Huang Yen-Chu, Weng Hsu-Huei, Tsai Yuan-Hsiung, Lin Leng-Chieh, Lee Jiann-Der, Yang Jen-Tsung, Pan Yi-Ting
Department of Neurology, Chang Gung Memorial Hospital at Chiayi, Chang-Gung University College of Medicine, No. 6 West Chia-Pu Road, Putz City, Chiayi County 613, Taiwan.
Department of Diagnostic Radiology, Chang Gung Memorial Hospital at Chiayi, Chang-Gung University College of Medicine, Chiayi, Taiwan.
Ther Adv Neurol Disord. 2025 Jul 24;18:17562864251357274. doi: 10.1177/17562864251357274. eCollection 2025.
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.
To assess the efficacy and safety of early dual antiplatelet therapy (DAPT) and high-intensity statins in reducing END and improving outcomes in BAD.
A prospective, single-arm study with a historical control group.
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.
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; = 0.034). Intensive therapy significantly reduced END at 7 days (34.1% vs 47.0%; aRR, 0.73; 95% CI, 0.54-1.00; = 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; = 0.002). Major bleeding and mortality did not differ between groups.
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.
ClinicalTrials.gov; Identifier: NCT04824911 (https://clinicaltrials.gov/study/NCT04824911).
分支动脉粥样硬化疾病（BAD）是缺血性卒中的一种亚型，与早期神经功能恶化（END）和不良预后相关。尽管BAD与大动脉粥样硬化有共同特征，但最佳治疗策略仍不明确。
评估早期双联抗血小板治疗（DAPT）和高强度他汀类药物在降低BAD患者的END及改善预后方面的疗效和安全性。
一项设有历史对照组的前瞻性单臂研究。
本研究报告了分支动脉粥样硬化疾病中他汀与双联抗血小板治疗预防早期神经功能恶化试验的结果。BAD相关缺血性卒中患者在症状发作后24小时内接受阿司匹林、氯吡格雷和高强度他汀类药物治疗。将结果与接受单药抗血小板治疗及中低强度他汀类药物治疗的历史对照队列进行比较。主要结局为END（定义为美国国立卫生研究院卒中量表评分在7天内增加≥2分）或30天内复发性卒中的复合结局。次要结局包括严重END、90天时的功能结局和安全事件。
共有91例患者接受强化治疗，285例接受标准治疗。强化治疗组主要终点事件的发生频率较低（34.1%对48.1%；调整风险比（aRR）为0.71；95%置信区间（CI）为0.52 - 0.98；P = 0.034）。强化治疗显著降低了7天时的END（34.1%对47.0%；aRR为0.73；95%CI为0.54 - 1.00；P = 0.049），但未降低30天时的复发性卒中（2.2%对1.8%；aRR为1.16；95%CI为0.25 - 5.43）。强化治疗组90天时良好结局（改良Rankin量表评分≤2）更为常见（73.6%对57.2%；aRR为1.27；95%CI为1.09 - 1.48；P = 0.002）。两组间大出血和死亡率无差异。
早期应用DAPT和高强度他汀类药物进行强化治疗可显著降低BAD患者的END并改善恢复情况，且不影响安全性。有必要进行进一步研究以验证这些发现。
ClinicalTrials.gov；标识符：NCT04824911（https://clinicaltrials.gov/study/NCT04824911）
