The authors' affiliations are listed in the Appendix.
N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.
There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not.
Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days.
The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata.
Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).
在接受非心脏手术的患者中，阿司匹林的围手术期应用存在很大差异，无论是在已经接受阿司匹林治疗的患者中，还是在未接受阿司匹林治疗的患者中。
我们采用 2×2 析因试验设计，随机分配 10010 名准备接受非心脏手术且存在血管并发症风险的患者接受阿司匹林或安慰剂加可乐定或安慰剂治疗。现将阿司匹林试验结果报告如下。根据患者在研究前是否服用阿司匹林（起始分层，5628 例患者）或正在服用阿司匹林方案（继续分层，4382 例患者）将患者分层。在起始分层中，患者在手术前开始服用阿司匹林（剂量为 200mg）或安慰剂，每天服用一次（剂量为 100mg），持续 30 天；在继续分层中，患者每天服用阿司匹林（剂量为 100mg），持续 7 天，然后恢复其常规阿司匹林方案。主要终点是 30 天内死亡或非致死性心肌梗死的复合终点。
在阿司匹林组的 4998 例患者中，有 351 例（7.0%）发生主要终点事件，在安慰剂组的 5012 例患者中，有 355 例（7.1%）发生主要终点事件（阿司匹林组的危险比为 0.99；95%置信区间[CI]为 0.86 至 1.15；P=0.92）。阿司匹林组的大出血发生率高于安慰剂组（230 例[4.6%] vs. 188 例[3.8%]；危险比为 1.23；95%CI 为 1.01 至 1.49；P=0.04）。在两个阿司匹林亚组中，主要终点和次要终点结果相似。
手术前和术后早期应用阿司匹林并未显著降低死亡或非致死性心肌梗死的复合终点发生率，但增加了大出血的风险。（由加拿大卫生研究院和其他机构资助；POISE-2 ClinicalTrials.gov 编号，NCT01082874。）
