Pacemaker or Defibrillator Surgery without Interruption of Anticoagulation
Pacemaker or Defibrillator Surgery without Interruption of Anticoagulation
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DOI：
10.1056/nejmoa1302946
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发表时间：
2013-05-30
影响因子：
158.5
通讯作者：
Essebag, Vidal
中科院分区：
文献类型：
--
作者：
Birnie, David H.;Healey, Jeff S.;Essebag, Vidal
背景：任何需要心脏起搏器或植入性心脏复律除颤器(ICD)手术的患者都在服用华法林。对于血栓栓子事件的高危患者，指南建议使用肝素进行桥接治疗；然而，病例系列表明，在不中断华法林治疗的情况下进行手术可能是安全的。很少有临床试验结果支持这种方法的安全性和有效性。方法：我们随机将每年血栓栓子事件风险在5%或以上的患者分配到继续华法林治疗或使用肝素桥接治疗。主要结果是临床上有意义的装置袋血肿，其定义为装置袋内血肿需要长时间住院、中断抗凝治疗或进一步手术(例如血肿清除)。结果在第二次预先指定的中期分析后，数据和安全监测委员会建议终止试验。持续应用华法林组343例患者中12例(3.5%)发生有临床意义的装置袋血肿，而肝素桥接组338例患者中54例(16.0%)发生有临床意义的装置袋血肿(相对危险度0.19；95%可信区间0.10~0.36；P
BACKGROUNDMany patients requiring pacemaker or implantable cardioverter-defibrillator (ICD) surgery are taking warfarin. For patients at high risk for thromboembolic events, guidelines recommend bridging therapy with heparin; however, case series suggest that it may be safe to perform surgery without interrupting warfarin treatment. There have been few results from clinical trials to support the safety and efficacy of this approach.METHODSWe randomly assigned patients with an annual risk of thromboembolic events of 5% or more to continued warfarin treatment or to bridging therapy with heparin. The primary outcome was clinically significant device-pocket hematoma, which was defined as device-pocket hematoma that necessitated prolonged hospitalization, interruption of anticoagulation therapy, or further surgery (e.g., hematoma evacuation).RESULTSThe data and safety monitoring board recommended termination of the trial after the second prespecified interim analysis. Clinically significant device-pocket hematoma occurred in 12 of 343 patients (3.5%) in the continued-warfarin group, as compared with 54 of 338 (16.0%) in the heparin-bridging group (relative risk, 0.19; 95% confidence interval, 0.10 to 0.36; P