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1. Collateral-based selection for endovascular treatment of acute ischaemic stroke in the late window (MR CLEAN-LATE): 2-year follow-up of a phase 3, multicentre, open-label, randomised controlled trial in the Netherlands

Author

van Oostenbrugge, Robert, van Zwam, Wim, Olthuis, Susanne, Pirson, Anne, Hinsenveld, Wouter, Goldhoorn, Robert-Jan, Staals, Julie, Dippel, Diederik, van der Lugt, Aad, van Es, Adriaan, Roozenbeek, Bob, van Doormaal, Pieter-Jan, Roos, Yvo, Majoie, Charles, Coutinho, Jonathan, Emmer, Bart, van der Worp, Bart, Lo, Rob, van Walderveen, Marianne, Wermer, Marieke, van Dijk, Ewoud, Jenniskens, Sjoerd, Boogaarts, Hieronymus, Uyttenboogaart, Maarten, Bokkers, Reinoud, Keizer, Koos, Gons, Rob, Yo, Lonneke, den Hertog, Heleen, van Hasselt, Boudewijn, Schonewille, Wouter, Vos, Jan-Albert, van Tuijl, Julia, Boukrab, Issam, Kortman, Hans, Hofmeijer, Jeannette, Martens, Jasper, van den Wijngaard, Ido, Boiten, Jelis, Lycklama à Nijeholt, Geert, Brouwers, Paul, Sturm, Emiel, Bulut, Tomas, de Laat, Karlijn, van Dijk, Lukas, Remmers, Michel, de Jong, Thijs, Rozeman, Anouk, Elgersma, Otto, Van der Veen, Bas, Sudiono, Davy, Mattle, Heinrich, Fiehler, Jens, van Kuijk, Sander, Nieboer, Daan, Lingsma, Hester, van Nuland, Rick, Roosendaal, Stefan, Krietemeijer, Menno, Postma, Alida, Van den Berg, René, Beenen, Ludo, Hammer, Sebastiaan, Meijer, Anton, van der Hoorn, Anouk, Yoo, Albert, Gerrits, Dick, Jansen, Ben, Truijman, Martine, Manschot, Sanne, Kerkhoff, Henk, Koudstaal, Peter, Chalos, Vicky, Berkhemer, Olvert, Versteeg, Adriaan, Wolff, Lennard, Su, Jiahang, van der Sluijs, Matthijs, van Voorst, Henk, Tolhuisen, Manon, ten Cate, Hugo, de Maat, Moniek, Donse-Donkel, Samantha, van Beusekom, Heleen, Taha, Aladdin, Barakzie, Aarazo, Treurniet, Kilian, van den Berg, Sophie, LeCouffe, Natalie, van de Graaf, Rob, de Ridder, Inger, Pinckaers, Florentina, Ceulemans, Angelique, Knapen, Robrecht, Robbe, Quirien, Sondag, Lotte, Kappelhof, Manon, Reinink, Rik, Silvis, Suzanne, Schreuder, Floris, Uniken Venema, Simone, van Meenen, Laura, Collette, Sabine, van Wijngaarden, Wilma, van der Steen, Wouter, Hoving, Jan, Verheesen, Sabrina, Sterrenberg, Martin, El Ghannouti, Naziha, Sprengers, Rita, van Ahee, Ayla, Zweedijk, Berber, Pellikaan, Wilma, Schonewille, Irati, Blauwendraat, Kitty, Drabbe, Yvonne, Kleine-Kathöfer, Anke, de Meris, Joke, Sandiman, Michelle, Dofferhoff-Vermeulen, Tamara, Simons, Michelle, Bongenaar, Hester, Smallegange, Maylee, van Loon, Anja, Kraus, Karin, Bos-Verheij, Erna, Santegoets, Ester, Kooij, Suze, Slotboom, Annemarie, Ponjee, Eva, Eilander, Rieke, Droste, Hanneke, van Veen, Esther, Visser, Rosalie, Lodico, Jasmijn, de Jong, Marieke, van der Minne, Friedus, Cleophas, Eefje, Muskens, Ernst, Nijst, Amy, Heiligers, Leontien, Martens, Yvonne, Slotboom, Miranda, Hintzen, Rogier, Jacobs, Bart, Huijberts, Ilse, Pinckaers, Florentina M E, Olthuis, Susanne G H, van Kuijk, Sander M J, Postma, Alida A, Boogaarts, Hieronymus D, Roos, Yvo B W E M, Majoie, Charles B L M, Dippel, Diederik W J, van Zwam, Wim H, and van Oostenbrugge, Robert J

Published
2024
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2. Prehospital transdermal glyceryl trinitrate in patients with presumed acute stroke (MR ASAP): an ambulance-based, multicentre, randomised, open-label, blinded endpoint, phase 3 trial

Author

van Ahee, Ayla, Visseren, Frank, Halkes, Patricia, van Eijk, Ruben, Simons, Michelle, Pellikaan, Wilma, Van Wijngaarden, Wilma, Ponjee, Eva, Geijtenbeek, Petra, Arts, Ton, Zock, Elles, Oudshoorn, Wilma, Steenwinkel, Frans, Samim, Hamdia, van Zandwijk, Mark, Vrielink, Lisette, Mulder, Peter Jan, Gerritsen, Aico, Ijzermans, Jim, Kooijman, Marjan, Francissen, Oscar, van Nuland, Rick, van Zwam, Wim, Jacobi, Linda, van den Berg, Rene, Beenen, Ludo, van Es, Adriaan, van Doormaal, Pieter-Jan, Lycklama a Nijeholt, Geert, van den Wijngaard, Ido, Yoo, Albert, Yo, Lonneke, Martens, Jasper, Hammer, Bas, Roosendaal, Stefan, Meijer, Anton, Krietemeijer, Menno, Bokkers, Reinoud, van der Hoorn, Anouk, Gerrits, Dick, Coutinho, Jonathan, Jansen, Ben, Manschot, Sanne, Koudstaal, Peter, Keizer, Koos, Chalos, Vicky, Versteeg, Adriaan, Wolff, Lennard, van Voorst, Henk, van der Sluijs, Matthijs, Hoving, Arnolt-Jan, Treurniet, Kilian, LeCouffe, Natalie, van de Graaf, Rob, Goldhoorn, Robert-Jan, Hinseveld, Wouter, Pirson, Anne, Sondag, Lotte, Kappelhof, Manon, Tolhuisen, Manon, Brouwer, Josje, van der Steen, Wouter, Rinkel, Leon, Bruggeman, Agnetha, Sprengers, Rita, Sterrenberg, Martin, Verheesen, Sabrina, Heiligers, Leontien, Martens, Yvonne, El Ghannouti, Naziha, Slotboom, Miranda, van den Berg, Sophie A, Uniken Venema, Simone M, Reinink, Hendrik, Hofmeijer, Jeannette, Schonewille, Wouter J, Miedema, Irene, Fransen, Puck S S, O Pruissen, D Martijn, Raaijmakers, Theodora W M, van Dijk, Gert W, de Leeuw, Frank-Erik, van Vliet, Jorine A, Kwa, Vincent I H, Kerkhoff, Henk, van 't Net, Alex, Boomars, Rene, Siegers, Arjen, Lok, Tycho, Caminada, Klaartje, Esteve Cuevas, Laura M, Visser, Marieke C, Zwetsloot, Casper P, Boomsma, Jooske M F, Schipper, Mirjam H, van Eijkelenburg, Roeland P J, Berkhemer, Olvert A, Nieboer, Daan, Lingsma, Hester F, Emmer, Bart J, van Oostenbrugge, Robert J, van der Lugt, Aad, Roos, Yvo B W E M, Majoie, Charles B L M, Dippel, Diederik W J, Nederkoorn, Paul J, and van der Worp, H Bart

