Background: Stroke risks associated with rapid climate change remain controversial due to a paucity of evidence.
Aims: To examine the risk of subarachnoid hemorrhage (SAH), intracranial hemorrhage (ICH), and ischemic stroke (IS) associated with meteorological parameters.
Methods: In this time-stratified case-crossover study, adult patients hospitalized for their first stroke between 2011 and 2020 from the insurance claims data in Taiwan were identified. The hospitalization day was designated as the case period, and three or four control periods were matched by the same day of the week and month of each case period. Daily mean and 24-h variations in ambient temperature, relative humidity, air pressure, and apparent temperature were measured. Conditional logistic regression models were applied to assess the risk of stroke associated with exposure to weather variables, using the third quintile as a reference, controlling for air pollutant levels.
Results: There were 7161 patients with SAH, 40,426 patients with ICH, and 107,550 patients with IS. There was an inverse linear relationship between mean daily temperature and apparent temperature with ICH. Elevated mean daily atmospheric pressure was associated with an increased risk of ICH. A greater decrease in apparent temperature over a 24-h period was associated with increased risk of ICH but decreased risk of IS (odds ratio (95% confidence interval) for the first vs. third quintile of changes in apparent temperature, 1.141 (1.053-1.237) and 0.946 (0.899-0.996), respectively).
Conclusions: There were considerable differences in short-term associations between meteorological parameters and three main pathological types of strokes.
Data access statement: The authors have no permission to share the data.
背景:目的:研究与气象参数相关的蛛网膜下腔出血(SAH)、颅内出血(ICH)和缺血性中风(IS)的风险:在这项时间分层病例交叉研究中,研究人员从台湾的保险理赔数据中识别了 2011 年至 2020 年期间因首次中风住院的成年患者。住院日被指定为病例期,每个病例期有三到四个对照期,每个对照期的星期和月份与病例期相同。测量了环境温度、相对湿度、气压和表观温度的日平均值和 24 小时变化。应用条件逻辑回归模型评估与暴露于天气变量相关的中风风险,以第三五分位数作为参考,并控制空气污染物水平:共有 7161 名 SAH 患者、40426 名 ICH 患者和 107,550 名 IS 患者。日平均气温和表观温度与 ICH 呈反向线性关系。日平均气压升高与 ICH 风险增加有关。24 小时内表观温度下降幅度越大,患 ICH 的风险越高,但患 IS 的风险越低(表观温度变化的第一五分位数与第三五分位数的几率比[95% 置信区间]分别为 1.141 [1.053-1.237] 和 0.946 [0.899-0.996]):结论:气象参数与脑卒中三种主要病理类型之间的短期关联存在相当大的差异:作者无权共享数据。
{"title":"Meteorological factors and risk of ischemic stroke, intracranial hemorrhage, and subarachnoid hemorrhage: A time-stratified case-crossover study.","authors":"Sheng-Jen Chen, Meng Lee, Bing-Chen Wu, Chih-Hsin Muo, Fung-Chang Sung, Pei-Chun Chen","doi":"10.1177/17474930241270483","DOIUrl":"10.1177/17474930241270483","url":null,"abstract":"<p><strong>Background: </strong>Stroke risks associated with rapid climate change remain controversial due to a paucity of evidence.</p><p><strong>Aims: </strong>To examine the risk of subarachnoid hemorrhage (SAH), intracranial hemorrhage (ICH), and ischemic stroke (IS) associated with meteorological parameters.</p><p><strong>Methods: </strong>In this time-stratified case-crossover study, adult patients hospitalized for their first stroke between 2011 and 2020 from the insurance claims data in Taiwan were identified. The hospitalization day was designated as the case period, and three or four control periods were matched by the same day of the week and month of each case period. Daily mean and 24-h variations in ambient temperature, relative humidity, air pressure, and apparent temperature were measured. Conditional logistic regression models were applied to assess the risk of stroke associated with exposure to weather variables, using the third quintile as a reference, controlling for air pollutant levels.</p><p><strong>Results: </strong>There were 7161 patients with SAH, 40,426 patients with ICH, and 107,550 patients with IS. There was an inverse linear relationship between mean daily temperature and apparent temperature with ICH. Elevated mean daily atmospheric pressure was associated with an increased risk of ICH. A greater decrease in apparent temperature over a 24-h period was associated with increased risk of ICH but decreased risk of IS (odds ratio (95% confidence interval) for the first vs. third quintile of changes in apparent temperature, 1.141 (1.053-1.237) and 0.946 (0.899-0.996), respectively).</p><p><strong>Conclusions: </strong>There were considerable differences in short-term associations between meteorological parameters and three main pathological types of strokes.</p><p><strong>Data access statement: </strong>The authors have no permission to share the data.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"1172-1181"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792410","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 : 2024-11-29DOI: 10.1177/17474930241306693
Kathryn Alice Radford, Alexandra Wright-Hughes, Ellen Thompson, David Clarke, Julie Phillips, Jain Holmes, Kathryn E Powers, Diane Trusson, Kristelle Craven, Caroline L Watkins, Audrey Bowen, Christopher J McKevitt, Judith Stevens, John D Murray, Rory J O'Connor, Sarah Pyne, Helen Risebro, Rory Cameron, Tracey H Sach, Florence Day, Amanda Farrin
Background: Return-to-work is a major goal achieved by fewer than 50% stroke survivors. Evidence on how to support return-to-work is lacking.
