Faculty of Medicine, Imperial College London, London, United Kingdom.
Department of Cardiology, King's College Hospital NHS Foundation Trust, Denmark Hill, London, United Kingdom.
JAMA. 2019 Jan 22;321(3):277-287. doi: 10.1001/jama.2018.20578.
The role for aspirin in cardiovascular primary prevention remains controversial, with potential benefits limited by an increased bleeding risk.
To assess the association of aspirin use for primary prevention with cardiovascular events and bleeding.
PubMed and Embase were searched on Cochrane Library Central Register of Controlled Trials from the earliest available date through November 1, 2018.
Randomized clinical trials enrolling at least 1000 participants with no known cardiovascular disease and a follow-up of at least 12 months were included. Included studies compared aspirin use with no aspirin (placebo or no treatment).
Data were screened and extracted independently by both investigators. Bayesian and frequentist meta-analyses were performed.
The primary cardiovascular outcome was a composite of cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke. The primary bleeding outcome was any major bleeding (defined by the individual studies).
A total of 13 trials randomizing 164 225 participants with 1 050 511 participant-years of follow-up were included. The median age of trial participants was 62 years (range, 53-74), 77 501 (47%) were men, 30 361 (19%) had diabetes, and the median baseline risk of the primary cardiovascular outcome was 9.2% (range, 2.6%-15.9%). Aspirin use was associated with significant reductions in the composite cardiovascular outcome compared with no aspirin (57.1 per 10 000 participant-years with aspirin and 61.4 per 10 000 participant-years with no aspirin) (hazard ratio [HR], 0.89 [95% credible interval, 0.84-0.95]; absolute risk reduction, 0.38% [95% CI, 0.20%-0.55%]; number needed to treat, 265). Aspirin use was associated with an increased risk of major bleeding events compared with no aspirin (23.1 per 10 000 participant-years with aspirin and 16.4 per 10 000 participant-years with no aspirin) (HR, 1.43 [95% credible interval, 1.30-1.56]; absolute risk increase, 0.47% [95% CI, 0.34%-0.62%]; number needed to harm, 210).
The use of aspirin in individuals without cardiovascular disease was associated with a lower risk of cardiovascular events and an increased risk of major bleeding. This information may inform discussions with patients about aspirin for primary prevention of cardiovascular events and bleeding.
阿司匹林在心血管一级预防中的作用仍存在争议，其潜在益处受到出血风险增加的限制。
评估阿司匹林用于一级预防与心血管事件和出血的相关性。
通过 Cochrane 图书馆对照试验中心注册库从最早可获得的日期搜索 PubMed 和 Embase，直至 2018 年 11 月 1 日。
纳入了至少 1000 名无已知心血管疾病且随访至少 12 个月的参与者的随机临床试验。纳入的研究比较了阿司匹林治疗与无阿司匹林（安慰剂或不治疗）。
两位研究者分别独立筛选和提取数据。进行了贝叶斯和频率主义荟萃分析。
主要心血管结局是心血管死亡率、非致死性心肌梗死和非致死性卒中的复合结局。主要出血结局是任何主要出血（由各个研究定义）。
共纳入了 13 项随机分配 164225 名参与者、随访 1050511 人年的试验。试验参与者的中位年龄为 62 岁（范围，53-74 岁），77501 名（47%）为男性，30361 名（19%）患有糖尿病，主要心血管结局的中位基线风险为 9.2%（范围，2.6%-15.9%）。与无阿司匹林相比，阿司匹林治疗与显著降低的复合心血管结局相关（阿司匹林组每 10000 人年发生 57.1 例，无阿司匹林组每 10000 人年发生 61.4 例）（风险比[HR]，0.89 [95%可信区间，0.84-0.95]；绝对风险降低，0.38%[95%置信区间，0.20%-0.55%]；需要治疗的人数，265）。与无阿司匹林相比，阿司匹林治疗与主要出血事件风险增加相关（阿司匹林组每 10000 人年发生 23.1 例，无阿司匹林组每 10000 人年发生 16.4 例）（HR，1.43 [95%可信区间，1.30-1.56]；绝对风险增加，0.47%[95%置信区间，0.34%-0.62%]；需要伤害的人数，210）。
在无心血管疾病的个体中使用阿司匹林与心血管事件风险降低和主要出血风险增加相关。这些信息可能有助于与患者讨论阿司匹林用于预防心血管事件和出血的一级预防。
