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1. The impact of patient-reported frailty on cardiovascular outcomes in elderly patients after non-ST-acute coronary syndrome

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, van den Broek, W. W.A., Gimbel, M. E., Hermanides, R. S., Runnett, C., Storey, R. F., Knaapen, P., Emans, M. E., Oemrawsingh, R. M., Cooke, J., Galasko, G., Walhout, R., Stoel, M. G., von Birgelen, C., van Bergen, Paul F.M.M., Brinckman, S. L., Aksoy, I., Liem, A., van't Hof, A. W.J., Jukema, J. W., Heestermans, A. A.C.M., Nicastia, D., Alber, H., Austin, D., Nasser, A., Deneer, V., ten Berg, J. M., Afd Pharmacoepi & Clinical Pharmacology, PECP – Centre for Clinical Therapeutics, Pharmacoepidemiology and Clinical Pharmacology, van den Broek, W. W.A., Gimbel, M. E., Hermanides, R. S., Runnett, C., Storey, R. F., Knaapen, P., Emans, M. E., Oemrawsingh, R. M., Cooke, J., Galasko, G., Walhout, R., Stoel, M. G., von Birgelen, C., van Bergen, Paul F.M.M., Brinckman, S. L., Aksoy, I., Liem, A., van't Hof, A. W.J., Jukema, J. W., Heestermans, A. A.C.M., Nicastia, D., Alber, H., Austin, D., Nasser, A., Deneer, V., and ten Berg, J. M.

Published
2024

2. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial

Author

Tardif, Jean-Claude, Ballantyne, Christie M, Barter, Philip, Dasseux, Jean-Louis, Fayad, Zahi A, Guertin, Marie-Claude, Kastelein, John JP, Keyserling, Constance, Klepp, Heather, Koenig, Wolfgang, L'Allier, Philippe L, Lespérance, Jacques, Lüscher, Thomas F, Paolini, John F, Tawakol, Ahmed, Waters, David D, Pfeffer, M, Brown, V, Rouleau, J, Watkins, P, Wei, LJ, Gosselin, G, Chayer, C, Lanthier, S, Pelletier, GB, Racine, N, Agarwal, H, Brilakis, E, Cannon, L, Carrié, D, Corbelli, J, Coste, P, de Winter, R, Diaz, A, Eisenberg, S, Ennis, B, Fajadet, J, Fam, N, Fortuin, D, Gessler, C, Grines, C, Guerra, D, Gum, H, Haldis, T, Heestermans, T, Herrman, JP, Huynh, T, Kedhi, E, Koren, M, Kouz, S, Krolick, M, Kumkumian, G, Lavi, S, Li, RJ, Masud, ARZ, McAlhany, C, McGrew, FA, O'Shaughnessy, C, Ophuis, AJM Oude, Parr, K, Penny, W, Pesant, Y, Post, H, Robinson, S, Rodes-Cabau, J, Roy, A, Schulman, S, Spence, F, Stouffer, G, Stys, T, Sussex, B, Tahirkheli, N, Tardif, J-C, Grégoire, J, Berg, J ten, van Boven, AJ, von Birgelen, C, and Weinstein, D

Subjects
Aging, Clinical Trials and Supportive Activities, Atherosclerosis, Clinical Research, Cardiovascular, Heart Disease - Coronary Heart Disease, Heart Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Acute Coronary Syndrome, Adult, Aged, Aged, 80 and over, Apolipoprotein A-I, Cardiovascular Agents, Coronary Angiography, Coronary Artery Disease, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Phospholipids, Prospective Studies, Recombinant Proteins, Treatment Outcome, Ultrasonography, Coronary disease, High-density lipoproteins, Clinical trial, Can HDL Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

AimHigh-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo.ObjectiveTo investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA).Design and settingA prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2-5) weeks after the last study infusion.PatientsFive hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively.InterventionPatients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001.Main outcome measuresThe primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints.ResultsThe nominal change in the total atheroma volume (adjusted means) was -2.71, -3.13, -1.50, and -3.05 mm(3) with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: P = 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, -0.02, 0.01, and 0.19%; nominal P = 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was -0.022, -0.036, -0.022, and -0.015 mm (nominal P = 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was -0.51, 2.65, 0.71, and -0.77% (compared with placebo, nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups.ConclusionCER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study. Name of the trial registry: Clinicaltrials.gov; Registry's URL: http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2;Trial registration numberNCT01201837.

Published
2014

5. Clinical outcome up to 2 years after percutaneous coronary intervention in all-comers with concomitant symptomatic peripheral arterial disease: a pooled analysis in 9,204 randomized trial participants

Author

Pinxterhuis, T H, primary, Ploumen, E H, additional, Zocca, P, additional, Doggen, C J M, additional, Schotborgh, C E, additional, Anthonio, R L, additional, Roguin, A, additional, Danse, P W, additional, Benit, E, additional, Aminian, A, additional, Stoel, M G, additional, Linssen, G C M, additional, Geelkerken, R H, additional, and Von Birgelen, C, additional

Published
2022
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6. COVID-19 pandemic, mechanical reperfusion and 30-day mortality in ST elevation myocardial infarction