Aims: To evaluate the clinical effectiveness of Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) versus UC alone for helping people return-to-work after stroke.
Methods: This pragmatic, multicentre, individually randomised controlled trial with embedded economic and process evaluations, compared ESSVR with UC in 21 NHS stroke services across England and Wales. Eligible participants were aged ≥18 years, in work at stroke onset, hospitalised with new stroke and within 12-weeks of stroke. People not intending to return-to-work were excluded. Participants were randomised (5:4) to individually-tailored ESSVR delivered by stroke-specialist occupational-therapists for up to 12-months or usual National Health Service rehabilitation. Primary outcome was self-reported return-to-work for ≥2 hours per week at 12-months. Primary and safety analyses were done in the intention-to-treat population.
Results: Between 1st June-2018, and 7th March-2022, 583 participants (mean age 54.1 years [SD 11.0], 69% male) were randomised to ESSVR (n=324) or UC (n=259). Primary outcome data were available for 454(77.9%) participants. Intention-to-treat analysis showed no evidence of a difference in the proportion of participants returned-to-work at 12-months (165/257[64.2%] ESSVR vs 117/197[59.4%] UC; adjusted odds ratio 1.12 [95%CI 0.8 to 1.87],p=0.3582). There was some indication that older participants and those with more post-stroke impairment were more likely to benefit from ESSVR (interaction p=0.0239 and p=0.0959 respectively).
Conclusions: To our knowledge, this is the largest trial of a stroke VR intervention ever conducted. We found no evidence that ESSVR conferred any benefits over UC in improving return-to-work rates 12-months post-stroke. Return-to-work (for at least 2 hours per week) rates were higher than in previous studies (64.2% ESSVR versus 59.4% UC) at 12-months and more than double that observed in our feasibility trial (26%). Interpretation of findings was limited by a predominantly mild-moderate sample of participants and the Covid-19 pandemic. The pandemic impacted the trial, ESSVR and UC delivery, altering the work environment and employer behaviour. These changes influenced our primary outcome and the meaning of work in people's lives; all pivotal to the context of ESSVR delivery and its mechanisms of action.
Data access: Data available on reasonable request.
{"title":"Effectiveness of early vocational rehabilitation versus usual care to support RETurn to work After stroKE: a pragmatic, parallel arm multi-centre, randomised-controlled trial.","authors":"Kathryn Alice Radford, Alexandra Wright-Hughes, Ellen Thompson, David Clarke, Julie Phillips, Jain Holmes, Kathryn E Powers, Diane Trusson, Kristelle Craven, Caroline L Watkins, Audrey Bowen, Christopher J McKevitt, Judith Stevens, John D Murray, Rory J O'Connor, Sarah Pyne, Helen Risebro, Rory Cameron, Tracey H Sach, Florence Day, Amanda Farrin","doi":"10.1177/17474930241306693","DOIUrl":"https://doi.org/10.1177/17474930241306693","url":null,"abstract":"<p><strong>Background: </strong>Return-to-work is a major goal achieved by fewer than 50% stroke survivors. Evidence on how to support return-to-work is lacking.</p><p><strong>Aims: </strong>To evaluate the clinical effectiveness of Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) versus UC alone for helping people return-to-work after stroke.</p><p><strong>Methods: </strong>This pragmatic, multicentre, individually randomised controlled trial with embedded economic and process evaluations, compared ESSVR with UC in 21 NHS stroke services across England and Wales. Eligible participants were aged ≥18 years, in work at stroke onset, hospitalised with new stroke and within 12-weeks of stroke. People not intending to return-to-work were excluded. Participants were randomised (5:4) to individually-tailored ESSVR delivered by stroke-specialist occupational-therapists for up to 12-months or usual National Health Service rehabilitation. Primary outcome was self-reported return-to-work for ≥2 hours per week at 12-months. Primary and safety analyses were done in the intention-to-treat population.</p><p><strong>Results: </strong>Between 1st June-2018, and 7th March-2022, 583 participants (mean age 54.1 years [SD 11.0], 69% male) were randomised to ESSVR (n=324) or UC (n=259). Primary outcome data were available for 454(77.9%) participants. Intention-to-treat analysis showed no evidence of a difference in the proportion of participants returned-to-work at 12-months (165/257[64.2%] ESSVR vs 117/197[59.4%] UC; adjusted odds ratio 1.12 [95%CI 0.8 to 1.87],p=0.3582). There was some indication that older participants and those with more post-stroke impairment were more likely to benefit from ESSVR (interaction p=0.0239 and p=0.0959 respectively).</p><p><strong>Conclusions: </strong>To our knowledge, this is the largest trial of a stroke VR intervention ever conducted. We found no evidence that ESSVR conferred any benefits over UC in improving return-to-work rates 12-months post-stroke. Return-to-work (for at least 2 hours per week) rates were higher than in previous studies (64.2% ESSVR versus 59.4% UC) at 12-months and more than double that observed in our feasibility trial (26%). Interpretation of findings was limited by a predominantly mild-moderate sample of participants and the Covid-19 pandemic. The pandemic impacted the trial, ESSVR and UC delivery, altering the work environment and employer behaviour. These changes influenced our primary outcome and the meaning of work in people's lives; all pivotal to the context of ESSVR delivery and its mechanisms of action.</p><p><strong>Data access: </strong>Data available on reasonable request.</p><p><strong>Registration: </strong>ISRCTN12464275.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241306693"},"PeriodicalIF":6.3,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754995","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 : 2024-11-20DOI: 10.1177/17474930241298778
Bea Goessinger, Stefan Greisenegger, Stefan Kastl, Raphael Rosenhek, Wolfgang Serles, Christian Hengstenberg, Harald Gabriel, Lore Schrutka
Background: Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence.