Published
2022
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3. Safety and efficacy of periprocedural antithrombotics in patients with successful reperfusion after endovascular stroke treatment

Author

van der Steen, Wouter, van der Sluijs, P. Matthijs, van de Graaf, Rob A., Su, Ruisheng, Wolff, Lennard, van Voorst, Henk, den Hertog, Heleen M., van Doormaal, Pieter Jan, van Es, Adriaan C.G.M., Staals, Julie, van Zwam, Wim, Lingsma, Hester F., van den Berg, René, Majoie, Charles B.L.M., van der Lugt, Aad, Dippel, Diederik W.J., and Roozenbeek, Bob

Published
2022
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4. Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised controlled trial

Author

van der Steen, Wouter, van de Graaf, Rob A, Chalos, Vicky, Lingsma, Hester F, van Doormaal, Pieter Jan, Coutinho, Jonathan M, Emmer, Bart J, de Ridder, Inger, van Zwam, Wim, van der Worp, H Bart, van der Schaaf, Irene, Gons, Rob A R, Yo, Lonneke S F, Boiten, Jelis, van den Wijngaard, Ido, Hofmeijer, Jeannette, Martens, Jasper, Schonewille, Wouter, Vos, Jan Albert, Tuladhar, Anil Man, de Laat, Karlijn F, van Hasselt, Boudewijn, Remmers, Michel, Vos, Douwe, Rozeman, Anouk, Elgersma, Otto, Uyttenboogaart, Maarten, Bokkers, Reinoud P H, van Tuijl, Julia, Boukrab, Issam, van den Berg, René, Beenen, Ludo F M, Roosendaal, Stefan D, Postma, Alida Annechien, Krietemeijer, Menno, Lycklama, Geert, Meijer, Frederick J A, Hammer, Sebastiaan, van der Hoorn, Anouk, Yoo, Albert J, Gerrits, Dick, Truijman, Martine T B, Zinkstok, Sanne, Koudstaal, Peter J, Manschot, Sanne, Kerkhoff, Henk, Nieboer, Daan, Berkhemer, Olvert, Wolff, Lennard, van der Sluijs, P Matthijs, van Voorst, Henk, Tolhuisen, Manon, Roos, Yvo B W E M, Majoie, Charles B L M, Staals, Julie, van Oostenbrugge, Robert J, Jenniskens, Sjoerd F M, van Dijk, Lukas C, den Hertog, Heleen M, van Es, Adriaan C G M, van der Lugt, Aad, Dippel, Diederik W J, and Roozenbeek, Bob

Published
2022
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5. Improving outcomes after endovascular stroke treatment:The periprocedural use of antithrombotics and the risk of intracranial hemorrhage

Author

van der Steen, Wouter and van der Steen, Wouter

Abstract

The aim of this thesis was to improve the outcome of patients treated with endovascular stroke treatment. Specific aims were to assess the safety and effectiveness of the periprocedural use of intravenous antithrombotics and to evaluate the impact and characteristics of intracranial hemorrhages that can occur as a complication.

Published
2023

6. Symptomatic Intracranial Hemorrhage after Endovascular Stroke Treatment:External Validation of Prediction Models

Author

Van Der Ende, Nadinda A.M., Kremers, Femke C.C., Van Der Steen, Wouter, Venema, Esmee, Kappelhof, Manon, Majoie, Charles B.L.M., Postma, Alida A., Boiten, Jelis, Van Den Wijngaard, Ido R., Van Der Lugt, Aad, Dippel, Diederik W.J., Roozenbeek, Bob, Van Der Ende, Nadinda A.M., Kremers, Femke C.C., Van Der Steen, Wouter, Venema, Esmee, Kappelhof, Manon, Majoie, Charles B.L.M., Postma, Alida A., Boiten, Jelis, Van Den Wijngaard, Ido R., Van Der Lugt, Aad, Dippel, Diederik W.J., and Roozenbeek, Bob

Abstract

Background: Symptomatic intracranial hemorrhage (sICH) is a severe complication of reperfusion therapy for ischemic stroke. Multiple models have been developed to predict sICH or intracranial hemorrhage (ICH) after reperfusion therapy. We provide an overview of published models and validate their ability to predict sICH in patients treated with endovascular treatment in daily clinical practice. Methods: We conducted a systematic search to identify models either developed or validated to predict sICH or ICH after reperfusion therapy (intravenous thrombolysis and/or endovascular treatment) for ischemic stroke. Models were externally validated in the MR CLEAN Registry (n=3180; Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). The primary outcome was sICH according to the Heidelberg Bleeding Classification. Model performance was evaluated with discrimination (c-statistic, ideally 1; a c-statistic below 0.7 is considered poor in discrimination) and calibration (slope, ideally 1, and intercept, ideally 0). Results: We included 39 studies describing 40 models. The most frequently used predictors were baseline National Institutes of Health Stroke Scale (NIHSS; n=35), age (n=22), and glucose level (n=22). In the MR CLEAN Registry, sICH occurred in 188/3180 (5.9%) patients. Discrimination ranged from 0.51 (SPAN-100 [Stroke Prognostication Using Age and National Institutes of Health Stroke Scale]) to 0.61 (SITS-SICH [Safe Implementation of Treatments in Stroke Symptomatic Intracerebral Hemorrhage] and STARTING-SICH [STARTING Symptomatic Intracerebral Hemorrhage]). Best calibrated models were IST-3 (intercept, -0.15 [95% CI, -0.01 to -0.31]; slope, 0.80 [95% CI, 0.50-1.09]), SITS-SICH (intercept, 0.15 [95% CI, -0.01 to 0.30]; slope, 0.62 [95% CI, 0.38-0.87]), and STARTING-SICH (intercept, -0.03 [95% CI, -0.19 to 0.12]; slope, 0.56 [95% CI, 0.35-0.76]). Conclusions: The investigated models to predict sICH or ICH dis

