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World Stroke Organization (WSO): Global intracerebral hemorrhage factsheet 2025. 世界中风组织(WSO):全球脑出血概况2025。
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-02-01 Epub Date: 2025-01-06 DOI: 10.1177/17474930241307876
Adrian R Parry-Jones, Rita Krishnamurthi, Wendy C Ziai, Ashkan Shoamanesh, Simiao Wu, Sheila O Martins, Craig S Anderson

Background: Intracerebral hemorrhage (ICH) is stroke caused by non-traumatic bleeding into the brain.

Aim: This factsheet provides summary statistics for ICH from the 2021 Global of Burden of Diseases Study.

Methods: Data were downloaded from the GBD results platform using "intracerebral hemorrhage" as a Level 4 cause of death or injury, extracting key metrics (number, percent, rate) for measures (incidence, disabilty adjusted life years [DALYs], deaths) described in this factsheet.

Results: Globally, stroke was the third leading cause of death in 2021, and ICH accounted for 28.8% of incident strokes. There were estimated to be 7,252,678 deaths due to stroke in 2021 of which ICH accounted for 3,308,367 (45.6%). When considering the burden of ICH in terms of DALYs, ICH accounts for nearly half of the burden of stroke at 49.5%, compared to 43.8% caused by ischemic stroke. ICH must therefore be considered on an equal footing with ischemic stroke, so that efforts can be made to reduce its burden through public health, research, and healthcare provision. Although the overall age-standardized incidence of ICH has been decreasing since 1990, the rate of reduction has been much slower in regions with lower socio-demographic index (SDI). Most of the burden of ICH lies in areas with lower SDI, with 94.2% of DALYs lost to ICH outside areas of high SDI. Geographically, the majority of DALYs due to ICH occur in Southeast Asia, East Asia, and Oceania, with 53.3% of global DALYs lost in these regions alone. The risk factors for ICH are dominated by high systolic blood pressure, which accounts for at least 50% of the burden of ICH, regardless of SDI. Areas with middle or high-middle SDI have a greater proportion of the burden of ICH accounted for by ambient particulate pollution, smoking, and diets high in sodium, whereas household air pollution from solid fuels accounts for much more of the risk of ICH in low SDI regions.

Conclusion: This World Stroke Organization (WSO) Global ICH Fact Sheet 2025 provides the most updated information on ICH that can be used to support communication with all internal and external stakeholders, inform healthcare policy, and raise public awareness. All statistics have been reviewed and approved for use by the WSO Executive Committee.

脑出血(ICH)是由非创伤性脑出血引起的中风。在全球范围内,中风是2021年第三大死亡原因,脑出血占中风事件的28.8%。据估计,2021年中风死亡人数为7252,678人,其中脑出血死亡人数为3,308,367人(45.6%)。从残疾调整生命年(DALYs)的角度考虑脑出血负担时,脑出血占卒中负担的近一半,为49.5%,而缺血性卒中占43.8%。因此,必须将脑出血与缺血性中风同等看待,以便通过公共卫生、研究和卫生保健提供努力减轻其负担。尽管自1990年以来,ICH的总体年龄标准化发病率一直在下降,但在社会人口指数(SDI)较低的地区,下降速度要慢得多。大多数脑出血的负担发生在低SDI地区,94.2%的DALYs损失在高SDI地区以外的脑出血。从地理上看,由非ICH引起的DALYs大部分发生在东南亚、东亚和大洋洲,仅这些地区就损失了53.3%的全球DALYs。脑出血的危险因素主要是高收缩压,无论SDI如何,它至少占脑出血负担的50%。中等或中高SDI地区因环境颗粒污染、吸烟和高钠饮食造成的脑出血负担比例更大,而在低SDI地区,来自固体燃料的家庭空气污染造成的脑出血风险要大得多。这份世界脑卒中组织(WSO) 2025年全球脑出血情况说明书提供了关于脑出血的最新信息,可用于支持与所有内部和外部利益相关者的沟通,为卫生保健政策提供信息,并提高公众意识。所有的统计数据都经过了WSO执行委员会的审查和批准。
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引用次数: 0
Clinically relevant findings on 24-h head CT after acute stroke therapy: The 24-h CT score. 急性脑卒中治疗后 24 小时头部 CT 的临床相关结果:24 小时 CT 评分。
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-02-01 Epub Date: 2024-10-16 DOI: 10.1177/17474930241289992
Bowei Zhang, Andrew J King, Barbara Voetsch, Scott Silverman, Lee H Schwamm, Xunming Ji, Aneesh B Singhal

Background: Routine head computed tomography (CT) is performed 24 h post-acute stroke thrombolysis and thrombectomy, even in patients with stable or improving clinical deficits. Predicting CT results that impact management could help prioritize patients at risk and potentially reduce unnecessary imaging.

Methods: In this institutional review board (IRB)-approved retrospective study, data from 1461 consecutive acute ischemic stroke patients at our Comprehensive Stroke Center (n = 8943, 2012-2022) who received intravenous thrombolysis or endovascular therapy, exhibited stable or improving 24-h exams, and underwent 24-h follow-up head CT per standard acute stroke care guidelines. CT reports 24 h post-stroke were reviewed for edema, mass effect, herniation, and hemorrhage. The primary outcome was any clinically relevant 24-h CT finding that led to changes in antithrombotic treatment or blood pressure goals, extended intensive care unit (ICU) stays or hospitalizations, neurosurgical interventions, or administration of mannitol or hypertonic saline. Multivariable logistic regression identified independent predictors of clinically meaningful CT abnormalities. A 24-h CT score was developed and cross-validated.

Results: The mean age was 70 years, with 47% women. The median National Institutes of Health Stroke Scale (NIHSS) score at admission was 12 (interquartile range (IQR): 6-18). Stroke-related abnormalities on 24-h CT were present in 325 patients (22.2%), with 183 (12.5%) showing clinically relevant findings. Age, admission NIHSS, and blood glucose levels were independent predictors of clinically relevant 24-h CT findings. The final model C statistic was 0.72 (95% confidence interval (CI): 0.68-0.76) in the derivation cohort and 0.72 (95% CI: 0.67-0.75) in bootstrapping validation. The 24-h CT score was developed using these predictors: NIHSS score 5-15 (+3); NIHSS score ⩾16 (+5); age < 75 years (+1); admission glucose ⩾ 140 mg/dL (+1). The prevalence of clinically relevant CT findings was 4.3% in the low-risk group (24-h CT score ⩽ 4), 11.3% in the medium-risk group (score 5), and 21.4% in the high-risk group (score ⩾ 6). The 24-h CT score demonstrated good calibration.