Methods: Data from patients undergoing PFO closure between 2010 and 2015 were collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up.
Results: 330 patients were included, mean age was 49 (±12) years, and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p = 0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p = 0.042), and a history of prior neurological events (adjHR: 9.94; p < 0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes.
Conclusion: In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score, and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.
{"title":"Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.","authors":"Bea Goessinger, Stefan Greisenegger, Stefan Kastl, Raphael Rosenhek, Wolfgang Serles, Christian Hengstenberg, Harald Gabriel, Lore Schrutka","doi":"10.1177/17474930241298778","DOIUrl":"10.1177/17474930241298778","url":null,"abstract":"<p><strong>Background: </strong>Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence.</p><p><strong>Methods: </strong>Data from patients undergoing PFO closure between 2010 and 2015 were collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up.</p><p><strong>Results: </strong>330 patients were included, mean age was 49 (±12) years, and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; <i>p</i> = 0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; <i>p</i> = 0.042), and a history of prior neurological events (adjHR: 9.94; <i>p</i> < 0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes.</p><p><strong>Conclusion: </strong>In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score, and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241298778"},"PeriodicalIF":6.3,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500518","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 : 2024-11-18DOI: 10.1177/17474930241303836
Joe Harbison, Joan McCormack, Olga Brych, Ronan Collins, Niamh O'Connell, Peter J Kelly, Tim Cassidy
<p><strong>Background: </strong>Atrial Fibrillation (AF) causes up to 20% of ischaemic strokes and 30% in some populations such as those over 80 years. Previous research in our population showed that widespread adoption of Direct Oral Anticoagulant (DOAC) prophylaxis had not been associated with a reduction in AF associated stroke prevalence but there was a considerable rate of breakthrough stroke in patients receiving anticoagulation and anticoagulation rate may be affected by increasing use of DOACs.</p><p><strong>Aims: </strong>We undertook a more detailed study using the Irish National Audit of Stroke (INAS) to determine the characteristics of anticoagulation practice in AF associated stroke, particularly breakthrough stroke, adherence to prescribing guidelines and effect on thrombolysis rate.</p><p><strong>Methods: </strong>Data from INASwere analysed for the period 2017-2022 inclusive as part of a cross-sectional, cohort study. Data on pre stroke, and discharge disability (modified Rankin Score (mRS)) were collected in addition to age, sex, length of stay and thrombolysis rate. An enhanced dataset with additional questions about adherence with prescription, reasons for non-concordance and International Normalized Ratio (INR) control for receiving Warfarin was collected for 2022 was also considered separately. Comparisons for continuous / quantitative data were made using Student's t tests and for proportional data using Pearson's Chi Square statistics and logistic regression analysesResults. Complete AF Data were available on 22485 of 26829 strokes admitted over this period. Of these strokes with AF data, 19260 (85.6%) were ischaemic, mean age was 71.8 and 57.1% male. AF was found in 5321 of these ischaemic strokes and this AF was identified pre-stroke in 2835 in 2835 (53.3%). 80.4% of patients with known AF had been prescribed anticoagulation. The population with previously unknown AF were significantly younger on average than those on anticoagulation (76.8 years vs. 79.1 years (p<0.0001, t-test)), or those with AF and not anticoagulated; 78.8 years (p<0.0001), they were also much more likely to have received thrombolysis (17.3 % vs. 4.0% (Chi Sq, p<0.0001)). Of patients receiving DOACs, only 52 received thrombolysis (2.9%) compared with 37 (8.5%) of the VKA Group (Chi Sq 29.0 p<0.0001). Or regression analysis, anticoagulation was not associated with differences in excellent outcome (mRS 0 or 1) achieved (OR 1.064, p=0.41) or with mortality. (OR 1.014, p=0.89). There were 4999 strokes in 2022, 4272 (85.4%) were ischaemic and 1270 (29.7%) of ischaemic strokes were AF associated. Of the 557 AF associated ischaemic strokes anticoagulated at presentation, 84.6% were prescribed DOACs. Forty-eight (9.5%) had their anticoagulation paused and 40 admitted to poor compliance (7.9%).</p><p><strong>Conclusion: </strong>Nearly half of people with AF identified had not previously had the arrhythmia detected pre-stroke. Those admitted with known AF were
