost saving from a national healthcare perspective but affected distinct healthcare sectors differently., (© 2023. The Author(s).)

Published
2023
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36. Influence of the interventionist's experience on outcomes of endovascular thrombectomy in acute ischemic stroke: results from the MR CLEAN Registry.

Author

Olthuis SGH, den Hartog SJ, van Kuijk SMJ, Staals J, Benali F, van der Leij C, Beumer D, Lycklama À Nijeholt GJ, Uyttenboogaart M, Martens JM, van Doormaal PJ, Vos JA, Emmer BJ, Dippel DWJ, van Zwam WH, van Oostenbrugge RJ, and de Ridder IR

Subjects
Humans, Treatment Outcome, Thrombectomy methods, Registries, Stroke diagnostic imaging, Stroke surgery, Ischemic Stroke etiology, Brain Ischemia diagnostic imaging, Brain Ischemia surgery, Endovascular Procedures methods
Abstract

Background: The relationship between the interventionist's experience and outcomes of endovascular thrombectomy (EVT) for acute ischemic stroke of the anterior circulation, is unclear., Objective: To assess the effect of the interventionist's level of experience on clinical, imaging, and workflow outcomes. Secondly, to determine which of the three experience definitions is most strongly associated with these outcome measures., Methods: We analysed data from 2700 patients, included in the MR CLEAN Registry. We defined interventionist's experience as the number of procedures performed in the year preceding the intervention (EXPfreq), total number of procedures performed (EXPno), and years of experience (EXPyears). Our outcomes were the baseline-adjusted National Institutes of Health Stroke Scale (NIHSS) score at 24-48 hours post-EVT, recanalization (extended Thrombolysis in Cerebral Infarction (eTICI) score ≥2B), and procedural duration. We used multilevel regression models with interventionists as random intercept. For EXPfreq and EXPno results were expressed per 10 procedures., Results: Increased EXPfreq was associated with lower 24-48 hour NIHSS scores (adjusted (a)β:-0.46, 95% CI -0.70 to -0.21). EXPno and EXPyears were not associated with short-term neurological outcomes. Increased EXPfreq and EXPno were both associated with recanalization (aOR=1.20, 95% CI 1.11 to 1.31 and aOR=1.08, 95% CI 1.04 to 1.12, respectively), and increased EXPfreq, EXPno, and EXPyears were all associated with shorter procedure times (aβ:-3.08, 95% CI-4.32 to -1.84; aβ:-1.34, 95% CI-1.84 to -0.85; and aβ:-0.79, 95% CI-1.45 to -0.13, respectively)., Conclusions: Higher levels of interventionist's experience are associated with better outcomes after EVT, in particular when experience is defined as the number of patients treated in the preceding year. Every 20 procedures more per year is associated with approximately one NIHSS score point decrease, an increased probability for recanalization (aOR=1.44), and a 6-minute shorter procedure time., Competing Interests: Competing interests: DWJD reports funding from the Dutch Heart Foundation, Brain Foundation Netherlands, The Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health, and unrestricted grants from Penumbra Inc., Stryker European Operations BV, Medtronic, Thrombolytic Science, LLC, and Cerenovus for research, all paid to the institution. DWJD participates in the DSMBs of ESCAPE-NEXT (stopped July 2021) and TESLAT (without receiving payments). WHvZ received consultation fees from Stryker, Nico Lab, and Cerenovus, paid to the institution. WHvZ participates in the DSMBs of Philips’WeTrust study, Anaconda’s Solonda study, in Extremis Studies, Montpellier, all funding was paid to the institution. BJE received grants from the Dutch Research Foundation (ZonMW), Dutch Ministery of Economy (TKI-PPP), and Nico Lab, all paid to the institution. CvdL participates in the Secretary Dutch Interventional Society (unpaid). SMJvK reports participation in DSMBs of multiple studies as a statistician, none in the same clinical field. JS participates in the executive committee of the MR CLEAN MED, unpaid. MU received grants from the Dutch Heart Foundation, paid to the CONTRAST consortium. MU also received financial support for interventional workshops and travel visits paid to Microvention, Stryker, Cerenovus. PJvD received consultation fees and payments/honoraria from Stryker, paid to the institution., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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37. Economic Evaluation of Endovascular Treatment for Acute Ischemic Stroke.