Conclusion: In patients undergoing thrombolysis or thrombectomy who undergo routine 24-h head CT despite remaining clinically stable or improving, only one in eight prove to have 24-h head CT findings that impact management. The 24-h CT score provides risk stratification that may improve resource utilization.

Data access statement: A.S. and B.Z. have full access to the data used in the analysis in this article. Deidentified data will be shared after ethics approval if requested by other investigators for purposes of replicating the results.

背景:急性卒中溶栓和血栓切除术后 24 小时常规进行头部计算机断层扫描(CT),即使是临床功能障碍稳定或改善的患者。预测影响治疗的 CT 结果有助于确定高危患者的优先次序,并有可能减少不必要的影像学检查:在这项经 IRB 批准的回顾性研究中,我们的综合卒中中心连续收治了 1461 名急性缺血性卒中患者(n=8943,2012-2022 年),这些患者接受了静脉溶栓或血管内治疗,24 小时检查结果显示病情稳定或好转,并根据标准急性卒中治疗指南接受了 24 小时随访头部 CT。对中风后 24 小时的 CT 报告进行审查,以确定是否存在水肿、肿块效应、疝和出血。主要结果是任何导致抗血栓治疗或血压目标改变、重症监护室住院时间延长或住院、神经外科干预或使用甘露醇或高渗盐水的临床相关 24 小时 CT 发现。多变量逻辑回归确定了具有临床意义的 CT 异常的独立预测因素。制定了 24 小时 CT 评分标准并进行了交叉验证:平均年龄为 70 岁,女性占 47%。入院时NIH卒中量表(NIHSS)评分中位数为12(IQR为6-18)。325名患者(22.2%)的24小时CT出现了与卒中相关的异常,其中183名患者(12.5%)出现了临床相关的结果。年龄、入院 NIHSS 和血糖水平是 24 小时 CT 临床相关结果的独立预测因素。推导队列的最终模型 C 统计量为 0.72(95% CI,0.68-0.76),自引导验证的最终模型 C 统计量为 0.72(95% CI,0.67-0.75)。24 小时 CT 评分就是利用这些预测因子得出的:NIHSS评分5-15分(+3);NIHSS评分≥16分(+5);年龄 结论:在接受溶栓或血栓切除术的患者中,尽管临床症状保持稳定或有所改善,但接受常规 24 小时头部 CT 检查的患者中,只有八分之一的患者的 24 小时头部 CT 检查结果会对治疗产生影响。24 小时 CT 评分可提供风险分层,从而提高资源利用率。
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引用次数: 0
Investigating undiagnosed Fabry disease in young adults with ischemic stroke: A multicenter cohort study. 调查缺血性中风青年患者中未确诊的法布里病:多中心队列研究
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-02-01 Epub Date: 2024-10-18 DOI: 10.1177/17474930241289864
Po-Yu Lin, Tien-Yu Lin, Sheng-Feng Sung, Helen L Po, Li-Chi Hsu, Sung-Chun Tang, Yen-Chu Huang, Cheng-Yang Hsieh, Yung-Chu Hsu, Ren-Ying Wu, Cheng-Chi Hsieh, Pi-Shan Sung, Chih-Hung Chen

Background: The global prevalence of ischemic stroke in young adults is increasing, leading to a significant social impact. Fabry disease is a recognized cause of ischemic stroke in young patients, and although disease-modifying treatments are available, further evidence is needed to confirm their effectiveness in reducing the incidence of ischemic strokes.

Aims: This study aimed to identify undiagnosed Fabry disease in young adult patients with ischemic stroke in a Taiwanese cohort.

Methods: This multicenter, prospective cohort study enrolled patients aged 20-55 years who had experienced an ischemic stroke or transient ischemic attack (TIA) within 10 days, from 1 January 2016 to 31 December 2020. Screening for Fabry disease was performed using a dry blood test to measure α-galactosidase activity in male patients and blood globotriaosylsphingosine (lyso-Gb3) levels in female patients. For patients with positive screen results, genetic diagnosis of Fabry disease was pursued through Sanger sequencing of the GLA gene, covering all exons and a segment of intron 4.

Results: A total of 977 patients (659 male, 68%) were enrolled from seven hospitals across Taiwan. Four patients (0.4%, all male) had positive screening results, and two patients (0.2%) were genetically diagnosed with Fabry disease. Case 1 had the GLA c.658C>T mutation and experienced ischemic stroke in the bilateral occipital regions. Case 2 had the GLA c.640-801G>A mutation and experienced an ischemic stroke in the left superficial watershed area.

Conclusion: The prevalence of undiagnosed Fabry disease in this cohort of Taiwanese young adults with ischemic stroke or TIA was 0.3% among the young male population. Understanding the prevalence of undiagnosed Fabry disease in young adults with ischemic stroke could help shape future Fabry disease screening policies.

Data access statement: The collected data will be available upon reasonable request from the corresponding author.

背景:全球青壮年缺血性中风的发病率正在上升,对社会造成了重大影响。法布里病是年轻患者缺血性脑卒中的公认病因之一,虽然目前已有改变病情的治疗方法,但还需要进一步的证据来证实其在降低缺血性脑卒中发病率方面的有效性:这项多中心、前瞻性队列研究招募了 20 至 55 岁、2016 年 1 月 1 日至 2020 年 12 月 31 日 10 天内经历过缺血性脑卒中或短暂性脑缺血发作 (TIA) 的患者。法布里病筛查采用干血检测法,男性患者检测α-半乳糖苷酶活性,女性患者检测血液中球蛋白鞘氨醇(lyso-Gb3)水平。对筛查结果呈阳性的患者,通过对 GLA 基因进行 Sanger 测序(包括所有外显子和一段 4 号内含子),进行法布里病的基因诊断:结果:共有来自台湾 7 家医院的 977 名患者(659 名男性,占 68%)参与了研究。4名患者(0.4%,均为男性)的筛查结果呈阳性,2名患者(0.2%)被基因诊断为法布里病。病例 1 患有 GLA c.658C>T 突变,双侧枕部缺血性中风。病例 2 患有 GLA c.640-801G>A 突变,左侧浅分水岭区域发生缺血性中风:结论:在这批患有缺血性中风或 TIA 的台湾年轻男性人群中,未确诊法布里病的患病率为 0.3%。了解缺血性中风青壮年中未确诊法布里病的患病率有助于制定未来的法布里病筛查政策。
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引用次数: 0
Mobile health delivered physical activity after mild stroke or transient ischemic attack: Is it feasible and acceptable? 轻度中风或短暂性脑缺血发作后的移动健康体育活动。这种方法可行吗?
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-30 DOI: 10.1177/17474930251315628
Charlotte Thurston, Sophia Humphries, Lucian Bezuidenhout, Sverker Johansson, Lisa Holmlund, Lena von Koch, Coralie English, David Moulaee Conradsson

Background and aims: Physical activity is a key component of secondary stroke prevention. Mobile health (mHealth) interventions show promise for enhancing post-stroke physical activity, but most studies have combined mHealth with onsite services. This study evaluated the feasibility and acceptability of a fully digitalized mHealth intervention for physical activity among individuals post-stroke or transient ischemic attack (TIA) in Sweden.

