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Rationale and Design of Dual Antiplatelet Therapy in Patients with Coronary Multi-Vessel Disease (DAPT-MVD): A
Jinwei Tian1,2,3,4, Zhuozhong Wang1,2,3, Yan Wang1,3
1Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.
Insights
This study investigates extended dual antiplatelet therapy (DAPT) versus aspirin monotherapy for coronary multi-vessel disease patients post-drug-eluting stent implantation. Findings will clarify optimal DAPT duration for improved cardiovascular outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation in patients with coronary multi-vessel disease (MVD) is not well-defined.
- Existing research has not conclusively determined the benefits and risks of extending DAPT beyond standard durations in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of extended DAPT compared to aspirin monotherapy in MVD patients 12 months after DES implantation.
- To determine the optimal duration of DAPT for reducing major adverse cardiovascular and cerebrovascular events (MACCE) in MVD patients.
Main Methods:
- A multicenter, open-label, randomized controlled trial (DAPT-MVD study) involving 8250 patients in China.
- Participants randomized 1:1 to receive either extended DAPT (clopidogrel + aspirin) or aspirin monotherapy beyond 12 months post-DES.
- Primary endpoint: MACCE (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke), with at least 12 months follow-up and blinded adjudication.
Main Results:
- Enrollment of 8250 participants completed as of April 2024.
- The study population comprised a mean age of 60.5 ± 8.8 years, with 69.7% males.
Conclusions:
- The DAPT-MVD study is the first large-scale trial assessing prolonged DAPT (clopidogrel + aspirin) beyond 12 months post-DES in MVD patients.
- The trial is expected to provide crucial insights into the optimal duration of DAPT for managing MVD patients, informing clinical practice guidelines.
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).
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