Published
2023

7. Type of intracranial hemorrhage after endovascular stroke treatment:association with functional outcome

Author

Van Der Steen, Wouter, Van Der Ende, Nadinda A.M., Luijten, Sven P.R., Rinkel, Leon A., Van Kranendonk, Katinka R., Van Voorst, Henk, Roosendaal, Stefan D., Beenen, Ludo F.M., Coutinho, Jonathan M., Emmer, Bart J., Van Oostenbrugge, Robert J., Majoie, Charles B.L.M., Lingsma, Hester F., Van Der Lugt, Aad, Dippel, Diederik W.J., Roozenbeek, Bob, Van Der Steen, Wouter, Van Der Ende, Nadinda A.M., Luijten, Sven P.R., Rinkel, Leon A., Van Kranendonk, Katinka R., Van Voorst, Henk, Roosendaal, Stefan D., Beenen, Ludo F.M., Coutinho, Jonathan M., Emmer, Bart J., Van Oostenbrugge, Robert J., Majoie, Charles B.L.M., Lingsma, Hester F., Van Der Lugt, Aad, Dippel, Diederik W.J., and Roozenbeek, Bob

Abstract

Background: Intracranial hemorrhage (ICH) is a frequent complication after endovascular stroke treatment. Objective: To assess the association of the occurrence and type of ICH after endovascular treatment (EVT) with functional outcome. Methods: We analyzed data from the MR CLEAN-NO IV and MR CLEAN-MED trials. Both trials included adult patients with ischemic stroke with a large vessel occlusion in the anterior circulation, who were eligible for EVT. ICH was classified (1) as asymptomatic or symptomatic (concomitant neurological deterioration of ≥4 points on the NIHSS, or ≥2 points on 1 NIHSS item), and (2) according to the Heidelberg Bleeding Classification. We used multivariable ordinal logistic regression analyses to assess the association of the occurrence and type of ICH with the modified Rankin Scale score at 90 days. Results: Of 1017 included patients, 331 (33%) had an asymptomatic ICH, and 90 (9%) had a symptomatic ICH. Compared with no ICH, both asymptomatic (adjusted common OR (acOR)=0.76; 95% CI 0.58 to 0.98) and symptomatic (acOR=0.07; 95% CI 0.04 to 0.14) ICH were associated with worse functional outcome. In particular, isolated parenchymal hematoma type 2 (acOR=0.37; 95% CI 0.14 to 0.95), combined parenchymal hematoma with hemorrhage outside infarcted brain tissue (acOR=0.17; 95% CI 0.10 to 0.30), and combined hemorrhages outside infarcted brain tissue (acOR=0.14; 95% CI 0.03 to 0.74) were associated with worse functional outcome than no ICH. Strength of the association of ICH with functional outcome depends on the type of ICH. Although the association is stronger for symptomatic ICH, asymptomatic ICH after EVT is also associated with worse functional outcome.

Published
2023

8. Improving outcomes after endovascular stroke treatment: The periprocedural use of antithrombotics and the risk of intracranial hemorrhage

Author

van der Steen, Wouter, Dippel, Diederik, van der Lugt, Aad, Roozenbeek, Bob, and Neurology

Abstract

The aim of this thesis was to improve the outcome of patients treated with endovascular stroke treatment. Specific aims were to assess the safety and effectiveness of the periprocedural use of intravenous antithrombotics and to evaluate the impact and characteristics of intracranial hemorrhages that can occur as a complication.

Published
2023

9. Type of intracranial hemorrhage after endovascular stroke treatment: association with functional outcome.

Author

van der Steen, Wouter, van der Ende, Nadinda A. M., Luijten, Sven P. R., Rinkel, Leon A., van Kranendonk, Katinka R., van Voorst, Henk, Roosendaal, Stefan D., Beenen, Ludo F. M., Coutinho, Jonathan M., and Emmer, Bart J.

Subjects
STATISTICS, SCIENTIFIC observation, CEREBRAL hemorrhage, CONFIDENCE intervals, INTRACRANIAL hemorrhage, MULTIPLE regression analysis, REGRESSION analysis, TREATMENT effectiveness, SUBARACHNOID hemorrhage, COMPARATIVE studies, DESCRIPTIVE statistics, SUBDURAL hematoma, RESEARCH funding, ENDOVASCULAR surgery, DATA analysis
Abstract

Background Intracranial hemorrhage (ICH) is a frequent complication after endovascular stroke treatment. Objective To assess the association of the occurrence and type of ICH after endovascular treatment (EVT) with functional outcome. Methods We analyzed data from the MR CLEANNO IV and MR CLEAN- MED trials. Both trials included adult patients with ischemic stroke with a large vessel occlusion in the anterior circulation, who were eligible for EVT. ICH was classified (1) as asymptomatic or symptomatic (concomitant neurological deterioration of ≥4 points on the NIHSS, or ≥2 points on 1 NIHSS item), and (2) according to the Heidelberg Bleeding Classification. We used multivariable ordinal logistic regression analyses to assess the association of the occurrence and type of ICH with the modified Rankin Scale score at 90 days. Results Of 1017 included patients, 331 (33%) had an asymptomatic ICH, and 90 (9%) had a symptomatic ICH. Compared with no ICH, both asymptomatic (adjusted common OR (acOR)=0.76; 95% CI 0.58 to 0.98) and symptomatic (acOR=0.07; 95% CI 0.04 to 0.14) ICH were associated with worse functional outcome. In particular, isolated parenchymal hematoma type 2 (acOR=0.37; 95% CI 0.14 to 0.95), combined parenchymal hematoma with hemorrhage outside infarcted brain tissue (acOR=0.17; 95% CI 0.10 to 0.30), and combined hemorrhages outside infarcted brain tissue (acOR=0.14; 95% CI 0.03 to 0.74) were associated with worse functional outcome than no ICH. Strength of the association of ICH with functional outcome depends on the type of ICH. Although the association is stronger for symptomatic ICH, asymptomatic ICH after EVT is also associated with worse functional outcome. [ABSTRACT FROM AUTHOR]