{"title":"Anticoagulation Usage and Thrombolytic Therapy in Subjects with Atrial Fibrillation Associated Ischaemic Stroke.","authors":"Joe Harbison, Joan McCormack, Olga Brych, Ronan Collins, Niamh O'Connell, Peter J Kelly, Tim Cassidy","doi":"10.1177/17474930241303836","DOIUrl":"https://doi.org/10.1177/17474930241303836","url":null,"abstract":"<p><strong>Background: </strong>Atrial Fibrillation (AF) causes up to 20% of ischaemic strokes and 30% in some populations such as those over 80 years. Previous research in our population showed that widespread adoption of Direct Oral Anticoagulant (DOAC) prophylaxis had not been associated with a reduction in AF associated stroke prevalence but there was a considerable rate of breakthrough stroke in patients receiving anticoagulation and anticoagulation rate may be affected by increasing use of DOACs.</p><p><strong>Aims: </strong>We undertook a more detailed study using the Irish National Audit of Stroke (INAS) to determine the characteristics of anticoagulation practice in AF associated stroke, particularly breakthrough stroke, adherence to prescribing guidelines and effect on thrombolysis rate.</p><p><strong>Methods: </strong>Data from INASwere analysed for the period 2017-2022 inclusive as part of a cross-sectional, cohort study. Data on pre stroke, and discharge disability (modified Rankin Score (mRS)) were collected in addition to age, sex, length of stay and thrombolysis rate. An enhanced dataset with additional questions about adherence with prescription, reasons for non-concordance and International Normalized Ratio (INR) control for receiving Warfarin was collected for 2022 was also considered separately. Comparisons for continuous / quantitative data were made using Student's t tests and for proportional data using Pearson's Chi Square statistics and logistic regression analysesResults. Complete AF Data were available on 22485 of 26829 strokes admitted over this period. Of these strokes with AF data, 19260 (85.6%) were ischaemic, mean age was 71.8 and 57.1% male. AF was found in 5321 of these ischaemic strokes and this AF was identified pre-stroke in 2835 in 2835 (53.3%). 80.4% of patients with known AF had been prescribed anticoagulation. The population with previously unknown AF were significantly younger on average than those on anticoagulation (76.8 years vs. 79.1 years (p<0.0001, t-test)), or those with AF and not anticoagulated; 78.8 years (p<0.0001), they were also much more likely to have received thrombolysis (17.3 % vs. 4.0% (Chi Sq, p<0.0001)). Of patients receiving DOACs, only 52 received thrombolysis (2.9%) compared with 37 (8.5%) of the VKA Group (Chi Sq 29.0 p<0.0001). Or regression analysis, anticoagulation was not associated with differences in excellent outcome (mRS 0 or 1) achieved (OR 1.064, p=0.41) or with mortality. (OR 1.014, p=0.89). There were 4999 strokes in 2022, 4272 (85.4%) were ischaemic and 1270 (29.7%) of ischaemic strokes were AF associated. Of the 557 AF associated ischaemic strokes anticoagulated at presentation, 84.6% were prescribed DOACs. Forty-eight (9.5%) had their anticoagulation paused and 40 admitted to poor compliance (7.9%).</p><p><strong>Conclusion: </strong>Nearly half of people with AF identified had not previously had the arrhythmia detected pre-stroke. Those admitted with known AF were ","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241303836"},"PeriodicalIF":6.3,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647801","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 : 2024-11-07DOI: 10.1177/17474930241293408
Canjia Zhang, Mingxiao Li, Miaomiao Yang, Jiaqi Lin, Jinyao Huang, Ying Lin, Xi Chen, Yongqiang Liang, Yuanhai Yang, Ziyuan Yu, Dongsheng Hu, Ming Zhang, Fulan Hu
Background: To estimate the associations of stroke risk with plasma metabolites, metabolic risk score (MRS), the combinations of MRS with hypertension or lifestyle, and lifestyle-related metabolic signature. To assess the improvement of the stroke risk prediction model through the incorporation of MRS.
Methods: A total of 77,315 participants from the UK Biobank were included in this study. Xgboost and LASSO-Cox regression were used to select metabolites and construct MRS. Elastic net regression was utilized to construct the lifestyle-related metabolic signature. Multivariate Cox regression was used to estimate the associations between metabolites, MRS, the combinations of MRS with hypertension or lifestyle, lifestyle-related metabolic signature, and stroke risk.
