Dario Bongiovanni, Antonio Landi, Enrico Frigoli, Dik Heg, Konstantina Chalkou, Jozef Bartunek, Laurent Delorme, Willem Dewilde, David Hildick-Smith, Gregor Leibundgut, Sergio Leonardi, Maciej Lesiak, Petr Kala, Sasko Kedev, Marco Roffi, Goran Stankovic, Pim A.L. Tonino, Vasil Velchev, Pascal Vranckx, Stephan Windecker, Pieter C. Smits, and Marco Valgimigli, MASTER DAPT Investigators
www.jacc.org/doi/10.1016/j.jacc.2025.05.010
Abstract
Background
The effect of dual antiplatelet therapy (DAPT) duration on total events in patients at high bleeding risk (HBR) after percutaneous coronary intervention (PCI) is unclear.
Objectives
This study aimed to evaluate an abbreviated (median duration, 34 days) vs prolonged (median duration, 192 days) DAPT regimen on total events in 4,579 HBR patients from the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen) trial.
Methods
The MASTER DAPT coprimary outcomes at 335 days were as follows: 1) net adverse clinical events (NACEs), the composite of all-cause death, myocardial infarction (MI), stroke, and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events; 2) major adverse cardiac and cerebral events (MACCEs), including all-cause death, MI, and stroke; and 3) major or clinically relevant nonmajor bleeding (MCB, type 2, 3, or 5 BARC bleeding). The differences between abbreviated and prolonged DAPT regimens were investigated using the Prentice, Williams, and Peterson model to account for recurrent events. Additional analyses were performed using the Andersen-Gill and Poisson incidence rate models.
Results
In the abbreviated DAPT (n = 2,295) arm of the trial, 214 NACEs occurred in 172 patients, compared with 227 NACEs in 182 patients in the prolonged DAPT arm (n = 2,284; HR: 0.95; 95% CI: 0.78-1.16; P = 0.64). A total of 156 MACCEs in 138 patients were observed in the abbreviated DAPT group compared with 160 MACCEs in 138 patients in the prolonged DAPT arm (HR: 0.96; 95% CI: 0.76-1.20; P = 0.69). Fewer total MCBs were observed in the abbreviated DAPT group (180 MCBs in 148 patients) compared with the prolonged DAPT group (240 MCBs in 211 patients, HR: 0.78; 95% CI: 0.64-0.94; P = 0.011). Abbreviated DAPT patients had significantly fewer total cerebrovascular accidents and fewer total strokes compared with the prolonged DAPT group (34 events in 32 patients, HR: 0.51; 95% CI: 0.28-0.91; P = 0.023; and 25 events in 24 patients, HR: 0.49; 95% CI: 0.25-0.98; P = 0.04, respectively). One MACCE in every 5 occurred after a bleeding event, and 1 bleeding event in every 25 occurred after a MACCE, thus emphasizing bleeding as a sentinel event.
Conclusions
A 1-month DAPT duration was associated with similar total NACEs and MACCEs and reduced total bleeding risk compared with prolonged DAPT. Providing a more comprehensive assessment of the total clinical burden, these findings support the use of an abbreviated duration of DAPT after PCI in HBR patients. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen [MASTER DAPT]; NCT03023020)
