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 - Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).
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. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).
KW - Drug Therapy, Combination
KW - Drug-Eluting Stents/adverse effects
KW - Hemorrhage/chemically induced
KW - Humans
KW - Medication Adherence
KW - Percutaneous Coronary Intervention/methods
KW - Platelet Aggregation Inhibitors/therapeutic use
KW - Polymers
KW - Treatment Outcome
U2 - 10.1016/j.jacc.2022.04.065
DO - 10.1016/j.jacc.2022.04.065
M3 - Article (Academic Journal)
C2 - 35981821
SN - 0735-1097
VL - 80
SP - 766
EP - 778
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 8
ER -