Pub Date : 2024-10-26DOI: 10.1177/17474930241298450
Christine Tunkl, Ayush Agarwal, Emily Ramage, Faddi Saleh Velez, Tamer Roushdy, Teresa Ullberg, Linxin Li, Leonardo Augusto Carbonera, Abdul Hanif Khan Yusof Khan, Bogdan Ciopleias, Zhe Kang Law, Aristeidis H Katsanos, Mirjam R Heldner, Maria Khan, Sarah Shali Matuja, Matias J Alet, Javier Lagos-Servellon, Jatinder S Minhas, Susanna Zuurbier, Maria Giulia Mosconi, Radhika Lotlikar, Ahmed Elkady, Stefan T Gerner, Shirsho Shreyan, Alexandra Krauss, Christoph Gumbinger, Padma Mv Srivastava, Pawel Kiper, Robin Ohannessian, Anne Berberich, Gisele Sampaio Silva, Anna Ranta
Background: Despite the proven efficacy of telestroke in improving clinical outcomes by providing access to specialized expertise and allowing rapid expert hyperacute stroke management and decision-making, detailed operational evidence is scarce, especially for less developed or lower - income regions.
Aim: We aimed to map the global telestroke landscape and characterize existing networks.
Methods: We employed a four-tiered approach to comprehensively identify telestroke networks, primarily involving engagement with national stroke experts, stroke societies, and international stroke authorities. A carefully designed questionnaire was then distributed to the leaders of all identified networks to assess these networks' structures, processes, and outcomes.
Results: We identified 254 telestroke networks distributed across 67 countries. High-income countries (HICs) concentrated 175 (69%) of the networks. No evidence of telestroke services was found in 58 (30%) countries. From the identified networks, 88 (34%) completed the survey, being 61 (71%) located in HICs. Network set-up was highly heterogenous, ranging from 17 (22%) networks with more than twenty affiliated hospitals, providing thousands of annual consultations using purpose-built highly specialized technology, to 11 (13%) networks with fewer than 120 consultations annually using generic videoconferencing equipment. Real-time video and image transfer was employed in 64 (75%) networks, while 62 (74%) conducting quality monitoring. Most networks established in the last three years were located in low- and middle-income countries (LMICs).
Conclusions: This comprehensive global survey of telestroke networks found significant variation in network coverage, set-up, and technology use. Most services are in HICs, and few services are in LMICs, although an emerging trend of new networks in these regions marks a pivotal moment in global telestroke care. The wide variation in quality monitoring practices across networks, with many failing to report key performance metrics, underscores the urgent need for standardized, resource-appropriate quality assurance measures that can be adapted to diverse settings.
{"title":"Telemedicine networks for acute stroke: an analysis of global coverage, gaps and opportunities.","authors":"Christine Tunkl, Ayush Agarwal, Emily Ramage, Faddi Saleh Velez, Tamer Roushdy, Teresa Ullberg, Linxin Li, Leonardo Augusto Carbonera, Abdul Hanif Khan Yusof Khan, Bogdan Ciopleias, Zhe Kang Law, Aristeidis H Katsanos, Mirjam R Heldner, Maria Khan, Sarah Shali Matuja, Matias J Alet, Javier Lagos-Servellon, Jatinder S Minhas, Susanna Zuurbier, Maria Giulia Mosconi, Radhika Lotlikar, Ahmed Elkady, Stefan T Gerner, Shirsho Shreyan, Alexandra Krauss, Christoph Gumbinger, Padma Mv Srivastava, Pawel Kiper, Robin Ohannessian, Anne Berberich, Gisele Sampaio Silva, Anna Ranta","doi":"10.1177/17474930241298450","DOIUrl":"https://doi.org/10.1177/17474930241298450","url":null,"abstract":"<p><strong>Background: </strong>Despite the proven efficacy of telestroke in improving clinical outcomes by providing access to specialized expertise and allowing rapid expert hyperacute stroke management and decision-making, detailed operational evidence is scarce, especially for less developed or lower - income regions.</p><p><strong>Aim: </strong>We aimed to map the global telestroke landscape and characterize existing networks.</p><p><strong>Methods: </strong>We employed a four-tiered approach to comprehensively identify telestroke networks, primarily involving engagement with national stroke experts, stroke societies, and international stroke authorities. A carefully designed questionnaire was then distributed to the leaders of all identified networks to assess these networks' structures, processes, and outcomes.</p><p><strong>Results: </strong>We identified 254 telestroke networks distributed across 67 countries. High-income countries (HICs) concentrated 175 (69%) of the networks. No evidence of telestroke services was found in 58 (30%) countries. From the identified networks, 88 (34%) completed the survey, being 61 (71%) located in HICs. Network set-up was highly heterogenous, ranging from 17 (22%) networks with more than twenty affiliated hospitals, providing thousands of annual consultations using purpose-built highly specialized technology, to 11 (13%) networks with fewer than 120 consultations annually using generic videoconferencing equipment. Real-time video and image transfer was employed in 64 (75%) networks, while 62 (74%) conducting quality monitoring. Most networks established in the last three years were located in low- and middle-income countries (LMICs).</p><p><strong>Conclusions: </strong>This comprehensive global survey of telestroke networks found significant variation in network coverage, set-up, and technology use. Most services are in HICs, and few services are in LMICs, although an emerging trend of new networks in these regions marks a pivotal moment in global telestroke care. The wide variation in quality monitoring practices across networks, with many failing to report key performance metrics, underscores the urgent need for standardized, resource-appropriate quality assurance measures that can be adapted to diverse settings.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500519","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}
Pub Date : 2024-10-21DOI: 10.1177/17474930241289235
Lauranne Scheldeman, Pierre Seners, Anke Wouters, Patrick Dupont, Soren Christensen, Michael Mlynash, Caroline Arquizan, Adrien Ter Schiphorst, Vincent Costalat, Hilde Henon, Martin Bretzner, Jean-François Albucher, Christophe Cognard, Jean-Marc Olivot, Jeremy J Heit, Gregory W Albers, Maarten G Lansberg, Robin Lemmens
Background: In patients with an acute ischemic stroke, the penumbra is defined as ischemic tissue that remains salvageable when reperfusion occurs. However, the expected clinical recovery congruent with penumbral salvage is not always observed.
