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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Atrial Fibrillation (AF); Drug-eluting Stent
• Intervention / Treatment: Drug: Single antiplatelet therapy; Drug: Oral anticoagulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yeji Kim, MD, PhD; Phone Number: +82-10-8680-9542; Email: lexie6169@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 07804
    • Ewha Womans University Mokdong Hospital
    • Contact: Yeji Kim, MD, PhD; Phone Number: +82-10-8680-9542; Email: lexie6169@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. 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.

2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhythm-guided antithrombotic strategy; Discontinuation of oral anticoagulation with continuation of single antiplatelet therapy after atrial fibrillation ablation.	Drug: Single antiplatelet therapy; Single antiplatelet therapy such as aspirin or a P2Y12 inhibitor.
Active Comparator: Continuous oral anticoagulation; Continuation of oral anticoagulation therapy after atrial fibrillation ablation in patients with prior drug-eluting stent implantation.	Drug: Oral anticoagulation; Non-vitamin K antagonist oral anticoagulant therapy used for stroke prevention in atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with net clinical outcome events	Composite of ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding, assessed as time-to-first event.	From randomization up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with ischemic stroke	Occurrence of ischemic stroke, defined according to standard clinical criteria.	From randomization up to 24 months
Number of participants with systemic embolism	Occurrence of systemic embolism confirmed by imaging or clinical diagnosis.	From randomization up to 24 months
Number of participants with myocardial infarction	Occurrence of myocardial infarction defined according to universal definition criteria.	From randomization up to 24 months
Number of participants with definite or probable stent thrombosis	Occurrence of definite or probable stent thrombosis according to ARC criteria.	From randomization up to 24 months
Number of participants with cardiovascular death	Death resulting from cardiovascular causes.	From randomization up to 24 months
Number of participants with major bleeding	Major bleeding defined according to ISTH criteria.	From randomization up to 24 months
Number of participants with clinically relevant non-major bleeding	Clinically relevant non-major bleeding defined according to ISTH criteria.	From randomization up to 24 months
Number of participants with atrial fibrillation recurrence	Any documented atrial fibrillation episode lasting more than 30 seconds.	From randomization up to 24 months
Atrial fibrillation burden (percentage of time in AF)	Percentage of time in atrial fibrillation measured by ambulatory monitoring or wearable monitoring.	From randomization up to 24 months
Number of participants with arrhythmia-related hospitalization	Hospitalization related to atrial arrhythmia.	From randomization up to 24 months
Number of participants undergoing repeat catheter ablation	Repeat catheter ablation for recurrent atrial arrhythmia.	From randomization up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with any adverse events	Occurrence of adverse events including bleeding, drug-related adverse events, and serious adverse events.	From randomization up to 24 months

Collaborators and Investigators

• Sponsor: Ewha Womans University Mokdong Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): February 28, 2032
• Study Completion (Estimated): March 1, 2035

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Catheter ablation; Atrial fibrillation ablation; Oral anticoagulation; Drug-eluting stent; Antithrombotic therapy; Single antiplatelet therapy; Non-vitamin K antagonist oral anticoagulant; Rhythm-guided strategy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Coronary Artery Disease
• Other Study ID Numbers: OPTIA-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding author after publication of the primary results.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.
• IPD Sharing Access Criteria: Access will be provided to qualified researchers for scientific purposes following approval of a research proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No