From the Alfred Hospital (P.S.M., D.J.C, S.M., S.W.) and Monash University (P.S.M., J.A.S., A.F., D.J.C., S.M., J.M.), Melbourne, VIC, St. Vincent's Hospital, Fitzroy, VIC (B.S.), and the Royal Adelaide Hospital, Adelaide, SA (T.P.) - all in Australia; Plymouth Medical School, Devon, United Kingdom (M.J.); and Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC, Canada (J.S.B).
N Engl J Med. 2016 Feb 25;374(8):728-37. doi: 10.1056/NEJMoa1507688.
Most patients with coronary artery disease receive aspirin for primary or secondary prevention of myocardial infarction, stroke, and death. Aspirin poses a risk of bleeding in patients undergoing surgery, but it is unclear whether aspirin should be stopped before coronary artery surgery.
We used a 2-by-2 factorial trial design to randomly assign patients who were scheduled to undergo coronary artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin trial are reported here. Patients were randomly assigned to receive 100 mg of aspirin or matched placebo preoperatively. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.
Among 5784 eligible patients, 2100 were enrolled; 1047 were randomly assigned to receive aspirin and 1053 to receive placebo. A primary outcome event occurred in 202 patients in the aspirin group (19.3%) and in 215 patients in the placebo group (20.4%) (relative risk, 0.94; 95% confidence interval, 0.80 to 1.12; P=0.55). Major hemorrhage leading to reoperation occurred in 1.8% of patients in the aspirin group and in 2.1% of patients in the placebo group (P=0.75), and cardiac tamponade occurred at rates of 1.1% and 0.4%, respectively (P=0.08).
Among patients undergoing coronary artery surgery, the administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications nor a higher risk of bleeding than that with placebo. (Funded by the Australian National Health and Medical Research Council and others; Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639.).
大多数患有冠状动脉疾病的患者接受阿司匹林用于心肌梗死、中风和死亡的一级或二级预防。阿司匹林会增加接受手术的患者出血的风险,但尚不清楚在冠状动脉手术前是否应该停止使用阿司匹林。
我们采用 2×2 析因试验设计,随机分配计划接受冠状动脉手术且有围手术期并发症风险的患者接受阿司匹林或安慰剂和氨甲环酸或安慰剂。现将阿司匹林试验的结果报告如下。患者术前随机接受 100mg 阿司匹林或匹配的安慰剂。主要结局是术后 30 天内死亡和血栓并发症(非致命性心肌梗死、中风、肺栓塞、肾衰竭或肠梗死)的复合事件。
在 5784 名合格患者中,有 2100 名患者入选;其中 1047 名患者被随机分配接受阿司匹林,1053 名患者接受安慰剂。阿司匹林组 202 例(19.3%)和安慰剂组 215 例(20.4%)发生主要结局事件(相对风险,0.94;95%置信区间,0.80 至 1.12;P=0.55)。阿司匹林组有 1.8%的患者发生大出血导致再次手术,安慰剂组有 2.1%(P=0.75),心脏压塞发生率分别为 1.1%和 0.4%(P=0.08)。
在接受冠状动脉手术的患者中,术前给予阿司匹林并未降低死亡或血栓并发症的风险,也未增加出血风险。(由澳大利亚国家卫生和医学研究委员会等资助;澳大利亚新西兰临床试验注册编号,ACTRN12605000557639.)。