Author

De Luca G, Algowhary M, Uguz B, Oliveira DC, Ganyukov V, Zimbakov Z, Cercek M, Jensen LO, Loh PH, Calmac L, Roura-Ferrer G, Quadros A, Milewski M, Scotto di Uccio F, von Birgelen C, Versaci F, Ten Berg J, Casella G, Wong ASL, Kala P, Diez Gil JL, Carrillo X, Dirksen MT, Becerra-Muñoz VM, Kang-Yin Lee M, Juzar DA, de Moura Joaquim R, Paladino R, Milicic D, Davlouros P, Bakraceski N, Zilio F, Donazzan L, Kraaijeveld AO, Galasso G, Lux A, Marinucci L, Guiducci V, Menichelli M, Scoccia A, Yamac A, Ugur Mert K, Flores Rios X, Kovarnik T, Kidawa M, Moreu J, Flavien V, Fabris E, Lozano Martìnez-Luengas I, Boccalatte M, Bosa Ojeda F, Arellano-Serrano C, Caiazzo G, Cirrincione G, Kao HL, Sanchis Fores J, Vignali L, Pereira H, Manzo-Silberman S, Ordonez S, Özkan AA, Scheller B, Lehtola H, Teles R, Mantis C, Ylitalo A, Brum Silveira JA, Zoni R, Bessonov I, Savonitto S, Kochiadakis G, Alexopoulos D, Uribe C, Kanakakis J, Faurie B, Gabrielli G, Gutiérrez A, Bachini JP, Rocha A, Tam FC, Rodriguez A, Lukito A, Saint-Joy V, Pessah G, Tuccillo B, Cortese G, Parodi G, Bouraghda MA, Kedhi E, Lamelas P, Suryapranata H, Nardin M, Verdoia M, ISACS-STEMI COVID-19, Collaborators, RS: Carim - H01 Clinical atrial fibrillation, Cardiologie, De Luca, G., Algowhary, M., Uguz, B., Oliveira, D. C., Ganyukov, V., Zimbakov, Z., Cercek, M., Jensen, L. O., Loh, P. H., Calmac, L., Roura-Ferrer, G., Quadros, A., Milewski, M., Scotto di Uccio, F., von Birgelen, C., Versaci, F., Ten Berg, J., Casella, G., Wong, A. S. L., Kala, P., Diez Gil, J. L., Carrillo, X., Dirksen, M. T., Becerra-Munoz, V. M., Kang-Yin Lee, M., Juzar, D. A., de Moura Joaquim, R., Paladino, R., Milicic, D., Davlouros, P., Bakraceski, N., Zilio, F., Donazzan, L., Kraaijeveld, A. O., Galasso, G., Lux, A., Marinucci, L., Guiducci, V., Menichelli, M., Scoccia, A., Yamac, A., Ugur Mert, K., Flores Rios, X., Kovarnik, T., Kidawa, M., Moreu, J., Flavien, V., Fabris, E., Lozano Martinez-Luengas, I., Boccalatte, M., Bosa Ojeda, F., Arellano-Serrano, C., Caiazzo, G., Cirrincione, G., Kao, H. -L., Sanchis Fores, J., Vignali, L., Pereira, H., Manzo-Silberman, S., Ordonez, S., Ozkan, A. A., Scheller, B., Lehtola, H., Teles, R., Mantis, C., Ylitalo, A., Brum Silveira, J. A., Zoni, R., Bessonov, I., Savonitto, S., Kochiadakis, G., Alexopoulos, D., Uribe, C., Kanakakis, J., Faurie, B., Gabrielli, G., Gutierrez, A., Bachini, J. P., Rocha, A., Tam, F. C., Rodriguez, A., Lukito, A., Saint-Joy, V., Pessah, G., Tuccillo, B., Cortese, G., Parodi, G., Bouraghda, M. A., Kedhi, E., Lamelas, P., Suryapranata, H., Nardin, M., and Verdoia, M.

Subjects
Registrie, Male, ST Elevation Myocardial Infarction/diagnosis, Time Factors, Percutaneous, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Coronary Artery Disease, Practice Patterns, 030204 cardiovascular system & hematology, Rate ratio, Time-to-Treatment/trends, Cardiologists, 0302 clinical medicine, Retrospective Studie, Heart Rate, Risk Factors, Pandemic, ST segment, Registries, Hospital Mortality, 030212 general & internal medicine, Myocardial infarction, Practice Patterns, Physicians', 10. No inequality, Percutaneous Coronary Intervention/adverse effects, Hospital Mortality/trends, COVID-19, myocardial infarction, percutaneous coronary intervention, Incidence, Incidence (epidemiology), Middle Aged, 3. Good health, Treatment Outcome, Cardiology, Female, Cardiology and Cardiovascular Medicine, Cardiologists/trends, Human, Aged, Humans, Percutaneous Coronary Intervention, Retrospective Studies, Risk Assessment, ST Elevation Myocardial Infarction, Time-to-Treatment, medicine.medical_specialty, Time Factor, Coronavirus disease 2019 (COVID-19), Cardiologist, 03 medical and health sciences, Internal medicine, medicine, Acute Coronary Syndrome, Pandemics, Physicians', SARS-CoV-2, business.industry, Risk Factor, COVID-19, myocardial infarction, percutaneous coronary intervention, Percutaneous coronary intervention, medicine.disease, Practice Patterns, Physicians'/trends, business
Abstract

ObjectiveThe initial data of the International Study on Acute Coronary Syndromes - ST Elevation Myocardial Infarction COVID-19 showed in Europe a remarkable reduction in primary percutaneous coronary intervention procedures and higher in-hospital mortality during the initial phase of the pandemic as compared with the prepandemic period. The aim of the current study was to provide the final results of the registry, subsequently extended outside Europe with a larger inclusion period (up to June 2020) and longer follow-up (up to 30 days).MethodsThis is a retrospective multicentre registry in 109 high-volume primary percutaneous coronary intervention (PPCI) centres from Europe, Latin America, South-East Asia and North Africa, enrolling 16 674 patients with ST segment elevation myocardial infarction (STEMI) undergoing PPPCI in March/June 2019 and 2020. The main study outcomes were the incidence of PPCI, delayed treatment (ischaemia time >12 hours and door-to-balloon >30 min), in-hospital and 30-day mortality.ResultsIn 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio 0.843, 95% CI 0.825 to 0.861, p75 years) (p=0.015), and was not related to the peak of cases or deaths due to COVID-19. The heterogeneity among centres was high (pConclusionPercutaneous revascularisation for STEMI was significantly affected by the COVID-19 pandemic, with a 16% reduction in PPCI procedures, especially among older patients (about 20%), and longer delays to treatment, which may have contributed to the increased in-hospital and 30-day mortality during the pandemic.Trial registration numberNCT04412655.

