Extended Dual Antiplatelet Therapy Lowers Major Cardiovascular Events in Multivessel CAD: NEJM
China: Extending dual antiplatelet therapy (DAPT) for an additional year after the standard 12-month course may offer greater protection against major cardiovascular events in selected patients with multivessel coronary artery disease (CAD) who remain free of ischemic or bleeding complications following drug-eluting stent implantation, a new study published in the New England Journal of Medicine has shown.
Led by Jinwei Tian from the Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China, the randomized trial found that extending dual antiplatelet therapy with clopidogrel plus aspirin for an additional year after the standard 12 months reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke without increasing clinically relevant bleeding.
Patients with multivessel coronary artery disease remain at high risk for recurrent ischemic events. Although current guidelines generally recommend 12 months of DAPT after drug-eluting stent implantation followed by aspirin monotherapy, evidence supporting prolonged DAPT in patients who remain event-free has been limited.
To assess the benefits of extended DAPT, researchers conducted an open-label, multicenter randomized trial across 97 hospitals in China involving 8,250 patients aged 18 to 75 years with multivessel CAD who had remained free of major ischemic or bleeding events after 12 months of DAPT following drug-eluting stent implantation.
Participants were randomly assigned to receive either an additional 12 months of clopidogrel plus aspirin (4,125 patients) or aspirin monotherapy (4,125 patients) and were followed for a median of 34.3 months.
The primary efficacy endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, while the primary safety endpoint was clinically relevant or major bleeding (Bleeding Academic Research Consortium BARC type ≥2).
Key findings from the study include:
- The primary efficacy endpoint occurred in 222 patients receiving extended DAPT compared with 266 patients receiving aspirin alone.
- At 36 months, the cumulative incidence of the primary efficacy outcome was 5.8% in the extended DAPT group versus 6.8% in the aspirin monotherapy group.
- Extended DAPT was associated with an 18% relative reduction in the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (hazard ratio [HR], 0.82).
- Clinically relevant or major bleeding occurred in 51 patients in the extended DAPT group and 57 patients in the aspirin-alone group.
- The cumulative incidence of bleeding at 36 months was 1.4% with extended DAPT and 1.5% with aspirin alone, showing no significant difference between the treatment groups (HR, 0.89).
The findings suggest that extending dual antiplatelet therapy may provide additional cardiovascular protection in carefully selected, event-free patients with multivessel coronary artery disease after drug-eluting stent implantation, without increasing bleeding risk.
The authors concluded, "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."
Reference:
DOI: 10.1056/NEJMoa2517588
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