阿司匹林在心血管疾病中的剂量比较效果。
Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.
机构信息
From Duke Clinical Research Institute, Duke University, Durham (W.S.J., H.M., L.M.W., M.J.P., M.T.R., H.R.R., L.H.C., A.G.S., L.G.B., B.G.H., D.F.H., L.G.Q., G.M.-G., A.F.H.), University of North Carolina at Chapel Hill, Chapel Hill (D.A.D.), and Wake Forest University School of Medicine, Winston-Salem (L.Z.) - all in North Carolina; Vanderbilt University Medical Center, Nashville (S.K., D.M., D.L.C., R.L.R.); Ochsner Health (M.B.E., R.N.R.) and Louisiana Public Health Institute (T.W.C., E.N.) - both in New Orleans; University of Kansas Medical Center, Kansas City (K.G.); University of Florida, Gainesville (R.D.A., C.J.P., E.M.H., B.R.M., E.A.S.); University of Pittsburgh Medical Center, Pittsburgh (S.K.J., K.M.M.), Penn State College of Medicine, Hershey (J.L.K.), and Temple University, Philadelphia (A.P.) - all in Pennsylvania; University of Iowa, Iowa City (S.G., D.R.); Medical College of Wisconsin, Milwaukee (J.W.), and Marshfield Clinic Research Institute, Marshfield (J.J.V.) - both in Wisconsin; Albert Einstein College of Medicine, Bronx (Y.H.G.), and Weill Cornell Medicine and New York-Presbyterian Hospital, New York (R.K.) - both in New York; Mayo Clinic, Rochester (V.L.R.), Essentia Health Heart and Vascular Center, Duluth (C.P.B.), and Allina Health and Minneapolis Heart Institute, Minneapolis (S.M.B.) - all in Minnesota; University of Utah School of Medicine (R.H.) and Intermountain Medical Center Heart Institute (K.U.K.) - both in Salt Lake City; University of Michigan, Ann Arbor (P.F.); Johns Hopkins University School of Medicine, Baltimore (D.E.F.); HealthCore, Wilmington, DE (K.H.); University of Chicago Medicine (T.S.P.) and Northwestern University Feinberg School of Medicine (D.J.F., F.S.A., A.M.K.) - both in Chicago; University of Nebraska Medical Center, Omaha (J.C.M., J.R.C.); University of California, Los Angeles, Los Angeles (D.S.B., G.C.F.), University of California, San Francisco, San Francisco (M.F.M., G.M.M.), and Stanford University School of Medicine, Stanford (R.A.H.) - all in California; University of Missouri School of Medicine, Columbia (L.R.W.); University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (F.A.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.M.A.); Chicago (D.R.D.); St. Joseph, MO (K.E.); Brighton, MI (J.G.M.); Columbia, TN (L.S.B.); Alachua, FL (D.N.Z.); Columbia, MD (T.E.M.); North Hills, CA (J.D.A.); and Metairie, LA (K.C.G.).
出版信息
N Engl J Med. 2021 May 27;384(21):1981-1990. doi: 10.1056/NEJMoa2102137. Epub 2021 May 15.
BACKGROUND
The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.
METHODS
Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.
RESULTS
A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).
CONCLUSIONS
In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).
背景
在已患有动脉粥样硬化性心血管疾病的患者中，使用何种剂量的阿司匹林能降低死亡率、心肌梗死和中风风险，同时将大出血的发生率降至最低，这是一个存在争议的问题。
方法
采用开放标签、实用主义设计，我们将已患有动脉粥样硬化性心血管疾病的患者随机分为每天服用 81 毫克或 325 毫克阿司匹林的策略。主要有效性结局是任何原因导致的死亡、因心肌梗死住院或因中风住院的复合结局，采用时间事件分析进行评估。主要安全性结局是因大出血住院，同样采用时间事件分析进行评估。
结果
共纳入 15076 例患者，中位随访时间为 26.2 个月（四分位距[IQR]，19.0 至 34.9）。在随机分组前，有 13537 例（可获取既往阿司匹林使用信息的患者中，96.0%）正在服用阿司匹林，其中 85.3%的患者正在服用每日 81 毫克的阿司匹林。81 毫克组有 590 例（估计百分比为 7.28%）患者发生死亡、因心肌梗死住院或因中风住院，325 毫克组有 569 例（估计百分比为 7.51%）患者发生上述事件（风险比，1.02；95%置信区间[CI]，0.91 至 1.14）。81 毫克组有 53 例（估计百分比为 0.63%）患者因大出血住院，325 毫克组有 44 例（估计百分比为 0.60%）患者因大出血住院（风险比，1.18；95%CI，0.79 至 1.77）。与 81 毫克组相比，被分配至 325 毫克组的患者更倾向于改变剂量（41.6%比 7.1%），且暴露于所分配剂量的中位天数更少（434 天[IQR，139 至 737]比 650 天[IQR，415 至 922]）。
结论
在这项涉及已患有心血管疾病患者的实用主义试验中，患者大量转换为每天服用 81 毫克的阿司匹林，且与每天服用 325 毫克阿司匹林的患者相比，服用 81 毫克阿司匹林的患者在心血管事件或大出血方面无显著差异。（由患者导向的结果研究所资助；ADAPTABLE 临床试验.gov 编号，NCT02697916。）
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