Results: We identified 48, 63, 39, and 4 metabolites associated with the risk of stroke, ischemic stroke (IS), subarachnoid hemorrhage (SAH), and intracerebral hemorrhage (ICH), respectively. High MRS significantly increased the risk of stroke (HR = 2.65 (95% confidence interval (CI): 2.09-3.35)), IS (HR = 2.45 (95% CI: 1.89-3.17)), ICH (HR = 2.74 (95% CI: 1.55-4.85)), and SAH (HR = 4.64 (95% CI: 2.25-9.56)). In the combination analyses, compared with normal systolic blood pressure (SBP) and low MRS, normal/high SBP, and high MRS significantly increased stroke risk (HR = 5.80 (95% CI: 2.75-12.27)/6.37 (95% CI: 3.22-12.62)). A favorable/unfavorable lifestyle and high MRS also significantly increased stroke risk (HR = 2.38 (95% CI: 1.73-3.28)/3.86 (95% CI: 2.63-5.67)) compared with a favorable lifestyle and low MRS. Incorporating MRS into the 15-year stroke and IS risk prediction model increased the areas under the curves (AUCs) from 0.746 to 0.766 and from 0.771 to 0.811, respectively. The metabolic signature was correlated with adherence to a healthy lifestyle (r = 0.414; P = 2.22e-16) and inversely associated with stroke risk (HR = 0.80 (95% CI: 0.73-0.86)).
Conclusions: Various metabolites and MRS were significantly associated with the risk of stroke, IS, ICH, and SAH. Individuals with a high MRS may face an elevated stroke risk among populations with high SBP or unhealthy lifestyle, even those with normal SBP or healthy lifestyle. MRS provided modest improvement to the stroke risk prediction model. The lifestyle-related metabolic signature could reduce 20% stroke risk.
{"title":"Plasma metabolites, systolic blood pressure, lifestyle, and stroke risk: A prospective cohort study.","authors":"Canjia Zhang, Mingxiao Li, Miaomiao Yang, Jiaqi Lin, Jinyao Huang, Ying Lin, Xi Chen, Yongqiang Liang, Yuanhai Yang, Ziyuan Yu, Dongsheng Hu, Ming Zhang, Fulan Hu","doi":"10.1177/17474930241293408","DOIUrl":"10.1177/17474930241293408","url":null,"abstract":"<p><strong>Background: </strong>To estimate the associations of stroke risk with plasma metabolites, metabolic risk score (MRS), the combinations of MRS with hypertension or lifestyle, and lifestyle-related metabolic signature. To assess the improvement of the stroke risk prediction model through the incorporation of MRS.</p><p><strong>Methods: </strong>A total of 77,315 participants from the UK Biobank were included in this study. Xgboost and LASSO-Cox regression were used to select metabolites and construct MRS. Elastic net regression was utilized to construct the lifestyle-related metabolic signature. Multivariate Cox regression was used to estimate the associations between metabolites, MRS, the combinations of MRS with hypertension or lifestyle, lifestyle-related metabolic signature, and stroke risk.</p><p><strong>Results: </strong>We identified 48, 63, 39, and 4 metabolites associated with the risk of stroke, ischemic stroke (IS), subarachnoid hemorrhage (SAH), and intracerebral hemorrhage (ICH), respectively. High MRS significantly increased the risk of stroke (HR = 2.65 (95% confidence interval (CI): 2.09-3.35)), IS (HR = 2.45 (95% CI: 1.89-3.17)), ICH (HR = 2.74 (95% CI: 1.55-4.85)), and SAH (HR = 4.64 (95% CI: 2.25-9.56)). In the combination analyses, compared with normal systolic blood pressure (SBP) and low MRS, normal/high SBP, and high MRS significantly increased stroke risk (HR = 5.80 (95% CI: 2.75-12.27)/6.37 (95% CI: 3.22-12.62)). A favorable/unfavorable lifestyle and high MRS also significantly increased stroke risk (HR = 2.38 (95% CI: 1.73-3.28)/3.86 (95% CI: 2.63-5.67)) compared with a favorable lifestyle and low MRS. Incorporating MRS into the 15-year stroke and IS risk prediction model increased the areas under the curves (AUCs) from 0.746 to 0.766 and from 0.771 to 0.811, respectively. The metabolic signature was correlated with adherence to a healthy lifestyle (r = 0.414; P = 2.22e-16) and inversely associated with stroke risk (HR = 0.80 (95% CI: 0.73-0.86)).</p><p><strong>Conclusions: </strong>Various metabolites and MRS were significantly associated with the risk of stroke, IS, ICH, and SAH. Individuals with a high MRS may face an elevated stroke risk among populations with high SBP or unhealthy lifestyle, even those with normal SBP or healthy lifestyle. MRS provided modest improvement to the stroke risk prediction model. The lifestyle-related metabolic signature could reduce 20% stroke risk.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241293408"},"PeriodicalIF":6.3,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465592","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 : 2024-11-06DOI: 10.1177/17474930241292988
Matilda Florentin, Dimitrios Sagris, Panagiotis Tasoudis, Eleni Korompoki, Roland Veltkamp, Lucio D'Anna, Rolf Wachter, Haralampos Milionis, George Ntaios
Background: Emerging evidence indicates a frequent occurrence of atrial fibrillation (AF) detection among patients with established causes of ischemic stroke unrelated to AF. This systematic review and meta-analysis aimed to evaluate AF detection rates in stroke patients with large or small vessel disease, considering the AF detection modality and duration of cardiac rhythm monitoring.
Aims: We conducted a comprehensive search of PubMed and Scopus databases up to 2 March 2024, to identify randomized controlled trials, non-randomized prospective studies, and retrospective studies assessing the frequency of AF detection in stroke patients with large or small vessel disease. The primary outcome of interest was the rate of AF detection. We utilized inverse-variance weights to produce the pooled prevalence (effect size (ES)) and 95% confidence interval (CI) of patients diagnosed with post-stroke AF.
