DIscontinuation of Anticoagulation With Intensive Rhythm MONitoring CompareD With Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial
DIAMOND-AF is a multicenter, randomized, open-label trial evaluating whether discontinuing oral anticoagulation after successful atrial fibrillation ablation can reduce bleeding risk without increasing death or thromboembolism risks. Adults aged 18-80 years, 60-365 days post-ablation, with CHA2DS2-VA ≥2, no prior stroke/TIA/systemic embolism, continuous NOAC use, and no documented atrial tachyarrhythmia recurrence will be randomized 1:1 to stop NOACs immediately or to continue NOAC therapy. All participants use intensified rhythm surveillance including smartwatch ECG and Holter/patch monitoring (at least every 6 months; every 2 months encouraged) to detect recurrence. Co-primary endpoints are (1) non-inferiority for the composite of all-cause death, ischemic stroke, or systemic embolism and (2) superiority for the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding. The planned sample size is 4,100 participants.
⁃ Participants must meet all of the following criteria:
• Age 18 to 80 years.
• 60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.
• CHA2DS2-VA score ≥2.
• No history of stroke, transient ischemic attack (TIA), or systemic embolism.
• Continuous use of a NOAC since AF/AFL ablation.
• No documented atrial tachyarrhythmia recurrence since ablation.
• No antiarrhythmic drug (AAD) use within the past 2 months.
• Able and willing to provide written informed consent.
• Able and willing to comply with study procedures and follow-up.