International Journal of Stroke最新文献

{"title":"World Stroke Organization (WSO): Global Stroke Fact Sheet 2025.","authors":"Valery L Feigin, Michael Brainin, Bo Norrving, Sheila Martins, Jeyaraj Durai Pandian, Patrice Lindsay, Maria Mia Fredin Grupper, Ilari Rautalin","doi":"10.1177/17474930241308142","DOIUrl":"https://doi.org/10.1177/17474930241308142","url":null,"abstract":"<p><p>Among non-communicable disorders (NCDs), stroke remains the second-leading cause of death and the third-leading cause of death and disability combined (as expressed by disability-adjusted life-years lost - DALYs) in the world. The estimated global cost of stroke is over US$890 billion (0.66% of the global GDP). From 1990 to 2021, the burden (in terms of the absolute number of cases) increased substantially (70.0% increase in incident strokes, 44.0% deaths from stroke, 86.0% prevalent strokes, and 32% DALYs), with the bulk of the global stroke burden (87.0% of deaths and 89.0% of DALYs) residing in lower-income and lower-middle-income countries (LMIC). Stroke attributable to metabolic risks constituted 69·0% of all strokes, environmental risks constituted 37.0%, and behavioural risks constituted 35·0%. This World Stroke Organisation (WSO) Global Stroke Fact Sheet 2025 provides the most updated information that can be used to inform communication with all internal and external stakeholders; all statistics have been reviewed and approved for use by the WSO Executive Committee as well as leaders from the Global Burden of Disease research group.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241308142"},"PeriodicalIF":6.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785429","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}

{"title":"Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC TRIAL) Study Protocol.","authors":"Jeyaraj Durai Pandian, Atul Phillips, Shweta J Verma, Deepti Arora, Aneesh Dhasan, Pheba S Raju, P N Sylaja, Biman Kanti Ray, Uddalak Chakraborty, Jacob Johnson, Praveen Kumar Sharma, Sanjeev Bhoi, Menka Jha, Thomas Iype, Chithra P, Dheeraj Khurana, Sucharita Ray, Dwijen Das, Naurima Kalita, Sweekriti Adhikari, Ashish Sharma, Jayanta Roy, Rajeshwar Sahonta, Sulena Singh, Vikram Chaudhary, Girish Menon, Sanjith Aaron, Deepti Bal, Rajinder Dhamija, Monali Chaturvedi, Siddharth Maheshwari, Aralikatte Onkarappa Saroja, Karkal R Naik, Neeraj Bhutani, Kailash Dhankhar, Dinesh Sharma, Rohit Bhatia, Sankar Prasad Gorthi, Binod Sarmah, Vijaya Pamidimukkala, Sankaralingam Saravanan, Sunil Narayan, Lakshya J Basumatary, Nagarjunakonda V Sundarachary, Aruna K Upputuri, Ummer Karadan, V G Pradeep Kumar, Rajsrinivas Parthasarathy, Darshan Doshi, Satish Wagh, Tcr Ramakrishnan, Saleem Akhtar, Soaham Desai, N C Borah, Rupjyoti Das, Gaurav Mittal, Agam Jain, Paul J Alapatt, Girish Baburao Kulkarni, Deepak Menon, Pritam Raja, Inder Puri, Vivek Nambiar, Muralidhar Reddy Yerasu, Shyam K Jaiswal, Kapil Zirpe, Sushma Gurav, Sudheer Sharma, S Kumaravelu, Rajesh Benny, Vicky Thakkar, Abhishek Pathak, Madhusudan B Kempegowda, Praveen Chander, Neetu Ramrakhiani, Arya Devi Ks, P Sankara Sarma, Rahul Huilgol, Meenakshi Sharma, Rupinder S Dhaliwal","doi":"10.1177/17474930241307933","DOIUrl":"https://doi.org/10.1177/17474930241307933","url":null,"abstract":"<p><strong>Rationale: </strong>Early mortality in intracerebral haemorrhage (ICH) is due to haematoma volume (HV) expansion and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug which is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious.</p><p><strong>Hypothesis: </strong>Administration of TXA in ICH patients when given within 4.5 hours of symptom onset will reduce early mortality at 30 days.</p><p><strong>Design: </strong>Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC Trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 hours of symptom onset or when last seen well. Study participants receive 2 grams of TXA administered within 45 minutes while control group receives standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed in done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction of HV at 24 hours from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90.</p><p><strong>Summary: </strong>If proven to be beneficial, TXA will have a major impact on medical management of ICH.</p><p><strong>Trial registration: </strong>Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241307933"},"PeriodicalIF":6.3,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780284","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}

