{"title":"替罗非班预防急性缺血性脑卒中伴颅内动脉狭窄患者神经功能恶化的作用：TREND试验的事后分析","authors":"Jing Wang, Yue Qiao, Sijie Li, Chuanhui Li, Chuanjie Wu, Pingping Wang, Ting Yang, Xunming Ji, Qingfeng Ma, Wenbo Zhao","doi":"10.1177/23969873251319151","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The degree of culprit artery stenosis affects the risk of early neurological deterioration (END) after acute ischemic stroke (AIS). The TREND trial demonstrated the efficacy of tirofiban in preventing END in patients with AIS. We aimed to investigate whether the degree of intracranial artery stenosis affects the efficacy of tirofiban in preventing END in patients with AIS.</p><p><strong>Patients and methods: </strong>We conducted a post hoc analysis of the TREND trial, which enrolled patients within 24 h of onset and randomly allocated to receive intravenous tirofiban or oral aspirin. We stratified the stenosis degrees into three subgroups: no stenosis, mild-to-moderate stenosis (stenosis <70%), and severe stenosis or occlusion (stenosis ⩾70%). The primary endpoint is END<sub>4</sub> defined as an increase of the NIHSS ⩾4 within 72 h after randomization. Secondary outcomes include END<sub>2</sub> (defined as an increase of NIHSS ⩾2) within 72 h after randomization, the proportion of mRS 0-1 and 0-2 at 90 days.</p><p><strong>Results: </strong>A total of 296 patients were analyzed. In patients with severe stenosis or occlusion, tirofiban significantly reduced the incidence of END<sub>4</sub> (5.7% vs 30.8%, adjusted OR 0.156, 95% CI 0.028-0.873, adjusted <i>p</i> = 0.034), whereas its effects in preventing END<sub>4</sub> were similar to those of aspirin in patients with no stenosis (2.4% vs 4.6%, adjusted OR 0.193, 95% CI 0.018-2.083, adjusted <i>p</i> = 0.175) or mild-to-moderate stenosis (2.9% vs 10.0%, adjusted OR 0.171, 95% CI 0.015-1.943, adjusted <i>p</i> = 0.155). The <i>p</i> value for interaction between stenosis subgroups and treatment was 0.513. Furthermore, tirofiban significantly reduced the incidence of END<sub>2</sub> in patients with mild-to-moderate stenosis (5.9% vs 22.5%, OR 0.146, 95% CI 0.022-0.951, adjusted <i>p</i> = 0.044) and severe stenosis or occlusion (11.4% vs 43.6%, adjusted OR 0.140, 95% CI 0.036-0.540, adjusted <i>p</i> = 0.004). A significant improvement in favorable outcomes with a 90-day mRS of 0-1 was observed only in patients with mild-to-moderate stenosis (85.3% vs 70.0%, adjusted OR 4.617, 95% CI 1.077-19.798, adjusted <i>p</i> = 0.039).</p><p><strong>Discussion and conclusion: </strong>Tirofiban may significantly reduce the incidence of END in patients with severe arterial stenosis or occlusion. Further studies are required to confirm the effects of intracranial artery stenosis on the benefits of intravenous tirofiban.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov; identifier: NCT04491695.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":" ","pages":"23969873251319151"},"PeriodicalIF":5.8000,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829278/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effects of tirofiban in preventing neurological deterioration in acute ischemic stroke with intracranial artery stenosis: A post hoc analysis of the TREND Trial.\",\"authors\":\"Jing Wang, Yue Qiao, Sijie Li, Chuanhui Li, Chuanjie Wu, Pingping Wang, Ting Yang, Xunming Ji, Qingfeng Ma, Wenbo Zhao\",\"doi\":\"10.1177/23969873251319151\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The degree of culprit artery stenosis affects the risk of early neurological deterioration (END) after acute ischemic stroke (AIS). The TREND trial demonstrated the efficacy of tirofiban in preventing END in patients with AIS. We aimed to investigate whether the degree of intracranial artery stenosis affects the efficacy of tirofiban in preventing END in patients with AIS.</p><p><strong>Patients and methods: </strong>We conducted a post hoc analysis of the TREND trial, which enrolled patients within 24 h of onset and randomly allocated to receive intravenous tirofiban or oral aspirin. We stratified the stenosis degrees into three subgroups: no stenosis, mild-to-moderate stenosis (stenosis <70%), and severe stenosis or occlusion (stenosis ⩾70%). The primary endpoint is END<sub>4</sub> defined as an increase of the NIHSS ⩾4 within 72 h after randomization. Secondary outcomes include END<sub>2</sub> (defined as an increase of NIHSS ⩾2) within 72 h after randomization, the proportion of mRS 0-1 and 0-2 at 90 days.