Julinda Mehilli1,2, Moritz Baquet1,2, Willibald Hochholzer3, Katharina Mayer4, Christian Tesche5, Daniel Aradi6, Yujun Xu7, Manuela Thienel1, Sarah Gschwendtner1, Magda Zadrozny1, David Jochheim1,2, Dirk Sibbing1,2, Stefanie Schüpke4,2, Ulrich Mansmann7, Ellen Hoffmann5, Adnan Kastrati4,2, Franz-Josef Neumann3, Steffen Massberg1,2. 1. Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.). 2. German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, all in Munich, Germany (J.M., M.R., D.J., D.S., S.S., A.K., S.M.). 3. Klinik für Kardiologie und Angiologie II, Universitäres Herzzentrum Freiburg, Bad Krozingen, Germany (W.H., F.-J.N.). 4. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.). 5. Klinik für Kardiologie und internistische Intensivmedizin, Klinikum Bogenhausen, Munich, Germany (C.T., E.H.). 6. Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University, Budapest, Hungary (D.A.). 7. Institut für medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, Munich, Germany (Y.X., U.M.).
Abstract
BACKGROUND: Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. METHODS: This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. RESULTS: Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P=0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32), P=0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73), P=0.70, respectively. CONCLUSIONS: In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.
RCT Entities:
BACKGROUND: Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. METHODS: This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. RESULTS: Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P=0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32), P=0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73), P=0.70, respectively. CONCLUSIONS: In biomarker-negative stable and unstable anginapatients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.
Authors: Johanne Silvain; Michel Zeitouni; Valeria Paradies; Huili L Zheng; Gjin Ndrepepa; Claudio Cavallini; Dimitri N Feldman; Samin K Sharma; Julinda Mehilli; Sebastiano Gili; Emanuele Barbato; Giuseppe Tarantini; Sze Y Ooi; Clemens von Birgelen; Allan S Jaffe; Kristian Thygesen; Gilles Montalescot; Heerajnarain Bulluck; Derek J Hausenloy Journal: Eur Heart J Date: 2021-01-21 Impact factor: 29.983
Authors: Heerajnarain Bulluck; Valeria Paradies; Emanuele Barbato; Andreas Baumbach; Hans Erik Bøtker; Davide Capodanno; Raffaele De Caterina; Claudio Cavallini; Sean M Davidson; Dmitriy N Feldman; Péter Ferdinandy; Sebastiano Gili; Mariann Gyöngyösi; Vijay Kunadian; Sze-Yuan Ooi; Rosalinda Madonna; Michael Marber; Roxana Mehran; Gjin Ndrepepa; Cinzia Perrino; Stefanie Schüpke; Johanne Silvain; Joost P G Sluijter; Giuseppe Tarantini; Gabor G Toth; Linda W Van Laake; Clemens von Birgelen; Michel Zeitouni; Allan S Jaffe; Kristian Thygesen; Derek J Hausenloy Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983