For patients with atrial fibrillation (AF) who are more than one year post-implantation of a drug-eluting stent (DES), continuing combination therapy with an anticoagulant and an antiplatelet agent increases bleeding risk. While guidelines suggest transitioning to monotherapy, robust evidence has been limited.¹˒² The ADAPT AF-DES trial was designed to assess the safety and efficacy of non–vitamin K antagonist oral anticoagulant (NOAC) monotherapy compared to combination therapy in this patient group.¹

The ADAPT AF-DES trial was a multicenter, randomised, open-label, noninferiority trial conducted in South Korea. The study enrolled 960 patients with AF who had undergone DES implantation at least one year previously. The mean age of participants 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 consisting of 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.

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. This resulted in an absolute difference of –7.6 percentage points (95.2% CI, −11.9 to −3.3), which met the criteria for noninferiority (p<0.001).

The results also demonstrated the superiority of monotherapy over combination therapy (HR 0.54; 95.2% CI, 0.37 to 0.77; p<0.001). The incidence of major bleeding or clinically relevant nonmajor bleeding was significantly lower in the monotherapy arm, occurring in 25 patients (5.2%) versus 63 patients (13.2%) in the combination-therapy arm (HR 0.38; 95% CI, 0.24 to 0.60).

These findings suggest that for patients with AF who are stable at least one year after receiving a DES, discontinuing clopidogrel and continuing with NOAC monotherapy reduces the risk of net adverse clinical events, driven primarily by a significant reduction in bleeding complications. 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.

References

1. Lee SJ, Yu HT, Lee YJ, et al. Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents. N Engl J Med. Published online November 8, 2025. https://doi.org/10.1056/NEJMoa2512091.

2. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021;42(5):373-498. https://doi.org/10.1093/eurheartj/ehaa612.

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