Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation.
Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation.
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DOI：
10.1056/nejmoa1501035
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发表时间：
2015-08-27
期刊：
影响因子：
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通讯作者：
BRIDGE Investigators
中科院分区：
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作者：
Douketis JD;Spyropoulos AC;Kaatz S;Becker RC;Caprini JA;Dunn AS;Garcia DA;Jacobson A;Jaffer AK;Kong DF;Schulman S;Turpie AG;Hasselblad V;Ortel TL;BRIDGE Investigators
对于需要中断华法林治疗以进行择期手术或其他择期侵入性操作的房颤患者，尚不确定是否需要桥接抗凝治疗。我们假设，在预防围手术期动脉血栓栓塞方面，放弃桥接抗凝治疗并不劣于用低分子肝素桥接，并且在大出血方面优于桥接治疗。我们进行了一项随机、双盲、安慰剂对照试验，在围手术期中断华法林治疗后，患者被随机分配接受低分子肝素（每公斤体重 100 IU 达肝素）或匹配安慰剂的桥接抗凝治疗，每天两次皮下注射，从手术前 3 天到手术前 24 小时，然后持续手术后 5 至 10 天。手术前 5 天停止华法林治疗，手术后 24 小时内恢复治疗。手术后继续对患者进行 30 天的随访。主要结局是动脉血栓栓塞（中风、全身性栓塞或短暂性脑缺血发作）和大出血。总共有 1884 名患者入组，其中 950 名被分配不接受桥接治疗，934 名被分配接受桥接治疗。非桥接组的动脉血栓栓塞发生率为 0.4%，桥接组为 0.3%（风险差异，0.1 个百分点；95% 置信区间 [CI]，-0.6 至 0.8；非劣效性 P = 0.01）。非桥接组的大出血发生率为 1.3%，桥接组为 3.2%（相对风险，0.41；95% CI，0.20 至 0.78；优越性 P = 0.005）。对于因择期手术或其他择期侵入性手术而中断华法林治疗的心房颤动患者，放弃桥接抗凝治疗预防动脉血栓栓塞的作用并不劣于围术期桥接使用低分子肝素，并降低了大出血的风险。 （由美国国立卫生研究院国家心肺血液研究所资助；BRIDGE ClinicalTrials.gov 编号，NCT00786474。）
It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure. We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding. We performed a randomized, double-blind, placebo-controlled trial in which, after perioperative interruption of warfarin therapy, patients were randomly assigned to receive bridging anticoagulation therapy with low-molecular-weight heparin (100 IU of dalteparin per kilogram of body weight) or matching placebo administered subcutaneously twice daily, from 3 days before the procedure until 24 hours before the procedure and then for 5 to 10 days after the procedure. Warfarin treatment was stopped 5 days before the procedure and was resumed within 24 hours after the procedure. Follow-up of patients continued for 30 days after the procedure. The primary outcomes were arterial thromboembolism (stroke, systemic embolism, or transient ischemic attack) and major bleeding. In total, 1884 patients were enrolled, with 950 assigned to receive no bridging therapy and 934 assigned to receive bridging therapy. The incidence of arterial thromboembolism was 0.4% in the no-bridging group and 0.3% in the bridging group (risk difference, 0.1 percentage points; 95% confidence interval [CI], −0.6 to 0.8; P = 0.01 for noninferiority). The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20 to 0.78; P = 0.005 for superiority). In patients with atrial fibrillation who had warfarin treatment interrupted for an elective operation or other elective invasive procedure, forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreased the risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health; BRIDGE ClinicalTrials.gov number, NCT00786474.)