SUNY Downstate Health Sciences University, Brooklyn, New York.
Paris University, Paris, France.
J Am Coll Cardiol. 2020 May 5;75(17):2110-2118. doi: 10.1016/j.jacc.2020.03.015. Epub 2020 Mar 16.
In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, atorvastatin was compared with placebo in 4,731 participants with recent stroke or transient ischemic attack and no known coronary heart disease. Atorvastatin reduced the first occurrence of stroke and the first occurrence of a composite of vascular events.
The aim of this post hoc analysis was to assess the occurrence of all (first and subsequent) vascular events and the effect of atorvastatin to reduce these events by vascular territory (cerebrovascular, coronary, or peripheral) in SPARCL.
Treatment effects on total adjudicated vascular events, overall and by vascular territory, were summarized by marginal proportional hazards models. Vascular event rates were estimated for each treatment group with cumulative incidence functions.
The placebo group had an estimated 41.2 first and 62.7 total vascular events per 100 participants over 6 years. There were 164 fewer first and 390 fewer total vascular events in the atorvastatin group (total events hazard ratio: 0.68; 95% confidence interval: 0.60 to 0.77). The total events reduction included 177 fewer cerebrovascular, 170 fewer coronary, and 43 fewer peripheral events. Over 6 years, an estimated 20 vascular events per 100 participants were avoided with atorvastatin treatment.
In participants with recent stroke or transient ischemic attack, the total number of vascular events prevented with atorvastatin was more than twice the number of first events prevented. Total event reduction provides a comprehensive metric to capture the totality of atorvastatin clinical efficacy in reducing disease burden after stroke or transient ischemic attack. (Lipitor in the Prevention of Stroke, for Patients Who Have Had a Previous Stroke [SPARCL]; NCT00147602).
在 SPARCL（通过积极降低胆固醇水平预防中风）试验中，4731 名近期患有中风或短暂性脑缺血发作且无已知冠心病的参与者被比较了阿托伐他汀与安慰剂。阿托伐他汀降低了首次中风和首次血管事件复合终点的发生。
本事后分析旨在评估 SPARCL 中所有（首次和随后的）血管事件的发生情况，以及阿托伐他汀通过血管区域（脑血管、冠状动脉或外周血管）降低这些事件的效果。
采用边缘比例风险模型总结治疗对总裁定血管事件、总体及各血管区域的影响。采用累积发病率函数估计每个治疗组的血管事件发生率。
安慰剂组在 6 年内估计每 100 名参与者有 41.2 例首次和 62.7 例总血管事件。阿托伐他汀组首次和总血管事件分别减少了 164 例和 390 例（总事件风险比：0.68；95%置信区间：0.60 至 0.77）。总事件减少包括 177 例脑血管事件、170 例冠状动脉事件和 43 例外周血管事件。阿托伐他汀治疗可使每 100 名参与者 6 年内估计避免 20 例血管事件。
在近期患有中风或短暂性脑缺血发作的参与者中，阿托伐他汀预防的血管事件总数超过预防首次事件的两倍。总事件减少提供了一个全面的指标，可捕获阿托伐他汀在中风或短暂性脑缺血发作后降低疾病负担的全部临床疗效。（先前有过中风的患者使用立普妥预防中风的研究[SPARCL]；NCT00147602）。
