The DESTINATION Study investigates whether anticoagulation therapy is necessary after successful catheter ablation (CA) for atrial fibrillation (AF). Current guidelines recommend continued anticoagulation based on stroke risk scores, even post-ablation, potentially exposing patients to unnecessary bleeding risks. This international, multicenter, randomized controlled trial aims to compare thromboembolic and bleeding event risks between patients who continue and discontinue anticoagulation after ablation. The study involves 3,160 AF patients, all free of AF recurrence within 6 months to 1 year after ablation. Smart wearable monitors will track recurrence, and patients are followed for 24 months to assess event rates. Findings may reshape anticoagulation guidelines, improving clinical practice for AF patients worldwide.
Age ≥18 years
Diagnosed paroxysmal, persistent, or longstanding persistent AF
Successful procedure (defined as restoration of sinus rhythm after PV isolation for paroxysmal AF, restoration of sinus rhythm after PV isolation and completion of additional ablation for persistent AF, according to 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation) and no recurrence within 3 months of ablation, using a cooled tip RF-, laser- or cryo-balloon-catheter
No periprocedural complications
Valvular AF (moderate- severe mitral insufficiency; relevant mitral stenosis with a mean pressure gradient >5mmHg)
Reversible AF (e.g. uncontrolled hyperthyroidism)
Prior AF ablation (including surgical ablation)
History of left atrial appendage occlusion/ligation/excision
Parallel
discontinue anticoagulation therapy
BehavioralParticipants in the discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.
Anticoagulant drugs
DrugParticipants in the continuation arm will receive oral anticoagulant drugs such as dabigatran, rivaroxaban, apixaban, warfarin, etc. tailored to their specific risk profiles. The discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.
Catheter Ablation
Procedure/SurgeryCatheter ablation is a medical procedure used to treat atrial fibrillation (AF) by targeting and destroying small areas of heart tissue that cause irregular heartbeats. Using a specialized catheter, radiofrequency energy, cryotherapy, or pulsed field ablation (PFA) is applied to isolate the pulmonary veins or ablate other specific heart areas. The goal is to restore normal heart rhythm by electrically isolating problematic areas responsible for AF. This FDA-regulated procedure is minimally invasive and requires follow-up monitoring for AF recurrence and other potential complications. No specific ablation technique is mandated, allowing flexibility for operators to choose based on their expertise and center practices. The ablation strategy may include pulmonary vein isolation or additional procedures based on the type of AF. This approach distinguishes the study by providing real-world applicability, reflecting the diversity of ablation methods used in clinical practice.
Composite outcome consisting of thromboembolic events and clinically significant bleeding events
The primary endpoint of this study comprises a composite outcome consisting of thromboembolic events and clinically significant bleeding events. Specifically, it encompasses the following components: 1. Incidence of ischemic stroke and systemic thromboembolism within the 2-year post-ablation period in each respective study group. 2. Incidence of clinically significant bleeding within the 2-year post-ablation period in each respective study group. Unit of Measure: Number of events (strokes, systemic embolism, major bleeding episodes).
AF Recurrence Rate
Percentage of patients with documented AF recurrence at 2 years.
Repeat Ablation Proportion
Percentage of patients undergoing repeat ablation within each group
Thromboembolic/Bleeding Event Rates after repeat procedure
Percentage of patients with Thromboembolic and Bleeding events after repeat ablation in each group
Thromboembolic/Bleeding Event Rates after recurrence in off-OAC
Percentage of patients with thromboembolic and bleeding event rates in patients resuming anticoagulation therapy due to AF recurrence in the no anticoagulation group
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