Author

van den Berg LA, Berkhemer OA, Fransen PSS, Beumer D, Lingsma H, Majoie CBM, Dippel DWJ, van der Lugt A, van Oostenbrugge RJ, van Zwam WH, Roos YB, and Dijkgraaf MGW

Subjects
Adult, Aged, Aged, 80 and over, Cost-Benefit Analysis, Female, Fibrinolytic Agents economics, Humans, Ischemic Stroke drug therapy, Ischemic Stroke surgery, Male, Middle Aged, Quality-Adjusted Life Years, Tissue Plasminogen Activator economics, Treatment Outcome, Young Adult, Endovascular Procedures economics, Fibrinolytic Agents therapeutic use, Ischemic Stroke therapy, Stents economics, Tissue Plasminogen Activator therapeutic use
Abstract

Background and Purpose: Endovascular treatment for acute ischemic stroke has been proven clinically effective, but evidence of the cost-effectiveness based on real-world data is scarce. The aim of this study was to assess whether endovascular therapy plus usual care is cost-effective in comparison to usual care alone in acute ischemic stroke patients., Methods: An economic evaluation was performed from a societal perspective with a 2-year time horizon. Empirical data on health outcomes and the use of resources following endovascular treatment were gathered parallel to the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) and its 2-year follow-up study. Incremental cost-effectiveness ratios were calculated as the extra costs per additional patient with functional independence (modified Rankin Scale score 0-2) and the extra cost per quality-adjusted life year gained., Results: The mean costs per patient in the intervention group were $126 494 versus $143 331 in the control group (mean difference, -$16 839 [95% CI, -$38 113 to $5456]). Compared with patients in the control group, more patients in the intervention group achieved functional independence, 37.2% versus 23.9% (absolute difference, 13.3% [95% CI, 4.0%-22.0%]) and they generated more quality-adjusted life years, 0.99 versus 0.83 (mean difference of 0.16 [95% CI, 0.04-0.29]). Endovascular treatment dominated standard treatment with $18 233 saved per extra patient with a good outcome and $105 869 saved per additional quality-adjusted life year., Conclusions: Endovascular treatment added to usual care is clinically effective, and cost saving in comparison to usual care alone in patients with acute ischemic stroke. Registration: URL: https://www.trialregister.nl/trial/695; Unique identifier: NL695. URL: https://www.isrctn.com; Unique identifier: ISRCTN10888758.

Published
2022
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38. A novel classification system for research reporting in rare and progressive genetic conditions.

Author

van Karnebeek CDM, Beumer D, Pawliuk C, Goez H, Mostafavi S, Andrews G, Steele R, and Siden H

Subjects
Consensus, Delphi Technique, Disease Progression, Humans, Observer Variation, Reproducibility of Results, Surveys and Questionnaires, Genetic Diseases, Inborn classification
Abstract

Aim: To create a classification system for severe, rare, and progressive genetic conditions for use in research reporting., Method: A modified Delphi consensus technique was used to create and reach agreement on a new system of condition categories. Interrater reliability was tested via two rounds of an online survey whereby physicians classified a subset of conditions using our novel system. Overall percentage agreement and agreement above chance were calculated using Fleiss' kappa (κ)., Results: Eleven physicians completed the first Delphi, with an overall agreement of 76.4%, the κ value was 0.57 (95% confidence interval 0.51-0.63), indicating moderate agreement (0.41-0.60) above chance. Based on the first survey several categories were described in more detail. The second survey confirmed a classification system with 12 categories, with an overall percentage agreement among the participants of 82.6%. The overall mean κ value was 0.71 (95% confidence interval 0.65-0.77), indicating substantial agreement (0.61-0.80)., Interpretation: Our new system was useful in categorizing a broad range of rare childhood diseases and may be applicable to other rare disease studies; further validation in larger cohorts is required., What This Paper Adds: This novel 12-category classification system can be used in research reporting in rare and progressive genetic conditions., (© 2019 Mac Keith Press.)

Published
2019
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39. Penumbral imaging and functional outcome in patients with anterior circulation ischaemic stroke treated with endovascular thrombectomy versus medical therapy: a meta-analysis of individual patient-level data.

Author

Campbell BCV, Majoie CBLM, Albers GW, Menon BK, Yassi N, Sharma G, van Zwam WH, van Oostenbrugge RJ, Demchuk AM, Guillemin F, White P, Dávalos A, van der Lugt A, Butcher KS, Cherifi A, Marquering HA, Cloud G, Macho Fernández JM, Madigan J, Oppenheim C, Donnan GA, Roos YBWEM, Shankar J, Lingsma H, Bonafé A, Raoult H, Hernández-Pérez M, Bharatha A, Jahan R, Jansen O, Richard S, Levy EI, Berkhemer OA, Soudant M, Aja L, Davis SM, Krings T, Tisserand M, San Román L, Tomasello A, Beumer D, Brown S, Liebeskind DS, Bracard S, Muir KW, Dippel DWJ, Goyal M, Saver JL, Jovin TG, Hill MD, and Mitchell PJ

Subjects
Aged, Aged, 80 and over, Brain Ischemia diagnostic imaging, Brain Ischemia drug therapy, Brain Ischemia surgery, Endovascular Procedures, Female, Humans, Magnetic Resonance Imaging, Middle Aged, Neuroimaging, Perfusion Imaging, Stroke diagnostic imaging, Stroke drug therapy, Stroke surgery, Tomography, X-Ray Computed, Treatment Outcome, Brain diagnostic imaging, Brain Ischemia therapy, Fibrinolytic Agents therapeutic use, Stroke therapy, Thrombectomy methods, Tissue Plasminogen Activator therapeutic use
Abstract

