Abbreviated or Standard Antiplatelet Therapy After PCI in Diabetic Patients at High Bleeding Risk
- PMID: 39603779
- DOI: 10.1016/j.jcin.2024.08.030
Abbreviated or Standard Antiplatelet Therapy After PCI in Diabetic Patients at High Bleeding Risk
Abstract
Background: Abbreviated antiplatelet therapy (APT) reduces bleeding without increasing ischemic events in largely unselected high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI). Diabetes mellitus (DM) is associated with higher ischemic risk, and its impact on the safety and effectiveness of abbreviated APT in HBR PCI patients remains unknown.
Objectives: This study sought to investigate the comparative effectiveness of abbreviated (1 month) vs standard (≥3 months) APT in HBR patients with and without DM after biodegradable polymer sirolimus-eluting coronary stent implantation.
Methods: This was a prespecified analysis from the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With a Abbreviated Versus Prolonged DAPT Regimen) trial, which randomized 4,579 HBR patients (1,538 [34%] with DM) to abbreviated (n = 2,295) or standard (n = 2,284) APT. The coprimary outcomes were net adverse clinical events (NACEs; composite of all-cause death, myocardial infarction, stroke, and major bleeding), major adverse cardiac or cerebral events (MACCEs; all-cause death, myocardial infarction, and stroke), and major or clinically relevant nonmajor bleeding at 11 months.
Results: HBR patients with DM had higher risks of MACCEs (HR: 1.28; 95% CI: 1.00-1.63) and similar net adverse or bleeding events compared with nondiabetic subjects. Abbreviated compared with standard APT was associated with similar NACEs and MACCEs (Pinteraction = 0.47 and 0.59, respectively) and reduced major or clinically relevant nonmajor bleeding (Pinteraction = 0.55) irrespective of diabetes status.
Conclusions: MACCE and NACE rates were similar, and bleeding rates were lower with abbreviated APT in patients with or without diabetes. Therefore, diabetes status did not modify the treatment effects of abbreviated vs standard APT in HBR patients after biodegradable polymer sirolimus-eluting coronary stent implantation. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With a Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).
Keywords: diabetes mellitus; dual antiplatelet therapy; high bleeding risk; percutaneous coronary intervention.
Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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. Dr Roffi has received institutional research grants from Cordis, Boston Scientific, Medtronic, Biotronik, and Terumo. Drs Heg and Chalkou are employed by the Department of Clinical Research, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees; however, DCR is involved in the 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 Chevalier is a minor shareholder of CERC. Dr Morice is a minor shareholder of Electroducer and Basecamps and a shareholder and CEO of CERC. Dr Vranckx has received personal fees from Bayer, Daiichi-Sankyo, and CLS Behring, outside the submitted work. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, V-Wave; has served as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; 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 Smits has received personal consulting or speaker fees from Terumo, Abiomed, and Opsense; has received grants and personal consulting fees from Abbott Vascular, Microport, and Daiichi-Sankyo; and has received grants from SMT. Dr Valgimigli has received grants and/or personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceuticals Ltd, Universität Basel Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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