AHA 2025 | OPTIMA-AF: 1 Month vs. 12 Months of Dual Therapy (DOAC + P2Y12) After PCI in Atrial Fibrillation

Concomitant atrial fibrillation (AF) and coronary artery disease is a common occurrence in clinical practice. In these patients, current guidelines recommend 1 month of triple therapy (direct oral anticoagulation [DOAC] + dual antiplatelet therapy [DAPT]) followed by 12 months of dual therapy (DOAC + P2Y12 inhibitor) after percutaneous coronary intervention (PCI). The OPTIMA-AF study assessed whether a shorter regimen — 1 month of DOAC + P2Y12, followed by DOAC monotherapy — could maintain efficacy while reducing the bleeding risk.

This randomized trial, conducted in 75 centers in Japan, included 1088 patients with AF undergoing PCI. The primary endpoint (PEP) was a composite of death, myocardial infarction (MI), or stroke at 1 year. The safety endpoint was the incidence of bleeding or deterioration in quality of life over the same period.

All procedures used Xience stents and intravascular imaging (intravascular ultrasound [IVUS]/optical coherence tomography [OCT]) guidance. Patients received aspirin (ASA) + P2Y12 + DOAC during the periprocedural period. The design included analyses for noninferiority and superiority. Mean age was 75 years, 80% of subjects were men, 94.1% had chronic coronary syndromes, and clopidogrel was used as the P2Y12 inhibitor in 48.5% of cases.

Read also: AHA 2025 | CLOSURE-AF: Left Atrial Appendage Occlusion (LAAO) vs. Medical Therapy in Atrial Fibrillation with High Stroke and Bleeding Risk

In the PEP analysis, there was an absolute event difference of 0.9%, thus meeting the noninferiority criterion (4.5% [1 month] vs. 5.4% [12 months]; hazard ratio [HR] 1.20; 95% confidence interval [CI] 0.70–2.07; p=0.002). Regarding safety, the 1-month arm showed a significant reduction in clinically relevant bleeding (4.8% vs. 9.5%; HR 0.50; 95% CI 0.31–0.80; p=0.004), being superior in this aspect.

Conclusions

In AF patients undergoing PCI, a 1-month regimen of DOAC + P2Y12 inhibitor followed by DOAC monotherapy proved noninferior for ischemic events and halved the incidence of clinically relevant bleeding.

Presented by Yohei Sotomi during the Late-Breaking Science session at AHA 2025, New Orleans, USA.