Methods: In this two-arm feasibility randomized controlled trial, adults with stroke or TIA were randomized to one of the following 6-month interventions: (1) the experiment group, receiving mHealth-delivered supervised exercise (two sessions weekly during months 1 to 3, one session weekly during months 4 to 6) and behavioral change techniques for physical activity (including two individual counseling and six follow-up sessions) or (2) the control group, receiving two mHealth-delivered individual counseling and three follow-up sessions. Feasibility (reach, retention, adherence, fidelity, safety) and acceptability were assessed according to pre-specified progression criteria.

Results: Of 114 participants, 105 (92%) completed the 6-month intervention and 102 (89%) completed the 12-month follow-up assessment. The intervention reached individuals from 20 of 21 Swedish regions. Sixty-eight percent of participants had a stroke (of which 96% were mild), 64% were female, and the average age was 71 years (standard deviation = 9). Ninety-five percent were born in Sweden, had a high level of education (61%), and an average daily step count of 6451 steps. Completion of outcome measures included digital questionnaires (98%), sensor-derived physical activity (92%), and blood pressure monitoring (97%). A total of 1781 supervised exercise sessions were delivered to the experiment group, with an adherence rate of 76%, and adherence to individual counseling and follow-up sessions was 96%. Ninety-five adverse events were recorded, of which 16 were related to the intervention (predominantly pain or muscle soreness) but non-serious. Overall satisfaction with the mobile app was 71%, and 76% of the experiment group believed the app could partly replicate in-person visits.

Conclusion: The mHealth intervention was overall feasible and acceptable; however, there is a need to develop recruitment procedures to increase diversity of included participants regarding socioeconomic status and physical activity level, prior to a phase 3 trial.

Trial registration: ClinicalTrials.gov (NCT05111951).

背景和目的:身体活动是二级卒中预防的关键组成部分。移动健康(mHealth)干预措施有望增强中风后的身体活动,但大多数研究都将移动健康与现场服务结合起来。本研究评估了瑞典卒中或短暂性脑缺血发作(TIA)后个体身体活动的完全数字化移动健康干预的可行性和可接受性。方法:在这项两组可行性随机对照试验中,患有中风或TIA的成年人被随机分配到以下六个月的干预之一:i)实验组,接受移动健康提供的有监督的锻炼(第1至3个月每周两次,第4至6个月每周一次)和身体活动的行为改变技术(包括两次个人咨询和六次后续会议),或ii)对照组,接受两次移动健康提供的个人咨询和三次后续会议。可行性(可及性、保留性、依从性、保真性、安全性)和可接受性根据预先指定的进展标准进行评估。结果:114名参与者中,105名(92%)完成了6个月的干预,102名(89%)完成了12个月的随访评估。干预涉及到瑞典21个地区中的20个。68%的参与者患有中风(其中96%为轻度中风),64%为女性,平均年龄为71岁(SD 9)。95%的参与者出生在瑞典,受教育程度高(61%),平均每日步数为6451步。完成的结果测量包括数字问卷(98%)、传感器衍生的身体活动(92%)和血压监测(97%)。实验组共接受了1781次有监督的锻炼,坚持率为76%,坚持接受个人咨询和随访的比例为96%。记录了95个不良事件,其中16个与干预有关(主要是疼痛或肌肉酸痛),但不严重。对这款手机应用的总体满意度为71%,76%的实验组认为,这款应用可以部分复制现场访问。结论:移动健康干预总体上是可行和可接受的,然而,在第三阶段试验之前,需要制定招募程序,以增加纳入参与者在社会经济地位和身体活动水平方面的多样性。关键词:身体活动,移动健康,中风,TIA,可行性。
{"title":"Mobile health delivered physical activity after mild stroke or transient ischemic attack: Is it feasible and acceptable?","authors":"Charlotte Thurston, Sophia Humphries, Lucian Bezuidenhout, Sverker Johansson, Lisa Holmlund, Lena von Koch, Coralie English, David Moulaee Conradsson","doi":"10.1177/17474930251315628","DOIUrl":"10.1177/17474930251315628","url":null,"abstract":"<p><strong>Background and aims: </strong>Physical activity is a key component of secondary stroke prevention. Mobile health (mHealth) interventions show promise for enhancing post-stroke physical activity, but most studies have combined mHealth with onsite services. This study evaluated the feasibility and acceptability of a fully digitalized mHealth intervention for physical activity among individuals post-stroke or transient ischemic attack (TIA) in Sweden.</p><p><strong>Methods: </strong>In this two-arm feasibility randomized controlled trial, adults with stroke or TIA were randomized to one of the following 6-month interventions: (1) the experiment group, receiving mHealth-delivered supervised exercise (two sessions weekly during months 1 to 3, one session weekly during months 4 to 6) and behavioral change techniques for physical activity (including two individual counseling and six follow-up sessions) or (2) the control group, receiving two mHealth-delivered individual counseling and three follow-up sessions. Feasibility (reach, retention, adherence, fidelity, safety) and acceptability were assessed according to pre-specified progression criteria.</p><p><strong>Results: </strong>Of 114 participants, 105 (92%) completed the 6-month intervention and 102 (89%) completed the 12-month follow-up assessment. The intervention reached individuals from 20 of 21 Swedish regions. Sixty-eight percent of participants had a stroke (of which 96% were mild), 64% were female, and the average age was 71 years (standard deviation = 9). Ninety-five percent were born in Sweden, had a high level of education (61%), and an average daily step count of 6451 steps. Completion of outcome measures included digital questionnaires (98%), sensor-derived physical activity (92%), and blood pressure monitoring (97%). A total of 1781 supervised exercise sessions were delivered to the experiment group, with an adherence rate of 76%, and adherence to individual counseling and follow-up sessions was 96%. Ninety-five adverse events were recorded, of which 16 were related to the intervention (predominantly pain or muscle soreness) but non-serious. Overall satisfaction with the mobile app was 71%, and 76% of the experiment group believed the app could partly replicate in-person visits.</p><p><strong>Conclusion: </strong>The mHealth intervention was overall feasible and acceptable; however, there is a need to develop recruitment procedures to increase diversity of included participants regarding socioeconomic status and physical activity level, prior to a phase 3 trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT05111951).</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930251315628"},"PeriodicalIF":6.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ischemic stroke prevention in patients with atrial fibrillation and a recent ischemic stroke, TIA, or intracranial hemorrhage: A World Stroke Organization (WSO) scientific statement. 房颤和近期缺血性卒中、TIA或颅内出血患者的缺血性卒中预防世界中风组织(WSO)科学声明。
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-30 DOI: 10.1177/17474930241312649
Luciano A Sposato, Alan C Cameron, Michelle C Johansen, Mira Katan, Santosh B Murthy, Micaela Schachter, Nicole B Sur, Shadi Yaghi, Sara Aspberg, Valeria Caso, Cheng-Yang Hsieh, Max J Hilz, Antonia Nucera, David J Seiffge, Mary N Sheppard, Sheila Co Martins, M Cecilia Bahit, Jan F Scheitz, Ashkan Shoamanesh