Aims: We aimed to determine whether the magnetic resonance imaging (MRI)-defined penumbra includes irreversible neuronal loss that impedes expected clinical recovery after reperfusion.
Methods: In the prospective French Acute Multimodal Imaging Study to Select Patients for Mechanical Thrombectomy (FRAME) and an observational cohort of patients with large vessel occlusions undergoing endovascular treatment, we quantified penumbral integrity by fluid-attenuated inversion recovery (FLAIR) changes. We studied the influence of recanalization status on the evolution of penumbral FLAIR changes and studied penumbral FLAIR changes as predictor of tissue fate and functional outcome on the 90-day modified Rankin Scale (mRS).
Results: Recanalization status did not modify the evolution of rFLAIR signal intensity (SI) over time in the total cohort, but was associated with lower SI in the FRAME subset (b = -0.06, p for interaction = 0.04). Median rFLAIR SI was higher at baseline in the subsequently infarcted penumbra compared to the salvaged (ratio = 1.07, standard deviation (SD) = 0.07 vs 1.03, SD = 0.06 p < 0.0001, n = 150). The severity and extent of rFLAIR SI changes did not predict 90-day functional outcome in univariate (p = 0.09) and multivariate logistic regression (p = 0.4).
Conclusions: Recanalization status did not influence the evolution of penumbral FLAIR changes. FLAIR SI changes in the baseline penumbra were associated with tissue fate, but not functional outcome.
背景:急性缺血性脑卒中患者的半影被定义为再灌注时仍可挽救的缺血组织。目的:我们旨在确定磁共振成像(MRI)定义的半影是否包括阻碍再灌注后预期临床恢复的不可逆神经元损失:在前瞻性的法国急性多模态成像研究(FRAME)和接受血管内治疗的大血管闭塞患者观察队列中,我们通过FLAIR变化量化了半影的完整性。我们研究了再通畅状态对半影FLAIR变化演变的影响,并研究了半影FLAIR变化作为组织命运和90天改良Rankin量表(mRS)功能结果的预测因子:再通畅状态并不改变rFLAIR信号强度(SI)随时间的变化,但在FRAME亚组中与较低的SI相关(b=-0.06,交互作用p=0.04)。随后梗死的半影中位rFLAIR SI基线高于挽救的半影(比值=1.07,标准差[SD] 0.07 vs 1.03,SD 0.06):再通畅状态并不影响半影 FLAIR 变化的演变。基线半影的FLAIR SI变化与组织命运有关,但与功能结果无关:支持本研究的数据可在合理要求下提供,但需签署数据访问协议。
{"title":"Early penumbral FLAIR changes predict tissue fate in patients with large vessel occlusions.","authors":"Lauranne Scheldeman, Pierre Seners, Anke Wouters, Patrick Dupont, Soren Christensen, Michael Mlynash, Caroline Arquizan, Adrien Ter Schiphorst, Vincent Costalat, Hilde Henon, Martin Bretzner, Jean-François Albucher, Christophe Cognard, Jean-Marc Olivot, Jeremy J Heit, Gregory W Albers, Maarten G Lansberg, Robin Lemmens","doi":"10.1177/17474930241289235","DOIUrl":"10.1177/17474930241289235","url":null,"abstract":"<p><strong>Background: </strong>In patients with an acute ischemic stroke, the penumbra is defined as ischemic tissue that remains salvageable when reperfusion occurs. However, the expected clinical recovery congruent with penumbral salvage is not always observed.</p><p><strong>Aims: </strong>We aimed to determine whether the magnetic resonance imaging (MRI)-defined penumbra includes irreversible neuronal loss that impedes expected clinical recovery after reperfusion.</p><p><strong>Methods: </strong>In the prospective French Acute Multimodal Imaging Study to Select Patients for Mechanical Thrombectomy (FRAME) and an observational cohort of patients with large vessel occlusions undergoing endovascular treatment, we quantified penumbral integrity by fluid-attenuated inversion recovery (FLAIR) changes. We studied the influence of recanalization status on the evolution of penumbral FLAIR changes and studied penumbral FLAIR changes as predictor of tissue fate and functional outcome on the 90-day modified Rankin Scale (mRS).</p><p><strong>Results: </strong>Recanalization status did not modify the evolution of rFLAIR signal intensity (SI) over time in the total cohort, but was associated with lower SI in the FRAME subset (b = -0.06, p for interaction = 0.04). Median rFLAIR SI was higher at baseline in the subsequently infarcted penumbra compared to the salvaged (ratio = 1.07, standard deviation (SD) = 0.07 vs 1.03, SD = 0.06 p < 0.0001, n = 150). The severity and extent of rFLAIR SI changes did not predict 90-day functional outcome in univariate (p = 0.09) and multivariate logistic regression (p = 0.4).</p><p><strong>Conclusions: </strong>Recanalization status did not influence the evolution of penumbral FLAIR changes. FLAIR SI changes in the baseline penumbra were associated with tissue fate, but not functional outcome.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307670","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}
Background and aim: Some patients with intracerebral hemorrhage are on antithrombotic agents at the time of the event and these may worsen outcome, but the relative risk of different oral anticoagulants and antiplatelet agents is uncertain. We determined associations between pre-onset intake of antithrombotic agents and initial stroke severity, and outcomes, in patients with intracerebral hemorrhage.