Published
2023
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10. Symptomatic Intracranial Hemorrhage After Endovascular Stroke Treatment: External Validation of Prediction Models

Author

van der Ende, Nadinda A. M., Kremers, Femke C. C., van der Steen, Wouter, Venema, Esmee, Kappelhof, Manon, Majoie, Charles B. L. M., Postma, Alida A., Boiten, Jelis, van den Wijngaard, Ido R., van der Lugt, Aad, Dippel, Diederik W. J., Roozenbeek, Bob, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), MUMC+: DA BV AIOS Nucleaire Geneeskunde (8), MUMC+: DA BV AIOS Radiologie (8), Neurology, Radiology & Nuclear Medicine, Emergency Medicine, Radiology and Nuclear Medicine, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Amsterdam Neuroscience - Compulsivity, Impulsivity & Attention, Amsterdam Neuroscience - Neurovascular Disorders, and Radiology and nuclear medicine

Subjects
Advanced and Specialized Nursing, endovascular treatment, RISK, symptomatic intracranial hemorrhage, INTRACEREBRAL HEMORRHAGE, THROMBECTOMY, SICH NOMOGRAM, THERAPY, TRANSFORMATION, SCORE, ischemic stroke, Neurology (clinical), ACUTE ISCHEMIC-STROKE, INTRAVENOUS THROMBOLYSIS, PLASMINOGEN-ACTIVATOR, Cardiology and Cardiovascular Medicine
Abstract

Background: Symptomatic intracranial hemorrhage (sICH) is a severe complication of reperfusion therapy for ischemic stroke. Multiple models have been developed to predict sICH or intracranial hemorrhage (ICH) after reperfusion therapy. We provide an overview of published models and validate their ability to predict sICH in patients treated with endovascular treatment in daily clinical practice. Methods: We conducted a systematic search to identify models either developed or validated to predict sICH or ICH after reperfusion therapy (intravenous thrombolysis and/or endovascular treatment) for ischemic stroke. Models were externally validated in the MR CLEAN Registry (n=3180; Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). The primary outcome was sICH according to the Heidelberg Bleeding Classification. Model performance was evaluated with discrimination (c-statistic, ideally 1; a c-statistic below 0.7 is considered poor in discrimination) and calibration (slope, ideally 1, and intercept, ideally 0). Results: We included 39 studies describing 40 models. The most frequently used predictors were baseline National Institutes of Health Stroke Scale (NIHSS; n=35), age (n=22), and glucose level (n=22). In the MR CLEAN Registry, sICH occurred in 188/3180 (5.9%) patients. Discrimination ranged from 0.51 (SPAN-100 [Stroke Prognostication Using Age and National Institutes of Health Stroke Scale]) to 0.61 (SITS-SICH [Safe Implementation of Treatments in Stroke Symptomatic Intracerebral Hemorrhage] and STARTING-SICH [STARTING Symptomatic Intracerebral Hemorrhage]). Best calibrated models were IST-3 (intercept, −0.15 [95% CI, −0.01 to −0.31]; slope, 0.80 [95% CI, 0.50−1.09]), SITS−SICH (intercept, 0.15 [95% CI, −0.01 to 0.30]; slope, 0.62 [95% CI, 0.38−0.87]), and STARTING−SICH (intercept, −0.03 [95% CI, −0.19 to 0.12]; slope, 0.56 [95% CI, 0.35−0.76]). Conclusions: The investigated models to predict sICH or ICH discriminate poorly between patients with a low and high risk of sICH after endovascular treatment in daily clinical practice and are, therefore, not clinically useful for this patient population.

Published
2023
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11. Blood Pressure in the First 6 Hours Following Endovascular Treatment for Ischemic Stroke Is Associated with Outcome

Author

Samuels, Noor, van de Graaf, Rob A., van den Berg, Carlijn A. L., Venema, Simone M. Uniken, Bala, Kujtesa, van Doormaal, Pieter Jan, van der Steen, Wouter, Witvoet, Elbert, Boiten, Jelis, den Hertog, Heleen, Schonewille, Wouter J., Hofmeijer, Jeannette, Schreuder, Floris, Schreuder, Tobien A. H. C. M. L., van der Worp, H. Bart, Roos, Yvo B. W. E. M., Majoie, Charles B. L. M., Burke, James F., van Es, Adriaan C. G. M., van der Lugt, Aad, Roozenbeek, Bob, Lingsma, Hester F., Dippel, Diederik W. J., van Oostenbrugge, Robert Jan, van Zwam, Wim, Goldhoorn, Robert-Jan, Staals, Julie, Postma - Jacobi, Linda, Public Health, Neurology, Radiology & Nuclear Medicine, ACS - Atherosclerosis & ischemic syndromes, ANS - Neurovascular Disorders, Radiology and Nuclear Medicine, ACS - Microcirculation, MUMC+: Hersen en Zenuw Centrum (3), RS: Carim - B05 Cerebral small vessel disease, MUMC+: MA Neurologie (3), Klinische Neurowetenschappen, RS: Carim - B06 Imaging, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), MUMC+: MA AIOS Neurologie (9), MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: DA BV AIOS Radiologie (9), and MUMC+: DA BV AIOS Nucleaire Geneeskunde (9)

Subjects
Male, Original Contributions, MULTICENTER, THERAPY, law.invention, Randomized controlled trial, law, Modified Rankin Scale, Acute ischemic stroke, Stroke, Endovascular Procedures, blood pressure, THROMBECTOMY, Middle Aged, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], reperfusion, SAFETY, Hypertension, Cardiology, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, TRIAL, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, guideline, Adult, medicine.medical_specialty, Clinical and Population Sciences, All institutes and research themes of the Radboud University Medical Center, Internal medicine, SCORE, medicine, ischemic stroke, Humans, cardiovascular diseases, Endovascular treatment, Aged, Advanced and Specialized Nursing, cerebral hemorrhage, business.industry, Odds ratio, Recovery of Function, medicine.disease, Blood pressure, Ischemic stroke, Neurology (clinical), business
Abstract