Background: Secondary stroke prevention in patients with atrial fibrillation (AF) is one of the fastest growing areas in the field of cerebrovascular diseases. This scientific statement from the World Stroke Organization Brain & Heart Task Force provides a critical analysis of the strength of current evidence on this topic, highlights areas of current controversy, identifies knowledge gaps, and proposes priorities for future research.

Methods: We select topics with the highest clinical relevance and perform a systematic search to answer specific practical questions. Based on the strength of available evidence and knowledge gaps, we identify topics that need to be prioritized in future research. For this purpose, we adopt a novel classification of evidence strength based on the availability of publications in which the primary population is patients with recent (<6 months) cerebrovascular events, the primary study endpoint is a recurrent ischemic stroke, and the quality of the studies (e.g. observational versus randomized controlled trial).

Summary: Priority areas include AF screening, molecular biomarkers, AF subtype classification, anticoagulation in device-detected AF, timing of anticoagulation initiation, effective management of breakthrough strokes on existing anticoagulant therapy, the role of left atrial appendage closure, novel approaches, and antithrombotic therapy post-intracranial hemorrhage. Strength of currently available evidence varies across the selected topics, with early anticoagulation being the one showing more consistent data.

Conclusion: Several knowledge gaps persist in most areas related to secondary stroke prevention in AF. Prioritizing research in this field is crucial to advance current knowledge and improve clinical care.

背景:心房颤动(AF)患者的二级卒中预防是脑血管疾病领域发展最快的领域之一。这份来自世界中风组织脑与心脏工作组的科学声明对该主题当前证据的强度进行了批判性分析,突出了当前争议的领域,确定了知识差距,并提出了未来研究的重点。方法:我们选择具有最高临床相关性的主题,并进行系统搜索以回答具体的实际问题。根据现有证据的强度和知识差距,我们确定了在未来研究中需要优先考虑的主题。为此,我们采用了一种新的证据强度分类,该分类基于出版物的可获得性,其中主要人群是近期(摘要:重点领域包括房颤筛查、分子生物标志物、房颤亚型分类、设备检测房颤的抗凝、抗凝起始时间、突破性卒中在现有抗凝治疗中的有效管理、左房附件关闭的作用、新入路和颅内出血后的抗血栓治疗。目前可获得的证据强度因所选主题而异,早期抗凝是显示更一致数据的一个。结论:在与房颤继发性卒中预防相关的大多数领域仍存在一些知识空白。优先研究这一领域对于推进现有知识和改善临床护理至关重要。
{"title":"Ischemic stroke prevention in patients with atrial fibrillation and a recent ischemic stroke, TIA, or intracranial hemorrhage: A World Stroke Organization (WSO) scientific statement.","authors":"Luciano A Sposato, Alan C Cameron, Michelle C Johansen, Mira Katan, Santosh B Murthy, Micaela Schachter, Nicole B Sur, Shadi Yaghi, Sara Aspberg, Valeria Caso, Cheng-Yang Hsieh, Max J Hilz, Antonia Nucera, David J Seiffge, Mary N Sheppard, Sheila Co Martins, M Cecilia Bahit, Jan F Scheitz, Ashkan Shoamanesh","doi":"10.1177/17474930241312649","DOIUrl":"10.1177/17474930241312649","url":null,"abstract":"<p><strong>Background: </strong>Secondary stroke prevention in patients with atrial fibrillation (AF) is one of the fastest growing areas in the field of cerebrovascular diseases. This scientific statement from the World Stroke Organization Brain & Heart Task Force provides a critical analysis of the strength of current evidence on this topic, highlights areas of current controversy, identifies knowledge gaps, and proposes priorities for future research.</p><p><strong>Methods: </strong>We select topics with the highest clinical relevance and perform a systematic search to answer specific practical questions. Based on the strength of available evidence and knowledge gaps, we identify topics that need to be prioritized in future research. For this purpose, we adopt a novel classification of evidence strength based on the availability of publications in which the primary population is patients with recent (<6 months) cerebrovascular events, the primary study endpoint is a recurrent ischemic stroke, and the quality of the studies (e.g. observational versus randomized controlled trial).</p><p><strong>Summary: </strong>Priority areas include AF screening, molecular biomarkers, AF subtype classification, anticoagulation in device-detected AF, timing of anticoagulation initiation, effective management of breakthrough strokes on existing anticoagulant therapy, the role of left atrial appendage closure, novel approaches, and antithrombotic therapy post-intracranial hemorrhage. Strength of currently available evidence varies across the selected topics, with early anticoagulation being the one showing more consistent data.</p><p><strong>Conclusion: </strong>Several knowledge gaps persist in most areas related to secondary stroke prevention in AF. Prioritizing research in this field is crucial to advance current knowledge and improve clinical care.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241312649"},"PeriodicalIF":6.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of mechanical thrombectomy in distal medium middle cerebral artery occlusion ischemic stroke patients on low-dose aspirin.
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-28 DOI: 10.1177/17474930251317883
Hamza Adel Salim, Vivek Yedavalli, Fathi Milhem, Basel Musmar, Nimer Adeeb, Motaz Daraghma, Kareem El Naamani, Nils Henninger, Sri Hari Sundararajan, Anna Luisa Kühn, Jane Khalife, Sherief Ghozy, Luca Scarcia, Benjamin Yq Tan, Robert W Regenhardt, Jeremy J Heit, Nicole M Cancelliere, Joshua D Bernstock, Aymeric Rouchaud, Jens Fiehler, Sunil Sheth, Ajit S Puri, Christian Dyzmann, Marco Colasurdo, Leonardo Renieri, João Pedro Filipe, Pablo Harker, Răzvan Alexandru Radu, Mohamad Abdalkader, Piers Klein, Thomas R Marotta, Julian Spears, Takahiro Ota, Ashkan Mowla, Pascal Jabbour, Arundhati Biswas, Frédéric Clarençon, James E Siegler, Thanh N Nguyen, Ricardo Varela, Amanda Baker, Muhammed Amir Essibayi, David Altschul, Nestor R Gonzalez, Markus A Möhlenbruch, Vincent Costalat, Benjamin Gory, Christian Paul Stracke, Constantin Hecker, Hamza Shaikh, Christoph J Griessenauer, David S Liebeskind, Alessandro Pedicelli, Andrea M Alexandre, Illario Tancredi, Tobias D Faizy, Erwah Kalsoum, Max Wintermark, Boris Lubicz, Aman B Patel, Vitor Mendes Pereira, Adrien Guenego, Adam A Dmytriw