Methods: Patients with intracerebral hemorrhage admitted within 24 h after onset between January 2017 and December 2020 and recruited to the Japan Stroke Data Bank, a hospital-based multicenter prospective registry, were included. Enrolled patients were classified into four groups based on the type of antithrombotic agents being used on admission. The outcomes were the National Institutes of Health Stroke Scale (NIHSS) score on admission and modified Rankin Scale (mRS) of 5-6 at discharge.
Results: Of a total 9810 patients with intracerebral hemorrhage (4267 females; mean age = 70 ± 15 years), 77.1% were classified into the no-antithrombotic group, 13.2% into the antiplatelet group, 4.0% into the warfarin group, and 5.8% into the direct oral anticoagulant (DOAC) group. Median (interquartile range) NIHSS score on admission was 12 (5-22), 13 (5-26), 15 (5-30), and 13 (6-24), respectively, in the four groups. In multivariable analysis, the prestroke warfarin use was associated with higher NIHSS score (adjusted incidence rate ratio = 1.09 (95% confidence interval (CI) = 1.06-1.13), with the no-antithrombotic group as the reference), but the antiplatelet group (1.00 (95% CI = 0.98-1.02)) and DOAC group (0.98 (95% CI = 0.95-1.01)) were not. The rate of mRS 5-6 at discharge was 30.8%, 41.9%, 48.6%, and 41.5%, respectively, in the four groups. In multivariable analysis, prestroke warfarin use was associated with mRS 5-6 (adjusted odds ratio = 1.90 (95% CI = 1.28-2.81), with the no-antithrombotic group as the reference), but the antiplatelet group (1.12 (95% CI = 0.91-1.37)) and DOAC group (1.25 (95% CI = 0.88-1.77)) were not.
Conclusion: Patients who were taking warfarin prior to intracerebral hemorrhage onset suffered more severe intracerebral hemorrhage as evidenced by higher admission NIHSS and higher discharge mRS. In contrast, no increase in severity was seen with antiplatelet agents.
{"title":"Stroke severity and outcomes in patients with intracerebral hemorrhage on anticoagulants and antiplatelet agents: An analysis from the Japan Stroke Data Bank.","authors":"Yoshito Arakaki, Sohei Yoshimura, Kazunori Toyoda, Kazutaka Sonoda, Shinichi Wada, Michikazu Nakai, Jin Nakahara, Masayuki Shiozawa, Junpei Koge, Akiko Ishigami, Kaori Miwa, Takako Torii-Yoshimura, Junji Miyazaki, Yoshihiro Miyamoto, Kazuo Minematsu, Masatoshi Koga","doi":"10.1177/17474930241292022","DOIUrl":"10.1177/17474930241292022","url":null,"abstract":"<p><strong>Background and aim: </strong>Some patients with intracerebral hemorrhage are on antithrombotic agents at the time of the event and these may worsen outcome, but the relative risk of different oral anticoagulants and antiplatelet agents is uncertain. We determined associations between pre-onset intake of antithrombotic agents and initial stroke severity, and outcomes, in patients with intracerebral hemorrhage.</p><p><strong>Methods: </strong>Patients with intracerebral hemorrhage admitted within 24 h after onset between January 2017 and December 2020 and recruited to the Japan Stroke Data Bank, a hospital-based multicenter prospective registry, were included. Enrolled patients were classified into four groups based on the type of antithrombotic agents being used on admission. The outcomes were the National Institutes of Health Stroke Scale (NIHSS) score on admission and modified Rankin Scale (mRS) of 5-6 at discharge.</p><p><strong>Results: </strong>Of a total 9810 patients with intracerebral hemorrhage (4267 females; mean age = 70 ± 15 years), 77.1% were classified into the no-antithrombotic group, 13.2% into the antiplatelet group, 4.0% into the warfarin group, and 5.8% into the direct oral anticoagulant (DOAC) group. Median (interquartile range) NIHSS score on admission was 12 (5-22), 13 (5-26), 15 (5-30), and 13 (6-24), respectively, in the four groups. In multivariable analysis, the prestroke warfarin use was associated with higher NIHSS score (adjusted incidence rate ratio = 1.09 (95% confidence interval (CI) = 1.06-1.13), with the no-antithrombotic group as the reference), but the antiplatelet group (1.00 (95% CI = 0.98-1.02)) and DOAC group (0.98 (95% CI = 0.95-1.01)) were not. The rate of mRS 5-6 at discharge was 30.8%, 41.9%, 48.6%, and 41.5%, respectively, in the four groups. In multivariable analysis, prestroke warfarin use was associated with mRS 5-6 (adjusted odds ratio = 1.90 (95% CI = 1.28-2.81), with the no-antithrombotic group as the reference), but the antiplatelet group (1.12 (95% CI = 0.91-1.37)) and DOAC group (1.25 (95% CI = 0.88-1.77)) were not.</p><p><strong>Conclusion: </strong>Patients who were taking warfarin prior to intracerebral hemorrhage onset suffered more severe intracerebral hemorrhage as evidenced by higher admission NIHSS and higher discharge mRS. In contrast, no increase in severity was seen with antiplatelet agents.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375465","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}
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.
