Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China (Y.C., C.H., Z.-A.L., Y.W., H.-S.C.).
Department of Medicine and Biological Information Engineering, Northeastern University, Shenyang, China (Y.W.).
Stroke. 2024 Nov;55(11):2590-2598. doi: 10.1161/STROKEAHA.124.048248. Epub 2024 Oct 10.
Dual antiplatelet therapy (DAPT) was noninferior to alteplase in minor nondisabling strokes in the ARAMIS trial (Antiplatelet Versus R-tPA for Acute Mild Ischemic Stroke); however, early neurological deterioration (END) associated with vessel stenosis may benefit from DAPT. We investigated whether the efficacy of DAPT was greater than alteplase in minor strokes with no large vessel occlusion (LVO).
This study was a prespecified post hoc analysis of the ARAMIS trial and included patients with responsible vessel examination in the as-treated analysis set of the ARAMIS trial who were divided into LVO group and non-LVO group. In each group, patients were further classified into DAPT and intravenous alteplase treatments. Primary outcome was END at 24 hours defined as more than or equal to 4-point National Institutes of Health Stroke Scale score increase compared with baseline, and safety outcomes were symptomatic intracerebral hemorrhage and bleeding events during study. The primary analysis was estimated with a risk difference calculated by a generalized linear model including adjusted different baseline characteristics between treatments.
Of 723 patients from the ARAMIS trial, 480 patients were included: 36 were categorized into LVO group and 444 into non-LVO group, of whom 20 patients had END. Compared with intravenous alteplase, a lower proportion of END was found after DAPT treatment in the non-LVO group (adjusted risk difference, -4.8% [95% CI, -6.9% to -2.6%]; <0.001), but not in the LVO group (adjusted risk difference, 2.3% [95% CI, -17.6% to 22.3%]; =0.82). The interaction was marginally significant between groups (=0.06). In the non-LVO group, a lower proportion of bleeding events was found after DAPT treatment than intravenous alteplase (adjusted risk difference, -6.4% [95% CI, -8.9% to -3.9%]; <0.001). Other safety outcomes were similar between the 2 treatments.
Among minor nondisabling acute ischemic stroke without LVO, DAPT may be superior to intravenous alteplase regarding preventing END with a better safety profile.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03661411.
ARAMIS 试验（抗血小板治疗与 r-tPA 治疗急性轻度缺血性卒中）表明，双重抗血小板治疗（DAPT）并不劣于阿替普酶用于轻度非致残性卒中；然而，与血管狭窄相关的早期神经功能恶化（END）可能受益于 DAPT。我们研究了 DAPT 在无大血管闭塞（LVO）的轻度卒中患者中的疗效是否优于阿替普酶。
这是 ARAMIS 试验的一项预设事后分析，纳入 ARAMIS 试验按治疗分析集进行责任血管检查的患者，分为 LVO 组和非 LVO 组。在每组中，患者进一步分为 DAPT 和静脉内阿替普酶治疗。主要结局为 24 小时 END，定义为与基线相比 NIHSS 评分增加≥4 分，安全性结局为症状性颅内出血和研究期间的出血事件。主要分析采用广义线性模型估计风险差异，该模型包括治疗间调整不同基线特征。
在 ARAMIS 试验的 723 例患者中，纳入 480 例患者：36 例归入 LVO 组，444 例归入非 LVO 组，其中 20 例发生 END。与静脉内阿替普酶相比，在非 LVO 组中 DAPT 治疗后 END 的比例较低（调整后的风险差异，-4.8%[95%CI，-6.9%至-2.6%]；<0.001），但在 LVO 组中并非如此（调整后的风险差异，2.3%[95%CI，-17.6%至 22.3%]；=0.82）。组间的交互作用具有边缘显著性（=0.06）。在非 LVO 组中，DAPT 治疗后出血事件的比例低于静脉内阿替普酶（调整后的风险差异，-6.4%[95%CI，-8.9%至-3.9%]；<0.001）。两种治疗的其他安全性结局相似。
在无 LVO 的轻度非致残性急性缺血性卒中患者中，DAPT 可能优于静脉内阿替普酶，在预防 END 方面具有更好的安全性。