Supplemental Digital Content is available in the text., Background and Purpose: Optimal blood pressure (BP) management in the acute phase of ischemic stroke remains an unresolved issue. It is uncertain whether guidelines for BP management during and after intravenous alteplase can be extrapolated to endovascular treatment (EVT) for stroke due to large artery occlusion in the anterior circulation. We evaluated the associations between systolic BP (SBP) in the first 6 hours following EVT and functional outcome as well as symptomatic intracranial hemorrhage. Methods: Patients of 8 MR CLEAN (Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry centers, with available data on SBP in the 6 hours following EVT, were analyzed. We evaluated maximum, minimum, and mean SBP. Study outcomes were functional outcome (modified Rankin Scale) at 90 days and symptomatic intracranial hemorrhage. We used multivariable ordinal and binary regression analysis to adjust for important prognostic factors and studied possible effect modification by successful reperfusion. Results: Post-EVT SBP data were available for 1161/1796 patients. Higher maximum SBP (per 10 mm Hg increments) was associated with worse functional outcome (adjusted common odds ratio, 0.93 [95% CI, 0.88–0.98]) and a higher rate of symptomatic intracranial hemorrhage (adjusted odds ratio, 1.17 [95% CI, 1.02–1.36]). The association between minimum SBP and functional outcome was nonlinear with an inflection point at 124 mm Hg. Minimum SBP lower and higher than the inflection point were associated with worse functional outcomes (adjusted common odds ratio, 0.85 per 10 mm Hg decrements [95% CI, 0.76–0.95] and adjusted common odds ratio, 0.81 per 10 mm Hg increments [95% CI, 0.71–0.92]). No association between mean SBP and functional outcome was observed. Successful reperfusion did not modify the relation of SBP with any of the outcomes. Conclusions: Maximum SBP in the first 6 hours following EVT is positively associated with worse functional outcome and an increased risk of symptomatic intracranial hemorrhage. Both lower and higher minimum SBP are associated with worse outcomes. A randomized trial to evaluate whether modifying post-intervention SBP results in better outcomes after EVT for ischemic stroke seems justified.

Published
2021
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12. Effect of Intravenous Alteplase Treatment on First-Line Stent Retriever Versus Aspiration Alone During Endovascular Treatment

Author

Rinkel, Leon A., primary, Treurniet, Kilian M., additional, Nieboer, Daan, additional, Kappelhof, Manon, additional, LeCouffe, Natalie E., additional, Bruggeman, Agnetha A.E., additional, van Zwam, Wim H., additional, Lycklama à Nijeholt, Geert J., additional, Ghariq, Elyas, additional, Uyttenboogaart, Maarten, additional, Dippel, Diederik W.J., additional, Roos, Yvo B.W.E.M., additional, Coutinho, Jonathan M., additional, Majoie, Charles B.L.M., additional, Emmer, Bart J., additional, Roozenbeek, Bob, additional, van Es, Adriaan, additional, de Ridder, Inger, additional, van der Worp, Bart, additional, Lo, Rob, additional, Keizer, Koos, additional, Gons, Rob, additional, Yo, Lonneke, additional, Boiten, Jelis, additional, van den Wijngaard, Ido, additional, Hofmeijer, Jeanette, additional, Martens, Jasper, additional, Schonewille, Wouter, additional, Albert Vos, Jan, additional, Tuladhar, Anil, additional, Schreuder, Floris, additional, Boogaarts, Jeroen, additional, Jenniskens, Sjoerd, additional, de Laat, Karlijn, additional, van Dijk, Lukas, additional, den Hertog, Heleen, additional, van Hasselt, Boudewijn, additional, Brouwers, Paul, additional, Sturm, Emiel, additional, Bulut, Tomas, additional, Remmers, Michel, additional, van Norden, Anouk, additional, de Jong, Thijs, additional, Rozeman, Anouk, additional, Elgersma, Otto, additional, Bokkers, Reinoud, additional, van Tuijl, Julia, additional, Boukrab, Issam, additional, Kortman, Hans, additional, Costalat, Vincent, additional, Arquizan, Caroline, additional, Lemmens, Robin, additional, Demeestere, Jelle, additional, Desfontaines, Philippe, additional, Brisbois, Denis, additional, Clarençon, Frédéric, additional, Samson, Yves, additional, Brown, Martin, additional, White, Phil, additional, Gregson, John, additional, van Nuland, Rick, additional, van der Lugt, Aad, additional, Jacobi, Linda, additional, van den Berg, René, additional, Beenen, Ludo, additional, van Doormaal, Pieter-Jan, additional, Yoo, Albert, additional, Hammer, Bas, additional, Roosendaal, Stefan, additional, Meijer, Anton, additional, Krietemeijer, Menno, additional, van der Hoorn, Anouk, additional, Gerrits, Dick, additional, van Oostenbrugge, Robert, additional, Jansen, Ben, additional, Manschot, Sanne, additional, Kerkhof, Henk, additional, Koudstaal, Peter, additional, Lingsma, Hester, additional, Chalos, Vicky, additional, Berkhemer, Olvert, additional, Versteeg, Adriaan, additional, Wolff, Lennard, additional, Su, Jiahang, additional, Tolhuisen, Manon, additional, van Voorst, Henk, additional, ten Cate, Hugo, additional, de Maat, Moniek, additional, Donse-Donkel, Samantha, additional, van Beusekom, Heleen, additional, Taha, Aladdin, additional, van den Berg, Sophie, additional, van de Graaf, Rob, additional, Goldhoorn, Robert-Jan, additional, Hinsenveld, Wouter, additional, Pirson, Anne, additional, Sondag, Lotte, additional, Reinink, Rik, additional, Brouwer, Josje, additional, Collette, Sabine, additional, van der Steen, Wouter, additional, Sprengers, Rita, additional, Sterrenberg, Martin, additional, El Ghannouti, Naziha, additional, Verheesen, Sabrina, additional, Pellikaan, Wilma, additional, Blauwendraat, Kitty, additional, Drabbe, Yvonne, additional, de Meris, Joke, additional, Simons, Michelle, additional, Bongenaar, Hester, additional, van Loon, Anja, additional, Ponjee, Eva, additional, Eilander, Rieke, additional, Kooij, Suze, additional, de Jong, Marieke, additional, Santegoets, Esther, additional, Roodenburg, Suze, additional, van Ahee, Ayla, additional, Moynier, Marinette, additional, Devroye, Annemie, additional, Marcis, Evelyn, additional, Iezzi, Ingrid, additional, David, Annie, additional, Talbi, Atika, additional, Heiligers, Leontien, additional, and Martens, Yvonne, additional

Published
2022
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13. Type of intracranial hemorrhage after endovascular stroke treatment: association with functional outcome

Author

van der Steen, Wouter, primary, van der Ende, Nadinda A M, additional, Luijten, Sven P R, additional, Rinkel, Leon A, additional, van Kranendonk, Katinka R, additional, van Voorst, Henk, additional, Roosendaal, Stefan D, additional, Beenen, Ludo F M, additional, Coutinho, Jonathan M, additional, Emmer, Bart J, additional, van Oostenbrugge, Robert J, additional, Majoie, Charles B L.M, additional, Lingsma, Hester F, additional, van der Lugt, Aad, additional, Dippel, Diederik W J, additional, and Roozenbeek, Bob, additional