{"title":"Investigating undiagnosed Fabry disease in young adults with ischemic stroke: A multicenter cohort study.","authors":"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","doi":"10.1177/17474930241289864","DOIUrl":"10.1177/17474930241289864","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>This study aimed to identify undiagnosed Fabry disease in young adult patients with ischemic stroke in a Taiwanese cohort.</p><p><strong>Methods: </strong>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 <i>GLA</i> gene, covering all exons and a segment of intron 4.</p><p><strong>Results: </strong>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 <i>GLA</i> c.658C>T mutation and experienced ischemic stroke in the bilateral occipital regions. Case 2 had the <i>GLA</i> c.640-801G>A mutation and experienced an ischemic stroke in the left superficial watershed area.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Data access statement: </strong>The collected data will be available upon reasonable request from the corresponding author.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346719","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}
Pub Date : 2024-10-16DOI: 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.
{"title":"Clinically relevant findings on 24-h head CT after acute stroke therapy: The 24-h CT score.","authors":"Bowei Zhang, Andrew J King, Barbara Voetsch, Scott Silverman, Lee H Schwamm, Xunming Ji, Aneesh B Singhal","doi":"10.1177/17474930241289992","DOIUrl":"10.1177/17474930241289992","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Data access statement: </strong>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.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346718","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}
Background: The association between aspirin use and the risk of intracerebral hemorrhage (ICH) among individuals without previous stroke events is inconclusive.
Aim: We investigated the association between regular aspirin use and ICH risk in middle-aged and older adults without previous stroke or transient ischemic attack (TIA).
Methods: This prospective population-based study included participants older than 40 years with no history of stroke or TIA from the UK Biobank. The main exposure was regular aspirin use. Cox regression analyses and propensity score matching analyses estimated the hazard ratios (HRs) for aspirin use for incident fatal and non-fatal ICH. We conducted pre-specified subgroup analyses for selecting individuals at high risk of ICH when using aspirin. Multiple sensitivity analyses were performed to test the robustness of our results.
Results: A total of 449,325 participants were included into final analyses (median (IQR) age 58 (50-63) years, 54.6% females), of whom 58,045 reported aspirin use. During a median follow-up of 12.75 (IQR: 12.03-13.47) years, 1557 (0.3%) incident ICH cases were identified, of which 399 (25.6%) were fatal. Aspirin was not associated with increased risk of overall (hazard ratio (HR): 1.11, 95% confidence interval (CI): 0.95-1.27, P = 0.188), fatal (HR: 1.03, 95% CI: 0.78-1.36, P = 0.846) and non-fatal (HR: 1.12, 95% CI: 0.95-1.33, P = 0.186) ICH. Propensity score matching analysis showed similar results. Subgroup analysis indicated that aspirin use in individuals older than 65 years or with concurrent anticoagulant use was correlated with increased risk of ICH.
Conclusion: In this large cohort study of middle-aged and older adults without stroke or TIA events, there was no significant association between aspirin use and ICH risk in the real-world setting. However, it is possible that aspirin use in those aged over 65 years and concurrent anticoagulant treatment may increase the risk of ICH.