Background: CT perfusion (CTP) and diffusion or perfusion MRI might assist patient selection for endovascular thrombectomy. We aimed to establish whether imaging assessments of irreversibly injured ischaemic core and potentially salvageable penumbra volumes were associated with functional outcome and whether they interacted with the treatment effect of endovascular thrombectomy on functional outcome., Methods: In this systematic review and meta-analysis, the HERMES collaboration pooled patient-level data from all randomised controlled trials that compared endovascular thrombectomy (predominantly using stent retrievers) with standard medical therapy in patients with anterior circulation ischaemic stroke, published in PubMed from Jan 1, 2010, to May 31, 2017. The primary endpoint was functional outcome, assessed by the modified Rankin Scale (mRS) at 90 days after stroke. Ischaemic core was estimated, before treatment with either endovascular thrombectomy or standard medical therapy, by CTP as relative cerebral blood flow less than 30% of normal brain blood flow or by MRI as an apparent diffusion coefficient less than 620 μm 2 /s. Critically hypoperfused tissue was estimated as the volume of tissue with a CTP time to maximum longer than 6 s. Mismatch volume (ie, the estimated penumbral volume) was calculated as critically hypoperfused tissue volume minus ischaemic core volume. The association of ischaemic core and penumbral volumes with 90-day mRS score was analysed with multivariable logistic regression (functional independence, defined as mRS score 0-2) and ordinal logistic regression (functional improvement by at least one mRS category) in all patients and in a subset of those with more than 50% endovascular reperfusion, adjusted for baseline prognostic variables. The meta-analysis was prospectively designed by the HERMES executive committee, but not registered., Findings: We identified seven studies with 1764 patients, all of which were included in the meta-analysis. CTP was available and assessable for 591 (34%) patients and diffusion MRI for 309 (18%) patients. Functional independence was worse in patients who had CTP versus those who had diffusion MRI, after adjustment for ischaemic core volume (odds ratio [OR] 0·47 [95% CI 0·30-0·72], p=0·0007), so the imaging modalities were not pooled. Increasing ischaemic core volume was associated with reduced likelihood of functional independence (CTP OR 0·77 [0·69-0·86] per 10 mL, p interaction =0·29; diffusion MRI OR 0·87 [0·81-0·94] per 10 mL, p interaction =0·94). Mismatch volume, examined only in the CTP group because of the small numbers of patients who had perfusion MRI, was not associated with either functional independence or functional improvement. In patients with CTP with more than 50% endovascular reperfusion (n=186), age, ischaemic core volume, and imaging-to-reperfusion time were independently associated with functional improvement. Risk of bias between studies was generally low., Interpretation: Estimated ischaemic core volume was independently associated with functional independence and functional improvement but did not modify the treatment benefit of endovascular thrombectomy over standard medical therapy for improved functional outcome. Combining ischaemic core volume with age and expected imaging-to-reperfusion time will improve assessment of prognosis and might inform endovascular thrombectomy treatment decisions., Funding: Medtronic., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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40. Dystonic Head Tremor and the Coexistence of Headache.

Author

Hulzenga MA, Beumer D, and Koehler PJ

Subjects
Aged, Female, Headache epidemiology, Headache physiopathology, Humans, Male, Middle Aged, Post-Traumatic Headache epidemiology, Post-Traumatic Headache physiopathology, Retrospective Studies, Torticollis epidemiology, Torticollis physiopathology, Tremor epidemiology, Tremor physiopathology, Headache complications, Post-Traumatic Headache complications, Torticollis complications, Tremor complications
Abstract

Background: Head tremor may be observed in the presence of cervical dystonia and sometimes coexists with headache. We wished to investigate the presence of headache in dystonic head tremor., Methods: We studied the files of 19 patients from our outpatient clinic (1997-2017) with dystonic head tremor and assessed the co-occurrence of headache. We also performed a literature search of the topic., Results: Cervicogenic headache was present in nearly 37% of patients with dystonic head tremor. More than 85% of our patients presented with a "no-no" head tremor., Discussion: Headache is common in dystonic head tremor. Cervicogenic headache seems to be more frequent in patients with dystonic head tremor than in the general population. Future studies should compare the presence of cervicogenic headache in essential head tremor patients with that in patients suffering from dystonic head tremor., Competing Interests: Funding: None. Conflicts of Interest: The authors report no conflict of interest. Ethics Statement: This study was reviewed by the authors’ institutional ethics committee and was considered exempted from further review.

Published
2017
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41. Endovascular thrombectomy in patients with acute ischaemic stroke and atrial fibrillation: a MR CLEAN subgroup analysis.

