Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.

Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.
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DOI:
10.1056/nejmoa1805819
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发表时间:
2018-10-18
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
ASPREE Investigator Group
ASPREE Investigator Group
中科院分区:
其他
文献类型:
--
作者:
McNeil JJ;Wolfe R;Woods RL;Tonkin AM;Donnan GA;Nelson MR;Reid CM;Lockery JE;Kirpach B;Storey E;Shah RC;Williamson JD;Margolis KL;Ernst ME;Abhayaratna WP;Stocks N;Fitzgerald SM;Orchard SG;Trevaks RE;Beilin LJ;Johnston CI;Ryan J;Radziszewska B;Jelinek M;Malik M;Eaton CB;Brauer D;Cloud G;Wood EM;Mahady SE;Satterfield S;Grimm R;Murray AM;ASPREE Investigator Group

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阿司匹林是一种公认的心血管事件二级预防疗法。然而,它在心血管疾病一级预防中的作用尚不清楚,特别是在风险增加的老年人中。从2010年到2014年,我们在澳大利亚和美国招募了年龄在70岁或以上(或≥65岁的美国黑人和西班牙裔)且无心血管疾病、痴呆或残疾的社区居住男性和女性。参与者被随机分配接受100毫克肠溶阿司匹林或安慰剂。主要终点为死亡、痴呆或持续性身体残疾;这个终点的结果发表在《华尔街日报》的另一篇文章中。次要终点包括大出血和心血管疾病(定义为致死性冠心病、非致死性心肌梗死、致死性或非致死性中风或因心力衰竭住院)。在参加试验的19,114人中,9525人被分配接受阿司匹林,9589人接受安慰剂。中位随访4.7年后,阿司匹林组心血管疾病发生率为每1000人年10.7例,安慰剂组为每1000人年11.3例(风险比0.95;95%可信区间[CI] 0.83 ~ 1.08)。大出血发生率分别为每1000人年8.6件和6.2件(风险比1.38;95% CI, 1.18 ~ 1.62; P<0.001)。在老年人中,使用低剂量阿司匹林作为一级预防策略导致大出血的风险显著增加,但没有导致心血管疾病的风险显著低于安慰剂。(由国家老龄研究所和其他机构资助;ASPREE ClinicalTrials.gov编号:NCT01038583。)
Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk. From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure). Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001). The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583.)