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
Authors' conclusion
Among patients with atrial fibrillation and predominantly chronic coronary syndrome undergoing PCI with intravascular imaging guidance, 1-month dual antithrombotic therapy followed by DOAC monotherapy was non-inferior to 12-month therapy for death or thromboembolic events and reduced major or clinically relevant non-major bleeding at 12 months, suggesting an overall favourable net clinical profile.
Study context
- Population
- Patients aged ≥20 years with non-valvular AF, CHADS2 ≥1, undergoing percutaneous coronary intervention (PCI) with intravascular imaging guidance for chronic coronary syndrome or unstable angina1,079 in full analysis set
- Participants
- 1,088 patients
- Comparison
- 1-month vs 12-month dual antithrombotic therapy (DOAC plus P2Y12 inhibitor), each followed by DOAC monotherapy
- 1-month dual therapyn = 542
- 12-month dual therapyn = 537reference
- Primary endpoint
- All-cause death or thromboembolic events (primary efficacy); major or clinically relevant non-major bleeding (primary safety)
- Follow-up
- 12 months
Methodological detailsmulticentre, open-label, hybrid non-inferiority and superiority, active-control, fixed-sequence testing, blinded endpoint adjudication, 75 sites in Japan
- Multicentre
- Open-label
- Hybrid non-inferiority and superiority
- Active-control
- Fixed-sequence testing
- Blinded endpoint adjudication
- 75 sites in Japan
Primary result
As reported in the abstract
All-cause death or thromboembolic events
Each group vs 12-month dual therapyAbsolute difference, percentage points (95% CI)
1-month dual therapy
1.1(−1.5 to 3.6)
Each group vs 12-month dual therapyHazard ratio (95% CI)
1-month dual therapy
1.25(0.73–2.17)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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. Lancet. Published 15 July 2026. doi:10.
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