Rationale and Design of Dual Antiplatelet Therapy in Patients with Coronary Multi-Vessel Disease (DAPT-MVD): A Multicenter, Randomized, Controlled Trial.

Background: The optimal duration of dual antiplatelet therapy (DAPT) for patients with coronary multi-vessel disease (MVD) who have received drug-eluting stents (DES) remains unclear.

Hypothesis And Methods: The Dual Antiplatelet Therapy in Patients with Coronary Multi-Vessel Disease (DAPT-MVD) study is a multicenter, open-label, randomized controlled trial designed to assess the efficacy and safety of extended DAPT in MVD patients 12 months following DES implantation. We plan to enroll 8250 patients across approximately 100 sites in China. Participants will be randomized in a 1:1 ratio to receive either extended DAPT (75 mg clopidogrel plus 75-150 mg aspirin daily) or monotherapy (75-150 mg aspirin daily) beyond 12 months post-DES implantation. The follow-up period will last at least 12 months, with all potential endpoints adjudicated by a blinded Clinical Events Committee. The primary endpoint is major adverse cardiovascular and cerebrovascular events (MACCE), including cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Results: As of April 2024, a total of 8250 participants have been enrolled in the study. The mean age of the enrolled patients was 60.5 ± 8.8years, with 5753 (69.7%) being men.

Conclusions: The DAPT-MVD study is the first large-scale trial to evaluate the efficacy and safety of prolonged DAPT with clopidogrel plus aspirin beyond 12 months after DES implantation in MVD patients. The trial will provide novel insights into the optimal duration of DAPT for MVD patients (ClinicalTrials. gov ID: NCT04624854. Registered on 10/27/2020).