{"title":"World Stroke Organisation (WSO): Global intracerebral haemorrhage factsheet 2025.","authors":"Adrian Robert Parry-Jones, Rita Krishnamurthi, Wendy Ziai, Ashkan Shoamanesh, Simiao Wu, Sheila Martins, Anderson Craig","doi":"10.1177/17474930241307876","DOIUrl":"https://doi.org/10.1177/17474930241307876","url":null,"abstract":"<p><p>Intracerebral haemorrhage (ICH) is stroke caused by non-traumatic bleeding into the brain. Globally, stroke was the third-leading cause of death in 2021, and ICH accounted for 28.8% of incident strokes. There were estimated to be 7,252,678 deaths due to stroke in 2021 of which ICH accounted for 3,308,367 (45.6%). When considering the burden of ICH in terms of disability adjusted life years (DALYs), ICH accounts for nearly half of the burden of stroke at 49.5%, compared to 43.8% caused by ischaemic stroke. ICH must therefore be considered on an equal footing with ischaemic stroke, so that efforts can be made to reduce its burden through public health, research and healthcare provision. Although the overall age-standardised incidence of ICH has been decreasing since 1990, the rate of reduction has been much slower in regions with lower socio-demographic index (SDI). Most of the burden of ICH lies in areas with lower SDI, with 94.2% of DALYs lost to ICH outside areas of high SDI. Geographically, the majority of DALYs due to ICH occur in Southeast Asia, East Asia, and Oceania, with 53.3% of global DALYs lost in these regions alone. The risk factors for ICH are dominated by high systolic blood pressure, which accounts for at least 50% of the burden of ICH, regardless of SDI. Areas with middle or high-middle SDI have a greater proportion of the burden of ICH accounted for by ambient particulate pollution, smoking and diets high in sodium, whereas household air pollution from solid fuels accounts for much more of the risk of ICH in low SDI regions. This World Stroke Organisation (WSO) Global ICH Fact Sheet 2025 provides the most updated information on ICH that can be used to support communication with all internal and external stakeholders, inform healthcare policy, and raise public awareness. All statistics have been reviewed and approved for use by the WSO Executive Committee.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241307876"},"PeriodicalIF":6.3,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768881","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}

{"title":"Validation of the Black-&-White sign to predict intracerebral hematoma expansion in the multi-center PREDICT study cohort.","authors":"Umberto Pensato, Koji Tanaka, Johanna Ospel, Richard I Aviv, David Rodriguez, Michael D Hill, Carlos A Molina, Yolanda Silva, Jean-Martin Boulanger, Gord Gubitz, Rohit Bhatia, Vasantha Padma, Jayanta Roy, Imanuel Dzialowski, Carlos Kase, Adam Kobayashi, Dar Dowlatshahi, Andrew M Demchuk","doi":"10.1177/17474930241307466","DOIUrl":"https://doi.org/10.1177/17474930241307466","url":null,"abstract":"<p><strong>Background: </strong>Hematoma expansion (HE) occurs in one-fourth to one-third of patients with acute intracerebral hemorrhage (ICH) and is associated with worse outcomes. The co-localization of non-contrast CT (NCCT) hypodensity and CT angiography (CTA) spot sign, the so-called Black-&-White (B&W) sign, has been shown to have high predictive accuracy for HE in a single-center cohort. In this analysis, we aimed to validate the predictive accuracy of the B&W sign for HE in a multi-center cohort.</p><p><strong>Methods: </strong>Acute ICH patients from the multicenter, observational PREDICT study (Predicting Hematoma Growth and Outcome in Intracerebral Hemorrhage Using Contrast Bolus CT) were included. Outcomes included HE (≥6mL or ≥33%) and severe HE (≥12.5mL or >66%). The association between B&W sign and outcomes was assessed with multivariable regression analyses adjusted for baseline factors.