Published
2022

7. Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial

Author

Warner Rintje Postma, Elvin Kedhi, Hans Wedel, Ronak Delewi, Enrico Fabris, Clemens Von Birgelen C, Stéphane Cook, Felix Zijlstra, Martin van der Ent, R. S. Hermanides, Giuseppe De Luca, Paweł Buszman, Cardiology, Postma, W., Fabris, E., Van der Ent, M., Hermanides, R., Buszman, P., Von Birgelen C, C., Cook, S., Wedel, H., De Luca, G., Delewi, R., Zijlstra, F., Kedhi, E., Health Technology & Services Research, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, and ACS - Pulmonary hypertension & thrombosis

Subjects
Male, Time Factors, medicine.medical_treatment, UT-Hybrid-D, 030204 cardiovascular system & hematology, antiplatelet therapy, Coronary artery disease, 0302 clinical medicine, Recurrence, Risk Factors, Cause of Death, 030212 general & internal medicine, Myocardial infarction, Prospective Studies, Registries, Stroke, Drug-eluting stents (DES), stent thrombosis, Dual Anti-Platelet Therapy, Drug-Eluting Stents, General Medicine, Middle Aged, surgical procedures, operative, Treatment Outcome, Drug-eluting stent, Cardiology, Female, Cardiology and Cardiovascular Medicine, TIMI, coronary artery disease, medicine.medical_specialty, acute myocardial infarction, Revascularization, Prosthesis Design, Risk Assessment, 03 medical and health sciences, Percutaneous Coronary Intervention, Internal medicine, medicine, drug-eluting stent, Humans, Radiology, Nuclear Medicine and imaging, cardiovascular diseases, Aged, Sirolimus, business.industry, Coronary Thrombosis, Stent, Percutaneous coronary intervention, Cardiovascular Agents, medicine.disease, n/a OA procedure, ST Elevation Myocardial Infarction, business
Abstract

To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second‐generation Resolute™ zotarolimus‐eluting stent (R‐ ZES) in patients enrolled in the DAPT‐STEMI Trial (NCT01459627).Background: R‐ ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.Methods: The Resolute‐STEMI is a prespecified prospective register that reports the safety and efficacy of R‐ZES in setting of ST‐Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all‐cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).Results: From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R‐ZES. At 6 months the PE occurred in 42 (4.2%) patients. All‐cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.Conclusions: The present analysis is the largest to date reporting short‐ term and mid‐term clinical outcomes with the R‐ZES stent in setting of STEMI. At 30 days and 6‐months R‐ZES has an outstanding safety and efficacy even in this high‐ risk category of patients.

Published
2020

10. Angiography-Based 4-Dimensional Superficial Wall Strain and Stress: A New Diagnostic Tool in the Catheterization Laboratory

Author

Wu, X, Ono, M, Kawashima, H, Poon, EKW, Torii, R, Shahzad, A, Gao, C, Wang, R, Barlis, P, von Birgelen, C, Reiber, JHC, Bourantas, C, Tu, S, Wijns, W, Serruys, PW, Onuma, Y, Wu, X, Ono, M, Kawashima, H, Poon, EKW, Torii, R, Shahzad, A, Gao, C, Wang, R, Barlis, P, von Birgelen, C, Reiber, JHC, Bourantas, C, Tu, S, Wijns, W, Serruys, PW, and Onuma, Y

Abstract

A novel method for four-dimensional superficial wall strain and stress (4D-SWS) is derived from the arterial motion as pictured by invasive coronary angiography. Compared with the conventional finite element analysis of cardiovascular biomechanics using the estimated pulsatile pressure, the 4D-SWS approach can calculate the dynamic mechanical state of the superficial wall in vivo, which could be directly linked with plaque rupture or stent fracture. The validation of this approach using in silico models showed that the distribution and maximum values of superficial wall stress were similar to those calculated by conventional finite element analysis. The in vivo deformation was validated on 16 coronary arteries, from the comparison of centerlines predicted by the 4D-SWS approach against the actual centerlines reconstructed from angiograms at a randomly selected time-point, which demonstrated a good agreement of the centerline morphology between both approaches (scaling: 0.995 ± 0.018 and dissimilarity: 0.007 ± 0.014). The in silico vessel models with softer plaque and larger plaque burden presented more variation in mean lumen diameter and resulted in higher superficial wall stress. In more than half of the patients (n = 16), the maximum superficial wall stress was found at the proximal lesion shoulder. Additionally, in three patients who later suffered from acute coronary syndrome, the culprit plaque rupture sites co-localized with the site of highest superficial wall stress on their baseline angiography. These representative cases suggest that angiography-based superficial wall dynamics have the potential to identify coronary segments at high-risk of plaque rupture and fracture sites of implanted stents. Ongoing studies are focusing on identifying weak spots in coronary bypass grafts, and on exploring the biomechanical mechanisms of coronary arterial remodeling and aneurysm formation. Future developments involve integration of fast computational techniques to allow

Published
2021

17. 1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score–Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents

