Stellbrink Christoph, Nixdorff Uwe, Hofmann Thomas, Lehmacher Walter, Daniel Werner Günther, Hanrath Peter, Geller Christoph, Mügge Andreas, Sehnert Walter, Schmidt-Lucke Caroline, Schmidt-Lucke Jan-André
Medizinische Klinik I, Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany.
Circulation. 2004 Mar 2;109(8):997-1003. doi: 10.1161/01.CIR.0000120509.64740.DC. Epub 2004 Feb 16.
Anticoagulation in cardioversion of atrial fibrillation is currently performed with unfractionated heparin (UFH) and oral anticoagulants, with or without guidance by transesophageal echocardiography (TEE). Low-molecular-weight heparins may reduce the risk of bleeding, may obviate the need for intravenous access, and do not require frequent anticoagulation monitoring.
In a randomized, prospective multicenter trial, we compared the safety and efficacy of enoxaparin administered subcutaneously with intravenous UFH followed by the oral anticoagulant phenprocoumon in 496 patients scheduled for cardioversion of atrial fibrillation of >48 hours' and < or =1 year's duration. Patients were stratified to cardioversion with (n=431) and without (n=65) guidance by TEE. The study aimed to demonstrate noninferiority of enoxaparin compared with UFH+phenprocoumon with regard to the incidence of embolic events, all-cause death, and major bleeding complications. Secondary end points included successful cardioversion, maintenance of sinus rhythm until study end, and minor bleeding complications. Of 496 randomized patients, 428 were analyzed per protocol. Enoxaparin was noninferior to UFH+phenprocoumon with regard to the incidence of the composite primary end point in a per-protocol analysis (7 of 216 patients versus 12 of 212 patients, respectively; P=0.016) and in an intention-to-treat analysis (7 of 248 patients versus 12 of 248 patients, respectively; P=0.013). There was no significant difference between the 2 groups in the number of patients reverted to sinus rhythm.
Enoxaparin is noninferior to UFH+phenprocoumon for prevention of ischemic and embolic events, bleeding complications, and death in TEE-guided cardioversion of atrial fibrillation. Its easier application and more stable anticoagulation may make it the preferred drug for initiation of anticoagulation in this setting.
目前房颤复律时的抗凝治疗采用普通肝素（UFH）和口服抗凝药，可在或不在经食管超声心动图（TEE）引导下进行。低分子量肝素可能会降低出血风险，无需静脉通路，且无需频繁进行抗凝监测。
在一项随机、前瞻性多中心试验中，我们比较了皮下注射依诺肝素与静脉注射UFH继以口服苯丙香豆素在496例计划进行房颤复律（持续时间>48小时且<或=1年）患者中的安全性和有效性。患者被分层为接受（n = 431）和不接受（n = 65）TEE引导下的复律。该研究旨在证明依诺肝素在栓塞事件、全因死亡和大出血并发症发生率方面不劣于UFH + 苯丙香豆素。次要终点包括成功复律、窦性心律维持至研究结束以及小出血并发症。496例随机分组患者中，428例按方案进行分析。在按方案分析中（分别为216例患者中的7例与212例患者中的12例；P = 0.016）以及在意向性分析中（分别为248例患者中的7例与248例患者中的12例；P = 0.013），依诺肝素在复合主要终点发生率方面不劣于UFH + 苯丙香豆素。两组在恢复窦性心律的患者数量上无显著差异。
在TEE引导的房颤复律中，依诺肝素在预防缺血性和栓塞事件、出血并发症及死亡方面不劣于UFH + 苯丙香豆素。其更简便的应用方式和更稳定的抗凝效果可能使其成为这种情况下启动抗凝治疗的首选药物。