</p><p><strong>Results: </strong>Three hundred four patients were included, with 106 (34.9%) showing HE. The spot sign was present in 76 (25%) patients, the hypodensity sign in 119 (39.1%), and the B&W sign in 29 (9.5%). In the stratum with positive spot signs, patients with B&W signs experienced more frequent HE (79.3% vs. 46.8%, p=0.008), hematoma absolute growth (19.1 mL [IQR=6.4-40] vs. 3.2 mL [0-23.3], p=0.018), and hematoma relative growth (92% [IQR=16-151%] vs. 24% [0-69%], p=0.038). There was a strong association between B&W sign and HE (adjusted OR 7.83 (95%CI=2.93-20.91) and severe HE (adjusted OR 5.67 (95%CI=2.41-13.36). The B&W sign yielded a PPV of 79.3% (IQR=61.7-90.1) for hematoma expansion. Inter-rater agreement was moderate (k=0.54).</p><p><strong>Conclusion: </strong>The Black-&-White sign is associated with an increased likelihood of HE and severe HE by approximately eightfold and fivefold, respectively.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"17474930241307466"},"PeriodicalIF":6.3,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768879","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}

{"title":"Carotid atherosclerotic plaque microcalcification is independently associated with recurrent neurovascular events: A pilot study.","authors":"Shiv Bhakta, Jason M Tarkin, Mohammed M Chowdhury, James Hf Rudd, Elizabeth A Warburton, Nicholas R Evans","doi":"10.1177/17474930241264734","DOIUrl":"10.1177/17474930241264734","url":null,"abstract":"<p><strong>Background: </strong>Microcalcification and macrocalcification are critical processes in atherosclerotic plaque progression, though how these processes relate to the risk of stroke recurrence in symptomatic carotid atherosclerosis is poorly understood.</p><p><strong>Methods: </strong>We performed a post hoc analysis of data from the ICARUSS (Imaging Carotid Atherosclerosis in the Recovery and Understanding of Stroke Severity) study, where individuals with acute ischemic stroke originating from ipsilateral carotid stenosis of ⩾ 50% underwent ¹⁸F-sodium fluoride positron emission tomography (NaF-PET) to measure microcalcification. Tracer uptake was quantified using maximum tissue-to-background ratio (TBR_max). Macrocalcification was measured on computed tomography (CT) using Agatston scoring. Patients were followed up for 6 months for recurrent ipsilateral neurovascular events.</p><p><strong>Results: </strong>Five (27.8%) of 18 individuals had a recurrent ischemic stroke or transient ischemic attack. Ipsilateral carotid plaque NaF uptake at baseline was higher in those with recurrent events compared to those without, and this association remained after adjustment for other vascular risk factors (adjusted odds ratio (aOR) = 1.24, 1.03-1.50). Macrocalcification score in the symptomatic artery was also significantly independently associated with ipsilateral recurrence, but the effect size was relatively smaller (aOR = 1.12, 1.06-1.17 for each 100 unit increase).</p><p><strong>Conclusions: </strong>Our findings indicate that microcalcification in symptomatic carotid plaques is independently associated with ipsilateral ischemic stroke recurrence. Furthermore, differences in the extent of active microcalcification in macrocalcified plaques may help explain variation in the relationship between calcified carotid plaques and stroke recurrence reported in the literature. Our pilot study indicates that evaluation of carotid artery microcalcification using NaF-PET may be a useful method for risk-stratification of carotid atherosclerosis, though our findings require confirmation in larger cohorts.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"1155-1161"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141419106","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}

