Extended DAPT with clopidogrel and aspirin reduces cardiovascular death, myocardial infarction, and stroke riskExtended dual antiplatelet therapy lowers risks for heart disease patients

This randomized trial evaluated the efficacy and safety of extending dual antiplatelet therapy (DAPT) in patients with multivessel coronary artery disease. The study enrolled 8250 patients between 18 and 75 years of age who had undergone drug-eluting stent implantation and remained free of major ischemic or bleeding events during an initial 12-month period of DAPT. The trial was conducted across 97 centers in China.

The study design compared two treatment regimens following the initial 12 months of therapy: extended DAPT consisting of clopidogrel plus aspirin for an additional 12 months, versus a transition to aspirin monotherapy. This investigation aimed to determine if extending the duration of dual therapy provided clinical benefits in patients with complex coronary anatomy.

The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. In the extended DAPT group, the incidence of this composite endpoint was 5.8% (222 events), compared to 6.8% (266 events) in the aspirin monotherapy group. This resulted in a hazard ratio of 0.82 with a 95% CI of [0.69 to 0.98] and a p-value of 0.03, indicating a statistically significant lower risk for patients remaining on DAPT.

Secondary outcomes were not specifically detailed beyond the primary composite endpoint analysis. However, the study focused heavily on the safety profile regarding bleeding events, which is a critical consideration when extending DAPT duration.

Regarding safety and tolerability, the incidence of clinically relevant or major bleeding (BARC type ≥2) was 1.4% in the extended DAPT group versus 1.5% in the aspirin monotherapy group. The hazard ratio for bleeding was 0.89 with a 95% CI of 0.61 to 1.30 and a p-value of 0.54, indicating no statistically significant difference in bleeding risk between the two groups.

These results provide important data for managing patients with multivessel coronary artery disease after drug-eluting stent implantation. While prior evidence has explored various interventions for coronary artery disease, such as comparing drug-coated balloons to drug-eluting stents or evaluating intravascular lithotripsy for calcified lesions, this study specifically addresses the timing of DAPT cessation.

Methodological limitations include the fact that the study was open-label. Additionally, while the sample size was large (8250), specific details on individual secondary outcomes were not reported. The trial was funded by the National Natural Science Foundation of China and others.

Clinical implications suggest that for patients with multivessel coronary artery disease who are stable after 12 months of DAPT, extending clopidogrel and aspirin for an additional year may reduce major cardiovascular events without increasing the risk of significant bleeding. This provides a clear evidence-based path for managing the duration of dual therapy in high-risk populations.

Questions remain regarding the long-term impact of this specific 12-month extension beyond the 34.3 months median follow-up and how these results apply to patients with different stent types or varying levels of baseline bleeding risk.