OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation

Официальное название

OPTIA-AF Trial: A Randomized Study of Rhythm-Guided Antithrombotic Strategy After Atrial Fibrillation Ablation in Patients With Prior Drug-Eluting Stent Implantation

Обзор

The OPTIA-AF trial is a prospective, multicenter randomized controlled trial designed to evaluate a rhythm-guided antithrombotic strategy in patients with atrial fibrillation (AF) who maintain durable sinus rhythm after catheter ablation and have a history of prior drug-eluting stent (DES) implantation. Current guidelines generally recommend long-term oral anticoagulation (OAC) in patients with AF, even after successful ablation, while antiplatelet therapy remains essential for prevention of coronary ischemic events following percutaneous coronary intervention. OPTIA-AF tests whether discontinuation of non-vitamin K antagonist oral anticoagulant (NOAC) therapy with transition to single antiplatelet therapy (SAPT) is non-inferior to continued NOAC therapy in patients who maintain sinus rhythm for at least 12 months after AF ablation. Participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with SAPT. The primary endpoint is a 24-month composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding.

Подробное описание

Atrial fibrillation (AF) and coronary artery disease frequently coexist, creating a complex clinical scenario in which patients require antithrombotic therapy for prevention of both thromboembolic and coronary ischemic events. Current guideline-directed management generally recommends long-term oral anticoagulation in patients with AF based on stroke risk stratification, while antiplatelet therapy remains central for prevention of stent-related ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.

Catheter ablation has become an established rhythm-control strategy for AF, and a substantial proportion of patients achieve durable maintenance of sinus rhythm after the procedure. Emerging evidence suggests that sustained sinus rhythm following successful ablation may reduce AF-related thromboembolic risk by decreasing atrial arrhythmia burden and atrial stasis. However, the optimal long-term antithrombotic strategy in patients who maintain stable sinus rhythm after ablation and have a prior history of DES implantation remains uncertain.

The OPTIA-AF trial (Optimal Post-ablation Therapy for Ischemic and Arrhythmic Risk in Atrial Fibrillation) is designed to evaluate whether a rhythm-guided strategy of discontinuing oral anticoagulation with transition to single antiplatelet therapy is non-inferior to continued NOAC therapy in patients with durable sinus rhythm after AF ablation.

This prospective, multicenter, open-label randomized controlled trial will enroll approximately 1,000 patients with nonvalvular AF who have maintained sinus rhythm for at least 12 months following catheter ablation and are at least 12 months removed from DES implantation. Eligible participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with transition to single antiplatelet therapy (SAPT). Structured rhythm surveillance including electrocardiography and ambulatory rhythm monitoring will be performed during follow-up.

Participants will be followed for 24 months. The primary endpoint is a composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding. Secondary outcomes include AF recurrence, AF burden, arrhythmia-related hospitalization, repeat catheter ablation, and individual components of the primary composite endpoint.

Вмешательства

• Препарат Oral anticoagulation
  Non-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.
• Препарат Single antiplatelet therapy
  Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.

Первичные конечные точки

• Number of participants with net clinical outcome events [Срок оценки: From randomization up to 24 months]

Вторичные конечные точки (11)

• Number of participants with ischemic stroke [Срок оценки: From randomization up to 24 months]
• Number of participants with systemic embolism [Срок оценки: From randomization up to 24 months]
• Number of participants with myocardial infarction [Срок оценки: From randomization up to 24 months]
• Number of participants with definite or probable stent thrombosis [Срок оценки: From randomization up to 24 months]
• Number of participants with cardiovascular death [Срок оценки: From randomization up to 24 months]
• Number of participants with major bleeding [Срок оценки: From randomization up to 24 months]
• Number of participants with clinically relevant non-major bleeding [Срок оценки: From randomization up to 24 months]
• Number of participants with atrial fibrillation recurrence [Срок оценки: From randomization up to 24 months]
• Atrial fibrillation burden (percentage of time in AF) [Срок оценки: From randomization up to 24 months]
• Number of participants with arrhythmia-related hospitalization [Срок оценки: From randomization up to 24 months]
• Number of participants undergoing repeat catheter ablation [Срок оценки: From randomization up to 24 months]

Критерии участия

• Inclusion Criteria

• Participants must meet all of the following criteria:
• Age ≥18 years.
• Documented history of atrial fibrillation (paroxysmal or persistent).
• Successful catheter ablation for atrial fibrillation performed within the previous 3-6 months.
• Maintenance of sinus rhythm after ablation, confirmed by follow-up electrocardiography or rhythm monitoring.
• History of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.
• Completion of the recommended duration of dual antiplatelet therapy (DAPT) following PCI.
• Currently receiving oral anticoagulation therapy with a non-vitamin K antagonist oral anticoagulant (NOAC).
• Clinically stable and considered eligible for long-term antithrombotic therapy adjustment by the treating physician.
• Ability to understand the study procedures and provide written informed consent.
• Exclusion Criteria

• Participants will be excluded if any of the following criteria are present:
• Recurrent atrial fibrillation documented after the index ablation procedure requiring repeat ablation or antiarrhythmic escalation.
• Presence of mechanical heart valve or moderate-to-severe mitral stenosis.
• Indication for long-term anticoagulation independent of atrial fibrillation (e.g., venous thromboembolism, mechanical valve).
• Recent acute coronary syndrome or PCI within the past 3 months.
• Planned coronary revascularization or cardiac surgery.
• History of intracranial hemorrhage or other major bleeding that contraindicates antithrombotic therapy.
• Severe renal dysfunction (e.g., estimated glomerular filtration rate <30 mL/min/1.73 m²).
• Severe hepatic dysfunction associated with coagulopathy.
• Known hypersensitivity or contraindication to aspirin or NOAC therapy.
• Pregnancy or breastfeeding.
• Life expectancy less than 1 year due to non-cardiovascular comorbidities.
• Participation in another interventional clinical trial that may interfere with the study outcomes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Ewha Womans University Mokdong Hospital — Seoul

Идентификаторы

NCT: NCT07496281 · OPTIA-AF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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