{"title":"Predictors of futile recanalization in ischemic stroke patients with low baseline NIHSS.","authors":"Christian Heitkamp, Alexander Heitkamp, Laurens Winkelmeier, Christian Thaler, Fabian Flottmann, Maximilian Schell, Helge C Kniep, Gabriel Broocks, Jeremy J Heit, Gregory W Albers, Götz Thomalla, Jens Fiehler, Tobias D Faizy","doi":"10.1177/17474930241264737","DOIUrl":"10.1177/17474930241264737","url":null,"abstract":"<p><strong>Background: </strong>There is yet no randomized controlled evidence that mechanical thrombectomy (MT) is superior to best medical treatment in patients with large vessel occlusion but minor stroke symptoms (National Institutes of Health Stroke Scale (NIHSS) <6). Prior studies of patients with admission NIHSS scores <b>≥</b>6 observed unfavorable functional outcomes despite successful recanalization, commonly termed as futile recanalization (FR), in up to 50% of cases.</p><p><strong>Aim: </strong>The aim of this study is to determine the prevalence of FR in patients with minor stroke and identify associated patient-specific risk factors.</p><p><strong>Methods: </strong>Our multicenter cohort study screened all patients prospectively enrolled in the German Stroke Registry Endovascular Treatment from 2015 to 2021 (n = 13,082). Included were patients who underwent MT for anterior circulation vessel occlusion with a baseline NIHSS score of <6 and successful recanalization (modified Thrombolysis in Cerebral Infarction (mTICI) scores of 2b-3). FR was defined by modified Rankin Scale (mRS) scores of 2-6 at 90 days. Multivariable logistic regression analysis was conducted to explore factors associated with FR.</p><p><strong>Results: </strong>A total of 674 patients met the inclusion criteria. FR occurred in 268 (40%) patients. Multivariable logistic regression analysis indicates that higher age (adjusted odds ratio (aOR) = 1.04 (95% confidence interval (CI) = 1.02-1.06)), pre-stroke mRS 1 (aOR = 2.70 (95% CI = 1.51-4.84)), transfer from admission hospital to comprehensive stroke center (aOR = 1.67 (95% CI = 1.08-2.56)), longer time from symptom onset/last seen well to admission (aOR = 1.02 (95% CI = 1.00-1.04)), MT under general anesthesia (aOR = 1.78 (95% CI = 1.13-2.82)), higher NIHSS after 24 h (aOR = 1.09 (95% CI = 1.05-1.14)), and symptomatic intracranial hemorrhage (aOR = 16.88 (95% CI = 2.03-140.14)) increased the odds of FR. There was no significant difference in primary outcome between achieving mTICI score of 2b or 3.</p><p><strong>Conclusions: </strong>Unfavorable functional outcomes despite successful vessel recanalization were frequent in acute ischemic stroke patients with low NIHSS scores on admission. We provide patient-specific risk factors that indicate an increased risk of FR and should be considered when treating patients with minor stroke.</p><p><strong>Data accessibility statement: </strong>The data that support the findings of our study are available on reasonable request after approval of the German Stroke Registry (GSR) steering committee.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"1102-1112"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141419108","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}

{"title":"Author Index.","authors":"","doi":"10.1177/17474930241306669","DOIUrl":"https://doi.org/10.1177/17474930241306669","url":null,"abstract":"","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":"19 3_suppl","pages":"134-138"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813066","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}

{"title":"Pretreatment predictors of very poor clinical outcomes in medium vessel occlusion stroke patients treated with mechanical thrombectomy.","authors":"Vivek Yedavalli, Hamza Salim, Basel Musmar, Nimer Adeeb, Kareem El Naamani, Nils Henninger, Sri Hari Sundararajan, Anna Luisa Kühn, Jane Khalife, Sherief Ghozy, Luca Scarcia, Benjamin Yq Tan, Jeremy J Heit, Robert W Regenhardt, Nicole M Cancelliere, Joshua D Bernstock, Aymeric Rouchaud, Jens Fiehler, Sunil Sheth, Muhammed Amir Essibayi, Ajit S Puri, Christian Dyzmann, Marco Colasurdo, Xavier Barreau, Leonardo Renieri, João Pedro Filipe, Pablo Harker, Răzvan Alexandru Radu, Thomas R Marotta, Julian Spears, Takahiro Ota, Ashkan Mowla, Pascal Jabbour, Arundhati Biswas, Frédéric Clarençon, James E Siegler, Thanh N Nguyen, Ricardo Varela, Amanda Baker, David Altschul, Nestor R Gonzalez, Markus A Möhlenbruch, Vincent Costalat, Benjamin Gory, Christian Paul Stracke, Mohammad Ali Aziz-Sultan, Constantin Hecker, Hamza Shaikh, David S Liebeskind, Alessandro Pedicelli, Andrea M Alexandre, Illario Tancredi, Tobias D Faizy, Erwah Kalsoum, Boris Lubicz, Aman B Patel, Vitor Mendes Pereira, Adrien Guenego, Adam A Dmytriw","doi":"10.1177/17474930241270524","DOIUrl":"10.1177/17474930241270524","url":null,"abstract":"<p><strong>Background: </strong>Acute ischemic stroke (AIS) from primary medium vessel occlusions (MeVO) is a prevalent condition associated with substantial morbidity and mortality. Despite the common use of mechanical thrombectomy (MT) in AIS, predictors of poor outcomes in MeVO remain poorly characterized.