TY - JOUR
T1 - Dual antiplatelet therapy after PCI in patients at high bleeding risk
AU - Valgimigli, Marco
AU - Frigoli, Enrico
AU - Heg, Dik
AU - Tijssen, Jan
AU - Juni, Peter
AU - Vranckx, Pascal
AU - Ozaki, Yukio
AU - Morice, Marie-Claude
AU - Chevalier, Bernard
AU - Onuma, Yoshinobu
AU - Windecker, Stephan
AU - Tonino, Pim A. L.
AU - Roffi, Marco
AU - Lesiak, Maciej
AU - Mahfoud, Felix
AU - Bartunek, Jozef
AU - Hildick-Smith, David
AU - Colombo, Antonio
AU - Stanković, Goran
AU - Iniguez, Andres
AU - Schultz, Carl
AU - Kornowski, Ran
AU - Ong, Paul J. L.
AU - Alasnag, Mirvat
AU - Rodriguez, Alfredo E.
AU - Moschovitis, Aris
AU - MASTER DAPT Investigators
AU - Laanmets, Peep
AU - Donahue, Michael
AU - Leonardi, Sergio
AU - Smits, Pieter C.
N1 - Funding Information:
The Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation with an Abbreviated versus Standard DAPT Regimen (MASTER DAPT) trial was an investigator-initiated, multicenter, randomized, open-label, noninferiority trial with sequential superiority testing. The trial was designed by the first and last authors and was approved by the institutional review board at each center.8 The European Cardiovascular Research Institute acted as the trial sponsor and received grant support from Terumo (see the Supplementary Appendix, available with the full text of this article at NEJM.org). The European Cardiovascular Research Institute and Terumo had no role in the trial design; in the collection, monitoring, analysis, or interpretation of the data; or in the writing of the manuscript. Editorial assistance was provided by a medical writer and was funded by the European Cardiovascular Research Institute. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol, available at NEJM.org.
Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/10/28
Y1 - 2021/10/28
N2 - Background: The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear. Methods: One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population. Results: Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority). Conclusions: One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.
AB - Background: The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear. Methods: One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population. Results: Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority). Conclusions: One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.
UR - https://www.scopus.com/pages/publications/85115075890
U2 - 10.1056/NEJMoa2108749
DO - 10.1056/NEJMoa2108749
M3 - Article
C2 - 34449185
SN - 0028-4793
VL - 385
SP - 1643
EP - 1655
JO - New England journal of medicine
JF - New England journal of medicine
IS - 18
ER -
SDG 3 Good Health and Well-being