This research is Trending!
July 1, 2026The Lancet
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
Y SotomiKen KozumaYoshiharu HiguchiGaku NakazawaYoshihiro MorinoK AndoJ AkoK TanabeT MuramatsuKen KobayashiYasuhiro IchiboriTakayuki IshiharaKeiji HirookaSatoru SuwaTakayuki WarisawaToru NaganumaAtsushi KikuchiRyu ShuttaNaotaka OkamotoYasuhiro TanabeA OkamuraKosuke KashiwabaraShungo HikosoYasushi Sakata
Key result
In 1,079 patients with atrial fibrillation undergoing PCI, 1-month dual antithrombotic therapy was non-inferior to 12-month therapy for death or thromboembolic events at 12 months.
Why the study?
The optimal duration of dual antithrombotic therapy after percutaneous coronary intervention in patients with atrial fibrillation remains uncertain.
Does 1-month dual antithrombotic therapy followed by DOAC monotherapy reduce bleeding without increasing death or thromboembolic events compared to 12-month dual therapy in patients with atrial fibrillation undergoing PCI?
Key Points
- This study aims to evaluate the safety and efficacy of 1-month versus 12-month dual antithrombotic therapy after PCI in patients with atrial fibrillation.
- Randomized, controlled trial with participants assigned 1:1 to 1-month or 12-month dual therapy.
- Conducted across 75 sites in Japan with a total of 1079 patients included.
- Used intravascular imaging guidance during PCI.
- 1-month dual therapy was non-inferior to 12-month therapy for death or thromboembolic events.
- 1-month therapy also significantly reduced major or clinically relevant non-major bleeding at 12 months.
- Event rates were lower than anticipated, warranting cautious interpretation of efficacy findings.
Study Design
Type
RCT (n=1,079)
Blinding
Open-label
Randomization
1:1
Multicenter
Yes
Structured PICO
Does 1-month dual antithrombotic therapy followed by DOAC monotherapy reduce bleeding without increasing death or thromboembolic events compared to 12-month dual therapy in patients with atrial fibrillation undergoing PCI?
P
Population
1,079 patients aged 20 years or older with non-valvular atrial fibrillation undergoing PCI with intravascular imaging guidance, followed for 12 months.
I
Intervention
1-month dual antithrombotic therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) followed by DOAC monotherapy
C
Comparator
12-month dual antithrombotic therapy (DOAC plus P2Y12 inhibitor) followed by DOAC monotherapy
O
Outcome
Composite of death or thromboembolic events, and major or clinically relevant non-major bleeding at 12 monthscomposite
In patients with atrial fibrillation undergoing PCI, dropping the P2Y12 inhibitor after 1 month to continue DOAC monotherapy reduces bleeding without increasing ischemic events compared to 12 months of dual therapy.
Limitations
- Lower-than-anticipated event rates
- Fixed absolute non-inferiority margin
- lower-than-anticipated event rates
- fixed absolute non-inferiority margin
Ask about this paper
Answers are grounded in this paper and cite their sources.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
DYDr. Yohei Sotomi
“Patients with atrial fibrillation who receive a stent may only need 1 month of dual antithrombotic therapy, instead of 1 year. This shorter treatment is just as effective and much safer in terms of bleeding.”
DYDr. Yohei Sotomi
“Previous studies confirmed that using two anti-clotting agents instead of three reduced bleeding, however, no study has tested whether the duration of dual therapy could be safely shortened to just one month. Our study is the first to...”
Implication
1-month dual therapy noninferior with less bleeding after PCI in AF; extends abbreviated DAT evidence for this population.
Abstract
No abstract yet. The journal hasn't published one we can show.
The Lancet · RCT. In AF after PCI, 1-month dual therapy was non-inferior, with less bleeding. 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 1,079 adults: AF patients undergoing PCI across 75 sites in Japan. Then DOAC monotherapy in both arms: 1-month DOAC + P2Y12 vs 12-month DOAC + P2Y12. Non-inferior efficacy, less bleeding at 12 months: Efficacy non-inferior, Less bleeding, Low event rates. Bottom line: 1-month dual therapy extends evidence for shorter regimens after PCI in AF.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Discussion
No takes yet. Share an insight, caveat, or question.
Cite This Study
Sotomi et al. (2026) conducted an RCT in Atrial fibrillation undergoing percutaneous coronary intervention (n=1,079). 1-month dual antithrombotic therapy (DOAC plus P2Y12 inhibitor) followed by DOAC monotherapy vs. 12-month dual antithrombotic therapy followed by DOAC monotherapy was evaluated on Death or thromboembolic events. In 1,079 patients with atrial fibrillation undergoing PCI, 1-month dual antithrombotic therapy was non-inferior to 12-month therapy for death or thromboembolic events at 12 months.