In atrial fibrillation (AF) patients post one-year drug-eluting stent (DES) implantation, non–vitamin K antagonist oral anticoagulant (NOAC) was shown to be noninferior to NOAC plus clopidogrel combination therapy.¹ Current guidelines recommend NOAC monotherapy in this patient population, but supporting evidence has been limited.²

Methodology

The ADAPT AF-DES trial was a multicenter, randomised, open-label, noninferiority study conducted in South Korea. The trial enrolled 960 patients with AF who had undergone DES implantation at least one year earlier. The mean age of the cohort was 71.1 years, and 21.4% were women.

Patients were assigned in a 1:1 ratio to receive either NOAC monotherapy (n=482) or combination therapy with a NOAC plus clopidogrel (n=478). The primary endpoint was net adverse clinical events (NACE), a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major or clinically relevant nonmajor bleeding at 12 months. The noninferiority margin was set at 3.0 percentage points.

Results

At the 12-month follow-up, the primary endpoint had occurred in 46 patients (Kaplan–Meier estimate, 9.6%) in the monotherapy group, compared to 82 patients (Kaplan–Meier estimate, 17.2%) in the combination therapy group. The absolute difference of –7.6 percentage points met the criteria for noninferiority (95.2% CI, −11.9 to −3.3; p<0.001). The results also demonstrated superiority for monotherapy (HR 0.54; 95.2% CI, 0.37 to 0.77; p<0.001).¹

Regarding safety, the incidence of major or clinically relevant nonmajor bleeding was significantly lower in the monotherapy arm. Bleeding events occurred in 25 patients (5.2%) in the monotherapy group versus 63 patients (13.2%) in the combination therapy group (HR 0.38; 95% CI, 0.24 to 0.60).

Interpretation

These findings suggest that for patients with AF who are stable at least one year after DES implantation, continuing combination antithrombotic therapy increases the risk of bleeding without providing additional benefit over NOAC monotherapy. The ADAPT AF-DES Investigators concluded, "Among patients with atrial fibrillation who had undergone implantation of a drug-eluting stent at least 1 year earlier, NOAC monotherapy was noninferior to combination therapy for net adverse clinical events."¹

This study was funded by the Cardiovascular Research Center and Samjin Pharmaceutical.

Disclaimer

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References

1. Lee SJ, Yu HT, Lee YJ, et al., for the ADAPT AF-DES Investigators. Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents. N Engl J Med 2026;394:658-668. https://doi.org/10.1056/NEJMoa2512091.

2. Lip GYH, Kuzma L. Thromboprophylaxis for Atrial Fibrillation in Patients with Drug-Eluting Stents. N Engl J Med2026;394(7):713-715. https://doi.org/10.1056/NEJMe2517711.