Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk

Abstract

Background: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear.

Objectives: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction.

Methods: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding.

Results: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT.

Conclusions: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Keywords: acute coronary syndrome; antiplatelet therapy; dual antiplatelet therapy; percutaneous coronary intervention.

Conflict of interest statement

Funding Support and Author Disclosures The study was sponsored by the European Cardiovascular Research Institute, a nonprofit organization, and received grant support from Terumo. The sponsor and funder had no role in the study design, data collection, data monitoring, analysis, interpretation, or writing of the report. Dr Smits has received personal fees from Terumo and Opsense; has received grants and personal fees from Abbott Vascular, Microport, and Daiichi-Sankyo; and has received grants from SMT and Microport. Dr Heg reports that CTU Bern, University of Bern, has a staff policy of not accepting honoraria or consultancy fees; however, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations—in particular, pharmaceutical and medical device companies provide direct funding to some of these studies. Dr Vranckx has received personal fees from Daiichi-Sankyo, Bayer AG, BLS Bering, and AstraZeneca. Dr Ozaki has received grants from Takeda Pharmaceutical Company Ltd, Daiichi-Sankyo Company Ltd, Otsuka Pharmaceutical Company Ltd, and Sanofi. Dr Morice is a shareholder and CEO of CERC, and a minor shareholder of Electroducer (a startup not involved in the MASTER DAPT trial). Dr Chevalier has received personal fees from Terumo and CERC; and holds stock options in Colibri. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CadioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sinomed, Terumo, and V-Wave; serves as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesiences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Roffi has received institutional research grants from Biotronik, Medtronic, Boston Scientific, GE Healthcare, and Terumo. Dr Mahfoud has received grants from Terumo, Deutsche Forschungsgemeinschaft (TRR 219), and Deutsche Gesellschaft für Kardiologie; has received grants and personal fees from Medtronic and Recor; and has received personal fees from Bayer and Boehringer Ingelheim. Dr Hildick-Smith has received personal fees from Terumo. Dr Schultz has received grants and personal fees from Abbott Vascular. Dr Valgimigli has received grants and personal fees from Terumo; and has received personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Bayer, CoreFLOW, Idorsia pharmaceuticals LTD, Universität Basel, Dept Klinische Forschung, Vifor, Bristol Myers Squibb SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.