Background: Acute ischemic stroke (AIS) from distal medium vessel occlusion (DMVO) presents unique treatment challenges. Mechanical thrombectomy (MT) is emerging as a viable option for these patients, yet the role of pre-stroke aspirin treatment is unclear. This study evaluates the impact of pre-stroke low-dose aspirin on outcomes in DMVO patients undergoing MT.

Methods: We conducted a multinational, multicenter, propensity score-weighted analysis within the Multicenter Analysis of primary Distal medium vessel occlusions: effect of Mechanical Thrombectomy (MAD-MT) registry. Patients with AIS due to DMVO, treated with MT, were included. We compared outcomes between patients on pre-stroke low-dose aspirin (75-100 mg) and those not on antiplatelet therapy. The primary outcome was functional independence at 90 days (modified Rankin Scale (mRS), 0-2). Secondary outcomes included excellent functional outcome at 90 days (mRS, 0-1), mortality, and day 1 post-MT National Institutes of Health Stroke Scale (NIHSS) score. Safety outcomes focused on hemorrhagic complications, including symptomatic intracerebral hemorrhage (sICH).

Results: Among 1354 patients, 150 were on pre-stroke low-dose aspirin. After applying inverse probability of treatment weighting (IPTW), aspirin use was associated with significantly better functional outcomes (mRS, 0-2: odds ratio (OR) = 1.89, 95% confidence interval (CI) = 1.14 to 3.12) and lower 90-day mortality (OR = 0.56, 95% CI = 0.32 to 1.00). The aspirin group had lower NIHSS scores on day 1 (β = -1.5, 95% CI = -2.8 to -0.27). The sICH rate was not significantly different between the groups (OR = 0.92, 95% CI = 0.60 to 1.43).

Conclusions: Pre-stroke low-dose aspirin was associated with improved functional outcomes and reduced mortality in patients with DMVO undergoing MT, without a significant increase in sICH. These findings suggest that low-dose aspirin may be safe and associated with more frequent excellent outcomes for this patient population. Further prospective studies are needed to validate these results and assess long-term outcomes.

{"title":"Efficacy and safety of mechanical thrombectomy in distal medium middle cerebral artery occlusion ischemic stroke patients on low-dose aspirin.","authors":"Hamza Adel Salim, Vivek Yedavalli, Fathi Milhem, Basel Musmar, Nimer Adeeb, Motaz Daraghma, Kareem El Naamani, Nils Henninger, Sri Hari Sundararajan, Anna Luisa Kühn, Jane Khalife, Sherief Ghozy, Luca Scarcia, Benjamin Yq Tan, Robert W Regenhardt, Jeremy J Heit, Nicole M Cancelliere, Joshua D Bernstock, Aymeric Rouchaud, Jens Fiehler, Sunil Sheth, Ajit S Puri, Christian Dyzmann, Marco Colasurdo, Leonardo Renieri, João Pedro Filipe, Pablo Harker, Răzvan Alexandru Radu, Mohamad Abdalkader, Piers Klein, Thomas R Marotta, Julian Spears, Takahiro Ota, Ashkan Mowla, Pascal Jabbour, Arundhati Biswas, Frédéric Clarençon, James E Siegler, Thanh N Nguyen, Ricardo Varela, Amanda Baker, Muhammed Amir Essibayi, David Altschul, Nestor R Gonzalez, Markus A Möhlenbruch, Vincent Costalat, Benjamin Gory, Christian Paul Stracke, Constantin Hecker, Hamza Shaikh, Christoph J Griessenauer, David S Liebeskind, Alessandro Pedicelli, Andrea M Alexandre, Illario Tancredi, Tobias D Faizy, Erwah Kalsoum, Max Wintermark, Boris Lubicz, Aman B Patel, Vitor Mendes Pereira, Adrien Guenego, Adam A Dmytriw","doi":"10.1177/17474930251317883","DOIUrl":"10.1177/17474930251317883","url":null,"abstract":"<p><strong>Background: </strong>Acute ischemic stroke (AIS) from distal medium vessel occlusion (DMVO) presents unique treatment challenges. Mechanical thrombectomy (MT) is emerging as a viable option for these patients, yet the role of pre-stroke aspirin treatment is unclear. This study evaluates the impact of pre-stroke low-dose aspirin on outcomes in DMVO patients undergoing MT.</p><p><strong>Methods: </strong>We conducted a multinational, multicenter, propensity score-weighted analysis within the Multicenter Analysis of primary Distal medium vessel occlusions: effect of Mechanical Thrombectomy (MAD-MT) registry. Patients with AIS due to DMVO, treated with MT, were included. We compared outcomes between patients on pre-stroke low-dose aspirin (75-100 mg) and those not on antiplatelet therapy. The primary outcome was functional independence at 90 days (modified Rankin Scale (mRS), 0-2). Secondary outcomes included excellent functional outcome at 90 days (mRS, 0-1), mortality, and day 1 post-MT National Institutes of Health Stroke Scale (NIHSS) score. Safety outcomes focused on hemorrhagic complications, including symptomatic intracerebral hemorrhage (sICH).</p><p><strong>Results: </strong>Among 1354 patients, 150 were on pre-stroke low-dose aspirin. After applying inverse probability of treatment weighting (IPTW), aspirin use was associated with significantly better functional outcomes (mRS, 0-2: odds ratio (OR) = 1.89, 95% confidence interval (CI) = 1.14 to 3.12) and lower 90-day mortality (OR = 0.56, 95% CI = 0.32 to 1.00). The aspirin group had lower NIHSS scores on day 1 (β = -1.5, 95% CI = -2.8 to -0.27). The sICH rate was not significantly different between the groups (OR = 0.92, 95% CI = 0.60 to 1.43).</p><p><strong>Conclusions: </strong>Pre-stroke low-dose aspirin was associated with improved functional outcomes and reduced mortality in patients with DMVO undergoing MT, without a significant increase in sICH. These findings suggest that low-dose aspirin may be safe and associated with more frequent excellent outcomes for this patient population. Further prospective studies are needed to validate these results and assess long-term outcomes.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930251317883"},"PeriodicalIF":6.3,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An exploration of serious falls after stroke using a large international stroke rehabilitation database.
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-27 DOI: 10.1177/17474930251314330
Julian Wang, Julie Bernhardt, Hannah Johns, Leonid Churilov, Catherine Said, Natalie A Fini, Frances Batchelor, Janice Collier, Fiona Ellery, Kelly J Bower

