Coronary disease & ACSRandomised controlled trial
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
- Randomised controlled trial
- multicentre
- open-label
- hybrid non-inferiority and superiority
- active-control
- fixed-sequence testing
- blinded endpoint adjudication
- 75 sites in Japan
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 dual therapy vs 12-month dual therapy
- 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
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:10.1016/s0140-6736(26)00665-3
Summarised from the published abstract; every number is checked against it