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超过90000例接受门诊治疗的非瓣膜性心房颤动患者在启动维生素K拮抗剂治疗时肝素桥接期间的短期出血风险

Short-Term Risk of Bleeding During Heparin Bridging at Initiation of Vitamin K Antagonist Therapy in More Than 90 000 Patients With Nonvalvular Atrial Fibrillation Managed in Outpatient Care.

作者信息

Bouillon Kim, Bertrand Marion, Boudali Lotfi, Ducimetière Pierre, Dray-Spira Rosemary, Zureik Mahmoud

机构信息

Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France

Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.

出版信息

J Am Heart Assoc. 2016 Oct 31;5(11):e004065. doi: 10.1161/JAHA.116.004065.

Abstract

BACKGROUND

Several studies have recently examined the risks of bleeding and of ischemic stroke and systemic embolism associated with perioperative heparin bridging anticoagulation in patients with nonvalvular atrial fibrillation. However, few studies have investigated bridging risks during vitamin K antagonist initiation in outpatient settings.

METHODS AND RESULTS

A retrospective cohort study was conducted on individuals starting oral anticoagulation between January 2010 and November 2014 for nonvalvular atrial fibrillation managed in outpatient care and identified from French healthcare insurance. Bleeding and ischemic stroke and systemic embolism events were identified from the hospitalization database. Adjusted hazard ratios with 95% CI were estimated using Cox models during the first and 2 following months of anticoagulation. Of 90 826 individuals, 30% had bridging therapy. A total of 318 (0.35%) cases of bleeding and 151 (0.17%) ischemic stroke and systemic embolism cases were identified during the first month of follow-up and 231 (0.31%) and 122 (0.16%) during the 2 following months, respectively. At 1 month of follow-up, the incidence of bleeding was higher in the bridged group compared with the nonbridged group (0.47% versus 0.30%; P<0.001), and this increased risk persisted after adjustment for covariates (hazard ratio=1.60; 95% CI, 1.28-2.01). This difference disappeared after the first month of treatment (0.93; 0.70-1.23). No significant difference in the occurrence of ischemic stroke and systemic embolism was observed either at 1 month of follow-up or later.

CONCLUSIONS

At vitamin K antagonist initiation for nonvalvular atrial fibrillation managed in ambulatory settings, bridging therapy is associated with a higher risk of bleeding and a similar risk of arterial thromboembolism compared with no bridging therapy.

摘要

背景

近期有多项研究探讨了非瓣膜性心房颤动患者围手术期肝素桥接抗凝治疗相关的出血风险以及缺血性卒中和全身性栓塞风险。然而,很少有研究调查门诊环境下启动维生素K拮抗剂治疗期间的桥接风险。

方法与结果

对2010年1月至2014年11月间开始口服抗凝治疗的非瓣膜性心房颤动患者进行回顾性队列研究,这些患者在门诊接受治疗并通过法国医疗保险识别。从住院数据库中识别出血、缺血性卒中和全身性栓塞事件。在抗凝治疗的第一个月及随后两个月,使用Cox模型估计调整后的风险比及95%置信区间。在90826名患者中,30%接受了桥接治疗。在随访的第一个月分别识别出318例(0.35%)出血病例和151例(0.17%)缺血性卒中和全身性栓塞病例,在随后两个月分别为231例(0.31%)和122例(0.16%)。在随访1个月时,桥接组的出血发生率高于非桥接组(0.47%对0.30%;P<0.001),在对协变量进行调整后这种增加的风险仍然存在(风险比=1.60;95%置信区间,1.28 - 2.01)。治疗第一个月后这种差异消失(0.93;0.70 - 1.23)。在随访1个月或之后,缺血性卒中和全身性栓塞的发生没有显著差异。

结论

在门诊管理的非瓣膜性心房颤动患者启动维生素K拮抗剂治疗时,与不进行桥接治疗相比,桥接治疗出血风险更高,动脉血栓栓塞风险相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/968c/5210354/9794cb8a9afa/JAH3-5-e004065-g001.jpg

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