Cui Yu, Wang Yue, Chen Hui-Sheng
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China
Stroke Vasc Neurol. 2025 Aug 26;10(4):481-490. doi: 10.1136/svn-2024-003615.
Systolic blood pressure (SBP) affects the risk of early neurological deterioration (END). This subgroup analysis of Antiplatelet Therapy in Acute Mild to Moderate Ischemic Stroke (ATAMIS) trial aimed to explore whether SBP at admission affected the efficacy of different antiplatelet therapies in preventing END.
Based on the modified intention-to-treat analysis set of the ATAMIS trial, patients were divided into two subgroups according to whether SBP at admission was equal to or higher than 140 mm Hg, which were further subdivided into clopidogrel plus aspirin and aspirin alone treatments according to the randomised assignment. We conducted multivariable regression analyses to detect relationship between SBP at admission and END, as well as efficacy of different antiplatelet therapies in each SBP subgroup. Primary endpoint was END defined as ≥2-point increase in 7-day National Institutes of Health Stroke Scale score. Safety endpoints included intracranial haemorrhage and bleeding events during the trial.
This study included 2915 patients. Risk of END raised by 16% as SBP at admission increased by every 10 mm Hg (p<0.001). Clopidogrel plus aspirin resulted in significantly lower risk of END than aspirin alone in patients with SBP≥140 mm Hg (5.5% vs 7.9%; adjusted risk difference (RD) and 95% CI -2.5% (-4.1% to -1.0%)), but not in those with SBP<140 mm Hg (3.4% vs 4.2%; adjusted RD and 95% CI -0.8% (-3.2% to 1.7%)). Efficacy of different antiplatelet therapies and SBP did not show significant interaction (p=0.50). Safety endpoints were similar between treatments in SBP subgroups.
The risk of END increases with elevated SBP at admission among patients with acute mild-to-moderate ischaemic stroke who are not suitable for reperfusion treatments. Fewer END occurred following clopidogrel plus aspirin compared with aspirin alone across different SBP levels. The finding should be interpreted cautiously.
收缩压(SBP)会影响早期神经功能恶化(END)的风险。急性轻至中度缺血性卒中抗血小板治疗(ATAMIS)试验的这项亚组分析旨在探讨入院时的SBP是否会影响不同抗血小板治疗预防END的疗效。
基于ATAMIS试验的改良意向性治疗分析集,根据入院时SBP是否等于或高于140 mmHg将患者分为两个亚组,并根据随机分配进一步细分为氯吡格雷加阿司匹林治疗组和单独使用阿司匹林治疗组。我们进行了多变量回归分析,以检测入院时SBP与END之间的关系,以及每个SBP亚组中不同抗血小板治疗的疗效。主要终点是END,定义为美国国立卫生研究院卒中量表7天评分增加≥2分。安全终点包括试验期间的颅内出血和出血事件。
本研究纳入2915例患者。入院时SBP每升高10 mmHg,END风险增加16%(p<0.001)。在SBP≥140 mmHg的患者中,氯吡格雷加阿司匹林导致的END风险显著低于单独使用阿司匹林(5.5%对7.9%;调整后的风险差异(RD)和95%CI为-2.5%(-4.1%至-1.0%)),但在SBP<140 mmHg的患者中并非如此(3.4%对4.2%;调整后的RD和95%CI为-0.8%(-3.2%至1.7%))。不同抗血小板治疗的疗效与SBP之间未显示出显著的相互作用(p=0.50)。SBP亚组中各治疗组的安全终点相似。
在不适合再灌注治疗的急性轻至中度缺血性卒中患者中,入院时SBP升高会增加END风险。在不同SBP水平下,氯吡格雷加阿司匹林治疗后的END发生率低于单独使用阿司匹林。该研究结果应谨慎解读。