Published
2022
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14. Determinants of Symptomatic Intracranial Hemorrhage After Endovascular Stroke Treatment: A Retrospective Cohort Study

Author

van der Steen, Wouter, primary, van der Ende, Nadinda A.M., additional, van Kranendonk, Katinka R., additional, Chalos, Vicky, additional, van Oostenbrugge, Robert J., additional, van Zwam, Wim H., additional, Roos, Yvo B.W.E.M., additional, van Doormaal, Pieter J., additional, van Es, Adriaan C.G.M., additional, Lingsma, Hester F., additional, Majoie, Charles B.L.M., additional, van der Lugt, Aad, additional, Dippel, Diederik W.J., additional, Roozenbeek, Bob, additional, Boiten, Jelis, additional, Albert Vos, Jan, additional, Jansen, Ivo G.H., additional, Mulder, Maxim J.H.L., additional, Goldhoorn, Robert- Jan B., additional, Compagne, Kars C.J., additional, Kappelhof, Manon, additional, Brouwer, Josje, additional, den Hartog, Sanne J., additional, Emmer, Bart J., additional, Coutinho, Jonathan M., additional, Schonewille, Wouter J., additional, Wermer, Marieke J.H., additional, van Walderveen, Marianne A.A., additional, Staals, Julie, additional, Hofmeijer, Jeannette, additional, Martens, Jasper M., additional, Lycklama à Nijeholt, Geert J., additional, de Bruijn, Sebastiaan F., additional, van Dijk, Lukas C., additional, van der Worp, H. Bart, additional, Lo, Rob H., additional, van Dijk, Ewoud J., additional, Boogaarts, Hieronymus D., additional, de Vries, J., additional, de Kort, Paul L.M., additional, van Tuijl, Julia, additional, Peluso, Jo P., additional, Fransen, Puck, additional, van den Berg, Jan S.P., additional, van Hasselt, Boudewijn A.A.M., additional, Aerden, Leo A.M., additional, Dallinga, René J., additional, Uyttenboogaart, Maarten, additional, Eschgi, Omid, additional, Bokkers, Reinoud P.H., additional, Schreuder, Tobien H.C.M.L., additional, Heijboer, Roel J.J., additional, Keizer, Koos, additional, Yo, Lonneke S.F., additional, den Hertog, Heleen M., additional, Bulut, Tomas, additional, Brouwers, Paul J.A.M., additional, Lycklama, Geert J., additional, Sprengers, Marieke E.S., additional, Jenniskens, Sjoerd F.M., additional, van den Berg, René, additional, Yoo, Albert J., additional, Beenen, Ludo F.M., additional, Postma, Alida A., additional, Roosendaal, Stefan D., additional, van der Kallen, Bas F.W., additional, van den Wijngaard, Ido R., additional, Vos, Jan Albert, additional, Bot, Joost, additional, Meijer, Anton, additional, Ghariq, Elyas, additional, van Proosdij, Marc P., additional, Krietemeijer, G. Menno, additional, Lo, Rob, additional, Dinkelaar, Wouter, additional, Auke, P.A., additional, Hammer, Bas, additional, Pegge, Sjoert, additional, van der Hoorn, Anouk, additional, Vinke, Saman, additional, Flach, H. Zwenneke, additional, el Ghannouti, Naziha, additional, Sterrenberg, Martin, additional, Pellikaan, Wilma, additional, Sprengers, Rita, additional, Elfrink, Marjan, additional, Simons, Michelle, additional, Vossers, Marjolein, additional, de Meris, Joke, additional, Vermeulen, Tamara, additional, Geerlings, Annet, additional, van Vemde, Gina, additional, Simons, Tiny, additional, Messchendorp, Gert, additional, Nicolaij, Nynke, additional, Bongenaar, Hester, additional, Bodde, Karin, additional, Kleijn, Sandra, additional, Lodico, Jasmijn, additional, Droste, Hanneke, additional, Wollaert, Maureen, additional, Verheesen, Sabrina, additional, Jeurrissen, D., additional, Bos, Erna, additional, Drabbe, Yvonne, additional, Sandiman, Michelle, additional, Aaldering, Nicoline, additional, Zweedijk, Berber, additional, Vervoort, Jocova, additional, Ponjee, Eva, additional, Romviel, Sharon, additional, Kanselaar, Karin, additional, Barning, Denn, additional, Venema, Esmee, additional, Geuskens, Ralph R., additional, van Straaten, Tim, additional, Ergezen, Saliha, additional, Harmsma, Roger R.M., additional, Muijres, Daan, additional, de Jong, Anouk, additional, Berkhemer, Olvert A., additional, Boers, Anna M.M., additional, Huguet, J., additional, Groot, P.F.C., additional, Mens, Marieke A., additional, Treurniet, Kilian M., additional, Tolhuisen, Manon L., additional, Alves, Heitor, additional, Weterings, Annick J., additional, Kirkels, Eleonora L.F., additional, Voogd, Eva J.H.F., additional, Schupp, Lieve M., additional, Collette, Sabine L., additional, Groot, Adrien E.D., additional, LeCouffe, Natalie E., additional, Konduri, Praneeta R., additional, Prasetya, Haryadi, additional, Arrarte- Terreros, Nerea, additional, Ramos, Lucas A., additional, Brown, Martin M., additional, Liebig, Thomas, additional, van der Heijden, Esther, additional, Ghannouti, Naziha, additional, Fleitour, Nadine, additional, Hooijenga, Imke, additional, Puppels, Corina, additional, Geerling, Annet, additional, Lindl-Velema, Annemieke, additional, de Ridder, Ans, additional, Greebe, Paut, additional, de Bont- Stikkelbroeck, Jose, additional, Haaglanden, MC, additional, Janssen, Kirsten, additional, Licher, Silvan, additional, Boodt, Nikki, additional, Ros, Adriaan, additional, Slokkers, Ilse, additional, Ganpat, Raymie-Jayce, additional, Mulder, Maxim, additional, Saiedie, Nawid, additional, Heshmatollah, Alis, additional, Schipperen, Stefanie, additional, Vinken, Stefan, additional, van Boxtel, Tiemen, additional, Koets, Jeroen, additional, Boers, Merel, additional, Santos, Emilie, additional, Borst, Jordi, additional, Jansen, Ivo, additional, Lucas, Marit, additional, Geuskens, Ralph Renan, additional, and Sales Barros, Roeland, additional

