Cui Yu, Chen Hui-Sheng
Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, Liaoning, China.
Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, Liaoning, China
Stroke Vasc Neurol. 2025 Aug 26;10(4):491-498. doi: 10.1136/svn-2024-003705.
The Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy (DAPT) to alteplase in minor non-disabling stroke. This prespecified secondary analysis aimed to investigate whether the treatment effects were similar across stroke territories.
Participants were divided according to stroke territory, which were subdivided into DAPT and alteplase. An excellent functional outcome at 90 days defined as modified Rankin Scale scoring 0-1 was primary outcome. National Institutes of Health Stroke Scale (NIHSS) score change and early neurological improvement measured by a 2-point decline in NIHSS score at 24 hours were secondary outcomes. Symptomatic intracerebral haemorrhage (sICH) and bleeding events were safety outcomes. Primary analyses adjusted unbalanced baseline characteristics between treatments by multivariate logistic regression.
A total of 719 patients were included: 566 in anterior circulation stroke (ACS) and 153 in posterior circulation stroke (PCS). Primary outcome was 94.1% in DAPT and 91.7% in alteplase among ACS patients (adjusted risk difference (RD) and 95% CI, 1.5% (-1.5% to 4.6%), p=0.32), while 91.2% in DAPT and 91.8% in alteplase among PCS patients (adjusted RD and 95% CI, -2.1% (-8.5% to 4.4%), p=0.53). Compared with alteplase, DAPT was associated with lower risk of sICH (p=0.03) and bleeding events (p<0.001) in ACS, but only lower risk of bleeding events (p=0.007) in PCS. Additionally, among ACS patients, the alteplase was superior to DAPT in terms of decrease in NIHSS score at 24 hours compared with admission (adjusted geometric mean ratio and 95% CI, -0.09 (-0.16 to -0.03), p=0.005) and early neurological improvement (adjusted RD and 95% CI, -7.2% (-11.6% to -2.7%), p=0.001).
Among ischaemic stroke with minor non-disabling symptoms, DAPT was similar with intravenous alteplase regarding long-term functional outcome and better safety regardless of ACS or PCS. The potential benefit of intravenous alteplase regarding early neurological improvement in patients with ACS warrants further investigation.
NCT03661411.
“急性轻度缺血性卒中抗血小板治疗与重组组织型纤溶酶原激活剂对比试验”已证明，在轻度非致残性卒中中，双重抗血小板治疗（DAPT）不劣于阿替普酶。这项预先设定的二次分析旨在研究不同卒中区域的治疗效果是否相似。
参与者根据卒中区域进行划分，再细分为接受DAPT治疗和阿替普酶治疗的组。90天时良好的功能结局定义为改良Rankin量表评分为0 - 1分，这是主要结局。美国国立卫生研究院卒中量表（NIHSS）评分变化以及通过24小时时NIHSS评分下降2分来衡量的早期神经功能改善是次要结局。有症状的颅内出血（sICH）和出血事件是安全性结局。主要分析通过多变量逻辑回归对治疗组之间不平衡的基线特征进行了调整。
共纳入719例患者：566例为前循环卒中（ACS）患者，153例为后循环卒中（PCS）患者。在ACS患者中，DAPT组的主要结局发生率为94.1%，阿替普酶组为91.7%（调整后的风险差异（RD）及95%置信区间为1.5%（-1.5%至4.6%），p = 0.32）；而在PCS患者中，DAPT组为91.2%，阿替普酶组为91.8%（调整后的RD及95%置信区间为 - 2.1%（-8.5%至4.4%），p = 0.53）。与阿替普酶相比，DAPT在ACS患者中sICH风险更低（p = 0.03），出血事件风险也更低（p < 0.001），但在PCS患者中仅出血事件风险更低（p = 0.007）。此外，在ACS患者中，与入院时相比，阿替普酶在24小时时NIHSS评分降低方面优于DAPT（调整后的几何平均比及95%置信区间为 - 0.09（-0.16至 - 0.03），p = 0.005），在早期神经功能改善方面也更优（调整后的RD及95%置信区间为 - 7.2%（-11.6%至 - 2.7%），p = 0.001）。
在有轻度非致残症状的缺血性卒中患者中，无论ACS还是PCS，DAPT在长期功能结局方面与静脉注射阿替普酶相似，且安全性更好。静脉注射阿替普酶在ACS患者早期神经功能改善方面的潜在益处值得进一步研究。
NCT03661411。