背景:目的:我们调查了无中风或短暂性脑缺血发作(TIA)史的中老年人定期服用阿司匹林与 ICH 风险之间的关系:这项基于人群的前瞻性研究纳入了英国生物库中 40 岁以上、无中风或 TIA 病史的参与者。主要暴露因素是定期服用阿司匹林。Cox 回归分析和倾向评分匹配分析估算了服用阿司匹林与发生致命性和非致命性 ICH 的危险比 (HRs)。我们进行了预设亚组分析,以筛选出使用阿司匹林时发生 ICH 的高风险人群。我们还进行了多重敏感性分析,以检验结果的稳健性:共有 449,325 名参与者被纳入最终分析(中位数 [IQR] 年龄 58 [50 - 63] 岁,54.6% 为女性),其中 58,045 人报告使用了阿司匹林。在中位数为 12.75(IQR 12.03 - 13.47)年的随访期间,共发现 1,557 例(0.3%)ICH 病例,其中 399 例(25-6%)为致命病例。阿司匹林与总体(HR 1.11,95% CI 0.95 - 1.27,P = 0.188)、致命(HR 1.03,95% CI 0.78 - 1.36,P = 0.846)和非致命(HR 1.12,95% CI 0.95 - 1.33,P = 0.186)ICH 风险增加无关。倾向评分匹配分析显示了相似的结果。亚组分析表明,65 岁以上人群服用阿司匹林或同时服用抗凝剂与 ICH 风险增加相关:结论:在这项针对无中风或 TIA 事件的中老年人的大型队列研究中,阿司匹林的使用与现实世界中的 ICH 风险无明显关联。然而,65 岁以上人群服用阿司匹林并同时接受抗凝治疗可能会增加 ICH 风险。
{"title":"Association of aspirin use with risk of intracerebral hemorrhage in patients without history of stroke or transient ischemic attack in the UK Biobank.","authors":"Zijie Wang, Xueyun Liu, Shanyu Zhang, Xiao Hu, Yanghua Tian, Qi Li","doi":"10.1177/17474930241288367","DOIUrl":"10.1177/17474930241288367","url":null,"abstract":"<p><strong>Background: </strong>The association between aspirin use and the risk of intracerebral hemorrhage (ICH) among individuals without previous stroke events is inconclusive.</p><p><strong>Aim: </strong>We investigated the association between regular aspirin use and ICH risk in middle-aged and older adults without previous stroke or transient ischemic attack (TIA).</p><p><strong>Methods: </strong>This prospective population-based study included participants older than 40 years with no history of stroke or TIA from the UK Biobank. The main exposure was regular aspirin use. Cox regression analyses and propensity score matching analyses estimated the hazard ratios (HRs) for aspirin use for incident fatal and non-fatal ICH. We conducted pre-specified subgroup analyses for selecting individuals at high risk of ICH when using aspirin. Multiple sensitivity analyses were performed to test the robustness of our results.</p><p><strong>Results: </strong>A total of 449,325 participants were included into final analyses (median (IQR) age 58 (50-63) years, 54.6% females), of whom 58,045 reported aspirin use. During a median follow-up of 12.75 (IQR: 12.03-13.47) years, 1557 (0.3%) incident ICH cases were identified, of which 399 (25.6%) were fatal. Aspirin was not associated with increased risk of overall (hazard ratio (HR): 1.11, 95% confidence interval (CI): 0.95-1.27, <i>P</i> = 0.188), fatal (HR: 1.03, 95% CI: 0.78-1.36, <i>P</i> = 0.846) and non-fatal (HR: 1.12, 95% CI: 0.95-1.33, <i>P</i> = 0.186) ICH. Propensity score matching analysis showed similar results. Subgroup analysis indicated that aspirin use in individuals older than 65 years or with concurrent anticoagulant use was correlated with increased risk of ICH.</p><p><strong>Conclusion: </strong>In this large cohort study of middle-aged and older adults without stroke or TIA events, there was no significant association between aspirin use and ICH risk in the real-world setting. However, it is possible that aspirin use in those aged over 65 years and concurrent anticoagulant treatment may increase the risk of ICH.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287342","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}
Background: Subarachnoid hemorrhage (SAH), primarily caused by rupture of intracranial aneurysm, has a high incidence rate in women. We aimed to evaluate the association between female hormonal and reproductive factors and SAH.
Methods: A prospective cohort of 226,469 participants from the UK Biobank was followed for a median period of 14.75 years. Cox proportional hazards models and restricted cubic splines were used to explore the associations between 13 major factors and SAH, including menarche age, menopausal status, age at menopause, reproductive lifespan, pregnancy history, age at first and last live births, number of live births, adverse fertility outcomes, history of oral contraception or hormone-replacement therapy (HRT) use, and surgical history of hysterectomy or bilateral oophorectomy.
Results: SAH occurred in 769 of participants during the follow-up period. Both women with a younger age at menarche (< 12 years) and post-menopausal women had a higher SAH risk (hazard ratio (HR), 1.28; 95% confidence interval (CI), 1.06-1.54) and (HR, 1.48; 95% CI, 1.10-1.99), respectively. A higher risk of SAH was identified in those with an earlier age at menopause (< 40 years: HR, 2.09; 95% CI, 1.43-3.06; 40-44 years: HR, 1.68; 95% CI, 1.23-2.29). A shorter reproductive lifespan (< 30 years) was associated with increased SAH risk (HR, 1.64; 95% CI, 1.28-2.11), while a longer reproductive lifespan (> 42 years) showed a protective effect (HR, 0.65; 95% CI, 0.55-0.77). Younger age at first live birth (< 24 years) was associated with SAH (HR, 1.39; 95% CI, 1.13-1.72). Hysterectomy (HR, 2.55; 95% CI, 2.12-3.05) or bilateral oophorectomy (HR, 1.51; 95% CI, 1.14-2.01) also predisposed women to SAH. Age at last live birth, number of live births, pregnancy history, adverse fertility outcomes, and HRT or oral contraceptive use were not associated with SAH.
