Abstract Body (Do not enter title and authors here): BACKGROUND
Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) are at increased risk of bleeding due to the concomitant use of oral anticoagulants; thus, minimizing the duration of antiplatelet therapy is desirable. However, the optimal antithrombotic regimen within one year after PCI for this population remains unclear. This trial aims to assess the safety and efficacy of a 1-month dual antithrombotic therapy regimen in patients with AF undergoing PCI with contemporary drug-eluting stents.
METHODS
In this multicenter, prospective, open-label, randomized controlled trial, patients with AF undergoing PCI were randomized in a 1:1 ratio to receive short 1-month dual antithrombotic therapy [a direct oral anticoagulant (DOAC) plus a P2Y₁₂ inhibitor] followed by monotherapy with a DOAC or standard 12-month dual antithrombotic therapy. PCI was performed with the XIENCE™ everolimus-eluting stent. The primary efficacy endpoint was a composite of death or thromboembolic events at 12 months. The primary safety endpoint was major bleeding or clinically relevant nonmajor bleeding at 12 months. The following 3 hypotheses will be tested in the intention-to-treat population in the following order: non-inferiority of the primary efficacy endpoint; superiority of the primary safety endpoint; and superiority of the primary efficacy endpoint. The sample size was calculated for a non-inferiority test, assuming a 10% event rate in the control group, a 5% non-inferiority margin, and a one-sided alpha of 0.05. A total of 1,036 patients provided 85% power for efficacy and 99.2% power for detecting a safety difference. Accounting for 5% attrition, 1,090 patients were required.
RESULTS
From 2019 through 2024, a total of 1,101 patients were enrolled at 75 sites in Japan. The final clinical follow-up will be completed in August 2025, with formal analysis to follow. The mean age of the patients was 75.2±8.4 years, and 224 (20.8%) patients were women. A total of 20% had prior PCI and 12.2% had prior ischemic stroke. Paroxysmal AF was present in 48.2% and 246 patients (22.6%) underwent complex PCI.
CONCLUSIONS
The OPTIMA-AF trial, involving patients with AF and stable coronary artery disease undergoing PCI, will provide data on the efficacy and safety of the 1-month dual antithrombotic therapy followed by DOAC monotherapy as compared to the 12-month dual antithrombotic therapy. (jRCTs051190053)