Abstract Body (Do not enter title and authors here): Background: Multivessel coronary artery disease (MVD), present in 40-60% of patients undergoing percutaneous coronary intervention (PCI), is associated with an increased risk of recurrent ischemic events compared with single vessel disease. This residual risk presents a clinical dilemma regarding the optimal duration of dual antiplatelet therapy (DAPT), particularly for patients with MVD who are stable 12 months after drug-eluting stent (DES) implantation. To address this evidence gap, we investigated the efficacy and safety of an additional 12-month DAPT regimen in these patients.
Methods: This investigator-initiated, multicenter, randomized, open-label, assessor-masked, superority trial enrolled MVD patients without major ischemic or bleeding events during the first 12 months post-DES. At 12-month post-PCI, stable patients were randomized to receive either DAPT (clopidogrel 75 mg/day plus aspirin 75-150 mg/day) or aspirin monotherapy (75-150 mg/day) for an additional 12 months. The primary efficacy endpoint was major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Safety endpoints were defined as Bleeding Academic Research Consortium (BARC) type 2-5 bleeding and BARC type 3-5 bleeding. This trial is registered at ClinicalTrials.gov, NCT04624854.
Results: Between October 28, 2020, and March 12, 2024, a total of 9127 participants were screened at 97 centers in China, with 877 deemed ineligible, leading to randomization of 8250 patients. The mean age was 60.5 ± 8.8 years, 69.7% were male, 28.2% had diabetes, and 53.5% had hypertension. The mean time from the most recent PCI to randomization was 378.6 ± 19.8 days. Over the study period, follow-up was completed for 98.1% of patients. Full analyses of the primary and secondary efficacy and safety endpoints will be presented for the first time at the AHA 2025 Scientific Sessions.
Conclusion: The DAPT-MVD trial was designed to evaluate the risk-benefit profile of extending DAPT in patients with MVD who remain stable 12 months post-DES implantation. The results will provide pivotal evidence for guiding the optimal duration of antiplatelet therapy in this high-risk population.