OPTIA-AF trial: A randomized study of rhythm-guided antithrombotic strategy after atrial fibrillation ablation in patients with prior drug-eluting stent implantation.

BACKGROUND

Recent randomized studies suggest that oral anticoagulation may be safely discontinued in carefully selected patients who maintain durable sinus rhythm (SR) after atrial fibrillation (AF) ablation. However, patients with previous drug-eluting stent (DES) implantation represent a distinct population in whom residual coronary ischemic risk persists and long-term antiplatelet therapy remains clinically relevant. The optimal antithrombotic strategy in this setting remains uncertain.

OBJECTIVE

The Optimal Postablation Therapy for Ischemic and Arrhythmic Risk in Atrial Fibrillation (OPTIA-AF) trial was designed to evaluate whether discontinuation of non-vitamin K antagonist oral anticoagulation (NOAC) with transition to single antiplatelet therapy is noninferior to continued NOAC therapy in patients with durable SR after AF ablation and previous DES implantation.

METHODS

OPTIA-AF is a prospective, multicenter, randomized controlled trial enrolling patients with nonvalvular AF who have maintained ≥12 months of documented SR after catheter ablation and are ≥12 months removed from DES implantation. Participants are randomized 1:1 to continued NOAC therapy or NOAC discontinuation with single antiplatelet therapy. Structured rhythm surveillance using electrocardiography and ambulatory monitoring is mandated throughout follow-up.

RESULTS

The primary end point is a 24-month net clinical outcome composite of ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding. Key secondary end points include individual components of the composite endpoint, clinically relevant nonmajor bleeding, AF recurrence, AF burden, arrhythmia-related hospitalization, and repeat ablation. Approximately 1000 patients will be enrolled to provide adequate power for noninferiority testing.

CONCLUSION

OPTIA-AF will provide randomized evidence to inform a rhythm-guided, individualized antithrombotic strategy after AF ablation in patients with concomitant coronary artery disease and previous DES implantation.