</p><p><strong>Methods: </strong>In this prospectively collected, retrospectively reviewed, multicenter, multinational study, data from the MAD-MT (Multicenter Analysis of primary Distal medium vessel occlusions: effect of Mechanical Thrombectomy) registry were analyzed. The study included 1568 patients from 37 academic centers across North America, Asia, and Europe, treated with MT, with or without intravenous tissue plasminogen activator (IVtPA), between September 2017 and July 2021.</p><p><strong>Results: </strong>Among the 1568 patients, 347 (22.2%) experienced very poor outcomes (modified Rankin score (mRS), 5-6). Key predictors of poor outcomes were advanced age (odds ratio (OR): 1.03; 95% confidence interval (CI): 1.02 to 1.04; p < 0.001), higher baseline National Institutes of Health Stroke Scale (NIHSS) scores (OR: 1.07; 95% CI: 1.05 to 1.10; p < 0.001), pre-operative glucose levels (OR: 1.01; 95% CI: 1.00 to 1.02; p < 0.001), and a baseline mRS of 4 (OR: 2.69; 95% CI: 1.25 to 5.82; p = 0.011). The multivariable model demonstrated good predictive accuracy with an area under the receiver-operating characteristic (ROC) curve of 0.76.</p><p><strong>Conclusions: </strong>This study demonstrates that advanced age, higher NIHSS scores, elevated pre-stroke mRS, and pre-operative glucose levels significantly predict very poor outcomes in AIS-MeVO patients who received MT. These findings highlight the importance of a comprehensive risk assessment in primary MeVO patients for personalized treatment strategies. However, they also suggest a need for cautious patient selection for endovascular thrombectomy. Further prospective studies are needed to confirm these findings and explore targeted therapeutic interventions.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"1123-1133"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792484","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}

{"title":"RhPro-UK in acute ischemic stroke within 4.5 h of stroke onset trial-2 (the PROST-2 study): Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial.","authors":"Shuya Li, Hong-Qiu Gu, Baoyu Feng, Qiang Dong, Dongsheng Fan, Yun Xu, Suiqiang Zhu, Yongjun Wang","doi":"10.1177/17474930241265654","DOIUrl":"10.1177/17474930241265654","url":null,"abstract":"<p><strong>Background: </strong>Recombinant prourokinase (rhPro-UK) is a specific plasmin activator, which has been approved to treat acute myocardial infarction in China.</p><p><strong>Aim: </strong>This phase 3 trial aimed to further demonstrate the efficacy and safety of rhPro-UK in patients with acute ischemic stroke (AIS) within 4.5 h of symptom onset.</p><p><strong>Methods and design: </strong>RhPro-UK in AIS within 4.5 h of stroke onset trial-2 (PROST-2) is a multicenter, prospective randomized, open-label, blinded end-point, non-inferiority, recombinant tissue plasmin activator (rt-PA)-controlled, phase 3 trial. A total of 1552 patients who are eligible for intravenous thrombolytic therapy from 72 clinical sites will be randomly assigned to receive either rhPro-UK 35 mg (15 mg bolus + 20 mg infusion/30 min) or rt-PA 0.9 mg/kg (10% bolus + 90% infusion/1 h).</p><p><strong>Study outcomes: </strong>The primary outcome is the proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days. Secondary efficacy outcomes include the proportion of patients with mRS score of 0-2, the distribution of mRS, self-care ability in daily life on the Barthel Index at 90 days, the proportion of subjects with ⩾ 4 points decrease in National Institutes of Health Stroke Scale (NIHSS) score or NIHSS score ⩽ 1 from baseline at 24 h and 7 days after treatment. Safety outcomes are symptomatic intracranial hemorrhage (sICH) and major systematic bleeding within 7 days as well as death from all causes within 90 days.</p><p><strong>Discussion: </strong>The results from the PROST-2 trial will comprehensively elucidate the efficacy and safety profile of rhPro-UK as a potential alternative agent for stroke thrombolysis.</p><p><strong>Clinical trial registration: </strong>URL: http://www.clinicaltrials.gov. Unique identifier: NCT05700591.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"1182-1187"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440415","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}