Author

Heshmatollah A, Fransen PSS, Berkhemer OA, Beumer D, van der Lugt A, Majoie CBLM, Oostenbrugge RJ, van Zwam WH, Koudstaal PJ, Roos YBWEM, and Dippel DWJ

Subjects
Aged, Aged, 80 and over, Atrial Fibrillation complications, Endovascular Procedures methods, Female, Humans, Male, Stroke complications, Thrombectomy methods, Treatment Outcome, Atrial Fibrillation therapy, Brain Ischemia therapy, Fibrinolytic Agents therapeutic use, Stroke therapy
Abstract

Aims: Endovascular thrombectomy (EVT) improves outcome after acute ischaemic stroke (AIS) caused by an intracranial occlusion. The aim of the present study was to determine whether atrial fibrillation (AF) modifies the effect of EVT., Methods and Results: MR CLEAN was a randomised clinical trial of EVT plus usual care vs. usual care alone for patients with an intracranial occlusion. The primary outcome was the modified Rankin scale (mRS) score at 90 days. The primary effect parameter was the adjusted common odds ratio (acOR), estimated with ordinal logistic regression and adjusted for age and stroke severity at baseline. Treatment effect modification by AF was assessed using a multiplicative interaction variable. We included all 500 patients. In total, 135 (27%) had AF. These patients were older, had a worse pre-stroke mRS score and were less often treated with IV alteplase. In patients without AF, the estimated treatment effect was similar to the overall treatment effect (acOR 1.9, 95% CI: 1.3 to 2.7). In patients with AF, the treatment effect appeared lower (acOR 1.0, 95% CI: 0.6 to 1.9). The interaction of treatment effect and AF was not significant (p=0.09, after adjustment p=0.12)., Conclusions: This study did not show significant difference in the EVT effect between acute stroke patients with and those without AF.

Published
2017
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42. Quality of life after intra-arterial treatment for acute ischemic stroke in the MR CLEAN trial-Update.

Author

Schreuders J, van den Berg LA, Fransen PS, Berkhemer OA, Beumer D, Lingsma HF, van Oostenbrugge RJ, van Zwam WH, Majoie CB, van der Lugt A, de Kort PL, Roos YB, and Dippel DW

Subjects
Acute Disease, Aged, Brain Ischemia mortality, Female, Follow-Up Studies, Humans, Male, Middle Aged, Netherlands, Self Report, Stroke mortality, Surveys and Questionnaires, Survival Analysis, Brain Ischemia therapy, Endovascular Procedures, Quality of Life, Stroke therapy
Abstract

Background Health-related quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire was one of the secondary outcomes in the Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (MR CLEAN). We reported no statistically significant difference in EuroQol Group 5-Dimension Self-Report Questionnaire score between the intervention and control groups, but deaths were not included. Aims Reanalyze the effect of intra-arterial treatment for large vessel occlusion in acute ischemic stroke patients on health-related quality of life in more detail. We now include patients who died during follow-up. Methods The EuroQol Group 5-Dimension Self-Report Questionnaire questionnaires were obtained 90 days after treatment. We used the Dutch tariff to derive a utility index from the EuroQol Group 5-Dimension Self-Report Questionnaire score. Treatment effect was estimated with the Mann-Whitney U test and linear regression. The effect of treatment on the distribution of EuroQol Group 5-Dimension Self-Report Questionnaire dimension scores was assessed with ordinal logistic regression. Results We obtained EuroQol Group 5-Dimension Self-Report Questionnaire scores from 457 (91.7%) of the 500 patients, including 108 who died before follow-up. Median EuroQol Group 5-Dimension Self-Report Questionnaire score in the intervention group was 0.57, and 0.39 in the control group (p = 0.03). Treatment effect estimated with linear regression was 0.07 (95%CI: -0.001 to 0.143). Treatment specifically affected EuroQol Group 5-Dimension Self-Report Questionnaire dimensions "mobility" (OR: 0.43, 95%CI: 0.29-0.66), "self-care" (OR: 0.60, 95%CI: 0.41-0.89), and "usual activities" (OR: 0.53, 95%CI: 0.36-0.79). Conclusion Treatment had a limited effect on quality of life, as measured with the EuroQol Group 5-Dimension Self-Report Questionnaire. Nevertheless, patients with acute ischemic stroke caused by an intracranial occlusion in the anterior circulation, who had intra-arterial treatment, experience better health-related quality of life than patients without intra-arterial treatment. Trial Registration URL: http://www.isrctn.com/ISRCTN10888758 Unique identifier: ISRCTN10888758.

Published
2017
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43. Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands).