Published
2022
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15. Timing of symptomatic intracranial hemorrhage after endovascular stroke treatment

Author

van der Steen, Wouter, primary, van der Ende, Nadinda AM, additional, van Kranendonk, Katinka R, additional, Chalos, Vicky, additional, Brouwer, Josje, additional, van Oostenbrugge, Robert J, additional, van Zwam, Wim H, additional, van Doormaal, Pieter J, additional, van Es, Adriaan CGM, additional, Majoie, Charles BLM, additional, van der Lugt, Aad, additional, Dippel, Diederik WJ, additional, and Roozenbeek, Bob, additional

Published
2022
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16. Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED):an open-label, multicentre, randomised controlled trial

Author

van der Steen, Wouter, van de Graaf, Rob A., Chalos, Vicky, Lingsma, Hester F., van Doormaal, Pieter Jan, Coutinho, Jonathan M., Emmer, Bart J., de Ridder, Inger, van Zwam, Wim, van der Worp, H. Bart, van der Schaaf, Irene, Gons, Rob A.R., Yo, Lonneke S.F., Boiten, Jelis, van den Wijngaard, Ido, Hofmeijer, Jeannette, Martens, Jasper, Schonewille, Wouter, Vos, Jan Albert, Tuladhar, Anil Man, de Laat, Karlijn F., van Hasselt, Boudewijn, Remmers, Michel, Vos, Douwe, Rozeman, Anouk, Elgersma, Otto, Uyttenboogaart, Maarten, Bokkers, Reinoud P.H., van Tuijl, Julia, Boukrab, Issam, van den Berg, René, Beenen, Ludo F.M., Roosendaal, Stefan D., Postma, Alida Annechien, Krietemeijer, Menno, Lycklama, Geert, Meijer, Frederick J.A., Hammer, Sebastiaan, van der Hoorn, Anouk, Yoo, Albert J., Gerrits, DIck, Truijman, MTB, Zinkstok, Sanne M., Koudstaal, Peter J., Manschot, Sanne, Kerkhoff, Henk, Nieboer, Daan, Berkhemer, Olvert, Wolff, Lennard, van der Sluijs, Matthijs, van Voorst, Henk, Tolhuisen, ML, Roos, Bwem, Majoie, Charles B.L.M., Staals, Julie, van Oostenbrugge, Robert J., Jenniskens, Sjoerd F.M., van Dijk, Lukas C., den Hertog, Heleen M., van Es, Adriaan C.G.M., van der Lugt, Aad, Dippel, Diederik W.J., Roozenbeek, Bob, van der Steen, Wouter, van de Graaf, Rob A., Chalos, Vicky, Lingsma, Hester F., van Doormaal, Pieter Jan, Coutinho, Jonathan M., Emmer, Bart J., de Ridder, Inger, van Zwam, Wim, van der Worp, H. Bart, van der Schaaf, Irene, Gons, Rob A.R., Yo, Lonneke S.F., Boiten, Jelis, van den Wijngaard, Ido, Hofmeijer, Jeannette, Martens, Jasper, Schonewille, Wouter, Vos, Jan Albert, Tuladhar, Anil Man, de Laat, Karlijn F., van Hasselt, Boudewijn, Remmers, Michel, Vos, Douwe, Rozeman, Anouk, Elgersma, Otto, Uyttenboogaart, Maarten, Bokkers, Reinoud P.H., van Tuijl, Julia, Boukrab, Issam, van den Berg, René, Beenen, Ludo F.M., Roosendaal, Stefan D., Postma, Alida Annechien, Krietemeijer, Menno, Lycklama, Geert, Meijer, Frederick J.A., Hammer, Sebastiaan, van der Hoorn, Anouk, Yoo, Albert J., Gerrits, DIck, Truijman, MTB, Zinkstok, Sanne M., Koudstaal, Peter J., Manschot, Sanne, Kerkhoff, Henk, Nieboer, Daan, Berkhemer, Olvert, Wolff, Lennard, van der Sluijs, Matthijs, van Voorst, Henk, Tolhuisen, ML, Roos, Bwem, Majoie, Charles B.L.M., Staals, Julie, van Oostenbrugge, Robert J., Jenniskens, Sjoerd F.M., van Dijk, Lukas C., den Hertog, Heleen M., van Es, Adriaan C.G.M., van der Lugt, Aad, Dippel, Diederik W.J., and Roozenbeek, Bob

Abstract

Background: Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke. Methods: We did an open-label, multicentre, randomised controlled trial with a 2 × 3 factorial design in 15 centres in the Netherlands. We enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage. Randomisation was done using a web-based procedure with permuted blocks and stratified by centre. Patients were randomly assigned (1:1) to receive either periprocedural intravenous aspirin (300 mg bolus) or no aspirin, and randomly assigned (1:1:1) to receive moderate-dose unfractionated heparin (5000 IU bolus followed by 1250 IU/h for 6 h), low-dose unfractionated heparin (5000 IU bolus followed by 500 IU/h for 6 h), or no unfractionated heparin. The primary outcome was the score on the modified Rankin Scale at 90 days. Symptomatic intracranial haemorrhage was the main safety outcome. Analyses were based on intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. This trial is registered with the International Standard Randomised Controlled Trial Number, ISRCTN76741621. Findings: Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-tre

Published
2022

17. Determinants of Symptomatic Intracranial Hemorrhage After Endovascular Stroke Treatment:A Retrospective Cohort Study

Author

Van Der Steen, Wouter, Van Der Ende, Nadinda A.M., Van Kranendonk, Katinka R., Chalos, Vicky, Van Oostenbrugge, Robert J., Van Zwam, Wim H., Roos, Yvo B.W.E.M., Van Doormaal, Pieter J., Van Es, Adriaan C.G.M., Lingsma, Hester F., Majoie, Charles B.L.M., Van Der Lugt, Aad, Dippel, Diederik W.J., Roozenbeek, Bob, Van Der Steen, Wouter, Van Der Ende, Nadinda A.M., Van Kranendonk, Katinka R., Chalos, Vicky, Van Oostenbrugge, Robert J., Van Zwam, Wim H., Roos, Yvo B.W.E.M., Van Doormaal, Pieter J., Van Es, Adriaan C.G.M., Lingsma, Hester F., Majoie, Charles B.L.M., Van Der Lugt, Aad, Dippel, Diederik W.J., and Roozenbeek, Bob

