达比加群的围手术期管理：一项前瞻性队列研究。
Perioperative Management of Dabigatran: A Prospective Cohort Study.
机构信息
From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
出版信息
Circulation. 2015 Jul 21;132(3):167-73. doi: 10.1161/CIRCULATIONAHA.115.015688. Epub 2015 May 12.
BACKGROUND
The perioperative management of dabigatran in clinical practice is heterogeneous. We performed this study to evaluate the safety of perioperative management of dabigatran using a specified protocol.
METHODS AND RESULTS
Patients treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The timing of the last dose of dabigatran before the procedure was based on the creatinine clearance and procedure-related bleeding risk. Resumption of dabigatran was prespecified according to the complexity of the surgery and consequences of a bleeding complication. Patients were followed up for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism, and death. We included 541 cases: 324 procedures (60%) with standard risk of bleeding and 217 procedures (40%) with increased risk of bleeding. The last dose of dabigatran was at 24, 48, or 96 hours before surgery according to the protocol in 46%, 37%, and 6%, respectively, of the patients. Resumption was timed according to protocol in 77% with 75 mg as the first dose on the day of procedure in 40% of the patients. Ten patients (1.8%; 95% confidence interval, 0.7-3.0) had major bleeding, and 28 patients (5.2%; 95% confidence interval, 3.3-7.0) had minor bleeding events. The only thromboembolic complication was transient ischemic attack in 1 patient (0.2%; 95% confidence interval, 0-0.5), and there were 4 deaths unrelated to bleeding or thrombosis. Bridging was not used preoperatively but was administered in 9 patients (1.7%) postoperatively.
CONCLUSION
Our protocol for perioperative management of dabigatran appears to be effective and feasible.
背景
达比加群在临床实践中的围手术期管理存在差异。我们开展此项研究，旨在通过特定方案评估达比加群围手术期管理的安全性。
方法和结果
接受达比加群治疗且计划进行有创操作的患者符合入组条件。术前最后一次达比加群给药时间取决于患者的肌酐清除率和手术相关出血风险。根据手术的复杂程度和出血并发症的后果，预设了达比加群的恢复时间。主要出血（主要结局）、轻微出血、动脉血栓栓塞和死亡是患者 30 天的随访终点。我们共纳入 541 例患者：324 例（60%）手术出血风险标准，217 例（40%）手术出血风险增加。根据方案，46%、37%和 6%的患者术前最后一次达比加群给药时间分别为 24、48 和 96 小时。77%的患者根据方案恢复用药，其中 40%的患者在手术当天首次剂量为 75mg。10 例患者（1.8%；95%置信区间，0.7-3.0）发生大出血，28 例患者（5.2%；95%置信区间，3.3-7.0）发生轻微出血事件。唯一的血栓栓塞性并发症是 1 例短暂性脑缺血发作（0.2%；95%置信区间，0-0.5），4 例死亡与出血或血栓无关。术前未进行桥接治疗，但术后 9 例（1.7%）患者接受了桥接治疗。
结论
我们的达比加群围手术期管理方案似乎是有效且可行的。
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