Background: Falls are common after stroke and can have serious consequences such as hip fracture. Prior research shows around half of individuals will fall within the 12 months post stroke, and these falls are more likely to cause serious injury compared to people without stroke. However, there is limited research on risk factors collected in the immediate post-stroke period that may relate to falls risk. Furthermore, the circumstances and consequences surrounding falls resulting in serious adverse events (serious falls) is underexplored.

Aims: Using longitudinal cohort data from A Very Early Rehabilitation Trial (AVERT), we aimed to describe the occurrence, consequences, and circumstances of serious falls over 12 months post stroke and examine potential risk factors associated with these serious falls.

Methods: Data from participants included in the AVERT trial (n = 2104; recruited from 56 stroke units across five countries) were analyzed. Serious falls were defined as those resulting in death, were life threatening, or required/prolonged hospitalization. Baseline variables included: demographics, pre-morbid function, stroke severity, hemi-neglect, functional independence, and mobility. Statistical analysis included Wilcoxon-Mann-Whitney tests, Fisher's tests, and Firth's logistic regressions (adjusting for age, stroke severity, and AVERT intervention group).

Results: Of the 2104 participants, 85 (4%) experienced at least one serious fall (mean age 78.1 years, 45 male), with 91 individual falls. Fifty-five (60%) serious falls resulted in fracture, with 23 (42%) being hip fractures. Two (2%) falls resulted in death. Serious falls were most common during the day (26 of 38 reported), at home (30 of 63 reported) and while ambulating (22 of 42 reported). More serious falls were experienced by participants who were older, had worse pre-morbid mobility, were unable to walk 10 m independently in the first 24 hours post stroke, or required longer than 14 days to walk 50 m unassisted.

Conclusion: This large international prospective study found 1 in 25 stroke survivors experienced serious falls in the first year after stroke. Fractures were a common outcome of these falls, but the true post-stroke fracture rate is likely to be underestimated due to our study methods, such as the exclusion of individuals with poor pre-morbid mobility and the absence of data on fractures not relating to falls or leading to an inpatient hospital admission. Clear associations between older age, impaired pre- and early post-stroke mobility and heightened risk of serious falls were found. Integrating these factors into post-stroke screening tools could improve identification of individuals at greater risk of serious falls and lead to more focused rehabilitation and injury prevention.

{"title":"An exploration of serious falls after stroke using a large international stroke rehabilitation database.","authors":"Julian Wang, Julie Bernhardt, Hannah Johns, Leonid Churilov, Catherine Said, Natalie A Fini, Frances Batchelor, Janice Collier, Fiona Ellery, Kelly J Bower","doi":"10.1177/17474930251314330","DOIUrl":"https://doi.org/10.1177/17474930251314330","url":null,"abstract":"<p><strong>Background: </strong>Falls are common after stroke and can have serious consequences such as hip fracture. Prior research shows around half of individuals will fall within the 12 months post stroke, and these falls are more likely to cause serious injury compared to people without stroke. However, there is limited research on risk factors collected in the immediate post-stroke period that may relate to falls risk. Furthermore, the circumstances and consequences surrounding falls resulting in serious adverse events (serious falls) is underexplored.</p><p><strong>Aims: </strong>Using longitudinal cohort data from A Very Early Rehabilitation Trial (AVERT), we aimed to describe the occurrence, consequences, and circumstances of serious falls over 12 months post stroke and examine potential risk factors associated with these serious falls.</p><p><strong>Methods: </strong>Data from participants included in the AVERT trial (n = 2104; recruited from 56 stroke units across five countries) were analyzed. Serious falls were defined as those resulting in death, were life threatening, or required/prolonged hospitalization. Baseline variables included: demographics, pre-morbid function, stroke severity, hemi-neglect, functional independence, and mobility. Statistical analysis included Wilcoxon-Mann-Whitney tests, Fisher's tests, and Firth's logistic regressions (adjusting for age, stroke severity, and AVERT intervention group).</p><p><strong>Results: </strong>Of the 2104 participants, 85 (4%) experienced at least one serious fall (mean age 78.1 years, 45 male), with 91 individual falls. Fifty-five (60%) serious falls resulted in fracture, with 23 (42%) being hip fractures. Two (2%) falls resulted in death. Serious falls were most common during the day (26 of 38 reported), at home (30 of 63 reported) and while ambulating (22 of 42 reported). More serious falls were experienced by participants who were older, had worse pre-morbid mobility, were unable to walk 10 m independently in the first 24 hours post stroke, or required longer than 14 days to walk 50 m unassisted.</p><p><strong>Conclusion: </strong>This large international prospective study found 1 in 25 stroke survivors experienced serious falls in the first year after stroke. Fractures were a common outcome of these falls, but the true post-stroke fracture rate is likely to be underestimated due to our study methods, such as the exclusion of individuals with poor pre-morbid mobility and the absence of data on fractures not relating to falls or leading to an inpatient hospital admission. Clear associations between older age, impaired pre- and early post-stroke mobility and heightened risk of serious falls were found. Integrating these factors into post-stroke screening tools could improve identification of individuals at greater risk of serious falls and lead to more focused rehabilitation and injury prevention.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930251314330"},"PeriodicalIF":6.3,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nontyphoidal salmonellosis is associated with an increased risk of stroke: Insights from multinational real-world data. 非伤寒沙门氏菌病与中风风险增加有关:来自跨国真实世界数据的见解
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-25 DOI: 10.1177/17474930251313717
Sunny Ssu-Yu Chen, Tina Ting-An Lin, Yi-Lin Chiang, Chien-Yun Chen, Wei-Jen Lin, Renin Chang

Background: Stroke is a significant cause of morbidity and mortality worldwide, contributing substantially to the global burden of disease. In low- and middle-income countries, stroke tends to occur at younger ages, with infection being one of the notable contributing factors. Previous studies have explored the impact of nontyphoidal Salmonella (NTS) on vascular and blood-related diseases, with animal experiments confirming related mechanisms. This study aims to investigate the association between NTS and cerebrovascular diseases (CVDs), with a focus on identifying specific patient populations more susceptible to stroke due to infection.