Author

Mulder MJHL, Ergezen S, Lingsma HF, Berkhemer OA, Fransen PSS, Beumer D, van den Berg LA, Lycklama À Nijeholt G, Emmer BJ, van der Worp HB, Nederkoorn PJ, Roos YBWEM, van Oostenbrugge RJ, van Zwam WH, Majoie CBLM, van der Lugt A, and Dippel DWJ

Subjects
Aged, Brain Ischemia epidemiology, Endovascular Procedures adverse effects, Endovascular Procedures statistics & numerical data, Female, Humans, Intracranial Hemorrhages epidemiology, Male, Middle Aged, Netherlands, Retrospective Studies, Stroke epidemiology, Blood Pressure physiology, Brain Ischemia therapy, Endovascular Procedures methods, Intracranial Hemorrhages etiology, Outcome Assessment, Health Care statistics & numerical data, Stroke therapy
Abstract

Background and Purpose: High blood pressure (BP) is associated with poor outcome and the occurrence of symptomatic intracranial hemorrhage in acute ischemic stroke. Whether BP influences the benefit or safety of intra-arterial treatment (IAT) is not known. We aimed to assess the relation of BP with functional outcome, occurrence of symptomatic intracranial hemorrhage and effect of IAT., Methods: This is a post hoc analysis of the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands). BP was measured at baseline, before IAT or stroke unit admission. We estimated the association of baseline BP with the score on the modified Rankin Scale at 90 days and safety parameters with ordinal and logistic regression analysis. Effect of BP on the effect of IAT was tested with multiplicative interaction terms., Results: Systolic BP (SBP) had the best correlation with functional outcome. This correlation was U-shaped; both low and high baseline SBP were associated with poor functional outcome. Higher SBP was associated with symptomatic intracranial hemorrhage (adjusted odds ratio, 1.25 for every 10 mm Hg higher SBP [95% confidence interval, 1.09-1.44]). Between SBP and IAT, there was no interaction for functional outcome, symptomatic intracranial hemorrhage, or other safety parameters; the absolute benefit of IAT was evident for the whole SBP range. The same was found for diastolic BP., Conclusions: BP does not affect the benefit or safety of IAT in patients with acute ischemic stroke caused by proximal intracranial vessel occlusion. Our data provide no arguments to withhold or delay IAT based on BP., Clinical Trial Registration: URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758., (© 2017 American Heart Association, Inc.)

Published
2017
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44. Extracranial Carotid Disease and Effect of Intra-arterial Treatment in Patients With Proximal Anterior Circulation Stroke in MR CLEAN.

Author

Berkhemer OA, Borst J, Kappelhof M, Yoo AJ, van den Berg LA, Fransen PSS, Beumer D, Schonewille WJ, Nederkoorn PJ, Wermer MJH, Marquering HA, Lingsma HF, Roos YBWEM, van Oostenbrugge RJ, Dippel DWJ, van Zwam WH, Majoie CBLM, Emmer BJ, and van der Lugt A

Subjects
Aged, Brain Ischemia etiology, Female, Humans, Male, Middle Aged, Postoperative Complications, Stroke etiology, Treatment Outcome, Brain Ischemia surgery, Carotid Stenosis complications, Stroke surgery
Abstract

Background: The presence of extracranial carotid disease (ECD) is associated with less favorable clinical outcomes in patients with acute ischemic stroke caused by intracranial proximal occlusion. Acute intra-arterial treatment (IAT) in the setting of extracranial and intracranial lesions is considered challenging, and whether it yields improved outcomes remains uncertain., Objective: To examine whether the presence of ECD modified the effect of IAT for intracranial proximal anterior circulation occlusion., Design: Prespecified subgroup analysis of a randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands. (Trial registrations: NTR1804 [Netherlands Trial Register] and ISRCTN10888758)., Setting: 16 hospitals in the Netherlands., Patients: Acute ischemic stroke caused by proximal intracranial arterial occlusion of the anterior circulation. Extracranial carotid disease was defined as cervical internal carotid artery stenosis (>50%) or occlusion., Intervention: IAT treatment versus no IAT., Measurements: The primary outcome was functional outcome, as measured by the modified Rankin Scale at 90 days and reported as adjusted common odds ratio (acOR) for a shift in direction of a better outcome. Multivariable ordinal logistic regression analysis with an interaction term was used to estimate treatment effect modification by ECD., Results: The overall acOR was 1.67 (95% CI, 1.21 to 2.30) in favor of the intervention. The acOR was 3.1 (CI, 1.7 to 5.8) in the prespecified subgroup of patients with ECD versus 1.3 (CI, 0.9 to 1.9) in patients presenting without ECD. Both acORs are in favor of the intervention (P for interaction = 0.07)., Limitation: The study was not powered for subgroup analysis., Conclusion: Intra-arterial treatment may be at least as effective in patients with ECD as in those without ECD, and it should not be withheld in these complex patients with acute ischemic stroke., Primary Funding Source: Dutch Heart Foundation, AngioCare BV, Medtronic/Covidien/EV3, MEDAC Gmbh/LAMEPRO, Penumbra, Stryker, and Top Medical/Concentric.