Author

Chandrasekhar, J., Kok, M.M., Kalkman, D.N., Aquino, M.B., Zocca, P., Woudstra, P., Beijk, M.A., Kerkmeijer, L.S., Sartori, S., Baber, U., Tijssen, J.G., Koch, K.T., Dangas, G.D., Colombo, A., Pocock, S., von Birgelen, C., Mehran, R., de Winter, R.J., van der Heijden, L.C., Danse, P.W., Schotborgh, C.E., Scholte, M., Joe Gin, M.T., Somi, S., van Houwelingen, K.G., Stoel, M.G., de Man, F.H.A.F., Louwerenburg, J.H.W., Hartmann, M., Linssen, G.C.M., van der Palen, J., Doggen, C.J.M., Löwik, M.M., Philosophy, Health Technology & Services Research, and TechMed Centre

Subjects
22/4 OA procedure
Published
2020

19. Platelet Inhibition, Endothelial Function, and Clinical Outcome in Patients Presenting With ST-Segment-Elevation Myocardial Infarction Randomized to Ticagrelor Versus Prasugrel Maintenance Therapy: Long-Term Follow-Up of the REDUCE-MVI Trial

Author

van der Hoeven, NW, Janssens, GN, Everaars, H, Nap, A, Lemkes, JS, de Waard, G A, van de Ven, PM, van Rossum, AC, Escaned, J, Mejia-Renteria, H, ten Cate, TJ, Piek, JJ, von Birgelen, C, Valgimigli, M, Diletti, Roberto, Riksen, NP, van Mieghem, Nicolas, Nijveldt, R, Leeuwen, MAH, Royen, N, van der Hoeven, NW, Janssens, GN, Everaars, H, Nap, A, Lemkes, JS, de Waard, G A, van de Ven, PM, van Rossum, AC, Escaned, J, Mejia-Renteria, H, ten Cate, TJ, Piek, JJ, von Birgelen, C, Valgimigli, M, Diletti, Roberto, Riksen, NP, van Mieghem, Nicolas, Nijveldt, R, Leeuwen, MAH, and Royen, N

Published
2020

20. Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials

Author

Hideo-Kajita, A, Garcia Garcia, HM, Kolma, P, Azizi, V, Ozaki, Y, Dan, K, Ince, H (Huseyin), Kische, S, Abizaid, A, Toelg, R, Lemos, PA, van Mieghem, Nicolas, Verheye, S, von Birgelen, C, Christiansen, EH, Wijns, W, Lefevre, T, Windecker, S, Waksman, R, Haude, M, Hideo-Kajita, A, Garcia Garcia, HM, Kolma, P, Azizi, V, Ozaki, Y, Dan, K, Ince, H (Huseyin), Kische, S, Abizaid, A, Toelg, R, Lemos, PA, van Mieghem, Nicolas, Verheye, S, von Birgelen, C, Christiansen, EH, Wijns, W, Lefevre, T, Windecker, S, Waksman, R, and Haude, M

Published
2020

22. Diabetic patients treated with novel thin composite-wire strut zotarolimus-eluting stents versus ultrathin strut sirolimus-eluting stents in the BIONYX trial: 2-year results of a prespecified analysis

Author

Ploumen, E, primary, Buiten, R.A, additional, Zocca, P, additional, Roguin, A, additional, Doggen, C.J.M, additional, Jessurun, G.A.J, additional, Schotborgh, C.E, additional, Danse, P.W, additional, Benit, E, additional, Aminian, A, additional, Van Houwelingen, K.G, additional, Stoel, M.G, additional, Hartmann, M, additional, Linssen, G.C.M, additional, and Von Birgelen, C, additional

Published
2020
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23. Comparison of two iterations of the zotarolimus-eluting stents: an analysis of all-comer patients from two consecutive randomised clinical trials

Author

Buiten, R.A, primary, Ploumen, E.H, additional, Zocca, P, additional, Jessurun, G.A.J, additional, Schotborgh, C.E, additional, Roguin, A, additional, Danse, P.W, additional, Benit, E, additional, Aminian, A, additional, Scholte, M, additional, Hartmann, M, additional, Van Houwelingen, K.G, additional, Doggen, C.J.M, additional, Linssen, G.C.M, additional, and Von Birgelen, C, additional

Published
2020
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24. Quantitative flow ratio to predict non-target-vessel-related events at 5 years in STEMI patients undergoing angiography-guided revascularization

Author

Baer, S, primary, Kavaliauskaite, R, additional, Ueki, Y, additional, Otsuka, T, additional, Engstrom, T, additional, Baumbach, A, additional, Roffi, M, additional, Von Birgelen, C, additional, Vukcevic, V, additional, Pedrazzini, G, additional, Kornowski, R, additional, Tueller, D, additional, Losdat, S, additional, Windecker, S, additional, and Raeber, L, additional

Published
2020
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25. Assessing the cardiology community position on transradial intervention and the use of bivalirudin in patients with acute coronary syndrome undergoing invasive management: results of an EAPCI survey