Conclusions: Female hormonal and reproductive factors are important for evaluating SAH risk in women. In particular, earlier menopause is associated with an increased risk of SAH.
Data access statement: The data utilized in this study were sourced from a third party and are not publicly accessible. The UK Biobank data that support the findings of this research are available from the UK Biobank (www.ukbiobank.ac.uk), subject to review and approval by the UK Biobank.
{"title":"Female hormonal and reproductive factors and the risk of subarachnoid hemorrhage.","authors":"Fang Cao, Junyu Liu, Yuge Wang, Qingyue He, Yuxin Guo, Junxia Yan","doi":"10.1177/17474930241283377","DOIUrl":"10.1177/17474930241283377","url":null,"abstract":"<p><strong>Background: </strong>Subarachnoid hemorrhage (SAH), primarily caused by rupture of intracranial aneurysm, has a high incidence rate in women. We aimed to evaluate the association between female hormonal and reproductive factors and SAH.</p><p><strong>Methods: </strong>A prospective cohort of 226,469 participants from the UK Biobank was followed for a median period of 14.75 years. Cox proportional hazards models and restricted cubic splines were used to explore the associations between 13 major factors and SAH, including menarche age, menopausal status, age at menopause, reproductive lifespan, pregnancy history, age at first and last live births, number of live births, adverse fertility outcomes, history of oral contraception or hormone-replacement therapy (HRT) use, and surgical history of hysterectomy or bilateral oophorectomy.</p><p><strong>Results: </strong>SAH occurred in 769 of participants during the follow-up period. Both women with a younger age at menarche (< 12 years) and post-menopausal women had a higher SAH risk (hazard ratio (HR), 1.28; 95% confidence interval (CI), 1.06-1.54) and (HR, 1.48; 95% CI, 1.10-1.99), respectively. A higher risk of SAH was identified in those with an earlier age at menopause (< 40 years: HR, 2.09; 95% CI, 1.43-3.06; 40-44 years: HR, 1.68; 95% CI, 1.23-2.29). A shorter reproductive lifespan (< 30 years) was associated with increased SAH risk (HR, 1.64; 95% CI, 1.28-2.11), while a longer reproductive lifespan (> 42 years) showed a protective effect (HR, 0.65; 95% CI, 0.55-0.77). Younger age at first live birth (< 24 years) was associated with SAH (HR, 1.39; 95% CI, 1.13-1.72). Hysterectomy (HR, 2.55; 95% CI, 2.12-3.05) or bilateral oophorectomy (HR, 1.51; 95% CI, 1.14-2.01) also predisposed women to SAH. Age at last live birth, number of live births, pregnancy history, adverse fertility outcomes, and HRT or oral contraceptive use were not associated with SAH.</p><p><strong>Conclusions: </strong>Female hormonal and reproductive factors are important for evaluating SAH risk in women. In particular, earlier menopause is associated with an increased risk of SAH.</p><p><strong>Data access statement: </strong>The data utilized in this study were sourced from a third party and are not publicly accessible. The UK Biobank data that support the findings of this research are available from the UK Biobank (www.ukbiobank.ac.uk), subject to review and approval by the UK Biobank.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107457","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}
Pub Date : 2024-10-07DOI: 10.1177/17474930241292915
Salah Elsherif, Brittney Legere, Ahmed Mohamed, Razan Saqqur, Nida Fatima, Maher Saqqur, Ashfaq Shuaib
Background: Non-contrast CT (NCCT) and CT angiogram (CTA) have become essential for endovascular treatment (EVT) in acute stroke. Patient selection may improve when CT perfusion imaging (CTP) is also added for patient selection. We aimed to analyze the effects of implementing CTP in acute ischemic stroke (AIS) patients' treatment to assess whether stroke outcomes differ in the late window.
Methods: We searched the PubMed, Embase, and Web of Sciences databases to obtain articles related to CTA and CTP in EVT. Collected patient data was split into two groups: the CTP and control (NCCT+CTA) cohorts. Primary outcomes evaluated were modified Rankin Scale (mRS) scores, symptomatic intracranial hemorrhages (sICH), mortality, and successful recanalization.
Results: There were 14 studies with 5,809 total patients in the final analysis: 2,602 received CTP and 3,202 were in the control group. CTP/CTA patients showed significantly lower rates of 90-day stroke-related mortality (OR: 0.72, 95% CI 0.60-0.87, p<0.01) and significantly higher successful recanalization (OR: 1.42, 95% CI 1.06-1.94, p<0.01) compared to CTA-only patients. Analysis of other outcomes including functional independence (mRS 0-2), critical times, and intracranial hemorrhages were non-significant (p > 0.05).
