Garcia David, Alexander John H, Wallentin Lars, Wojdyla Daniel M, Thomas Laine, Hanna Michael, Al-Khatib Sana M, Dorian Paul, Ansell Jack, Commerford Patrick, Flaker Greg, Lanas Fernando, Vinereanu Dragos, Xavier Denis, Hylek Elaine M, Held Claes, Verheugt Freek W A, Granger Christopher B, Lopes Renato D
Division of Hematology, University of Washington, Seattle, WA;
Duke Clinical Research Institute, Duke Medicine, Durham, NC;
Blood. 2014 Dec 11;124(25):3692-8. doi: 10.1182/blood-2014-08-595496. Epub 2014 Oct 15.
Using data from ARISTOTLE, we describe the periprocedural management of anticoagulation and rates of subsequent clinical outcomes among patients chronically anticoagulated with warfarin or apixaban. We recorded whether (and for how long) anticoagulant therapy was interrupted preprocedure, whether bridging therapy was used, and the proportion of patients who experienced important clinical outcomes during the 30 days postprocedure. Of 10 674 procedures performed during follow-up in 5924 patients, 9260 were included in this analysis. Anticoagulant treatment was not interrupted preprocedure 37.5% of the time. During the 30 days postprocedure, stroke or systemic embolism occurred after 16/4624 (0.35%) procedures among apixaban-treated patients and 26/4530 (0.57%) procedures among warfarin-treated patients (odds ratio [OR] 0.601; 95% confidence interval [CI] 0.322-1.120). Major bleeding occurred in 74/4560 (1.62%) procedures in the apixaban arm and 86/4454 (1.93%) in the warfarin arm (OR 0.846; 95% CI 0.614-1.166). The risk of death was similar with apixaban (54/4624 [1.17%]) and warfarin (49/4530 [1.08%]) (OR 1.082; 95% CI 0.733-1.598). Among patients in ARISTOTLE, the 30-day postprocedure stroke, death, and major bleeding rates were low and similar in apixaban- and warfarin-treated patients, regardless of whether anticoagulation was stopped beforehand. Our findings suggest that many patients on chronic anticoagulation can safely undergo procedures; some will not require a preprocedure interruption of anticoagulation. ARISTOTLE was registered at www.clinicaltrials.gov as #NCT00412984.
利用ARISTOTLE研究的数据，我们描述了长期使用华法林或阿哌沙班进行抗凝治疗的患者围手术期的抗凝管理及后续临床结局发生率。我们记录了术前抗凝治疗是否中断（以及中断时长）、是否采用桥接治疗，以及术后30天内发生重要临床结局的患者比例。在对5924例患者进行随访期间共实施了10674例手术，其中9260例纳入本分析。37.5%的手术术前未中断抗凝治疗。术后30天内，阿哌沙班治疗组的4624例手术中有16例（0.35%）发生卒中或全身性栓塞，华法林治疗组的4530例手术中有26例（0.57%）发生（比值比[OR]0.601；95%置信区间[CI]0.322 - 1.120）。阿哌沙班组4560例手术中有74例（1.62%）发生大出血，华法林组4454例手术中有86例（1.93%）发生（OR 0.846；95% CI 0.614 - 1.166）。阿哌沙班（4624例中有54例[1.17%]）和华法林（4530例中有49例[1.08%]）的死亡风险相似（OR 1.082；95% CI 0.733 - 1.598）。在ARISTOTLE研究的患者中，术后30天的卒中、死亡和大出血发生率较低，阿哌沙班和华法林治疗的患者相似，无论术前是否停用抗凝药。我们的研究结果表明，许多长期抗凝治疗的患者可安全接受手术；部分患者术前无需中断抗凝治疗。ARISTOTLE研究已在www.clinicaltrials.gov注册，注册号为#NCT00412984。
