Age and effect of intensive statin in acute mild ischemic stroke or transient ischemic attack: Subgroup analysis of the INSPIRES trial.

Background: It is unclear whether immediate-intensive statin is safe and effective for patients age 65 years and older with acute cerebral ischemia associated with atherosclerosis.

Methods: Patients from the Intensive Statin and Antiplatelet Therapy for High-risk Intracranial or Extracranial Atherosclerosis (INSPIRES) trial were divided into an elderly group (≥ 65 years, n = 2960) and a younger group (< 65 years, n = 3140). Primary exposures were age category and statin treatment allocation. The primary efficacy outcome (new stroke within 90 days), and the primary safety outcome (moderate-to-severe bleeding), were analyzed through Cox proportional hazards models. Secondary outcomes included composite vascular event and any bleeding (Cox regression), plus poor functional outcome (binary logistic regression). Age-treatment interactions were tested by Cox models.

Results: In elderly patients, higher proportions of stroke (hazard ratio [HR], 1.22; 95% CI, 1.02-1.47; P = .03), composite vascular event (HR, 1.26; 95% CI, 1.05-1.51; P = .01), poor functional outcome, and any bleeding were observed. Specifically, 124 (8.3%) elderly patients who received immediate statin therapy and 138 (9.4%) patients with delayed statin therapy experienced a stroke within 90 days, while in younger patients, 121 (7.7%) patients with immediate statin therapy and 118 (7.5%) patients with delayed statin therapy suffered a new stroke. There were no age and treatment interactions for risk of new stroke, moderate-to-severe bleeding, composite vascular event, poor functional outcome, and any bleeding events.

Conclusion: Immediate vs delayed intensive statin therapy demonstrates comparable safety and treatment response profiles in older and younger patients.