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正在服用达比加群或华法林的患者的紧急手术或操作:来自RE-LY试验的围手术期结果分析。

Urgent surgery or procedures in patients taking dabigatran or warfarin: Analysis of perioperative outcomes from the RE-LY trial.

作者信息

Douketis James D, Healey Jeff S, Brueckmann Martina, Fraessdorf Mandy, Spyropoulos Alex C, Wallentin Lars, Oldgren Jonas, Reilly Paul, Ezekowitz Michael D, Connolly Stuart J, Yusuf Salim, Eikelboom John W

机构信息

Department of Medicine, McMaster University, Hamilton, Canada.

Department of Medicine, McMaster University, Hamilton, Canada; Population Health Research Institute, McMaster University, Hamilton, Canada.

出版信息

Thromb Res. 2016 Mar;139:77-81. doi: 10.1016/j.thromres.2016.01.004. Epub 2016 Jan 9.

DOI:10.1016/j.thromres.2016.01.004
PMID:26916299
Abstract

BACKGROUND

There is concern about the management of anticoagulated patients with atrial fibrillation (AF) who require an urgent surgery/procedure, especially in those who are receiving a direct oral anticoagulant such as dabigatran.

METHODS

We accessed the database from RE-LY, a randomized trial comparing dabigatran (110mg and 150mg twice daily) with warfarin for stroke prevention in AF, to assess patients who had an urgent and elective surgery/procedure. We compared the risk for thromboembolism, major bleeding and mortality according to treatment allocation (dabigatran 110mg or 150mg, or warfarin) or surgery/procedure type (urgent or elective). Outcomes were assessed from day-7 to day 30 after a surgery/procedure.

RESULTS

353 patients (2.0% of study population) had an urgent surgery/procedure and 4168 patients (23.1% of study population) had an elective surgery/procedure. In patients on dabigatran 110mg, dabigatran 150mg and warfarin who had an urgent surgery/procedure: rates of thromboembolism were 16.1%, 7.4%, and 10.5%; rates of major bleeding were 17.0%, 17.6%, and 22.9%; rates of mortality were 6.3%, 1.5%, and 2.9%, respectively (P>0.50 for all comparisons). Rates of these outcomes were multi-fold higher in patients having an urgent rather than an elective surgery/procedure (P<0.5 for all comparisons).

CONCLUSION

In anticoagulated patients with atrial fibrillation who require an urgent surgery/procedure, the risks for thromboembolism, major bleeding and mortality did not differ depending on treatment with dabigatran or warfarin, but rates of these outcomes were multi-fold higher than in patients having an elective surgery/procedure.

摘要

背景

对于需要紧急手术/操作的房颤抗凝患者的管理存在担忧,尤其是那些正在接受直接口服抗凝剂(如达比加群)治疗的患者。

方法

我们查阅了RE-LY试验的数据库,该试验比较了达比加群(每日两次,110mg和150mg)与华法林用于房颤患者预防卒中的效果,以评估那些接受了紧急和择期手术/操作的患者。我们根据治疗分配(达比加群110mg或150mg,或华法林)或手术/操作类型(紧急或择期)比较了血栓栓塞、大出血和死亡风险。在手术/操作后第7天至第30天评估结果。

结果

353例患者(占研究人群的2.0%)接受了紧急手术/操作,4168例患者(占研究人群的23.1%)接受了择期手术/操作。在接受紧急手术/操作的服用达比加群110mg、达比加群150mg和华法林的患者中:血栓栓塞发生率分别为16.1%、7.4%和10.5%;大出血发生率分别为17.0%、17.6%和22.9%;死亡率分别为6.3%、1.5%和2.9%(所有比较P>0.50)。这些结果的发生率在接受紧急手术/操作的患者中比接受择期手术/操作的患者高几倍(所有比较P<0.5)。

结论

对于需要紧急手术/操作的房颤抗凝患者,血栓栓塞、大出血和死亡风险在达比加群或华法林治疗之间并无差异,但这些结果的发生率比接受择期手术/操作的患者高几倍。

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