Objectives: The aim of this multicenter study was to evaluate the safety of discontinuing oral anticoagulation therapy (OAT) after apparently successful pulmonary vein isolation.
Background: Atrial fibrillation (AF) is associated with an increased risk of thromboembolic events (TE) and often requires OAT. Pulmonary vein isolation is considered an effective treatment for AF.
Methods: We studied 3,355 patients, of whom 2,692 (79% male, mean age 57 +/- 11 years) discontinued OAT 3 to 6 months after ablation (Off-OAT group) and 663 (70% male, mean age 59 +/- 11 years) remained on OAT after this period (On-OAT group). CHADS(2) (congestive heart failure, hypertension, age [75 years and older], diabetes mellitus, and a history of stroke or transient ischemic attack) risk scores of 1 and > or =2 were recorded in 723 (27%) and 347 (13%) Off-OAT group patients and in 261 (39%) and 247 (37%) On-OAT group patients, respectively.
Results: During follow-up (mean 28 +/- 13 months vs. 24 +/- 15 months), 2 (0.07%) Off-OAT group patients and 3 (0.45%) On-OAT group patients had an ischemic stroke (p = 0.06). No other thromboembolic events occurred. No Off-OAT group patient with a CHADS(2) risk score of > or =2 had an ischemic stroke. A major hemorrhage was observed in 1 (0.04%) Off-OAT group patient and 13 (2%) On-OAT group patients (p < 0.0001).
Conclusions: In this nonrandomized study, the risk-benefit ratio favored the suspension of OAT after successful AF ablation even in patients at moderate-high risk of TE. This conclusion needs to be confirmed by future large randomized trials.
Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.