Summary of review: In the analysis of 14 eligible studies encompassing 4334 patients, AF was identified in 154 out of 2082 patients with strokes attributed to small or large vessel disease, yielding a pooled prevalence of 6.27% (ES; 95% confidence interval (CI): 3.18-10.17, I2 = 87.83%). Among patients with large vessel disease strokes, AF was diagnosed in 79 out of 1042 patients, accounting for a pooled prevalence of 5.07% (ES; 95% CI: 1.30-10.33, I2 = 77.05%). Similarly, among those with small vessel disease strokes, AF was detected in 75 out of 1040 patients, with a pooled prevalence of 5.03% (ES; 95% CI: 1.96-9.06, I2 = 78.05%).
Conclusions: AF is often found in ischemic stroke patients with large or small vessel disease. Detection rates increase with longer cardiac rhythm monitoring. The safety and benefits of oral anticoagulation for these AF episodes are uncertain.
{"title":"Detection of atrial fibrillation after stroke due to large or small vessel disease: Systematic review and meta-analysis.","authors":"Matilda Florentin, Dimitrios Sagris, Panagiotis Tasoudis, Eleni Korompoki, Roland Veltkamp, Lucio D'Anna, Rolf Wachter, Haralampos Milionis, George Ntaios","doi":"10.1177/17474930241292988","DOIUrl":"10.1177/17474930241292988","url":null,"abstract":"<p><strong>Background: </strong>Emerging evidence indicates a frequent occurrence of atrial fibrillation (AF) detection among patients with established causes of ischemic stroke unrelated to AF. This systematic review and meta-analysis aimed to evaluate AF detection rates in stroke patients with large or small vessel disease, considering the AF detection modality and duration of cardiac rhythm monitoring.</p><p><strong>Aims: </strong>We conducted a comprehensive search of PubMed and Scopus databases up to 2 March 2024, to identify randomized controlled trials, non-randomized prospective studies, and retrospective studies assessing the frequency of AF detection in stroke patients with large or small vessel disease. The primary outcome of interest was the rate of AF detection. We utilized inverse-variance weights to produce the pooled prevalence (effect size (ES)) and 95% confidence interval (CI) of patients diagnosed with post-stroke AF.</p><p><strong>Summary of review: </strong>In the analysis of 14 eligible studies encompassing 4334 patients, AF was identified in 154 out of 2082 patients with strokes attributed to small or large vessel disease, yielding a pooled prevalence of 6.27% (ES; 95% confidence interval (CI): 3.18-10.17, <i>I</i><sup>2</sup> = 87.83%). Among patients with large vessel disease strokes, AF was diagnosed in 79 out of 1042 patients, accounting for a pooled prevalence of 5.07% (ES; 95% CI: 1.30-10.33, <i>I</i><sup>2</sup> = 77.05%). Similarly, among those with small vessel disease strokes, AF was detected in 75 out of 1040 patients, with a pooled prevalence of 5.03% (ES; 95% CI: 1.96-9.06, <i>I</i><sup>2</sup> = 78.05%).</p><p><strong>Conclusions: </strong>AF is often found in ischemic stroke patients with large or small vessel disease. Detection rates increase with longer cardiac rhythm monitoring. The safety and benefits of oral anticoagulation for these AF episodes are uncertain.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241292988"},"PeriodicalIF":6.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390462","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: Cerebral venous disruption is one of the characteristic findings in cerebral small vessel disease (CSVD), and its disruption may impede perivascular glymphatic drainage. And lower diffusivity along perivascular space (DTI-ALPS) index has been suggested to be with the presence and severity of CSVD. However, the relationships between venous disruption, DTI-ALPS index, and CSVD neuroimaging features remain unclear.
Aims: To investigate the association between venous integrity and perivascular diffusion activity, and explore the mediating role of DTI-ALPS index between venous disruption and CSVD imaging features.
Methods: In this cross-sectional study, 31 patients (mean age, 59.0 ± 9.9 years) were prospectively enrolled and underwent 7-T magnetic resonance (MR) imaging. DTI-ALPS index was measured to quantify the perivascular diffusivity. The visibility and continuity of deep medullary veins (DMVs) were evaluated based on a brain region-based visual score on high-resolution susceptibility-weighted imaging. White matter hyperintensity (WMH) and perivascular space (PVS) were assessed using qualitative and quantitative methods. Linear regression and mediation analysis were performed to analyze the relationships among DMV scores, DTI-ALPS index, and CSVD features.
Results: The DTI-ALPS index was significantly associated with the parietal DMV score (β = -0.573, p corrected = 0.004). Parietal DMV score was associated with WMH volume (β = 0.463, p corrected = 0.013) and PVS volume in basal ganglia (β = 0.415, p corrected = 0.028). Mediation analyses showed that DTI-ALPS index manifested a full mediating effect on the association between parietal DMV score and WMH (indirect effect = 0.115, Pm = 43.1%), as well as between parietal DMV score and PVS volume in basal ganglia (indirect effect = 0.161, Pm = 42.8%).