{"title":"Trends in sex differences of functional outcome after intravenous thrombolysis in patients with acute ischemic stroke.","authors":"Martha Marko, Dominika Miksova, Melanie Haidegger, Jakob Schneider, Johanna Ebner, Marie B Lang, Wolfgang Serles, Stefan Kiechl, Michael Knoflach, Marek Sykora, Julia Ferrari, Thomas Gattringer, Stefan Greisenegger","doi":"10.1177/17474930241273696","DOIUrl":"10.1177/17474930241273696","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Intravenous thrombolysis (IVT) is an approved treatment for patients with acute ischemic stroke irrespective of sex. However, the current literature on sex differences in functional outcomes following IVT is inconsistent. So far, a number of studies-including a previous analysis based on data from the Austrian Stroke Unit Registry (ASUR)-detected significant sex-related differences in functional outcome, while others did not report any differences between women and men. In addition, currently there is a lack of data on how sex-related differences evolve over time.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aims: &lt;/strong&gt;To assess time trends of sex-related differences in functional outcome of ischemic stroke in a large nationwide cohort and to investigate associations of patient characteristics with functional outcome post thrombolysis in women and men. These data will offer crucial insights into whether sex differences in functional outcome persist despite the large advances in acute stroke treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We analyzed retrospective data of consecutive patients with acute ischemic stroke treated with IVT in 39 stroke centers contributing to the ASUR between 2006 and 2021. We included patients over 18 years of age diagnosed with an acute ischemic stroke who received IVT and with available data on functional outcome at 3 months after treatment. The primary outcome parameter was favorable functional outcome (modified Rankin Scale (mRS) of 0-2) at 3 months. Multivariable logistic regression analysis was performed in the overall population and stratified by sex to assess associations of baseline characteristics with functional outcome.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 11,840 patients receiving IVT, 2489 of 5503 (45.4%) women achieved favorable functional outcome compared to 3787 of 6337 (59.8%) men. Overall, female sex was a statistically significant predictor of functional outcome after thrombolysis, but additional predictors of outcome differed between women and men. Female sex was independently associated with decreased chances of achieving functional independency (adjusted odds ratio (adjOR) = 0.87, 95% confidence interval (CI) = 0.79-0.96, p = 0.005) and we detected a statistically significant improvement in functional outcome over time only in men (year of treatment, adjOR (per year) = 1.04, 95% CI = 1.02-1.06, p &lt; 0.001) but not in women (adjOR (per year) = 1.01, 95% CI = 0.99-1.03, p = 0.280). Hypertension, smoking, and longer or unknown onset-to-door times were statistically significant predictors of outcome only in male patients, whereas atrial fibrillation, prior myocardial infarction, and longer door-to-needle times were significantly associated with outcome only in women.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Sex differences in functional outcome after IVT for acute ischemic stroke are persisting over the past years. Results of our analysis can increase awareness and a resulting focus on sex differences i","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"1147-1154"},"PeriodicalIF":6.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859716","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}