Abstract
BACKGROUND: Branch atheromatous disease (BAD) is a subtype of ischemic stroke associated with early neurological deterioration (END) and poor outcomes. Although BAD shares features with large artery atherosclerosis, optimal treatment strategies remain undefined. OBJECTIVES: To assess the efficacy and safety of early dual antiplatelet therapy (DAPT) and high-intensity statins in reducing END and improving outcomes in BAD. DESIGN: A prospective, single-arm study with a historical control group. METHODS: This study reports the results of the Statin and Dual Antiplatelet Therapy in Preventing Early Neurological Deterioration in Branch Atheromatous Disease trial. Patients with BAD-related ischemic stroke were treated with aspirin, clopidogrel, and high-intensity statins within 24 h of symptom onset. Outcomes were compared with a historical control cohort treated with single antiplatelet therapy and moderate- or low-intensity statins. The primary outcome was the composite of END (defined as an National Institutes of Health Stroke Scale score increase ⩾2 points within 7 days) or recurrent stroke within 30 days. Secondary outcomes included severe END, functional outcomes at 90 days, and safety events. RESULTS: A total of 91 patients received intensive therapy and 285 received standard treatment. The primary endpoint occurred less frequently in the intensive group (34.1% vs 48.1%; adjusted risk ratio (aRR), 0.71; 95% confidence interval (CI), 0.52-0.98; p = 0.034). Intensive therapy significantly reduced END at 7 days (34.1% vs 47.0%; aRR, 0.73; 95% CI, 0.54-1.00; p = 0.049) but not recurrent stroke at 30 days (2.2% vs 1.8%; aRR, 1.16; 95% CI, 0.25-5.43). Good outcomes at 90 days (modified Rankin Scale ⩽2) were more common with intensive therapy (73.6% vs 57.2%; aRR, 1.27; 95% CI, 1.09-1.48; p = 0.002). Major bleeding and mortality did not differ between groups. CONCLUSION: Early intensive therapy with DAPT and high-intensity statins significantly reduced END and improved recovery in BAD without compromising safety. Further studies are warranted to validate these findings. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT04824911 (https://clinicaltrials.gov/study/NCT04824911).