From the Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (L.D.B., J.D.B., P.S., P.M., J.E.S., R. Horton, G.J.G., J.Z., B.R., S.M., A.N.); Albert Einstein College of Medicine, Montefiore Hospital, New York, NY (L.D.B.); Department of Biomedical Engineering, University of Texas, Austin (L.D.B., A.N.); Department of Cardiology, University of Foggia, Foggia, Italy (L.D.B., P.S.); Ospedale dell'Angelo, Mestre Venice, Italy (S.T., A.R.); University of Kansas, Kansas City (D.L., M.R.); California Pacific Medical Center, San Francisco (S.H., R. Hongo, S.B., A.N.); University of Kentucky, Lexington (C.S.E.); University of Tor Vergata, Rome, Italy (G. Forleo); University of Sacred Heart, Rome, Italy (G.P., M.L.N.); Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy (A.D.R., M.C., G. Fassini, C.T.); Akron General Hospital, Akron, OH (R.A.S.); Division of Cardiology, Stanford University, CA (A.N.); Case Western Reserve University, Cleveland, OH (A.N.); and Interventional Electrophysiology, Scripps Clinic, La Jolla, CA (A.N.).
Circulation. 2014 Jun 24;129(25):2638-44. doi: 10.1161/CIRCULATIONAHA.113.006426. Epub 2014 Apr 17.
Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists.
This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001).
This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin.
http://www.clinicaltrials.gov. Unique identifier: NCT01006876.
围手术期血栓栓塞和出血事件是房颤（AF）导管消融术的令人担忧的并发症。围手术期抗凝管理可能在这些并发症的发生中发挥作用。尽管似乎不中断华法林进行消融术与较低的血栓栓塞风险相关，但尚无随机研究存在。
这是一项前瞻性、开放标签、随机、平行组、多中心研究，评估了连续华法林治疗在预防射频导管消融术后围手术期血栓栓塞和出血事件中的作用。纳入 CHADS2 评分≥1 的患者。患者以 1:1 的比例随机分配至停华法林或不停华法林组。消融后 48 小时内血栓栓塞事件的发生率为研究的主要终点。该研究纳入了 1584 例患者：790 例被分配至停华法林组（组 1），794 例被分配至持续华法林组（组 2）。两组患者的基线特征无统计学差异。组 1 中有 39 例血栓栓塞事件（3.7%为脑卒中[n=29]，1.3%为短暂性脑缺血发作[n=10]）：2 例事件（0.87%）发生在阵发性 AF 患者中，4 例（2.3%）发生在持续性 AF 患者中，33 例（8.5%）发生在持续性永久性 AF 患者中。仅在组 2 中观察到 2 例（0.25%）持续性永久性 AF 患者发生脑卒中（P<0.001）。华法林停药是围手术期血栓栓塞的强烈预测因子（比值比，13；95%置信区间，3.1-55.6；P<0.001）。
这是第一项随机研究，表明与桥接低分子量肝素相比，不中断华法林进行 AF 导管消融术可降低围手术期卒中及轻微出血并发症的发生。
