Ben Gurion University of the Negev, Be'er Sheva, Israel.
New England Geriatric Research Education and Clinical Center, Bedford and Boston, Massachusetts.
JAMA Netw Open. 2023 Dec 1;6(12):e2346373. doi: 10.1001/jamanetworkopen.2023.46373.
There are limited data for the utility of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and death in adults with chronic kidney disease (CKD).
To evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events (MACE) among US veterans older than 65 years with CKD stages 3 to 4.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study used a target trial emulation design for statin initiation among veterans with moderate CKD (stages 3 or 4) using nested trials with a propensity weighting approach. Linked Veterans Affairs (VA) Healthcare System, Medicare, and Medicaid data were used. This study considered veterans newly diagnosed with moderate CKD between 2005 and 2015 in the VA, with follow-up through December 31, 2017. Veterans were older than 65 years, within 5 years of CKD diagnosis, had no prior ASCVD or statin use, and had at least 1 clinical visit in the year prior to trial baseline. Eligibility criteria were assessed for each nested trial, and Cox proportional hazards models with bootstrapping were run. Analysis was conducted from July 2021 to October 2023.
Statin initiation vs none.
Primary outcome was all-cause mortality; secondary outcome was time to first MACE (myocardial infarction, transient ischemic attack, stroke, revascularization, or mortality).
Included in the analysis were 14 828 veterans. Mean (SD) age at CKD diagnosis was 76.9 (8.2) years, 14 616 (99%) were men, 10 539 (72%) White, and 2568 (17%) Black. After expanding to person-trials and assessing eligibility at each baseline, there were 151 243 person-trials (14 685 individuals) of nonstatin initiators and 2924 person-trials (2924 individuals) of statin initiators included. Propensity score adjustment via overlap weighting with nonparametric bootstrapping resulted in covariate balance, with mean (SD) follow-up of 3.6 (2.7) years. The hazard ratio for all-cause mortality was 0.91 (95% CI, 0.85-0.97) comparing statin initiators to noninitiators. The hazard ratio for MACE was 0.96 (95% CI, 0.91-1.02). Results remained consistent in prespecified subgroup analyses.
In this target trial emulation of statin initiation in US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was significantly associated with a lower risk of all-cause mortality but not MACE. Results should be confirmed in a randomized clinical trial.
对于患有慢性肾脏病（CKD）的成年人，他汀类药物在动脉粥样硬化性心血管疾病（ASCVD）和死亡的一级预防中的效用数据有限。
评估他汀类药物在 65 岁以上患有 CKD 分期 3 至 4 期的美国退伍军人中的全因死亡率和主要不良心血管事件（MACE）之间的相关性。
设计、设置和参与者：这项队列研究使用嵌套试验中的倾向评分加权方法，通过目标试验模拟设计，评估他汀类药物在患有中度 CKD（分期 3 或 4）的退伍军人中的应用。使用退伍军人事务部（VA）医疗保健系统、医疗保险和医疗补助数据。这项研究考虑了在 VA 中被诊断为中度 CKD（分期 3 或 4）的退伍军人，随访至 2017 年 12 月 31 日。退伍军人年龄在 65 岁以上，在 CKD 诊断后 5 年内，没有 ASCVD 或他汀类药物使用史，并且在试验基线前的一年内至少有一次临床就诊。对每个嵌套试验进行了资格评估，并使用 bootstrap 运行 Cox 比例风险模型。分析于 2021 年 7 月至 2023 年 10 月进行。
他汀类药物的起始使用与不使用。
主要结局是全因死亡率；次要结局是首次发生 MACE（心肌梗死、短暂性脑缺血发作、中风、血运重建或死亡）的时间。
共纳入 14828 名退伍军人。CKD 诊断时的平均（标准差）年龄为 76.9（8.2）岁，14616 名（99%）为男性，10539 名（72%）为白人，2568 名（17%）为黑人。在扩展到个人试验并在每个基线评估资格后，包括了 151243 个人试验（14685 人）的非他汀类药物使用者和 2924 个人试验（2924 人）的他汀类药物使用者。通过非参数引导的重叠加权进行倾向评分调整后，协变量达到平衡，平均（标准差）随访时间为 3.6（2.7）年。与非使用者相比，他汀类药物使用者的全因死亡率风险比为 0.91（95%CI，0.85-0.97）。MACE 的风险比为 0.96（95%CI，0.91-1.02）。在预先指定的亚组分析中，结果仍然一致。
在这项针对 65 岁以上患有 CKD 分期 3 至 4 期且无 ASCVD 既往史的美国退伍军人中进行的他汀类药物起始的目标试验模拟研究中，他汀类药物的起始与较低的全因死亡率风险相关，但与 MACE 无关。应在随机临床试验中证实这些结果。
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