Key Points
- The ADAPT AF-DES randomized trial compared NOAC monotherapy (apixaban or rivaroxaban) versus NOAC plus clopidogrel in atrial fibrillation (AF) patients who had undergone drug-eluting stent (DES) implantation ≥1 year earlier.
- NOAC monotherapy reduced net adverse clinical events (9.6% vs 17.2%; HR 0.54; P<0.001) and significantly decreased major or clinically relevant nonmajor bleeding (5.2% vs 13.2%; HR 0.38).
- The trial demonstrated noninferiority and superiority of monotherapy for the composite endpoint without increasing ischemic complications.
Antithrombotic management in patients with AF and prior PCI remains a clinical balancing act, minimizing thromboembolism while mitigating bleeding. Although current ACC/AHA and ESC guidelines endorse oral anticoagulant monotherapy beyond one-year post-PCI, supporting evidence from randomized trials has been sparse, especially in patients with modern-generation DES.
At the American Heart Association 2025 Scientific Sessions, Dr. Jung-Sun Kim (Yonsei University College of Medicine, Seoul) presented results of the ADAPT AF-DES trial, simultaneously published in the New England Journal of Medicine. The findings clarify the long-debated role of dual versus single antithrombotic therapy in stable post-PCI AF patients.
Conducted across 32 centers in South Korea, ADAPT AF-DES randomized 960 patients (mean age 71 years; 21% women) with AF and DES implantation ≥12 months earlier to: NOAC monotherapy: apixaban 5 mg BID or rivaroxaban 20 mg QD (dose-adjusted as indicated), or Combination therapy: same NOAC plus clopidogrel 75 mg QD (rivaroxaban 15 mg QD in combination arm). The primary endpoint was net adverse clinical events (NACE)—a composite of death, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major/clinically relevant nonmajor bleeding at 12 months.
At one year, Net Adverse Clinical Events (NACE) occurred in 9.6% of patients receiving monotherapy vs 17.2% with combination therapy (absolute difference −7.6%; HR 0.54; 95.2% CI 0.37–0.77; P<0.001 for both noninferiority and superiority).Bleeding outcomes drove the benefit: Major or CRNM bleeding: 5.2% vs 13.2% (HR 0.38; 95% CI 0.24–0.60), Major bleeding: 2.3% vs 6.1% (HR 0.37; 95% CI 0.18–0.74), Ischemic events including MI (0.8% vs 1.3%), stroke (1.0% vs 0.8%), and stent thrombosis (0.4% both) were comparable between arms, confirming preserved antithrombotic efficacy.
According to Dr. Jung-Sun Kim, “Our population was very challenging – we need to prevent thromboembolism but also avoid bleeding. Current guidelines recommend oral anticoagulant monotherapy beyond one year, but data were limited. In ADAPT AF-DES, NOAC monotherapy clearly reduced bleeding without sacrificing ischemic protection, proving it’s both noninferior and superior to combination therapy”. He emphasized that these results extend prior evidence from AFIRE and EPIC-CAD, while focusing exclusively on DES-treated patients which was previously underrepresented in clinical trials.
The ADAPT AF-DES trial establishes that NOAC monotherapy (either apixaban or rivaroxaban) offers superior net clinical benefit and reduces bleeding compared with continued NOAC plus clopidogrel combination therapy in AF patients with stable CAD ≥1 year after stenting. These findings consolidate the shift toward simplified single-agent anticoagulation for secondary prevention, highlighting safety without sacrificing ischemic protection.
