An overview of the 4 randomized trials of aspirin therapy in the primary prevention of vascular disease.
An overview of the 4 randomized trials of aspirin therapy in the primary prevention of vascular disease.
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DOI：
10.1001/archinte.160.20.3123
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发表时间：
2000-11
影响因子：
--
通讯作者：
P. Hebert;C. Hennekens
中科院分区：
文献类型：
--
作者：
P. Hebert;C. Hennekens
背景：在心血管疾病的一级预防方面，与美国胸科医师学会和美国心脏协会的建议相反，美国食品和药物管理局最近表示，没有足够的证据来判断阿司匹林治疗是否能降低首次心肌梗死的风险。目的对阿司匹林治疗的4项一级预防试验进行综述，以获得阿司匹林治疗对各种血管疾病终点影响的最可靠估计。方法与结果这4项试验纳入了51,000多名受试者和2284个重要血管事件。接受阿司匹林治疗的患者非致死性心肌梗死发生率显著降低32%(95%可信区间[CI]， 21%-41%)，任何重要血管事件发生率显著降低13% （95% CI, 5%-19%）。血管疾病相关死亡（1%;95% CI， -12%至16%）和非致命性中风（8%;95% CI， -12%至33%）的风险可能有小幅但不显著的增加。当卒中按类型细分时，阿司匹林治疗对缺血性卒中的风险无显著影响，但基于小样本，出血性卒中的风险明显增加1.7倍（95% CI, 6%-269%），确实具有统计学意义。结论：对于血管疾病的一级预防，阿司匹林治疗对首次心肌梗死和任何重要血管事件都有显著的有益作用；这些影响具有重要的临床意义。由于迄今为止完成的一级预防试验中事件的数量不足，治疗是否会降低血管疾病相关死亡或卒中的发生率尚不清楚。出血性中风也需要更多的数据。此外，需要随机试验数据，特别是妇女，但也需要男性的随机试验数据，以帮助为处于通常风险中的个人制定合理的公共卫生政策。同时，这些数据为阿司匹林治疗在心肌梗死一级预防中的显著益处提供了证据。
BACKGROUND In the primary prevention of cardiovascular disease, in contrast to the recommendations of the American College of Chest Physicians and the American Heart Association, the US Food and Drug Administration recently stated that there was insufficient evidence to judge whether aspirin therapy decreases the risk of a first myocardial infarction. OBJECTIVE To perform an overview of the 4 primary prevention trials of aspirin therapy to obtain the most reliable estimates of the effects of aspirin therapy on various vascular disease end points. METHODS AND RESULTS These 4 trials included more than 51,000 subjects and 2284 important vascular events. Those assigned to aspirin therapy experienced significant reductions of 32% (95% confidence interval [CI], 21%-41%) for nonfatal myocardial infarction and 13% (95% CI, 5%-19%) for any important vascular event. There were possible small but nonsignificant increases in risks of vascular disease-related death (1%; 95% CI, -12% to 16%) and nonfatal stroke (8%; 95% CI, -12% to 33%). When strokes were subdivided by type, there was no significant effect of aspirin therapy on the risk of ischemic stroke, but, while based on small numbers, there was a 1.7-fold apparent increase (95% CI, 6%-269%) in the risk of hemorrhagic stroke, which did achieve statistical significance. CONCLUSIONS For the primary prevention of vascular disease, aspirin therapy confers significant beneficial effects on first myocardial infarction and, as a result, on any important vascular event; these effects are clinically important. Whether there is any reduction in vascular disease-related death or stroke associated with treatment remains unclear because of inadequate numbers of events in the primary prevention trials completed to date. More data on hemorrhagic stroke are also needed. In addition, randomized trial data, especially in women but also in men, are needed to help to formulate a rational public health policy for individuals at usual risk. Meanwhile, these data provide evidence for a significant benefit of aspirin therapy in the primary prevention of myocardial infarction.