Conclusion: The study highlights the usefulness of CTP-guided therapy as a supplementary tool in EVT selection in the late window. Although the addition of CTP resulted in lower mortality, the favorable outcomes did not improve. Further evidence is required to establish a clearer understanding of the potential advantages or limitations of incorporating CTP in stroke imaging.
{"title":"Beyond Conventional Imaging: A Systematic Review and Meta-Analysis Assessing the Impact of Computed Tomography Perfusion on Ischemic Stroke Outcomes in the Late-Window.","authors":"Salah Elsherif, Brittney Legere, Ahmed Mohamed, Razan Saqqur, Nida Fatima, Maher Saqqur, Ashfaq Shuaib","doi":"10.1177/17474930241292915","DOIUrl":"https://doi.org/10.1177/17474930241292915","url":null,"abstract":"<p><strong>Background: </strong>Non-contrast CT (NCCT) and CT angiogram (CTA) have become essential for endovascular treatment (EVT) in acute stroke. Patient selection may improve when CT perfusion imaging (CTP) is also added for patient selection. We aimed to analyze the effects of implementing CTP in acute ischemic stroke (AIS) patients' treatment to assess whether stroke outcomes differ in the late window.</p><p><strong>Methods: </strong>We searched the PubMed, Embase, and Web of Sciences databases to obtain articles related to CTA and CTP in EVT. Collected patient data was split into two groups: the CTP and control (NCCT+CTA) cohorts. Primary outcomes evaluated were modified Rankin Scale (mRS) scores, symptomatic intracranial hemorrhages (sICH), mortality, and successful recanalization.</p><p><strong>Results: </strong>There were 14 studies with 5,809 total patients in the final analysis: 2,602 received CTP and 3,202 were in the control group. CTP/CTA patients showed significantly lower rates of 90-day stroke-related mortality (OR: 0.72, 95% CI 0.60-0.87, p<0.01) and significantly higher successful recanalization (OR: 1.42, 95% CI 1.06-1.94, p<0.01) compared to CTA-only patients. Analysis of other outcomes including functional independence (mRS 0-2), critical times, and intracranial hemorrhages were non-significant (p > 0.05).</p><p><strong>Conclusion: </strong>The study highlights the usefulness of CTP-guided therapy as a supplementary tool in EVT selection in the late window. Although the addition of CTP resulted in lower mortality, the favorable outcomes did not improve. Further evidence is required to establish a clearer understanding of the potential advantages or limitations of incorporating CTP in stroke imaging.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390461","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}
Pub Date : 2024-10-01Epub Date: 2024-04-11DOI: 10.1177/17474930241242952
Niall M Broomfield, Joshua Blake, Fergus Gracey, Tom Steverson
Background: Post-stroke emotionalism affects one in five stroke sufferers 6 months after their stroke, but despite its frequency remains a poorly understood stroke symptom. The literature is limited, especially compared to other frequently observed neurological conditions such as aphasia and visual neglect.
Aim and methods: This narrative review presents a summary of the post-stroke emotionalism literature, to inform clinical practice and future research. We cover discussion of definitions, prevalence, neurobiology, predisposing and precipitating factors, and treatment.
Results: Increasing evidence suggests that damage to specific areas functionally linked to emotion expression or regulation processes, disruption to structural pathways and those related to serotonin production and modulation individually or in concert give rise to emotionalism-type presentations. A range of emotionalism measurement tools have been used in research contexts making between study comparisons difficult. Testing for Emotionalism after Recent Stroke-Questionnaire (TEARS-Q) has recently been developed to allow standardized assessment. Treatment options are limited, and there have been few adequately powered treatment trials. Antidepressants may reduce severity, but more trial data are required. There have been no randomized-controlled trials of non-pharmacological interventions.
Conclusions: More research is needed to improve recognition and treatment of this common and disabling symptom. We conclude with research priorities and recommendations for the field.
{"title":"Post-stroke emotionalism: Diagnosis, pathophysiology, and treatment.","authors":"Niall M Broomfield, Joshua Blake, Fergus Gracey, Tom Steverson","doi":"10.1177/17474930241242952","DOIUrl":"10.1177/17474930241242952","url":null,"abstract":"<p><strong>Background: </strong>Post-stroke emotionalism affects one in five stroke sufferers 6 months after their stroke, but despite its frequency remains a poorly understood stroke symptom. The literature is limited, especially compared to other frequently observed neurological conditions such as aphasia and visual neglect.</p><p><strong>Aim and methods: </strong>This narrative review presents a summary of the post-stroke emotionalism literature, to inform clinical practice and future research. We cover discussion of definitions, prevalence, neurobiology, predisposing and precipitating factors, and treatment.</p><p><strong>Results: </strong>Increasing evidence suggests that damage to specific areas functionally linked to emotion expression or regulation processes, disruption to structural pathways and those related to serotonin production and modulation individually or in concert give rise to emotionalism-type presentations. A range of emotionalism measurement tools have been used in research contexts making between study comparisons difficult. Testing for Emotionalism after Recent Stroke-Questionnaire (TEARS-Q) has recently been developed to allow standardized assessment. Treatment options are limited, and there have been few adequately powered treatment trials. Antidepressants may reduce severity, but more trial data are required. There have been no randomized-controlled trials of non-pharmacological interventions.</p><p><strong>Conclusions: </strong>More research is needed to improve recognition and treatment of this common and disabling symptom. We conclude with research priorities and recommendations for the field.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-08-15DOI: 10.1177/17474930241270447
Xinzhi Hu, Zongmuyu Zhang, Caiyan Liu, Mingli Li, Yiyang Liu, Anqi Cheng, Qiuyu Yu, Haoyao Guo, Yinxi Zou, Li Zhou, Hebo Wang, Bo Song, Yong You, Jian Xia, Jingfen Zhang, Zhibing Ai, Qinjian Sun, Ju Han, Jing Liu, Baoquan Lu, Qiwen Deng, Guanzeng Li, Peng-Fei Wang, Xiangqing Li, Yi An, Bo Wu, Zhongrui Yan, Yining Wang, Wei-Hai Xu
Rationale: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors enable an additional 54-75% reduction in low-density lipoprotein cholesterol (LDL-C) in statin-treated patients, demonstrating plaque regression in coronary artery disease. However, the impact of achieving an extremely low level of LDL-C with PCSK9 inhibitors (e.g. Evolocumab) on symptomatic intracranial atherosclerosis remains unexplored.