Published
2017
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45. The relationship between interventionists' experience and clinical and radiological outcome in intra-arterial treatment for acute ischemic stroke. A MR CLEAN pretrial survey.

Author

Beumer D, van Boxtel TH, Schipperen S, van Zwam WH, Lycklama À Nijeholt GJ, Brouwer PA, Jenniskens SFM, Schonewille WJ, Vos JA, van der Lugt A, Roos YB, Majoie CB, van Oostenbrugge RJ, and Dippel DWJ

Subjects
Adolescent, Adult, Aged, Blood Pressure drug effects, Brain Ischemia complications, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Regression Analysis, Retrospective Studies, Severity of Illness Index, Stroke etiology, Tomography Scanners, X-Ray Computed, Young Adult, Fibrinolytic Agents administration & dosage, Injections, Intra-Arterial methods, Stroke diagnostic imaging, Stroke drug therapy, Tissue Plasminogen Activator administration & dosage, Treatment Outcome
Abstract

Background: Intra-arterial treatment in acute ischemic stroke is safe and effective as recently shown in several randomized clinical trials. The level of experience of the interventionist performing the IAT procedure has not been studied. The present study investigates effects of interventionists' experience on technical aspects of the procedure and clinical outcome of the patient., Methods: In this study of 313 patients with a proximal intracranial arterial anterior circulation occlusion, treated in the Netherlands from 2002 until participation in the Multicenter Randomized Clinical trial of Endovascular treatment for acute ischemic stroke (MR CLEAN), data were collected retrospectively. The association of the senior interventionists' experience with duration of the procedure, adverse events, recanalization, neurological outcome, and functional outcome at discharge was analyzed. Multiple regression models adjusted for age, sex, stroke severity, carotid terminus occlusion, use of a retrievable stent and onset to door time were used., Results: No association between interventionists' experience and recanalization, neurological outcome, or functional outcome was observed in a strict selection of patients. This strict selection include a start of intra-arterial treatment within 6h, no coagulation disturbances, systolic blood pressure<185mmHg and diastolic blood pressure<110mmHg), blood glucose level between 2.7 and 22.2mmol/L and the existence of a proximal intracranial occlusion. However, significant shorter procedure times were found with more experienced interventionists' [adjusted beta coefficient -0.67, 95% CI: -1.24 to -0.11], when using less strict inclusion criteria., Conclusion: No significant relation between the level of experience and either serious neurologic adverse events or poor outcomes was observed in this study of treatments by interventionists with experience of <50 previous procedures. We need further research to explore the relation of much higher levels of interventionists' and team experience with procedure times, results and patient outcomes., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Published
2017
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46. Admission Glucose and Effect of Intra-Arterial Treatment in Patients With Acute Ischemic Stroke.

Author

Osei E, den Hertog HM, Berkhemer OA, Fransen PSS, Roos YBWEM, Beumer D, van Oostenbrugge RJ, Schonewille WJ, Boiten J, Zandbergen AAM, Koudstaal PJ, and Dippel DWJ

Subjects
Aged, Aged, 80 and over, Brain Ischemia diagnostic imaging, Female, Humans, Male, Middle Aged, Single-Blind Method, Stents, Stroke diagnostic imaging, Blood Glucose, Brain Ischemia blood, Brain Ischemia therapy, Hyperglycemia blood, Intracranial Hemorrhages, Outcome Assessment, Health Care, Stroke blood, Stroke therapy, Thrombectomy methods
Abstract

Background and Purpose: Hyperglycemia on admission is common after ischemic stroke. It is associated with unfavorable outcome after treatment with intravenous thrombolysis and after intra-arterial treatment. Whether hyperglycemia influences the effect of reperfusion treatment is unknown. We assessed whether increased admission serum glucose modifies the effect of intra-arterial treatment in patients with acute ischemic stroke., Methods: We used data from the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). Hyperglycemia was defined as admission serum glucose >7.8 mmol/L. The primary outcome measure was the adjusted common odds ratio for a shift in the direction of a better outcome on the modified Rankin Scale at 90 days, estimated with ordinal logistic regression. Secondary outcome variable was symptomatic intracranial hemorrhage. We assessed treatment effect modification of hyperglycemia and admission serum glucose levels with multiplicative interaction factors and adjusted for prognostic variables., Results: Four hundred eighty-seven patients were included. Mean admission serum glucose was 7.2 mmol/L (SD, 2.2). Fifty-seven of 226 patients (25%) randomized to intra-arterial treatment were hyperglycemic compared with 61 of 261 patients (23%) in the control group. The interaction of either hyperglycemia or admission serum glucose levels and treatment effect on modified Rankin Scale scores was not significant ( P =0.67 and P =0.87, respectively). The same applied for occurrence of symptomatic hemorrhage ( P =0.39 for hyperglycemia, P =0.39 for admission serum glucose)., Conclusions: We found no evidence for effect modification of intra-arterial treatment by admission serum glucose in patients with acute ischemic stroke., Clinical Trial Registration: URL: www.isrctn.com. Unique identifier: ISRCTN10888758., (© 2017 American Heart Association, Inc.)

