AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)

Summary

There has no evidence for the anticoagulation in patients who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However, anticoagulation can increase the risk of bleeding, the study evaluating the role of oral anticoagulation is needed in this patients. This study will compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus rhythm one year after catheter ablation of AF.

Timeline

Start

2020-07-28

Primary completion

2026-07

Completion

2028-10

Outcome

Met primary endpoint

paper 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 PMID 40886309 ↗

paper absolute difference, -1.9 percentage points [95% CI, -3.5 to -0.3]; P = .02. PMID 40886309 ↗

paper discontinuing oral anticoagulant therapy resulted in a lower risk for the composite outcome of stroke, systemic embolism, and major bleeding vs continuing PMID 40886309 ↗

Publications

• Kim D, Shim J, Choi EK, Oh IY, Kim J, Lee YS, Park J, Ko JS, Park KM, Sung JH, Park HW, Park HS, Kim JY, Kang KW, Kim D, Park JK, Kim DH, Kim JB, Yu HT, Kim TH, Uhm JS, Pak HN, Joung B; ALONE-AF Investigators. Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial. JAMA. 2025 Oct 14;334(14):1246-1254. doi: 10.1001/jama.2025.14679.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apixaban	Small molecule	2.5 mg	Oral
Subject	Apixaban	Small molecule	5 mg	Oral

Indications

No indication recorded.