Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus
Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus
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DOI：
10.1056/nejmoa1804988
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发表时间：
2018-10-18
影响因子：
158.5
通讯作者：
Armitage, Jane
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文献类型：
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作者：
Bowman, Louise;Mafham, Marion;Armitage, Jane
背景糖尿病与心血管事件风险增加相关。使用阿司匹林可降低血管闭塞事件的风险，但会增加出血的风险；预防糖尿病患者首次心血管事件的益处和风险的平衡尚不清楚。方法我们随机分配患有糖尿病但没有明显心血管疾病的成年人接受每日 100 毫克剂量的阿司匹林或匹配的安慰剂。主要疗效结局是首次严重血管事件（即心肌梗塞、中风或短暂性脑缺血发作，或任何血管原因导致的死亡，不包括任何确诊的颅内出血）。主要安全性结局是首次重大出血事件（即颅内出血、眼部危及视力的出血事件、胃肠道出血或其他严重出血）。次要结局包括胃肠道癌症。结果共有 15,480 名参与者接受了随机分组。在平均 7.4 年的随访期间，阿司匹林组发生严重血管事件的参与者比例显着低于安慰剂组（658 名参与者 [8.5%] 对比 743 名参与者 [9.6%]；发生率比，0.88；95% 置信区间 [CI]，0.79 至 0.97；P=0.01）。相比之下，阿司匹林组有 314 名参与者（4.1%）发生大出血事件，而安慰剂组有 245 名参与者（3.2%）发生大出血事件（比率为 1.29；95% CI，1.09 至 1.52；P=0.003），其中大部分为胃肠道出血和其他颅外出血。阿司匹林组和安慰剂组在胃肠道癌症（分别为 157 名受试者 [2.0%] 和 158 名 [2.0%]）或所有癌症（897 名受试者 [11.6%] 和 887 名 [11.5%]）的发病率上没有显着差异；计划对这些结果进行长期随访。结论对于患有糖尿病并且在试验开始时没有明显心血管疾病的患者来说，使用司匹林可以预防严重的血管事件，但它也会导致严重的出血事件。绝对益处在很大程度上被出血危险所抵消。 （由英国心脏基金会和其他机构资助；ASCEND 当前对照试验编号，ISRCTN60635500；ClinicalTrials.gov 编号，NCT00135226。）
BACKGROUNDDiabetes mellitus is associated with an increased risk of cardiovascular events. Aspirin use reduces the risk of occlusive vascular events but increases the risk of bleeding; the balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear.METHODSWe randomly assigned adults who had diabetes but no evident cardiovascular disease to receive aspirin at a dose of 100 mg daily or matching placebo. The primary efficacy outcome was the first serious vascular event (i.e., myocardial infarction, stroke or transient ischemic attack, or death from any vascular cause, excluding any confirmed intracranial hemorrhage). The primary safety outcome was the first major bleeding event (i.e., intracranial hemorrhage, sight-threatening bleeding event in the eye, gastrointestinal bleeding, or other serious bleeding). Secondary outcomes included gastrointestinal tract cancer.RESULTSA total of 15,480 participants underwent randomization. During a mean follow-up of 7.4 years, serious vascular events occurred in a significantly lower percentage of participants in the aspirin group than in the placebo group (658 participants [8.5%] vs. 743 [9.6%]; rate ratio, 0.88; 95% confidence interval [CI], 0.79 to 0.97; P=0.01). In contrast, major bleeding events occurred in 314 participants (4.1%) in the aspirin group, as compared with 245 (3.2%) in the placebo group (rate ratio, 1.29; 95% CI, 1.09 to 1.52; P=0.003), with most of the excess being gastrointestinal bleeding and other extracranial bleeding. There was no significant difference between the aspirin group and the placebo group in the incidence of gastrointestinal tract cancer (157 participants [2.0%] and 158 [2.0%], respectively) or all cancers (897 [11.6%] and 887 [11.5%]); long-term follow-up for these outcomes is planned.CONCLUSIONSAspirin use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease at trial entry, but it also caused major bleeding events. The absolute benefits were largely counterbalanced by the bleeding hazard. (Funded by the British Heart Foundation and others; ASCEND Current Controlled Trials number, ISRCTN60635500; ClinicalTrials.gov number, NCT00135226.)