ADAPT AF-DES Trial (2025)
Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents
Multicenter, randomized, open-label, noninferiority trial
Objective:
In patients with atrial fibrillation (AF) who previously underwent drug-eluting stent (DES) implantation, does NOAC monotherapy provide similar protection against ischemic and bleeding events compared with NOAC plus clopidogrel combination therapy?
Inclusion Criteria:
- Age >19 years
- Non-valvular atrial fibrillation requiring long-term anticoagulation
- PCI with DES ≥12 months before enrollment
Population:
960 patients (mean age 71 years, 21% women)
- NOAC Monotherapy (n=482)
vs. - NOAC + Clopidogrel (n=478)
Primary Outcome:
Composite of death, MI, stent thrombosis, stroke, systemic embolism, or major/clinically relevant nonmajor bleeding at 12 months
- Monotherapy: 9.6%
- Combination therapy: 17.2%
- HR 0.54 (95% CI 0.37–0.77); P<0.001 for superiority
- Noninferiority margin: 3.0 percentage points (P<0.001 for noninferiority)
Secondary Outcome (Bleeding):
- Major or clinically relevant nonmajor bleeding:
- Monotherapy: 5.2%
- Combination: 13.2%
- HR 0.38 (95% CI 0.24–0.60)
Conclusion:
In patients with AF who had DES implantation ≥1 year earlier, NOAC monotherapy was both noninferior and superior to combination therapy for net adverse clinical events, reducing bleeding without increasing ischemic risk. These results support simplified long-term NOAC monotherapy in stable post-PCI AF patients.
Citation:
Lee S-J, Yu HT, Lee Y-J, et al. N Engl J Med. 2025; DOI: 10.1056/NEJMoa2512091