Aim and hypothesis: To determine whether combining Evolocumab and statins achieves a more significant symptomatic intracranial plaque regression than statin therapy alone.
Sample size estimates: With a sample size of 1000 subjects, a two-sided α of 0.05, and 20% lost to follow-up, the study will have 83.3% power to detect the difference in intracranial plaque burden.
Methods and design: This is an investigator-initiated multicenter, randomized, open-label, outcome assessor-blinded trial, evaluating the impact of combining Evolocumab and statins on intracranial plaque burden assessed by high-resolution magnetic resonance imaging at baseline in patients undergoing a clinically indicated acute stroke or transient ischemic attack due to intracranial artery stenosis, and after 24 weeks of treatment. Subjects (n = 1000) were randomized 1:1 into two groups to receive either Evolocumab 140 mg every 2 weeks with statin therapy or statin therapy alone.
Study outcomes: The primary endpoint is the change in intracranial plaque burden assessed by high-resolution magnetic resonance imaging, performed at baseline and at the end of the 24-week treatment period.
Discussion: This trial will explore whether more significant intracranial plaque regression is achievable with the treatment of combining Evolocumab and statins, providing information about efficacy and safety data.
{"title":"PCSK9 Inhibitor with Statin Therapy for Intracranial Artery Stenosis ( PISTIAS): Rationale and design of a multicenter randomized controlled trial.","authors":"Xinzhi Hu, Zongmuyu Zhang, Caiyan Liu, Mingli Li, Yiyang Liu, Anqi Cheng, Qiuyu Yu, Haoyao Guo, Yinxi Zou, Li Zhou, Hebo Wang, Bo Song, Yong You, Jian Xia, Jingfen Zhang, Zhibing Ai, Qinjian Sun, Ju Han, Jing Liu, Baoquan Lu, Qiwen Deng, Guanzeng Li, Peng-Fei Wang, Xiangqing Li, Yi An, Bo Wu, Zhongrui Yan, Yining Wang, Wei-Hai Xu","doi":"10.1177/17474930241270447","DOIUrl":"10.1177/17474930241270447","url":null,"abstract":"<p><strong>Rationale: </strong>Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors enable an additional 54-75% reduction in low-density lipoprotein cholesterol (LDL-C) in statin-treated patients, demonstrating plaque regression in coronary artery disease. However, the impact of achieving an extremely low level of LDL-C with PCSK9 inhibitors (e.g. Evolocumab) on symptomatic intracranial atherosclerosis remains unexplored.</p><p><strong>Aim and hypothesis: </strong>To determine whether combining Evolocumab and statins achieves a more significant symptomatic intracranial plaque regression than statin therapy alone.</p><p><strong>Sample size estimates: </strong>With a sample size of 1000 subjects, a two-sided α of 0.05, and 20% lost to follow-up, the study will have 83.3% power to detect the difference in intracranial plaque burden.</p><p><strong>Methods and design: </strong>This is an investigator-initiated multicenter, randomized, open-label, outcome assessor-blinded trial, evaluating the impact of combining Evolocumab and statins on intracranial plaque burden assessed by high-resolution magnetic resonance imaging at baseline in patients undergoing a clinically indicated acute stroke or transient ischemic attack due to intracranial artery stenosis, and after 24 weeks of treatment. Subjects (n = 1000) were randomized 1:1 into two groups to receive either Evolocumab 140 mg every 2 weeks with statin therapy or statin therapy alone.</p><p><strong>Study outcomes: </strong>The primary endpoint is the change in intracranial plaque burden assessed by high-resolution magnetic resonance imaging, performed at baseline and at the end of the 24-week treatment period.</p><p><strong>Discussion: </strong>This trial will explore whether more significant intracranial plaque regression is achievable with the treatment of combining Evolocumab and statins, providing information about efficacy and safety data.</p><p><strong>Trial registration number: </strong>ChiCTR2300068868; https://www.chictr.org.cn/.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792411","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}