</p><p><strong>Results: </strong>A total of 296 patients were analyzed. In patients with severe stenosis or occlusion, tirofiban significantly reduced the incidence of END<sub>4</sub> (5.7% vs 30.8%, adjusted OR 0.156, 95% CI 0.028-0.873, adjusted <i>p</i> = 0.034), whereas its effects in preventing END<sub>4</sub> were similar to those of aspirin in patients with no stenosis (2.4% vs 4.6%, adjusted OR 0.193, 95% CI 0.018-2.083, adjusted <i>p</i> = 0.175) or mild-to-moderate stenosis (2.9% vs 10.0%, adjusted OR 0.171, 95% CI 0.015-1.943, adjusted <i>p</i> = 0.155). The <i>p</i> value for interaction between stenosis subgroups and treatment was 0.513. Furthermore, tirofiban significantly reduced the incidence of END<sub>2</sub> in patients with mild-to-moderate stenosis (5.9% vs 22.5%, OR 0.146, 95% CI 0.022-0.951, adjusted <i>p</i> = 0.044) and severe stenosis or occlusion (11.4% vs 43.6%, adjusted OR 0.140, 95% CI 0.036-0.540, adjusted <i>p</i> = 0.004). A significant improvement in favorable outcomes with a 90-day mRS of 0-1 was observed only in patients with mild-to-moderate stenosis (85.3% vs 70.0%, adjusted OR 4.617, 95% CI 1.077-19.798, adjusted <i>p</i> = 0.039).</p><p><strong>Discussion and conclusion: </strong>Tirofiban may significantly reduce the incidence of END in patients with severe arterial stenosis or occlusion. 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引用次数: 0
摘要
主犯动脉狭窄程度影响急性缺血性卒中（AIS）后早期神经功能恶化（END）的风险。TREND试验证实了替罗非班在AIS患者中预防END的有效性。我们的目的是研究颅内动脉狭窄程度是否影响替罗非班预防AIS患者END的疗效。患者和方法：我们对TREND试验进行了事后分析，该试验在发病24小时内招募患者，并随机分配接受静脉注射替罗非班或口服阿司匹林。我们将狭窄程度分为三个亚组：无狭窄，轻度至中度狭窄（狭窄4定义为随机化后72小时内NIHSS小于或等于4的增加）。次要结局包括随机化后72小时内的END2（定义为NIHSS大于或等于2的增加），90天mRS 0-1和0-2的比例。结果：共分析296例患者。在严重狭窄或闭塞的患者中，替罗非班显著降低了END4的发生率（5.7% vs 30.8%，校正or 0.156, 95% CI 0.028-0.873，校正p = 0.034），而在无狭窄患者中，替罗非班预防END4的效果与阿司匹林相似（2.4% vs 4.6%，校正or 0.193, 95% CI 0.018-2.083，校正p = 0.175）或轻度至中度狭窄（2.9% vs 10.0%，校正or 0.171, 95% CI 0.015-1.943，校正p = 0.155）。狭窄亚组与治疗相互作用的p值为0.513。此外，替罗非班显著降低了轻度至中度狭窄（5.9% vs 22.5%, OR 0.146, 95% CI 0.022-0.951，校正p = 0.044）和重度狭窄或闭塞（11.4% vs 43.6%，校正OR 0.140, 95% CI 0.036-0.540，校正p = 0.004）患者的END2发生率。仅在轻度至中度狭窄患者中观察到90天mRS为0-1的有利结果的显著改善（85.3% vs 70.0%，调整OR为4.617,95% CI为1.077-19.798，调整p = 0.039）。讨论与结论：替罗非班可显著降低严重动脉狭窄或闭塞患者的END发生率。需要进一步的研究来证实颅内动脉狭窄对静脉注射替罗非班益处的影响。试验注册：ClinicalTrials.gov；标识符:NCT04491695。
Effects of tirofiban in preventing neurological deterioration in acute ischemic stroke with intracranial artery stenosis: A post hoc analysis of the TREND Trial.
Introduction: The degree of culprit artery stenosis affects the risk of early neurological deterioration (END) after acute ischemic stroke (AIS). The TREND trial demonstrated the efficacy of tirofiban in preventing END in patients with AIS. We aimed to investigate whether the degree of intracranial artery stenosis affects the efficacy of tirofiban in preventing END in patients with AIS.
Patients and methods: We conducted a post hoc analysis of the TREND trial, which enrolled patients within 24 h of onset and randomly allocated to receive intravenous tirofiban or oral aspirin. We stratified the stenosis degrees into three subgroups: no stenosis, mild-to-moderate stenosis (stenosis <70%), and severe stenosis or occlusion (stenosis ⩾70%). The primary endpoint is END4 defined as an increase of the NIHSS ⩾4 within 72 h after randomization. Secondary outcomes include END2 (defined as an increase of NIHSS ⩾2) within 72 h after randomization, the proportion of mRS 0-1 and 0-2 at 90 days.
Results: A total of 296 patients were analyzed. In patients with severe stenosis or occlusion, tirofiban significantly reduced the incidence of END4 (5.7% vs 30.8%, adjusted OR 0.156, 95% CI 0.028-0.873, adjusted p = 0.034), whereas its effects in preventing END4 were similar to those of aspirin in patients with no stenosis (2.4% vs 4.6%, adjusted OR 0.193, 95% CI 0.018-2.083, adjusted p = 0.175) or mild-to-moderate stenosis (2.9% vs 10.0%, adjusted OR 0.171, 95% CI 0.015-1.943, adjusted p = 0.155). The p value for interaction between stenosis subgroups and treatment was 0.513. Furthermore, tirofiban significantly reduced the incidence of END2 in patients with mild-to-moderate stenosis (5.9% vs 22.5%, OR 0.146, 95% CI 0.022-0.951, adjusted p = 0.044) and severe stenosis or occlusion (11.4% vs 43.6%, adjusted OR 0.140, 95% CI 0.036-0.540, adjusted p = 0.004). A significant improvement in favorable outcomes with a 90-day mRS of 0-1 was observed only in patients with mild-to-moderate stenosis (85.3% vs 70.0%, adjusted OR 4.617, 95% CI 1.077-19.798, adjusted p = 0.039).
Discussion and conclusion: Tirofiban may significantly reduce the incidence of END in patients with severe arterial stenosis or occlusion. Further studies are required to confirm the effects of intracranial artery stenosis on the benefits of intravenous tirofiban.
期刊介绍：
Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.
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