Author

Adamo, Marianna, Byrne, Robert A., Baumbach, Andreas, Haude, Michael, Windecker, Stephan, Valgimigli, Marco, Aaroe, J., Abdeltawab, A. A., Accardi, R., Addad, F., Agostoni, P., Alajab, A., Alcázar, E., Alhabil, B., Altug Cakmak, H., Amico, F., Amoroso, G., Anderson, R., Andò, G., Andreou, A. Y., Antoniadis, D., Aquilina, M., Aramberry, L., Auer, J., Auffret, V., Ausiello, A., Austin, D., Avram, A., Ayman, E., Babunashvili, V., Bagur, R., Bakotic, Z., Balducelli, M., Ballesteros, S. M., Baptista, S., Baranauskas, A., Barbeau, G., Bax, M., Benchimol, C., Berroth, R., Biasco, L., Bilal, A., Binias, K., Blanco Mata, R., Boccuzzi, G., Bolognese, L., Boskovic, S., Bourboulis, N., Briguori, C., Bunc, M., Buysschaert, I., Calabro’, P., Campo, G., Candiello, A., Caprotta, U. F., Cardenas, M., Carrilho-Ferreira, P., Carrizo, S., Caruso, M., Cassar, A., Cernigliaro, C., Chacko, G., Chamie, D., Clapp, B., Coceani, M., Colangelo, S., Colombo, A., Comeglio, M., Connaughton, M., Conway, D., Cortese, B., Cosgrave, J., Costa, F., Couvoussis, E., Crimi, G., Crook, R., Cruz-Alvarado, J. E., Curello, S., D’Ascenzo, F., D’Urbano, M., Dana, A., De Backer, O., De Carlo, M., De Cesare, N., De Iaco, G., De La Torre, H. J. M., De Oliveira Netoj, B., Devlin, G. P., Di Lorenzo, E., Díaz, A., Dina, C., Dorsel, T. H., Eberli, F. R., Echeverría, R., Eftychiou, C., Elguindy, A., Ercilla, J., Ernst, A., Esposito, G., Ettori, F., Eufracino, Null, Ezquerra Aguilera, W., Falcone, C., Falu, R. M., Feres, F., Ferlini, M., Fernández, G., Fernández-Rodríguez, D., Fileti, L., Fischetti, D., Florescu, N., Formigli, D., Fouladvand, F., Franco, N., Fresco, C., Frigoli, E., Furmaniuk, J., Gabaldo, K., Galli, M., Galli, S., Garbo, R., Garducci, S., Garg, S., Gavrielatos, G., Gensch, J., Giacchi, G., Giunio, L., Giustino, G., Goldberg, L., Goldsmit, R., Gommeaux, A., González Godínez, H., Gosselin, G., Govorov, A., Grimfjard, P., Gross, E., Grosz, C., Guagliumi, G., Hadad, W., Hadadi, L., Hansen, P. R., Harb, S., Hatrick, R., Hayrapetyan, H. G., Hernández-Enríquez, M., Ho Heo, J., Horvath, I. G., Huan Loh, P., Ibrahim, A. M., Ierna, S., Ilic, I., Imperadore, F., Ionescu-Silva, E., Jacksch, R., James, S., Janiak, B., Jensen, S. E., Jeroen, S., Jugessur, R. K., Kala, P., Kambis, M., Kanakakis, J., Karamasis, G., Karchevsky, D., Karpovskiy, A., Kayaert, P., Kedev, S., Kemala, E., Ketteler, T., Khan, S. Q., Kharlamov, A., Kiernan, T., Kiviniem, T., Koltowski, L., Koskinas, K. 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G., Vishwanath, R., Vlachojannis, G. J., Vlachojannis, M., Vlad, V., Von Birgelen, C., Vukcevic, V., Wahab, A., Waksman, R., Wei-Wen, L., Weisz, G., Whittaker, A., Yadav, A., Yokoi, Y., Zacharoulis, A., Zahran, M., Zamani, J., Ziakas, A., Zimmermann, J. P., and Cardiology

Subjects
Hirudin, Percutaneous, Antithrombin, medicine.medical_treatment, Psychological intervention, 030204 cardiovascular system & hematology, medical, 0302 clinical medicine, Peptide Fragment, Surveys and Questionnaires, Surveys and Questionnaire, Medicine, Bivalirudin, 030212 general & internal medicine, Societies, Medical, Transradial, Anticoagulant, Hirudins, Middle Aged, Recombinant Protein, Recombinant Proteins, Femoral Artery, Radial Artery, Cardiology, acute coronary syndrome, bivalirudin, transradial, adult, antithrombins, cardiology, femoral artery, hirudins, humans, middle aged, peptide fragments, percutaneous coronary intervention, recombinant proteins, societies, medical, surveys and questionnaires, attitude of health personnel, radial artery, Acute coronary syndrome, Cardiology and Cardiovascular Medicine, Human, medicine.drug, Adult, medicine.medical_specialty, Attitude of Health Personnel, medicine.drug_class, MEDLINE, Antithrombins, 03 medical and health sciences, societies, Percutaneous Coronary Intervention, Internal medicine, Humans, Acute Coronary Syndrome, Peptide Fragments, Management of acute coronary syndrome, business.industry, Percutaneous coronary intervention, medicine.disease, business
Abstract

AIMS Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) collecting the opinion of the cardiology community on the invasive management of acute coronary syndrome (ACS), before and after the MATRIX trial presentation at the American College of Cardiology (ACC) 2015 Scientific Sessions. METHODS AND RESULTS A web-based survey was distributed to all individuals registered on the EuroIntervention mailing list (n=15,200). A total of 572 and 763 physicians responded to the pre- and post-ACC survey, respectively. The radial approach emerged as the preferable access site for ACS patients undergoing invasive management with roughly every other responder interpreting the evidence for mortality benefit as definitive and calling for a guidelines upgrade to class I. The most frequently preferred anticoagulant in ACS patients remains unfractionated heparin (UFH), due to higher costs and greater perceived thrombotic risks associated with bivalirudin. However, more than a quarter of participants declared the use of bivalirudin would increase after MATRIX. CONCLUSIONS The MATRIX trial reinforced the evidence for a causal association between bleeding and mortality and triggered consensus on the superiority of the radial versus femoral approach. The belief that bivalirudin mitigates bleeding risk is common, but UFH still remains the preferred anticoagulant based on lower costs and thrombotic risks.

