Department of Cerebrovascular Medicine and Neurology Cerebrovascular Center and Clinical Research Institute National Hospital Organization Kyushu Medical Center Fukuoka Japan.
J Am Heart Assoc. 2020 Mar 3;9(5):e012774. doi: 10.1161/JAHA.119.012774. Epub 2020 Feb 21.
Background Optimal management of antithrombotic agents during surgery has yet to be established. We performed a prospective multicenter observational study to determine the current status of the management of antithrombotic agents during surgery or other medical procedures with bleeding (MARK [Management of Antithrombotic Agents During Surgery or Other Kinds of Medical Procedures With Bleeding] study) in Japan. Methods and Results The participants were 9700 patients who received oral antithrombotic agents and underwent scheduled medical procedures with bleeding at 59 National Hospital Organization institutions in Japan. Primary outcomes were thromboembolic events, bleeding events, and death within 2 weeks before and 4 weeks after the procedures. We investigated the relationships between each outcome and patient demographics, comorbidities, type of procedure, and management of antithrombotic therapy. With respect to the periprocedural management of antithrombotic agents, 3551 patients continued oral antithrombotic agents (36.6%, continuation group) and 6149 patients discontinued them (63.4%, discontinuation group). The incidence of any thromboembolic event (1.7% versus 0.6%, <0.001), major bleeding (7.6% versus 0.4%, <0.001), and death (0.8% versus 0.4%, <0.001) was all greater in the discontinuation group than the continuation group. In multivariate analysis, even after adjusting for confounding factors, discontinuation of anticoagulant agents was significantly associated with higher risk for both thromboembolic events (odds ratio: 4.55; 95% CI, 1.67-12.4; =0.003) and major bleeding (odds ratio: 11.1; 95% CI, 2.03-60.3; =0.006) in procedures with low bleeding risk. In contrast, heparin bridging therapy was significantly associated with higher risk for both thromboembolic events (odds ratio: 2.03; 95% CI, 1.28-3.22; =0.003) and major bleeding (odds ratio: 1.36; 95% CI, 1.10-1.68; =0.005) in procedures with high bleeding risk. Conclusions Discontinuation of oral antithrombotic agents and addition of low-dose heparin bridging therapy appear to be significantly associated with adverse events in the periprocedural period.
背景 手术期间抗血栓药物的最佳管理尚未确定。我们进行了一项前瞻性多中心观察性研究，以确定日本手术或其他有出血医疗程序（MARK [手术或其他有出血的医疗程序期间抗血栓药物管理] 研究）中抗血栓药物管理的现状。
方法和结果 参与者为 9700 名在日本 59 家国立医院组织机构接受口服抗血栓药物治疗并接受有出血医疗程序的患者。主要结局为术前 2 周和术后 4 周内的血栓栓塞事件、出血事件和死亡。我们调查了每个结局与患者人口统计学、合并症、手术类型和抗血栓治疗管理之间的关系。关于围手术期抗血栓药物的管理，3551 名患者继续服用口服抗血栓药物（36.6%，继续组），6149 名患者停用（63.4%，停用组）。停药组任何血栓栓塞事件（1.7%比 0.6%，<0.001）、大出血（7.6%比 0.4%，<0.001）和死亡（0.8%比 0.4%，<0.001）的发生率均高于继续组。多变量分析显示，即使在校正混杂因素后，抗凝药物的停药与低出血风险手术中血栓栓塞事件（比值比：4.55；95%置信区间，1.67-12.4；=0.003）和大出血（比值比：11.1；95%置信区间，2.03-60.3；=0.006）风险的增加显著相关。相比之下，肝素桥接治疗与高出血风险手术中血栓栓塞事件（比值比：2.03；95%置信区间，1.28-3.22；=0.003）和大出血（比值比：1.36；95%置信区间，1.10-1.68；=0.005）风险的增加显著相关。
结论 停用口服抗血栓药物和加用低剂量肝素桥接治疗似乎与围手术期不良事件显著相关。
