Published July 15, 2026
N Engl J Med 2026;395:233-242
DOI: 10.1056/NEJMoa2517588
Abstract
Background
Patients with multivessel coronary artery disease often receive 12 months of dual antiplatelet therapy (DAPT) after stenting to reduce the risk of ischemic events. Whether extending DAPT beyond 12 months in event-free patients with multivessel disease provides a benefit is uncertain.
Methods
We conducted an open-label, randomized trial at 97 centers in China. Patients 18 to 75 years of age with multivessel coronary artery disease who had no major ischemic or bleeding events while receiving DAPT for 12 months after implantation of a drug-eluting stent were randomly assigned in a 1:1 ratio to receive an additional 12 months of DAPT (clopidogrel plus aspirin) or aspirin monotherapy. The primary efficacy end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary safety end point was clinically relevant or major bleeding (i.e., a bleeding event of Bleeding Academic Research Consortium [BARC] type ≥2; BARC types range from 0 to 5, with higher values indicating greater severity of bleeding).
Results
A total of 8250 patients were randomly assigned to receive extended DAPT (4125 patients) or aspirin monotherapy (4125 patients). The median follow-up was 34.3 months. A primary efficacy end-point event occurred in 222 patients in the DAPT group and in 266 patients in the aspirin-monotherapy group (36-month Kaplan–Meier cumulative incidence, 5.8% vs. 6.8%; hazard ratio, 0.82; 95% confidence interval [CI], 0.69 to 0.98; P=0.03). Clinically relevant or major bleeding occurred in 51 patients in the DAPT group and in 57 patients in the aspirin-monotherapy group (36-month Kaplan–Meier cumulative incidence, 1.4% vs. 1.5%; hazard ratio, 0.89; 95% CI, 0.61 to 1.30; P=0.54).
Conclusions
Among patients with multivessel coronary artery disease who were in stable condition 12 months after implantation of a drug-eluting stent, extending DAPT with clopidogrel and aspirin for an additional 12 months led to a lower risk of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke than continuing aspirin alone, without an increased risk of bleeding. (Funded by the National Natural Science Foundation of China and others; DAPT-MVD ClinicalTrials.gov number, NCT04624854.)
Are you a member of an institution such as a university or hospital?Learn more about Institutional Access
Notes
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
Supported by grants (62135002 and 82525006) from the National Natural Science Foundation of China, the Tou-Yan Innovation Team Program of the Heilongjiang Province, a grant (CSCF2020A02) from the Chinese Society of Cardiology Clinical Research Special Fund Project, and Lepu Medical Technology.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
We thank Maoyi Tian, Xiling Zhang, and Chao Fang for their advice on the implementation of the project.
Supplementary Material
Information & Authors
Information
Published In
Copyright
Copyright © 2026 Massachusetts Medical Society. All rights reserved.
For personal use only. Any commercial reuse of NEJM Group content requires permission.
History
Published online: July 15, 2026
Published in issue: July 16, 2026
Topics
Authors
Metrics & Citations
Metrics
Altmetrics
Citations
Export citation
Select the format you want to export the citation of this publication.
Cited by
- Balancing the Scales — Extended DAPT in Coronary Artery Disease, New England Journal of Medicine, 395, 3, (304-305), (2026)./doi/full/10.1056/NEJMe2604885
Loading...