Published
2016

37. P1966Impact of coronary artery calcification on long-term outcomes after implantation of first and second-generation drug-eluting stents: a patient-level analysis of 18 randomized trials

Author

Guedeney, P, primary, Claessen, B, additional, Mehran, R, additional, Mintz, G, additional, Liu, M, additional, Sorrentino, S, additional, Farhan, S, additional, Leon, M B, additional, Serruys, P, additional, Smits, P C, additional, Von Birgelen, C, additional, Redfors, B, additional, Madhavan, M V, additional, Ben-Yehuda, O, additional, and Stone, G W, additional

Published
2019
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39. Everolimus-eluting stents or bypass surgery for left main coronary artery disease

Author

Stone, Gw, Sabik, Jf, Serruys, Pw, Simonton, Ca, Généreux, P, Puskas, J, Kandzari, De, Morice, Mc, Lembo, N, Brown WM 3rd, Taggart, Dp, Banning, A, Merkely, B, Horkay, F, Boonstra, Pw, van Boven AJ, Ungi, I, Bogáts, G, Mansour, S, Noiseux, N, Sabaté, M, Pomar, J, Hickey, M, Gershlick, A, Buszman, P, Bochenek, A, Schampaert, E, Pagé, P, Dressler, O, Kosmidou, I, Mehran, R, Pocock, Sj, Kappetein, Ap, van Es GA, Leon, Mb, Gersh, B, Chaturvedi, S, Kint, Pp, Valgimigli, M, Colombo, A, Costa, M, Di Mario, C, Ellis, S, Fajadet, J, Fearon, W, Kereiakes, D, Makkar, R, Mintz, Gs, Moses, Jw, Teirstein, P, Ruel, M, Sergeant, P, Mack, M, Fontana, G, Mohr, Fw, Nataf, P, Smith, C, Boden, B, Fox, K, Maron, D, Steg, G, Blackstone, E, Juni, P, Parise, H, Wallentin, L, Bertrand, M, Krucoff, M, Turina, M, Ståhle, E, Tijssen, J, Brill, D, Atkins, C, Applegate, B, Argenziano, M, Faly, Rc, Dauerman, H, Davidson, C, Griffith, B, Reisman, M, Rizik, D, Sakwa, M, Shemin, R, Romano, M, Hamm, C, Gummert, J, Tamburino, C, Alfieri, O, Savina, C, de Bruyne, B, Machado, Fp, Uva, S, Moccetti, T, Siclari, F, Hildick Smith, D, Szekely, L, Erglis, A, Stradins, P, Abizaid, A, Bento Sousa LC, Belardi, J, Navia, D, Park, Sj, Lee, Jw, Meredith, I, Smith, J, Yehuda, Ob, Schneijdenberg, R, Ronden, J, Jonk, J, Jonkman, A, van Remortel, E, de Zwart, I, Elshout, L, de Vries, T, Andreae, R, Tol van, J, Teurlings, E, Balachandran, S, Breazna, A, Jenkins, P, Mcandrew, T, Marx, So, Connolly, Mw, Hong, Mk, Weinberger, J, Wong, Sc, Dizon, J, Biviano, A, Morrow, J, Wang, D, Corral, M, Alfonso, M, Sanchez, R, Wright, D, Djurkovic, C, Lustre, M, Jankovic, I, Sanidas, E, Lasalle, L, Maehara, A, Matsumura, M, Sun, E, Iacono, S, Greenberg, T, Jacobson, J, Pullano, A, Gacki, M, Liu, S, Cohen, Dj, Magnuson, E, Baron, Sj, Wang, K, Traylor, K, Worthley, S, Stuklis, R, Barbato, E, Stockman, B, Dubois, C, Meuris, B, Vrolix, M, Dion, R, Bento de Souza LC, Costantini, C, Woitowicz, V, Hueb, W, Stolf, N, Beydoun, H, Baskett, R, Curtis, M, Kieser, T, Doucet, S, Pellerin, M, Hamburger, J, Cook, R, Kutryk, M, Peterson, M, Madan, M, Fremes, S, Mehta, S, Cybulsky, I, Prabhakar, M, Peniston, C, Welsh, R, Macarthur, R, Berland, J, Bessou, Jp, Carrié, D, Glock, Y, Darremont, O, Deville, C, Grimaud, Jp, Soula, P, Lefèvre, T, Maupas, E, Durrleman, N, Silvestri, M, Houel, R, Pratt, A, Francis, J, Van Belle, E, Vicentelli, A, Luchner, A, Hilker, M, Endemann, Dh, Felix, S, Wollert, Hg, Walther, T, Erbel, R, Jacob, H, Kahlert, P, Kupatt, C, Näbauer, M, Schmitz, C, Scholtz, W, Börgermann, J, Schuler, G, Borger, M, Davierwala, P, Fontos, G, Székely, L, Bedogni, F, Panisi, P, Berti, S, Glauber, M, Marzocchi, A, Di Bartolomeo, R, Merlo, M, Guagliumi, G, Fenili, F, Napodano, M, Gerosa, G, Ribichini, F, Faggian, Giuseppe, Saccà, S, Giacomin, A, Mignosa, C, Tumscitz, C, Savini, C, Van Mieghem, N, von Birgelen, C, Grandjean, J, Kubica, J, Anisimowicz, L, Zmudka, K, Sadowski, J, Hernández García, J, Such, M, Macaya, C, Rodríguez Hernández JE, Maroto, L, Serra, A, Padro, J, Tenas, Ms, De Souza, A, Egred, M, Clark, S, Trivedi, U, Jain, A, Uppal, R, Redwood, S, Young, C, Stables, Rh, Pullan, M, Uren, N, Pessotto, R, Abu Fadel, M, Peyton, M, Allaqaband, S, O’Hair, D, Bachinsky, W, Mumtaz, M, Blankenship, J, Casale, A, Brott, B, Davies, J, Brown, D, Cannon, L, Talbott, J, Chang, G, Macheers, S, Choi, J, Henry, C, Cutlip, D, Khabbaz, K, Das, G, Liao, K, Diver, D, Thayer, J, Dobies, D, Fliegner, K, Fischbein, M, Feldman, T, Pearson, P, Foster, M, Briggs, R, Giugliano, G, Engelman, D, Gordon, P, Ehsan, A, Grantham, J, Allen, K, Grodin, J, Jessen, M, Gruberg, L, Taylor JR Jr, Gupta, S, Hermiller J., Jr, Heimansohn, D, Iwaoka, R, Chan, B, Kander, Nh, Duff, S, Brown, W, Karmpaliotis, D, Kini, A, Filsoufi, F, Kong, D, Lin, S, Kutcher, M, Kincaid, E, Leya, F, Bakhos, M, Liberman, H, Halkos, M, Lips, D, Eales, F, Mahoney, P, Rich, J, Barreiro, C, Cheng, W, Metzger, C, Greenfield, T, Moses, J, Palacios, I, Macgillivray, T, Perin, E, Del Prete, J, Pompili, V, Kilic, A, Ragosta, M, Kron, I, Rashid, J, Mueller, D, Riley, R, Reimers, C, Patel, N, Resar, J, Shah, A, Schneider, J, Landvater, L, Reardon, M, Shavelle, D, Baker, C, Singh, J, Maniar, H, Wei, L, Strain, J, Zapolanski, A, Taheri, H, Ad, N, Tannenbaum, M, Prabhakar, G, Waksman, R, Corso, P, Wang, J, Fiocco, M, Wilson, Bh, Steigel, Rm, Chadwick, S, Zidar, F, Oswalt, J., Stone, Gregg W., Sabik, Joseph F., Serruys, Patrick W., Simonton, Charles A., Généreux, Philippe, Puskas, John, Kandzari, David E., Morice, Marie Claude, Lembo, Nichola, Brown, W. Morri, Taggart, David P., Banning, Adrian, Merkely, Béla, Horkay, Ferenc, Boonstra, Piet W., Van Boven, Ad J., Ungi, Imre, Bogáts, Gabor, Mansour, Samer, Noiseux, Nicola, Sabaté, Manel, Pomar, José, Hickey, Mark, Gershlick, Anthony, Buszman, Pawel, Bochenek, Andrzej, Schampaert, Erick, Pagé, Pierre, Dressler, Ovidiu, Kosmidou, Ioanna, Mehran, Roxana, Pocock, Stuart J., Kappetein, A. Pieter, for the EXCEL Trial Investigators:, [. . ., Antonio, Marzocchi, DI BARTOLOMEO, Roberto, ], . ., and Cardiothoracic Surgery