Conclusion: Cerebral venous disruption is associated with glymphatic activity, and with WMH and PVS volumes. Our results suggest cerebral venous integrity may play a critical role in preserving perivascular glymphatic activity; while disruption of small veins may impair the perivascular diffusivity, thereby contributing to the development of WMH and PVS enlargement.
{"title":"Unveiling connections between venous disruption and cerebral small vessel disease using diffusion tensor image analysis along perivascular space (DTI-ALPS): A 7-T MRI study.","authors":"Xue Zhang, Xun Pei, Yulu Shi, Yingying Yang, Xiaoyan Bai, Tong Chen, Yuanbin Zhao, Qianqian Yang, Jinyi Ye, Xinyi Leng, Qi Yang, Ruiliang Bai, Yilong Wang, Binbin Sui","doi":"10.1177/17474930241293966","DOIUrl":"10.1177/17474930241293966","url":null,"abstract":"<p><strong>Background: </strong>Cerebral venous disruption is one of the characteristic findings in cerebral small vessel disease (CSVD), and its disruption may impede perivascular glymphatic drainage. And lower diffusivity along perivascular space (DTI-ALPS) index has been suggested to be with the presence and severity of CSVD. However, the relationships between venous disruption, DTI-ALPS index, and CSVD neuroimaging features remain unclear.</p><p><strong>Aims: </strong>To investigate the association between venous integrity and perivascular diffusion activity, and explore the mediating role of DTI-ALPS index between venous disruption and CSVD imaging features.</p><p><strong>Methods: </strong>In this cross-sectional study, 31 patients (mean age, 59.0 ± 9.9 years) were prospectively enrolled and underwent 7-T magnetic resonance (MR) imaging. DTI-ALPS index was measured to quantify the perivascular diffusivity. The visibility and continuity of deep medullary veins (DMVs) were evaluated based on a brain region-based visual score on high-resolution susceptibility-weighted imaging. White matter hyperintensity (WMH) and perivascular space (PVS) were assessed using qualitative and quantitative methods. Linear regression and mediation analysis were performed to analyze the relationships among DMV scores, DTI-ALPS index, and CSVD features.</p><p><strong>Results: </strong>The DTI-ALPS index was significantly associated with the parietal DMV score (<i>β</i> = -0.573, <i>p</i> corrected = 0.004). Parietal DMV score was associated with WMH volume (<i>β</i> = 0.463, <i>p</i> corrected = 0.013) and PVS volume in basal ganglia (<i>β</i> = 0.415, <i>p</i> corrected = 0.028). Mediation analyses showed that DTI-ALPS index manifested a full mediating effect on the association between parietal DMV score and WMH (indirect effect = 0.115, Pm = 43.1%), as well as between parietal DMV score and PVS volume in basal ganglia (indirect effect = 0.161, Pm = 42.8%).</p><p><strong>Conclusion: </strong>Cerebral venous disruption is associated with glymphatic activity, and with WMH and PVS volumes. Our results suggest cerebral venous integrity may play a critical role in preserving perivascular glymphatic activity; while disruption of small veins may impair the perivascular diffusivity, thereby contributing to the development of WMH and PVS enlargement.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241293966"},"PeriodicalIF":6.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465594","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 : 2024-11-05DOI: 10.1177/17474930241295890
Sohyun Chun, Kyungdo Han, Bongseong Kim, Dagyeong Lee, In Young Cho, Hea Lim Choi, Jun Hee Park, Junseok Jeon, Hye Ryoun Jang, Dong Wook Shin
Background: Estimating the incidence of end-stage kidney disease (ESKD) in stroke survivors is important to assess and predict clinical course, improve post-stroke quality of life, and ultimately reduce health burden.
Aim: Our objective was to assess the risk of ESKD in patients compared to a matched stroke-free control cohort.
Methods: A nationwide retrospective cohort study was conducted in 315,326 stroke subjects and 390,781 matched stroke-free control subjects. Health examination results and claims data were collected from the Korean National Health Insurance Service during 2010-2018. Cox proportional hazard models were used to assess the risk of ESKD in the stroke cohort.
Results: During a mean follow-up period of 4.3 years, the incidence of ESKD was 1.83 per 100,000 person-years in the stroke cohort versus 0.57 per 100,000 person-years in the control cohort. The stroke cohort exhibited a significantly higher risk of developing ESKD compared to the matched control, with an adjusted hazard ratio (aHR) of 1.79 (95% confidence interval (CI) = 1.67-1.93). Stroke survivors were associated with a higher risk of developing ESKD, regardless of the severity of disability (aHRs of 1.93, 95% CI = 1.69-2.21 for severe disability; 1.71, 95% CI = 1.41-2.07 for mild disability; and 1.78, 95% CI = 1.65-1.92 for no disability), compared to the matching control cohort. The elevated risk was observed in both hemorrhagic stroke (aHR = 1.96, 95% CI = 1.73-2.23) and ischemic stroke (aHR = 1.75, 95% CI = 1.62-1.89).