Abstract

Background: Symptomatic intracranial hemorrhage (sICH) is a serious complication after endovascular treatment for ischemic stroke. We aimed to identify determinants of its occurrence and location. Methods: We retrospectively analyzed data from the Dutch MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) and MR CLEAN registry. We included adult patients with a large vessel occlusion in the anterior circulation who underwent endovascular treatment within 6.5 hours of stroke onset. We used univariable and multivariable logistic regression analyses to identify determinants of overall sICH occurrence, sICH within infarcted brain tissue, and sICH outside infarcted brain tissue. Results: SICH occurred in 203 (6%) of 3313 included patients and was located within infarcted brain tissue in 50 (25%), outside infarcted brain tissue in 23 (11%), and both within and outside infarcted brain tissue in 116 (57%) patients. In 14 patients (7%), data on location were missing. Prior antiplatelet use, baseline systolic blood pressure, baseline plasma glucose levels, post-endovascular treatment modified treatment in cerebral ischemia score, and duration of procedure were associated with all outcome parameters. In addition, determinants of sICH within infarcted brain tissue included history of myocardial infarction (adjusted odds ratio, 1.65 [95% CI, 1.06-2.56]) and poor collateral score (adjusted odds ratio, 1.42 [95% CI, 1.02-1.95]), whereas determinants of sICH outside infarcted brain tissue included level of occlusion on computed tomography angiography (internal carotid artery or internal carotid artery terminus compared with M1: adjusted odds ratio, 1.79 [95% CI, 1.16-2.78]). Conclusions: Several factors, some potentially modifiable, are associated with sICH occurrence. Further studies should investigate whether modification of baseline systolic blood pressure or plasma glucose level could reduce the risk of

Published
2022

18. sj-docx-1-eso-10.1177_23969873221112279 – Supplemental material for Timing of symptomatic intracranial hemorrhage after endovascular stroke treatment

Author

van der Steen, Wouter, van der Ende, Nadinda AM, van Kranendonk, Katinka R, Chalos, Vicky, Brouwer, Josje, van Oostenbrugge, Robert J, van Zwam, Wim H, van Doormaal, Pieter J, van Es, Adriaan CGM, Majoie, Charles BLM, van der Lugt, Aad, Dippel, Diederik WJ, and Roozenbeek, Bob

Subjects
FOS: Clinical medicine, Cardiology, Medicine, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, sj-docx-1-eso-10.1177_23969873221112279 for Timing of symptomatic intracranial hemorrhage after endovascular stroke treatment by Wouter van der Steen, Nadinda AM van der Ende, Katinka R van Kranendonk, Vicky Chalos, Josje Brouwer, Robert J van Oostenbrugge, Wim H van Zwam, Pieter J van Doormaal, Adriaan CGM van Es, Charles BLM Majoie, Aad van der Lugt, Diederik WJ Dippel and Bob Roozenbeek in European Stroke Journal

Published
2022
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19. Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design.

Author

Chalos, Vicky, A. van de Graaf, Rob, Roozenbeek, Bob, C. G. M. van Es, Adriaan, M. den Hertog, Heleen, Staals, Julie, van Dijk, Lukas, F.M. Jenniskens, Sjoerd, J. van Oostenbrugge, Robert, H. van Zwam, Wim, B.W.E.M. Roos, Yvo, B.L.M. Majoie, Charles, F. Lingsma, Hester, van der Lugt, Aad, W.J. Dippel, Diederik, on behalf of the MR CLEAN-MED investigators, Dippel, Diederik, van der Lugt, Aad, van de Graaf, Rob, and van der Steen, Wouter

Subjects
ASPIRIN, ENDOVASCULAR surgery, HEPARIN, PLATELET aggregation inhibitors, CLINICAL trials, TREATMENT effectiveness
Abstract

Background: Despite evidence of a quite large beneficial effect of endovascular treatment (EVT) for ischemic stroke caused by anterior circulation large vessel occlusion, many patients do not recover even after complete recanalization. To some extent, this may be attributable to incomplete microvascular reperfusion, which can possibly be improved by antiplatelet agents and heparin. It is unknown whether periprocedural antithrombotic medication in patients treated with EVT improves functional outcome. The aim of this study is to assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin (UFH), alone, or in combination, given to patients with an ischemic stroke caused by an intracranial large vessel occlusion in the anterior circulation during EVT.Methods: MR CLEAN-MED is a multicenter phase III trial with a prospective, 2 × 3 factorial randomized, open label, blinded end-point (PROBE) design, which aims to enroll 1500 patients. The trial is designed to evaluate the effect of intravenous ASA (300 mg), UFH (low or moderate dose), both or neither as adjunctive therapy to EVT. We enroll adult patients with a clinical diagnosis of stroke (NIHSS ≥ 2) and with a confirmed intracranial large vessel occlusion in the anterior circulation on CTA or MRA, when EVT within 6 h from symptom onset is indicated and possible. The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Treatment effect on the mRS will be estimated with ordinal logistic regression analysis, with adjustment for main prognostic variables. Secondary outcomes include stroke severity measured with the NIHSS at 24 h and at 5-7 days, follow-up infarct volume, symptomatic intracranial hemorrhage (sICH), and mortality.Discussion: Clinical equipoise exists whether antithrombotic medication should be administered during EVT for a large vessel occlusion, as ASA and/or UFH may improve functional outcome, but might also lead to an increased risk of sICH. When one or both of the study treatments show the anticipated effect on outcome, we will be able to improve outcome of patients treated with EVT by 5%. This amounts to more than 50 patients annually in the Netherlands, more than 1800 in Europe, and more than 1300 in the USA.Trial Registration: ISRCT, ISRCTN76741621 . Dec 6, 2017. [ABSTRACT FROM AUTHOR]

Published
2020
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20. [Vitamin B6 deficiency caused by the use of levodopa].

Author

van der Steen W, den Heijer T, and Groen J

Subjects
Administration, Oral, Aged, Antiparkinson Agents administration & dosage, Carbidopa administration & dosage, Drug Combinations, Humans, Levodopa administration & dosage, Middle Aged, Tablets, Antiparkinson Agents adverse effects, Carbidopa adverse effects, Levodopa adverse effects, Vitamin B 6 Deficiency chemically induced
Abstract

Background: There are indications that the use of levodopa/carbidopa can cause symptomatic vitamin B6 deficiency. However, this has only been described for patients who used the product in the form of an intestinal gel., Case Description: We are describing 3 patients who developed vitamin B6 deficiency while using levodopa/carbidopa in tablet form. All 3 patients developed symptoms consistent with peripheral axonal polyneuropathy., Conclusion: The cases of our patients are providing support for the idea that oral use of levodopa/carbidopa can cause symptomatic vitamin B6 deficiency.

Published
2018

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