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Percutaneous Coronary Intervention, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Drug-Eluting Stent, Humans, Everolimus, 030212 general & internal medicine, cardiovascular diseases, Coronary Artery Bypass, Aged, Female, Middle Aged, Drug-Eluting Stents, business.industry, Coronary Artery Bypa, Medicine (all), Percutaneous coronary intervention, General Medicine, medicine.disease, Surgery, Cardiac surgery, Everolimu, surgical procedures, operative, Bypass surgery, Conventional PCI, Cardiology, business, medicine.drug, Human
Abstract

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P

Published
2017

42. Patients' Priorities for Oral Anticoagulation Therapy in Non-valvular Atrial Fibrillation: a Multi-criteria Decision Analysis

Author

Weernink, MGM, Vaanholt, MCW, Groothuis-Oudshoorn, CGM, von Birgelen, C, IJzerman, MJ, van Til, JA, Weernink, MGM, Vaanholt, MCW, Groothuis-Oudshoorn, CGM, von Birgelen, C, IJzerman, MJ, and van Til, JA

Abstract

INTRODUCTION: Effectiveness of oral anticoagulants (OACs) is critically dependent on patients' adherence to intake regimens. We studied the relative impact of attributes related to effectiveness, safety, convenience, and costs on the value of OAC therapy from the perspective of patients with non-valvular atrial fibrillation. METHODS: Four attributes were identified by literature review and expert interviews: effectiveness (risk of ischemic stroke), safety (risk of major bleeding, minor bleeding, gastrointestinal complaints), convenience (intake frequency, diet restrictions, international normalized ratio [INR] blood monitoring, pill type/intake instructions), and out-of-pocket costs. Focus groups were held in Spain, Germany, France, Italy and the United Kingdom (N = 48) to elicit patients' preferences through the use of the analytical hierarchy process method. RESULTS: Effectiveness (60%) and side effects (27%) have a higher impact on the perceived value of OACs than drug convenience (7%) and out-of-pocket costs (6%). As for convenience, eliminating monthly INR monitoring was given the highest priority (40%), followed by reducing diet restrictions (27%), reducing intake frequency (17%) and improving the pill type/intake instructions (15%). The most important side effect was major bleeding (75%), followed by minor bleeding (15%) and gastrointestinal complaints (10%). Furthermore, 71% of patients preferred once-daily intake to twice-daily intake. DISCUSSION: Although the relative impact of convenience on therapy value is small, patients have different preferences for options within convenience criteria. Besides considerations on safety and effectiveness, physicians should also discuss attributes of convenience with patients, as it can be assumed that alignment to patient preferences in drug prescription and better patient education could result in higher adherence.

