Randomised controlled trial to investigate optimal antithrombotic therapy in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: a study protocol of the OPTIMA-AF trial
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Published on: February 28, 2012
Yohei Sotomi1, Ken Kozuma2, Kosuke Kashiwabara3
1Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Insights
The OPTIMA-AF trial evaluates short dual therapy versus long dual therapy for atrial fibrillation patients undergoing PCI. Short dual therapy aims for non-inferior efficacy and superior safety, with results pending.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Optimal antithrombotic strategies for atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI) remain uncertain.
- Current research explores short dual antiplatelet therapy for non-AF patients, but short dual therapy (P2Y12 inhibitor + direct oral anticoagulant) in AF patients undergoing PCI is unevaluated.
Purpose of the Study:
- To compare the efficacy and safety of a 1-month dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor, followed by DOAC monotherapy) versus a 12-month dual therapy in AF patients undergoing PCI.
- To determine if short dual therapy is non-inferior in efficacy and superior in safety compared to long dual therapy.
Main Methods:
- The OPTIMA-AF trial is a prospective, randomized controlled trial involving 1090 patients.
- Participants are randomized 1:1 to receive either 1-month or 12-month dual therapy (DOAC + P2Y12 inhibitor).
- Primary endpoints include a composite of death or thromboembolic events (efficacy) and major or clinically relevant non-major bleeding (safety) at 365 days.
Main Results:
- This is a pre-results abstract; therefore, main results are not yet available.
- The study is designed to provide critical data on the optimal duration of dual antithrombotic therapy in this high-risk patient population.
Conclusions:
- The OPTIMA-AF trial will provide crucial insights into the balance between efficacy and safety of shorter versus longer dual antithrombotic durations in AF patients undergoing PCI.
- Findings are expected to inform clinical guidelines and improve patient outcomes by potentially reducing bleeding complications without compromising thrombotic event prevention.
Introduction:
The optimal antithrombotic strategy for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is uncertain. For patients with non-AF, many trials are now evaluating short 1-month dual antiplatelet therapy. In patients with AF undergoing PCI, in contrast, short dual therapy (P2Y12 inhibitor +direct oral anticoagulant (DOAC)) has not yet been evaluated.
Methods And Analysis:
The OPTIMA-AF trial (OPTIMAl antiplatelet therapy in combination with direct oral anticoagulants in patients with non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention with everolimus-eluting stent) is an investigator-initiated, open-label, nationwide, multicentre, prospective, randomised controlled trial. The primary objective is to compare the efficacy and safety of short dual therapy (1-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) against long dual therapy (12-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) in the treatment of AF subjects undergoing PCI. The primary efficacy endpoint is a composite of death or thromboembolic events (myocardial infarction, definite stent thrombosis, stroke or systemic embolism) at 365 days; and the primary safety endpoint is bleeding (International Society on Thrombosis and Haemostasis major or clinically relevant non-major bleeding) at 365 days. This trial is intended to show the non-inferiority of short dual therapy versus long dual therapy in terms of the primary efficacy endpoint and show superiority in terms of the primary safety endpoint. A total of 1090 subjects will be randomised in a 1:1 ratio at approximately 60 sites.
Ethics And Dissemination:
This study received approval from the Certified Review Board of Osaka University (a certified research ethics committee by the Japanese Clinical Research Act). The findings will be disseminated through peer-reviewed publications and conference presentations.
Trial Registration Number:
Japan Registry of Clinical Trials: jRCTs051190053; Pre-results.
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