Published
2017
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47. Two-Year Outcome after Endovascular Treatment for Acute Ischemic Stroke.

Author

van den Berg LA, Dijkgraaf MG, Berkhemer OA, Fransen PS, Beumer D, Lingsma HF, Majoie CB, Dippel DW, van der Lugt A, van Oostenbrugge RJ, van Zwam WH, and Roos YB

Subjects
Activities of Daily Living, Aged, Brain Ischemia surgery, Disability Evaluation, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Mortality, Quality of Life, Stroke classification, Treatment Outcome, Endovascular Procedures, Stroke surgery
Abstract

Background: Several trials involving patients with acute ischemic stroke have shown better functional outcomes with endovascular treatment than with conventional treatment at 90 days after initiation of treatment. However, results on long-term clinical outcomes are lacking., Methods: We assessed clinical outcomes 2 years after patients were randomly assigned to receive either endovascular treatment (intervention group) or conventional treatment (control group) for acute ischemic stroke. The primary outcome was the score on the modified Rankin scale at 2 years; this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). Secondary outcomes included all-cause mortality and the quality of life at 2 years, as measured by means of a health utility index that is based on the European Quality of Life-5 Dimensions questionnaire (scores range from -0.329 to 1, with higher scores indicating better health)., Results: Of the 500 patients who underwent randomization in the original trial, 2-year data for this extended follow-up trial were available for 391 patients (78.2%) and information on death was available for 459 patients (91.8%). The distribution of outcomes on the modified Rankin scale favored endovascular treatment over conventional treatment (adjusted common odds ratio, 1.68; 95% confidence interval [CI], 1.15 to 2.45; P=0.007). There was no significant difference between the treatment groups in the percentage of patients who had an excellent outcome (i.e., a modified Rankin scale score of 0 or 1). The mean quality-of-life score was 0.48 among patients randomly assigned to endovascular treatment as compared with 0.38 among patients randomly assigned to conventional treatment (mean difference, 0.10; 95% CI, 0.03 to 0.16; P=0.006). The cumulative 2-year mortality rate was 26.0% in the intervention group and 31.0% in the control group (adjusted hazard ratio, 0.9; 95% CI, 0.6 to 1.2; P=0.46)., Conclusions: In this extended follow-up trial, the beneficial effect of endovascular treatment on functional outcome at 2 years in patients with acute ischemic stroke was similar to that reported at 90 days in the original trial. (Funded by the Netherlands Organization for Health Research and Development and others; MR CLEAN Current Controlled Trials number, ISRCTN10888758 , and Netherlands Trial Register number, NTR1804 , and MR CLEAN extended follow-up trial Netherlands Trial Register number, NTR5073 .).

Published
2017
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48. Clot Burden Score on Baseline Computerized Tomographic Angiography and Intra-Arterial Treatment Effect in Acute Ischemic Stroke.

Author

Treurniet KM, Yoo AJ, Berkhemer OA, Lingsma HF, Boers AM, Fransen PS, Beumer D, van den Berg LA, Sprengers ME, Jenniskens SF, Lycklama À Nijeholt GJ, van Walderveen MA, Bot JC, Beenen LF, van den Berg R, van Zwam WH, van der Lugt A, van Oostenbrugge RJ, Dippel DW, Roos YB, Marquering HA, and Majoie CB

Subjects
Aged, Brain Ischemia therapy, Female, Humans, Infusions, Intra-Arterial, Male, Middle Aged, Stroke therapy, Thrombolytic Therapy, Thrombosis therapy, Brain Ischemia diagnostic imaging, Cerebral Angiography methods, Computed Tomography Angiography methods, Outcome Assessment, Health Care, Stroke diagnostic imaging, Thrombectomy methods, Thrombosis diagnostic imaging
Abstract

