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Minerva Cardioangiologica 2020 Dec 01

DOI: 10.23736/S0026-4725.20.05353-0

Copyright © 2020 EDIZIONI MINERVA MEDICA

lingua: Inglese

Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials

Mahesh V. MADHAVAN 1, 2, Behnood BIKDELI 1, 2, Björn REDFORS 1, 2, 3, Giuseppe BIONDI-ZOCCAI 4, 5, Nicholas J. VARUNOK 1, John R. BURTON 1, Aaron CROWLEY 2, Dominic P. FRANCESE 2, Aakriti GUPTA 1, 2, Caroline DER NIGOGHOSSIAN 1, Saurav CHATTERJEE 6, Tullio PALMERINI 7, Umberto BENEDETTO 8, Seng-Chan YOU 9, Magnus OHMAN 10, Adnan KASTRATI 11, 12, Philippe G. STEG 13, C. Michael GIBSON 14, Dominick J. ANGIOLILLO 15, Harlan M. KRUMHOLZ 16, Gregg W. STONE 2, 17

1 NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA; 2 Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; 3 Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; 4 Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; 5 Mediterranea Cardiocentro, Napoli, Italy; 6 St. Francis Hospital, Hartford, CT, USA; 7 Unità Operativa di Cardiologia, Policlinico S. Orsola, Bologna, Italy; 8 University of Bristol, Bristol, United Kingdom; 9 Ajou University, Suwon, South Korea; 10 Duke Clinical Research Institute/Duke University Medical Center, Durham, NC, USA; 11 Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 12 DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; 13 FACT (French Alliance for Cardiovascular Trials) Université de Paris, INSERM U-1148, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; 14 Beth Israel Deaconess Medical Center, Boston, MA, USA; 15 Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA; 16 Yale School of Medicine, New Haven, CT, USA; 17 The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA


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INTRODUCTION: The optimal choice of oral P2Y12 receptor inhibitors has the potential to significantly influence outcomes. We seek to compare the safety and efficacy of the three most commonly used oral P2Y12 receptor inhibitors (clopidogrel, prasugrel, and ticagrelor) in acute coronary syndromes (ACS) via a comprehensive systematic review and network meta-analysis.
EVIDENCE ACQUISITION: We will perform a comprehensive search for randomized clinical trials which compared cardiovascular and hemorrhagic outcomes after use of at least two of the distinct oral P2Y12 receptor inhibitors (i.e. clopidogrel, prasugrel, and ticagrelor). In addition, key inclusion criteria will be trial size of at least 100 patients and at least 1 month of follow-up time. Several pre-specified subgroups will be explored, including Asian patients, patients presenting with ST-elevation myocardial infarction, patients of advanced age, and others.
EVIDENCE SYNTHESIS: Exploratory frequentist pairwise meta-analyses will be based primarily on a random-effects method, relying on relative risks (RR) for short-term endpoints and incidence rate ratios (IRR) for long-term endpoints. Inferential frequentist network meta-analysis will be based primarily on a random-effects method, relying on RR and IRR as specified above. Results will be reported as point summary of effect, 95% CI, and p-values for effect, and graphically represented using forest plots.
CONCLUSIONS: An international collaborative network meta-analysis has begun to comprehensively analyze the safety and efficacy of prasugrel, ticagrelor and clopidogrel, each on a background of aspirin, for management of patients with ACS. It is our hope that the rigor and breadth of the undertaking described herein will provide novel insights that will inform optimal patient care for patients with ACS treated conservatively, or undergoing revascularization.


KEY WORDS: Antiplatelet agents; P2Y12 receptor antagonists; Acute coronary syndrome; Network meta-analysis

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