Dell'Angelo Hospital, Mestre-Venice, Italy.
J Am Coll Cardiol. 2010 Feb 23;55(8):735-43. doi: 10.1016/j.jacc.2009.11.039.
The aim of this multicenter study was to evaluate the safety of discontinuing oral anticoagulation therapy (OAT) after apparently successful pulmonary vein isolation.
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.
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.
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).
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.
本多中心研究旨在评估在肺静脉隔离术（PVI）后成功停止口服抗凝治疗（OAT）的安全性。
房颤（AF）与血栓栓塞事件（TE）风险增加相关，通常需要 OAT。PVI 被认为是 AF 的有效治疗方法。
我们研究了 3355 名患者，其中 2692 名（70%为男性，平均年龄 57±11 岁）在消融后 3 至 6 个月停止 OAT（Off-OAT 组），663 名（70%为男性，平均年龄 59±11 岁）在此期间继续 OAT（On-OAT 组）。记录了 723 名（27%）和 347 名（13%）Off-OAT 组患者以及 261 名（39%）和 247 名（37%）On-OAT 组患者的 CHADS2（充血性心力衰竭、高血压、年龄[75 岁及以上]、糖尿病和中风或短暂性脑缺血发作史）评分 1 和≥2。
在随访期间（平均 28±13 个月 vs. 24±15 个月），2 名（0.07%）Off-OAT 组患者和 3 名（0.45%）On-OAT 组患者发生缺血性中风（p=0.06）。没有其他血栓栓塞事件发生。CHADS2 评分≥2 的 Off-OAT 组患者无一例发生缺血性中风。1 名（0.04%）Off-OAT 组患者和 13 名（2%）On-OAT 组患者发生重大出血（p<0.0001）。
在这项非随机研究中，即使在 TE 中高危患者中，AF 消融后停止 OAT 的风险获益比也有利于停药。这一结论需要未来的大型随机试验来证实。
