TY - JOUR
T1 - Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy
AU - MASTER DAPT Investigators
AU - Valgimigli, Marco
AU - Frigoli, Enrico
AU - Vranckx, Pascal
AU - Ozaki, Yukio
AU - Morice, Marie Claude
AU - Chevalier, Bernard
AU - Onuma, Yoshinobu
AU - Windecker, Stephan
AU - Delorme, Laurent
AU - Kala, Petr
AU - Kedev, Sasko
AU - Abhaichand, Rajpal K.
AU - Velchev, Vasil
AU - Dewilde, Willem
AU - Podolec, Jakub
AU - Leibundgut, Gregor
AU - Topic, Dragan
AU - Schultz, Carl
AU - Stankovic, Goran
AU - Lee, Astin
AU - Johnson, Thomas
AU - Tonino, Pim A.L.
AU - Klotzka, Aneta
AU - Lesiak, Maciej
AU - Lopes, Renato D.
AU - Smits, Pieter C.
AU - Heg, Dik
N1 - Funding Information:
The MASTER DAPT trial is conducted with support from Terumo. The study sponsor, European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands, a nonprofit organization, received grant support from Terumo for the conduct of the MASTER DAPT trial. ECRI outsourced to Clinical trial Unit, Bern, Switzerland all statistical analyses of the present paper under a research contract agreement between the 2 institutions. None of the authors received personal or institutional payment for the present paper. 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, Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio. Dr Heg’s institution, 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, and 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 start-up 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 grants from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CadioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson and Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sinomed, Terumo, and V-Wave; serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; 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; is an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee; is a member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and of the Advisory Board of the Australian Victorian Heart Institute; and is chairperson of the ESC Congress Program Committee, former chairperson of the ESC Clinical Practice Guidelines Committee, and Deputy Editor of JACC: Cardiovascular Interventions. Dr Kala has served as a consultant for Boston Scientific; has received research support from Novartis; and has received honoraria from Bayer, Servier, AstraZeneca, Chiesi, and Boehringer Ingelheim. Dr Schultz has received grants and personal fees from Abbott Vascular. Dr Lopes has received institutional research grants and consulting fees from Bristol Myers Squibb, Pfizer, GlaxoSmithKline, Medtronic PLC, and Sanofi; and has received consulting fees from Amgen, Bayer, and Boehringer Ingelheim. Dr Podolec has received grants and personal fees from Amgen, Terumo, The Medicines Company, AstraZeneca, and Meril. 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. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2022 American College of Cardiology Foundation
PY - 2022/8/23
Y1 - 2022/8/23
N2 - Background: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. Objectives: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. Methods: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. Results: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. Conclusions: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB.
AB - Background: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. Objectives: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. Methods: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. Results: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. Conclusions: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB.
UR - http://www.scopus.com/inward/record.url?scp=85135706469&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85135706469&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2022.04.065
DO - 10.1016/j.jacc.2022.04.065
M3 - Article
C2 - 35981821
AN - SCOPUS:85135706469
VL - 80
SP - 766
EP - 778
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 8
ER -