Methods: This retrospective cohort study utilized the TriNetX database, including 4708 patients infected with NTS compared with a healthy population, with disease risk tracked over 6 months, 1 year, and lifelong periods. The primary outcome was CVDs (ICD-10-CM: I60-I69), while secondary outcomes examined hemorrhagic stroke (ICD-10-CM: I60-I62) and ischemic stroke (ICD-10-CM: I63). Subgroup analyses were conducted based on gender and age at index, with sensitivity analysis performed by comparing hospitalized patients, utilizing different databases, and evaluating the specificity of the NTS-CVD association by examining patients with a higher risk of acute myocardial infarction (AMI).

Results: The lifelong hazard ratios (HRs) for cerebrovascular diseases (CVD), hemorrhagic stroke, and ischemic stroke following NTS infection were 1.606 (95% confidence interval (CI), 1.410-1.830), 1.866 (95% CI, 1.304-2.669), and 1.717 (95% CI, 1.385-2.130), respectively. A significant increase in the risk of hemorrhagic stroke was observed in the short term and mid-term, with HRs of 3.345 (95% CI, 1.091-10.259) and 2.816 (95% CI, 1.184-6.699), respectively. Subgroup analyses indicated statistically significant associations with the primary outcomes across all age groups. Males demonstrated a higher risk of hemorrhagic stroke, with an HR of 1.891 (95% CI, 1.142-3.310), whereas females exhibited a stronger association with ischemic stroke, with an HR of 1.592 (95% CI, 1.189-2.132). These associations remained significant among hospitalized patients, while no significant relationship was observed between NTS infection and AMI. The findings of this study were reproducible in a US-based database.

Conclusion: There is a significant association between NTS and CVD, with a particularly important impact on the occurrence of stroke in younger populations, especially regarding the elevated risk of hemorrhagic stroke.

背景:脑卒中是世界范围内发病率和死亡率的重要原因,是全球疾病负担的重要组成部分。在低收入和中等收入国家,中风往往发生在较年轻的年龄,感染是一个显著的促成因素。以往的研究探讨了非伤寒沙门氏菌(NTS)对血管和血液相关疾病的影响,动物实验证实了相关机制。本研究旨在探讨NTS与脑血管疾病(CVD)之间的关系,重点是确定由于感染而更容易发生卒中的特定患者群体。方法:这项回顾性队列研究利用TriNetX数据库,包括4708名与健康人群相比感染NTS的患者,在6个月、1年和终身期间追踪疾病风险。主要结局为脑血管疾病(ICD-10-CM: I60-I69),次要结局为出血性卒中(ICD-10-CM: I60-I62)和缺血性卒中(ICD-10-CM: I63)。根据性别和年龄指数进行亚组分析,通过比较住院患者,利用不同的数据库进行敏感性分析,并通过检查急性心肌梗死(AMI)风险较高的患者来评估NTS-CVD关联的特异性。结果:非伤寒沙门氏菌(NTS)感染后心血管疾病(CVD)、出血性卒中和缺血性卒中的终生危险比(HRs)分别为1.606 (95% CI, 1.410 ~ 1.830)、1.866 (95% CI, 1.304 ~ 2.669)和1.717 (95% CI, 1.385 ~ 2.130)。短期和中期出血性卒中风险显著增加,hr分别为3.345 (95% CI, 1.091-10.259)和2.816 (95% CI, 1.184-6.699)。亚组分析显示与所有年龄组的主要结果有统计学意义的关联。男性出血性卒中的风险较高,HR为1.891 (95% CI, 1.142-3.310),而女性与缺血性卒中的相关性更强,HR为1.592 (95% CI, 1.189-2.132)。这些关联在住院患者中仍然显著,而NTS感染与急性心肌梗死(AMI)之间没有显著关系。这项研究的结果在美国的一个数据库中是可重复的。结论:NTS与CVD之间存在显著相关性,对年轻人群卒中的发生具有特别重要的影响,特别是在出血性卒中的风险升高方面。
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引用次数: 0
Design and early progress of the Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial. 颅内血管粥样硬化症抗凝疗法和抗血小板疗法比较试验(CAPTIVA)的设计和早期进展。
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-25 DOI: 10.1177/17474930241313301
Brian L Hoh, Renee' H Martin, Sharon D Yeatts, Tanya N Turan, Renee M Boyette, Stephanie McLaren, Lesley Butler, Keith R Peters, Jessica Smith, Larisa H Cavallari, Ashley M Wabnitz, Noor Sabagha, Christian Unger, Jamey S Frasure, Joseph P Broderick, Marc I Chimowitz

Background: The usual antithrombotic treatment for symptomatic intracranial atherosclerotic stenosis (ICAS) consists of dual treatment with clopidogrel and aspirin for 90 days followed by aspirin alone but the risk of recurrent stroke remains high up to 12 months. The Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial was designed to determine whether other combinations of dual antithrombotic therapy are superior to clopidogrel and aspirin.

Methods: CAPTIVA is an ongoing, prospective, double-blinded, three-arm clinical trial at over 100 sites in the United States and Canada that will randomize 1683 high-risk subjects with a symptomatic infarct attributed to 70-99% stenosis of a major intracranial artery to 12 months of treatment with (1) ticagrelor (180 mg loading dose, then 90 mg twice daily), (2) low-dose rivaroxaban (2.5 mg twice daily), or (3) clopidogrel (600 mg loading dose, then 75 mg daily). All subjects receive aspirin (81 mg daily), intensive risk factor management, and will undergo blinded CYP2C19 genotype analysis. The primary goal of the trial is to determine whether rivaroxaban or ticagrelor or both are superior to clopidogrel for lowering the primary endpoint (ischemic stroke, intracerebral hemorrhage (ICH), or vascular death) within 12 months. A prespecified interim safety analysis will be conducted when the first 450 randomized subjects have been followed for 12 months to evaluate the risk of major hemorrhage in the rivaroxaban and ticagrelor arms.

Results: Enrollment began in August 2022 and, as of 26 June 2024, the 450th subject was randomized into the study.

Conclusion: CAPTIVA is evaluating two alternative dual antithrombotic therapies to clopidogrel and aspirin to maximize the chance of establishing more effective antithrombotic therapy for symptomatic ICAS, one of the most common and high-risk cerebrovascular diseases worldwide.

