JAMA. 2025;334(14):1246-1254.
Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial.
제1저자 김태훈, 심재민, 최의근 · 교신저자 정보영
소속 (18)
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
- Department of Cardiology, Korea University Hospital, Seoul, South Korea.
- Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea.
- Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, South Korea.
- Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
- Division of Cardiology, Daegu Catholic University Hospital, Daegu, South Korea.
- Department of Cardiology, Ewha Womans University Hospital, Seoul, South Korea.
- Division of Cardiology, Department of Internal Medicine, Wonkwang University School of Medicine and Hospital, Iksan, South Korea.
- Division of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
- Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.
- Division of Cardiovascular Medicine, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, South Korea.
- Division of Cardiology, Keimyung University Hospital, Daegu, South Korea.
- Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Seoul, South Korea.
- Division of Cardiology, Chung-Ang University Hospital, Seoul, South Korea.
- Division of Cardiology, Department of Internal Medicine, Dankook University College of Medicine, Cheonan, South Korea.
- Department of Cardiology, Hanyang University Seoul Hospital, Seoul, South Korea.
- Department of Cardiology, Inha University College of Medicine and Inha University Hospital, Incheon, South Korea.
- Division of Cardiology, Kyung Hee University Medical Center, Seoul, South Korea.
Abstract
IMPORTANCE Data from randomized clinical trials on a long-term anticoagulation strategy for patients after catheter-based ablation for atrial fibrillation (AF) are lacking.
OBJECTIVE To evaluate whether discontinuing oral anticoagulant therapy provides superior clinical outcomes compared with continuing oral anticoagulant therapy in patients without documented atrial arrhythmia recurrence after catheter ablation for AF.
DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial including 840 adult patients (aged 19-80 years) who were enrolled and randomized from July 28, 2020, to March 9, 2023, at 18 hospitals in South Korea. Enrolled patients had at least 1 non-sex-related stroke risk factor (determined using the CHA2DS2-VASc score [range, 0-9]) and no documented recurrence of atrial arrhythmia for at least 1 year after catheter ablation for AF. The CHA2DS2-VASc score is used as an assessment of stroke risk among patients with AF (calculated using point values for congestive heart failure, hypertension, ≥75 years of age, diabetes, stroke or transient ischemic attack, vascular disease, between 65 and 74 years of age, and sex category). The date of final follow-up was June 4, 2025.
INTERVENTIONS The patients were randomly assigned in a 1:1 ratio to discontinue oral anticoagulant therapy (n = 417) or continue oral anticoagulant therapy (with direct oral anticoagulants; n = 423).
MAIN OUTCOMES AND MEASURES The primary outcome was the first occurrence of a composite of stroke, systemic embolism, and major bleeding at 2 years. Individual components of the primary outcome (such as ischemic stroke and major bleeding) were assessed as secondary outcomes.
RESULTS Of the 840 adults randomized, the mean age was 64 (SD, 8) years, 24.9% were women, the mean CHA2DS2-VASc score was 2.1 (SD, 1.0), and 67.6% had paroxysmal AF. At 2 years, the primary outcome occurred in 1 patient (0.3%) in the discontinue oral anticoagulant therapy group vs 8 patients (2.2%) in the continue oral anticoagulant therapy group (absolute difference, -1.9 percentage points [95% CI, -3.5 to -0.3]; P = .02). The 2-year cumulative incidence of ischemic stroke was 0.3% in the discontinue oral anticoagulant therapy group vs 0.8% in the continue oral anticoagulant therapy group (absolute difference, -0.5 percentage points [95% CI, -1.6 to 0.6]). Major bleeding occurred in 0 patients in the discontinue oral anticoagulant therapy group vs 5 patients (1.4%) in the continue oral anticoagulant therapy group (absolute difference, -1.4 percentage points [95% CI, -2.6 to -0.2]).
CONCLUSIONS AND RELEVANCE Among patients without documented atrial arrhythmia recurrence after catheter ablation for AF, discontinuing oral anticoagulant therapy resulted in a lower risk for the composite outcome of stroke, systemic embolism, and major bleeding vs continuing direct oral anticoagulant therapy.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04432220.
Comment · 정정
Conflict of interest statement
Conflict of Interest Disclosures: Dr Choi reported receiving grants or speaking fees from Abbott, Bayer, BMS/Pfizer, Biosense Webster, Chong Kun Dang, Daewoong Pharmaceutical Co, Daiichi-Sankyo, DeepQure, Dreamtech Co Ltd, Jeil Pharmaceutical Co Ltd, Medtronic, Samjinpharm, Samsung Electronics Co Ltd, Seers Technology, Skylabs, and Yuhan Corporation. Dr Joung reported receiving speaking fees from Bayer, BMS/Pfizer, Medtronic, and Daiichi-Sankyo and receiving research funding from Samjin, Yuhan, Medtronic, Boston Scientific, and Abbott Korea. No other disclosures were reported.
그 밖의 정보
- 출판 형태
- Clinical Trial, Phase IV, Equivalence Trial, Journal Article, Multicenter Study
- 저널
- JAMA · eISSN 1538-3598
- MeSH
- Adult · Aged · Aged, 80 and over · Female · Humans · Male · Middle Aged · Young Adult · Administration, Oral · Anticoagulants* / administration & dosage / adverse effects · Atrial Fibrillation* / surgery / complications / drug therapy · Catheter Ablation* / adverse effects · Hemorrhage / chemically induced / epidemiology · Postoperative Complications* / epidemiology / etiology / prevention & control · Prospective Studies · Recurrence · Risk Factors · Stroke / prevention & control / epidemiology / etiology · Thromboembolism / epidemiology / etiology / prevention & control · Treatment Outcome · Withholding Treatment*
- Substances
- Anticoagulants
- 데이터
- ClinicalTrials.gov: NCT04432220
- 참고문헌
- 31편