Stam-Slob Manon C, Visseren Frank L J, Wouter Jukema J, van der Graaf Yolanda, Poulter Neil R, Gupta Ajay, Sattar Naveed, Macfarlane Peter W, Kearney Patricia M, de Craen Anton J M, Trompet Stella
Department of Vascular Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
University Medical Center Utrecht, F02.224, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Clin Res Cardiol. 2017 Jan;106(1):58-68. doi: 10.1007/s00392-016-1023-8. Epub 2016 Aug 23.
To estimate the absolute treatment effect of statin therapy on major adverse cardiovascular events (MACE; myocardial infarction, stroke and vascular death) for the individual patient aged ≥70 years.
Prediction models for MACE were derived in patients aged ≥70 years with (n = 2550) and without (n = 3253) vascular disease from the "PROspective Study of Pravastatin in Elderly at Risk" (PROSPER) trial and validated in the "Secondary Manifestations of ARTerial disease" (SMART) cohort study (n = 1442) and the "Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm" (ASCOT-LLA) trial (n = 1893), respectively, using competing risk analysis. Prespecified predictors were various clinical characteristics including statin treatment. Individual absolute risk reductions (ARRs) for MACE in 5 and 10 years were estimated by subtracting on-treatment from off-treatment risk.
Individual ARRs were higher in elderly patients with vascular disease [5-year ARRs: median 5.1 %, interquartile range (IQR) 4.0-6.2 %, 10-year ARRs: median 7.8 %, IQR 6.8-8.6 %] than in patients without vascular disease (5-year ARRs: median 1.7 %, IQR 1.3-2.1 %, 10-year ARRs: 2.9 %, IQR 2.3-3.6 %). Ninety-eight percent of patients with vascular disease had a 5-year ARR ≥2.0 %, compared to 31 % of patients without vascular disease.
With a multivariable prediction model the absolute treatment effect of a statin on MACE for individual elderly patients with and without vascular disease can be quantified. Because of high ARRs, treating all patients is more beneficial than prediction-based treatment for secondary prevention of MACE. For primary prevention of MACE, the prediction model can be used to identify those patients who benefit meaningfully from statin therapy.
评估他汀类药物治疗对年龄≥70岁的个体患者主要不良心血管事件(MACE;心肌梗死、中风和血管性死亡)的绝对治疗效果。
从“普伐他汀对高危老年人的前瞻性研究”(PROSPER)试验中,在有(n = 2550)和无(n = 3253)血管疾病的≥70岁患者中推导MACE预测模型,并分别在“动脉疾病的次要表现”(SMART)队列研究(n = 1442)和“盎格鲁-斯堪的纳维亚心脏结局试验-降脂组”(ASCOT-LLA)试验(n = 1893)中使用竞争风险分析进行验证。预先设定的预测因素是包括他汀类药物治疗在内的各种临床特征。通过用未治疗风险减去治疗风险来估计5年和10年MACE的个体绝对风险降低(ARR)。
有血管疾病的老年患者个体ARR更高[5年ARR:中位数5.1%,四分位间距(IQR)4.0 - 6.2%,10年ARR:中位数7.8%,IQR 6.8 - 8.6%],高于无血管疾病的患者(5年ARR:中位数1.7%,IQR 1.3 - 2.1%,10年ARR:2.9%,IQR 2.3 - 3.6%)。98%有血管疾病的患者5年ARR≥2.0%,而无血管疾病的患者为31%。
使用多变量预测模型可以量化他汀类药物对有和无血管疾病的个体老年患者MACE的绝对治疗效果。由于ARR高,对所有患者进行治疗比基于预测的治疗对MACE的二级预防更有益。对于MACE的一级预防,该预测模型可用于识别那些从他汀类药物治疗中获得显著益处的患者。