Lower rate of ischemic events with alirocumab in patients with atherosclerotic cardiovascular disease but without prior acute ischemic events

作者：D L Bhatt, L Tokgozoglu, N Marx, I Khan, M C Cabezas, J Tunon, M Vrablik, P P Filardi, Susan Gruber, M Van Der Laan, Katherine Andrade, Z Lou, K Pol, K Lee, K K Ray · 发表于：European Heart Journal · 年份：2025 · DOI：10.1093/eurheartj/ehaf784.4289 · 研究领域：Lipoproteins and Cardiovascular Health、Atherosclerosis and Cardiovascular Diseases、Antiplatelet Therapy and Cardiovascular Diseases

Abstract Background ODYSSEY OUTCOMES showed a significant reduction in cardiovascular events, including mortality, in patients with recent acute coronary syndromes, randomized to alirocumab vs. placebo, for lowering low-density lipoprotein cholesterol (LDL-C). However, the trial did not evaluate patients without a prior history of acute events. Purpose To evaluate the potential benefit of alirocumab on acute ischemic events and mortality in patients with atherosclerotic cardiovascular disease (ASCVD) but without prior history of myocardial infarction or stroke. Methods Patients with ASCVD but without prior acute ischemic events were identified from the Optum Research Database (January 2016–December 2022). Patients initiating alirocumab were matched 1:2 with no-PCSK9i (mAb or siRNA) users based on a propensity score that utilized patients’ baseline characteristics. The primary endpoint was the composite of nonfatal myocardial infarction, nonfatal ischemic stroke, and all-cause mortality. The causal estimands were defined as the relative risk reduction (RRR) and absolute risk reduction (ARR) at 3 years with a per-protocol analysis, meaning sustained treatment over time. Rigorous statistical methods for causal inference were utilized to try to obtain unbiased findings. Targeted maximum likelihood estimation (TMLE) was the primary analysis; parametric G-formula was the secondary analysis. The confounder set in these analyses included all baseline characteristics. Results A total ...