1-month versus 12-month dual antithrombotic therapy after percutaneous coronary intervention in patients with atrial fibrillation (OPTIMA-AF): a multicentre, open-label, hybrid non-inferiority and superiority, randomised, controlled trial.

Summary

In 1,079 AF patients undergoing imaging-guided PCI, one-month dual therapy (DOAC plus P2Y12) followed by DOAC monotherapy was non-inferior to 12 months for death or thromboembolism and significantly reduced major/CRNM bleeding. Lower-than-expected event rates warrant cautious interpretation, but the net clinical benefit favored the short strategy.

Key Findings

• One-month dual therapy (DOAC + P2Y12) followed by DOAC monotherapy was non-inferior to 12-month dual therapy for death or thromboembolic events at 12 months.
• Major or clinically relevant non-major bleeding was reduced with the 1-month regimen.
• Trial population: 1,079 patients, median age 76 years; intravascular imaging guidance used across 75 sites in Japan.

Clinical Implications

For AF-PCI patients (predominantly chronic coronary syndrome) treated with intravascular imaging guidance, a 1-month dual therapy followed by DOAC monotherapy can be considered to minimize bleeding while preserving thromboembolic protection, pending local practice and patient risk.

Limitations

• Lower-than-anticipated event rates and a fixed absolute non-inferiority margin may limit power for some efficacy inferences.
• Open-label design and single-country (Japan) setting may affect generalizability.

Future Directions

Pragmatic trials across diverse health systems (with and without intravascular imaging) and enriched high-ischemic- or high-bleeding-risk cohorts can refine patient selection and validate net clinical benefit globally.