Efficacy and safety of dual-antiplatelet therapy with high-intensity statin versus single-antiplatelet therapy with high-intensity statin in patients with stroke or high-risk mini-stroke of atherosclerotic origin: A cohort study

Abstract

Listen

Translate article

Objectives: The aim was to study the efficacy and safety of two treatment regimes for stroke or high-risk transient ischemic attack (TIA) of atherosclerotic origin. Materials and Methods: A prospective observational cohort study was conducted in patients with stroke (National Institutes of Health Stroke Scale [NIHSS], 1–10; atherosclerotic-origin) who did not undergo thrombolysis or thrombectomy and in patients with high-risk TIA (ABCD2, ≥4). Two treatment regimes studied included; dual-antiplatelet therapy (DAPT) (1–21 days) followed by single-antiplatelet therapy (SAPT) (22–90 days) with high-intensity statin (HIS) for 90 days (Group-A) versus SAPT for 90 days with HIS for 60 days (Group-B). Patients were followed up for efficacy endpoints including prevention of early neurological deterioration (END), new stroke/TIA, and neurofunctional recovery at three months. The safety endpoints included a composite of cardiovascular events, bleeding events, and muscle-toxic effects. A multivariate logistic regression and Cox-proportional hazards model were used to evaluate endpoints. Results: Of 160 patients, 82 completed Group-A therapy, and 78 completed Group-B therapy. The NIHSS for qualifying stroke was median (Interquartile range) 5 (2–8). END occurred in 2.4% (Group-A) versus 7.7% (Group-B) patients (hazards ratio [HR], 0.66; 95% confidence interval [CI], 0.42–0.91; P = 0.08). A new stroke/TIA occurred in 4.8% (Group-A) versus 11.5% (Group-B) patients (HR, 0.75; 95% CI, 0.61–0.93; P = 0.06). A change in the severity of stroke or high-risk TIA combined with a modified Rankin scale toward favorable outcomes was observed in Group A (odds ratio, 3.12; 95% CI, 1.71–5.52; P = 0.001). Though the risk was minimal in both cohorts, bleeding events and muscle-toxic effects were 4.7 and 4.6% points higher in Group-A patients. Conclusion: Compared to Group-B therapy, Group-A therapy was found to be more effective in preventing END and new stroke/TIA, and in improving neurofunctional recovery at three months, albeit at the expense of minimal safety hazards. Multicentric and randomized controlled trials are required for generalization of the study findings.