Published
2018

45. Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: Insights from the DUTCH PEERS trial

Author

Lowik, M, Van Der Heijden, L C, Kok, M M, Zocca, P, Danse, P W, Jessurun, G A J, Hautvast, R.W.M., Hartmann, M, Stoel, M G, Linssen, G C M, Doggen, C.J.M., Von Birgelen, C, and Health Technology & Services Research

Subjects
Kaplan Meier method, conference abstract, polymer, heart infarction, log rank test, clinical outcome, zotarolimus eluting coronary stent, male, target vessel revascularization, follow up, controlled study, everolimus eluting coronary stent, heart death, human, outcome assessment, single blind procedure, treatment failure, stent thrombosis, adult, clinical assessment, organization, syndrome, adverse device effect, major clinical study, 22/4 OA procedure, unclassified drug, blood vessel wall, monitoring, female, multicenter study, randomized controlled trial, incidence
Abstract

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

Published
2017

46. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial†

Author

Tardif, Jean-Claude, Ballantyne, Christie M., Barter, Philip, Dasseux, Jean-Louis, Fayad, Zahi A., Guertin, Marie-Claude, Kastelein, John J. P., Keyserling, Constance, Klepp, Heather, Koenig, Wolfgang, L'Allier, Philippe L., Lespérance, Jacques, Lüscher, Thomas F., Paolini, John F., Tawakol, Ahmed, Waters, David D., Pfeffer, M., Brown, V., Rouleau, J., Watkins, P., Wei, L.J., Gosselin, G., Chayer, C., Lanthier, S., Pelletier, G.B., Racine, N., Agarwal, H., Brilakis, E., Cannon, L., Carrié, D., Corbelli, J., Coste, P., de Winter, R., Diaz, A., Eisenberg, S., Ennis, B., Fajadet, J., Fam, N., Fortuin, D., Gessler, C., Grines, C., Guerra, D., Gum, H., Haldis, T., Heestermans, T., Herrman, J.P., Huynh, T., Kedhi, E., Koren, M., Kouz, S., Krolick, M., Kumkumian, G., Lavi, S., Li, R.J., Masud, ARZ, McAlhany, C., McGrew, F.A., O'Shaughnessy, C., Oude Ophuis, A.J.M., Parr, K., Penny, W., Pesant, Y., Post, H., Robinson, S., Rodes-Cabau, J., Roy, A., Schulman, S., Spence, F., Stouffer, G., Stys, T., Sussex, B., Tahirkheli, N., Tardif, J-C, Grégoire, J., ten Berg, J., van Boven, A.J., von Birgelen, C., and Weinstein, D.

Abstract

Aim High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo. Objective To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA). Design and setting A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2-5) weeks after the last study infusion. Patients Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively. Intervention Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001. Main outcome measures The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints. Results The nominal change in the total atheroma volume (adjusted means) was −2.71, −3.13, −1.50, and −3.05 mm3 with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: P = 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, −0.02, 0.01, and 0.19%; nominal P = 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was −0.022, −0.036, −0.022, and −0.015 mm (nominal P = 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was −0.51, 2.65, 0.71, and −0.77% (compared with placebo, nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups. Conclusion CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study. Name of the trial registry: Clinicaltrials.gov; Registry's URL: http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2; Trial registration number: NCT01201837

Published
2017

48. Impact of gender and age on 3-year clinical outcome and chest pain of patients with coronary artery disease treated with contemporary drug-eluting stents: A patient-level pooled analysis

Author

Kok, Marlies, van der Heijden, Liefke, Lowik, Marijke, Zocca, Paolo, Doggen, Carine J. M., Danse, Peter, Anthonio, Rutger L., Hartmann, Marc, Linssen, Gerard C.M., Maas, Angela, Mehran, Roxana, Von Birgelen, C, and Health Technology & Services Research

Subjects
hypertension, polymer, heart infarction, prevalence, clinical outcome, male, death, gender, follow up, controlled study, family study, human, rest, controlled clinical trial, exercise, disease course, percutaneous coronary intervention, thorax pain, aged, female, multivariate analysis, risk factor, diabetes mellitus, randomized controlled trial, 2023 OA procedure, revascularization, drug eluting stent, coronary artery disease, meta analysis
Abstract

BACKGROUND Women report more often chest pain following percutaneous coronary intervention (PCI), yet little is known about the impact of age on these symptoms. We aimed to assess age and gender-related differences in chest pain following PCI with newergeneration drug-eluting stents (DES). METHODS A patient-level pooled analysis of the TWENTE and DUTCH PEERS randomized trials (NCT01066650; NCT01331707) was performed, in which patients were treated with newer generation permanent polymer DES. The primary endpoint of both studies was target vessel failure (TVF); secondary endpoints included MACE (composite of any death, any myocardial infarction (MI), emergent CABG or target lesion revascularization) and POCE (composite of any death, any MI and any revascularization). RESULTS Clinical follow-up was available in 3,188 patients (99.8%). Women had more risk factors including diabetes (24.2% vs. 17.8%, p65 years. Women 65 years, both women and men reported similar levels of chest pain at rest or mild exertion (8.8% and 8.7%, p=0.76); in this subgroup gender did not independently predict chest pain (adjusted OR 1.27 95%-CI:0.8-1.9, p=0.26). Nevertheless, in women and men similar 3-year rates of TVF, MACE, and POCE were found (11.6% vs. 11.3%, p=0.81; 13.6% vs. 12.5%, p=0.43; 18.8% vs. 18.0%, p=0.60, respectively). CONCLUSION While for both genders the incidence of adverse cardiovascular events was low and similar, women

Published
2016

50. Rehospitalizations Following Primary Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction: Results From a Multi-Center Randomized Trial

Author

Spitzer, Ernest, Frei, M, Zaugg, S, Hadorn, S, Kelbaek, H, Ostojic, M, Baumbach, A, Tuller, D, Roffi, M, Engstrom, T, Pedrazzini, G, Vukcevic, V, Magro, Michael, Kornowski, R, Luscher, TF, von Birgelen, C, Heg, D, Windecker, S, Raber, L, Spitzer, Ernest, Frei, M, Zaugg, S, Hadorn, S, Kelbaek, H, Ostojic, M, Baumbach, A, Tuller, D, Roffi, M, Engstrom, T, Pedrazzini, G, Vukcevic, V, Magro, Michael, Kornowski, R, Luscher, TF, von Birgelen, C, Heg, D, Windecker, S, and Raber, L

Published
2017

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