Conclusions: This study demonstrates that stroke patients have a significantly higher risk of incident ESKD. This highlights the need for heightened clinical awareness and improved monitoring of kidney function in this population.
{"title":"Elevated risk of end-stage kidney disease in stroke patients: A population-based observational study.","authors":"Sohyun Chun, Kyungdo Han, Bongseong Kim, Dagyeong Lee, In Young Cho, Hea Lim Choi, Jun Hee Park, Junseok Jeon, Hye Ryoun Jang, Dong Wook Shin","doi":"10.1177/17474930241295890","DOIUrl":"10.1177/17474930241295890","url":null,"abstract":"<p><strong>Background: </strong>Estimating the incidence of end-stage kidney disease (ESKD) in stroke survivors is important to assess and predict clinical course, improve post-stroke quality of life, and ultimately reduce health burden.</p><p><strong>Aim: </strong>Our objective was to assess the risk of ESKD in patients compared to a matched stroke-free control cohort.</p><p><strong>Methods: </strong>A nationwide retrospective cohort study was conducted in 315,326 stroke subjects and 390,781 matched stroke-free control subjects. Health examination results and claims data were collected from the Korean National Health Insurance Service during 2010-2018. Cox proportional hazard models were used to assess the risk of ESKD in the stroke cohort.</p><p><strong>Results: </strong>During a mean follow-up period of 4.3 years, the incidence of ESKD was 1.83 per 100,000 person-years in the stroke cohort versus 0.57 per 100,000 person-years in the control cohort. The stroke cohort exhibited a significantly higher risk of developing ESKD compared to the matched control, with an adjusted hazard ratio (aHR) of 1.79 (95% confidence interval (CI) = 1.67-1.93). Stroke survivors were associated with a higher risk of developing ESKD, regardless of the severity of disability (aHRs of 1.93, 95% CI = 1.69-2.21 for severe disability; 1.71, 95% CI = 1.41-2.07 for mild disability; and 1.78, 95% CI = 1.65-1.92 for no disability), compared to the matching control cohort. The elevated risk was observed in both hemorrhagic stroke (aHR = 1.96, 95% CI = 1.73-2.23) and ischemic stroke (aHR = 1.75, 95% CI = 1.62-1.89).</p><p><strong>Conclusions: </strong>This study demonstrates that stroke patients have a significantly higher risk of incident ESKD. This highlights the need for heightened clinical awareness and improved monitoring of kidney function in this population.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241295890"},"PeriodicalIF":6.3,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465591","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 : 2024-11-04DOI: 10.1177/17474930241297031
Nicola Rifino, Dominique Hervè, Francesco Acerbi, Satoshi Kuroda, Giuseppe Lanzino, Peter Vajkoczy, Anna Bersano
Despite the progress made in understanding the management and outcomes of Moyamoya angiopathy (MMA), several aspects of the disease remain largely unknown. In particular, evidence on the disease history and management of MMA is lacking, mainly due to methodological and selection biases in the available studies and the lack of large, randomized prospective studies. Therefore, the care of MMA patients remains limited to a few expert centers worldwide, and management is often based on local expertise and available resources. Over the years, recommendations or expert opinions have been written to provide guidance to physicians in the treatment of this condition with the goal of reducing the risk of stroke recurrence and long-term disability. However, there is no complete agreement between the available guidelines and recommendations due to differences in the articles addressed, methodologies, expertise, and validated approaches to literature review. This lack of consensus on the management of MMA may confuse clinicians and highlight some important issues and points. The aim of this comprehensive review article is to critically examine three recent guidelines and recommendations on MMA, discussing their differences and similarities and highlighting gaps in MMA care that need to be covered.
{"title":"Diagnosis and management of adult Moyamoya angiopathy: An overview of guideline recommendations and identification of future research directions.","authors":"Nicola Rifino, Dominique Hervè, Francesco Acerbi, Satoshi Kuroda, Giuseppe Lanzino, Peter Vajkoczy, Anna Bersano","doi":"10.1177/17474930241297031","DOIUrl":"10.1177/17474930241297031","url":null,"abstract":"<p><p>Despite the progress made in understanding the management and outcomes of Moyamoya angiopathy (MMA), several aspects of the disease remain largely unknown. In particular, evidence on the disease history and management of MMA is lacking, mainly due to methodological and selection biases in the available studies and the lack of large, randomized prospective studies. Therefore, the care of MMA patients remains limited to a few expert centers worldwide, and management is often based on local expertise and available resources. Over the years, recommendations or expert opinions have been written to provide guidance to physicians in the treatment of this condition with the goal of reducing the risk of stroke recurrence and long-term disability. However, there is no complete agreement between the available guidelines and recommendations due to differences in the articles addressed, methodologies, expertise, and validated approaches to literature review. This lack of consensus on the management of MMA may confuse clinicians and highlight some important issues and points. The aim of this comprehensive review article is to critically examine three recent guidelines and recommendations on MMA, discussing their differences and similarities and highlighting gaps in MMA care that need to be covered.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241297031"},"PeriodicalIF":6.3,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465590","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: 2024-08-15DOI: 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":" ","pages":"1071-1076"},"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}