Background and Purpose: A high clot burden score (CBS) is associated with favorable outcome after intravenous treatment for acute ischemic stroke. The added benefit of intra-arterial treatment might be less in these patients. The aim of this exploratory post hoc analysis was to assess the relation of CBS with neurological improvement and endovascular treatment effect., Methods: For 499 of 500 patients in the MR CLEAN study (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), the CBS was determined. Ordinal logistic regression models with and without main baseline prognostic variables were used to assess the association between CBS (continuous or dichotomized at CBS of 6) and a shift toward better outcome on the modified Rankin Scale. The model without main baseline prognostic variables only included treatment allocation and CBS. Models with and without a multiplicative interaction term of CBS and treatment were compared using the χ 2 test to assess treatment effect modification by CBS., Results: Higher CBS was associated with a shift toward better outcome on the modified Rankin Scale; adjusted common odds ratio per point CBS was 1.12 (95% confidence interval, 1.04-1.20]. Dichotomized CBS had an adjusted common odds ratio of 1.67 (95% confidence interval, 1.12-2.51). Both effect estimates were slightly attenuated by adding baseline prognostic variables. The addition of the interaction terms did not significantly improve the fit of the models. There was a small and insignificant increase of intra-arterial treatment efficacy in the high CBS group., Conclusions: A higher CBS is associated with improved outcome and may be used as a prognostic marker. We found no evidence that CBS modifies the effect of intra-arterial treatment., Clinical Trial Registration: URL: http://www.trialregister.nl. Unique identifier: NTR1804. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758., (© 2016 American Heart Association, Inc.)

Published
2016
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49. Influence of Device Choice on the Effect of Intra-Arterial Treatment for Acute Ischemic Stroke in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands).

Author

Dippel DW, Majoie CB, Roos YB, van der Lugt A, van Oostenbrugge RJ, van Zwam WH, Lingsma HF, Koudstaal PJ, Treurniet KM, van den Berg LA, Beumer D, Fransen PS, and Berkhemer OA

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Netherlands, Treatment Outcome, Brain Ischemia therapy, Endovascular Procedures methods, Stents, Stroke drug therapy, Thrombectomy methods
Abstract

Background and Purpose: Intra-arterial treatment by means of retrievable stents has been proven safe and effective. In MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), the choice of the type of thrombectomy device was left to the discretion of the interventionist. The aim of this study was to explore the differences in functional outcome, neurological recovery, reperfusion, extent of infarction, and adverse events according to stent type and make., Methods: The primary outcome was functional outcome at 90 days, assessed with the modified Rankin Scale (mRS). Neuroimaging outcomes included occlusion on computed tomographic angiography at 24 hours, infarct volume at 5 to 7 days, and modified thrombolysis in cerebral infarction scores. Safety outcomes included death within 90 days and any symptomatic intracerebral hemorrhage. We analyzed possible interactions between stent type and treatment with multiple regression models. Treatment effects were adjusted for patient age, stroke severity, and collateral score., Results: Of the 500 patients included in the trial, 233 were allocated to intervention. Of these, 124 (53%) were first treated with Trevo (adjusted common odds ratio for shift on the mRS [acOR, 1.98; 95% confidence interval, 1.30-2.92]), 31 (13%) with Solitaire (acOR, 1.90; 95% confidence interval, 0.97-3.73), 40 (17%) with other retrievable stents or mechanical devices (acOR, 0.96; 95% confidence interval, 0.51-3.93], and 38 (16%) could not be treated. There was no interaction between device and treatment effect on functional outcome and all other secondary and safety outcomes., Conclusions: We found no evidence for a differential effect of thrombectomy for acute ischemic stroke by type of stent., Clinical Trial Registration: URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758., (© 2016 American Heart Association, Inc.)

Published
2016
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50. Is Intra-Arterial Treatment for Acute Ischemic Stroke Less Effective in Women than in Men?

Author

de Ridder IR, Fransen PS, Beumer D, Berkhemer OA, van den Berg LA, Wermer MJ, Lingsma H, van Zwam WH, Roos YB, van Oostenbrugge RJ, Majoie CB, van der Lugt A, and Dippel DW

Abstract

Introduction: Stroke etiology and outcome after ischemic stroke differ between men and women. We examined if sex modifies the effect of intra-arterial treatment (IAT) in a randomized clinical trial of IAT for acute ischemic stroke in the Netherlands (MR CLEAN)., Patients and Methods: The primary outcome was the score on the modified Rankin scale at 90 days. We tested for interaction between sex and treatment and estimated the treatment effect by sex with multiple ordinal logistic regression with adjustment for prognostic factors., Results: All 500 patients were included in the analysis; 292 (58.4%) were men. The treatment effect (adjusted common odds ratio) was 2.39 [95% confidence interval (CI) 1.55-3.68] in men and 0.99 (95% CI 0.60-1.66) in women (p interaction = 0.016). In women, mortality was higher in the intervention group than in the control group (24 vs. 15%, p = 0.07). Serious adverse events occurred more often in women than in men undergoing intervention. There were no differences in neuro-imaging outcomes., Discussion and Conclusion: Contrary to other studies, we found a significant interaction between sex and treatment effect in the MR CLEAN trial. Pooled analyses of all published thrombectomy trials did not confirm this finding. In MR CLEAN, women seem to have a slightly more unfavorable profile, causing higher mortality and more serious adverse events, but insufficient to explain the absence of an overall effect. This suggests a play of chance and makes it clear that IAT should not be withheld in women.

Published
2016
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