{"title":"Design and early progress of the Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.","authors":"Brian L Hoh, Renee' H Martin, Sharon D Yeatts, Tanya N Turan, Renee M Boyette, Stephanie McLaren, Lesley Butler, Keith R Peters, Jessica Smith, Larisa H Cavallari, Ashley M Wabnitz, Noor Sabagha, Christian Unger, Jamey S Frasure, Joseph P Broderick, Marc I Chimowitz","doi":"10.1177/17474930241313301","DOIUrl":"10.1177/17474930241313301","url":null,"abstract":"<p><strong>Background: </strong>The usual antithrombotic treatment for symptomatic intracranial atherosclerotic stenosis (ICAS) consists of dual treatment with clopidogrel and aspirin for 90 days followed by aspirin alone but the risk of recurrent stroke remains high up to 12 months. The Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial was designed to determine whether other combinations of dual antithrombotic therapy are superior to clopidogrel and aspirin.</p><p><strong>Methods: </strong>CAPTIVA is an ongoing, prospective, double-blinded, three-arm clinical trial at over 100 sites in the United States and Canada that will randomize 1683 high-risk subjects with a symptomatic infarct attributed to 70-99% stenosis of a major intracranial artery to 12 months of treatment with (1) ticagrelor (180 mg loading dose, then 90 mg twice daily), (2) low-dose rivaroxaban (2.5 mg twice daily), or (3) clopidogrel (600 mg loading dose, then 75 mg daily). All subjects receive aspirin (81 mg daily), intensive risk factor management, and will undergo blinded <i>CYP2C19</i> genotype analysis. The primary goal of the trial is to determine whether rivaroxaban or ticagrelor or both are superior to clopidogrel for lowering the primary endpoint (ischemic stroke, intracerebral hemorrhage (ICH), or vascular death) within 12 months. A prespecified interim safety analysis will be conducted when the first 450 randomized subjects have been followed for 12 months to evaluate the risk of major hemorrhage in the rivaroxaban and ticagrelor arms.</p><p><strong>Results: </strong>Enrollment began in August 2022 and, as of 26 June 2024, the 450th subject was randomized into the study.</p><p><strong>Conclusion: </strong>CAPTIVA is evaluating two alternative dual antithrombotic therapies to clopidogrel and aspirin to maximize the chance of establishing more effective antithrombotic therapy for symptomatic ICAS, one of the most common and high-risk cerebrovascular diseases worldwide.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241313301"},"PeriodicalIF":6.3,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP): Study protocol and rationale. 后循环急性缺血性卒中成功取栓后动脉内阿替普酶溶栓(IAT-TOP):研究方案和基本原理。
IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-01-23 DOI: 10.1177/17474930251313940
Bin Yang, Xuesong Bai, Tingyu Yi, Haibo Wang, Yifeng Liu, Lin Ma, Sheng Liu, Shaoguang Wu, Liyong Zhang, Ya Peng, Raul G Nogueira, Wenhuo Chen, Liqun Jiao

Rationale: The Chemical Optimization of Cerebral Embolectomy (CHOICE) trial suggested that the administration of intra-arterial alteplase after successful endovascular thrombectomy (EVT) may improve neurological outcomes in patients with acute ischemic stroke due to large-vessel occlusion (AIS-LVO) in the anterior circulation. However, the use of adjunctive intra-arterial alteplase following successful EVT in acute posterior circulation stroke remains unexplored.

Aims: This study aims to investigate the efficacy and safety of intra-arterial alteplase after successful EVT for AIS-LVO in the posterior circulation.

Sample size: To detect an estimated 15% difference in the primary outcome between the two groups, a total of 376 patients will be enrolled. This sample size allows for 80% power and a 5% significance level, with an interim analysis planned after half of the sample (188 patients) has completed a 90-day follow-up.

Methods and design: The Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP) trial is a multicenter, prospective, randomized clinical trial using an open-label treatment design with blinded endpoint assessment (PROBE) conducted in China. Patients with acute basilar artery occlusion will be randomly assigned in a 1:1 ratio to receive either intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) or standard care following successful thrombectomy (defined as expanded thrombolysis in cerebral infarction [eTICI] ⩾ 2b50).

Study outcomes: The primary outcome is the modified Rankin Scale (mRS) score of 0-2 at 90 days. Key secondary outcomes include changes in eTICI scores after intra-arterial thrombolysis (in the experimental group), mRS 0-3 at 90 days, ordinal shift analysis of mRS at 90 days, early neurological improvement at 48 h, and improvement in National Institutes of Health Stroke Scale (NIHSS) scores at 48 h and 7 days or discharge. Safety outcomes include symptomatic intracranial hemorrhage (sICH) rates at 48 h, 90-day mortality, non-intracranial hemorrhagic complications, and non-hemorrhagic serious adverse events.

Discussion: The IAT-TOP trial will provide crucial evidence regarding the potential benefits of adjunctive intra-arterial alteplase in patients with AIS-LVO in the posterior circulation following successful thrombectomy.

Trial registration: ClinicalTrials.gov NCT05897554.

原理:化学优化的脑栓塞切除术(CHOICE)试验表明,成功的血管内取栓(EVT)后动脉内给药阿替普酶可能改善因前循环大血管闭塞(AIS-LVO)引起的急性缺血性卒中患者的神经预后。然而,急性后循环卒中EVT成功后辅助动脉内阿替普酶的应用仍未被探索。目的:本研究旨在探讨后循环AIS-LVO EVT成功后动脉内应用阿替普酶的疗效和安全性。样本量:为了检测两组之间主要结局估计有15%的差异,总共将入组376例患者。该样本量允许80%的有效性和5%的显著性水平,在一半的样本(188例患者)完成90天随访后计划进行中期分析。方法和设计:IAT-TOP试验是一项在中国进行的多中心、前瞻性、随机临床试验,采用开放标签治疗设计和盲法终点评估(PROBE)。急性基底动脉闭塞患者将按1:1的比例随机分配接受动脉内阿替普酶(0.225 mg/kg;最大剂量,22.5 mg)或成功取栓后的标准治疗(定义为脑梗死扩大溶栓[eTICI] 2b≥50)。研究结果:主要结果为90天的改良Rankin量表(mRS)评分0-2分。关键的次要结局包括动脉溶栓后(实验组)eTICI评分的变化,90天时mRS 0-3, 90天时mRS的顺序移位分析,48小时早期神经系统改善,以及48小时和7天或出院时美国国立卫生研究院卒中量表(NIHSS)评分的改善。安全性结局包括48小时症状性颅内出血(sICH)发生率、90天死亡率、非颅内出血性并发症和非出血性严重不良事件。讨论:IAT-TOP试验将为成功取栓后后循环AIS-LVO患者辅助动脉内阿替普酶的潜在益处提供关键证据。试验注册:ClinicalTrials.gov NCT05897554。
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引用次数: 0
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International Journal of Stroke
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