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Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open- label, controlled trial

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Stroke & Vascular Neurology 2024年第1期9卷 82-89页

作者： Yunyun Xiong Bruce C V Campbell Marc Fisher lee h schwamm Mark Parsons hao Li Yuesong Pan Xia Meng Xingquan Zhao Yongjun Wang Neurology Beijing Tiantan HospitalBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Department of Medicine and Neurology The University of MelbourneMelbourneVictoriaAustralia Neurology Beth Israel Deaconess Medical CenterBostonMassachusettsUSA Department of Neurology and Comprehensive Stroke Center Massachusetts General HospitalBostonMassachusettsUSA Department of Neurology University of New South Wales South Western Sydney Clinical SchoolLiverpoolNew South WalesAustralia

Background and purpose Recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)was not inferior to alteplase for ischaemic stroke within *** study aimed to investigate the efficacy and safety of rhTNK-tPA in patients who had an ischaemic stroke due to large vessel occlusion(LVO)of anterior circulation beyond *** and design Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III(TRACE III)is a multicentre,prospective,randomised,open-label,blind endpoint,controlled clinical *** who had an ischaemic stroke due to anterior circulation LVO(internal carotid artery,middle cerebral artery M1 and M2 segments)within 4.5–24hours from last known well(including wake-up stroke and no witness stroke)and with salvageable tissue(ischaemic core volumeh ratio≥1.8 and mismatch volume≥15mL)based on CT perfusion or MRI perfusion-weighted imaging(PWI)were included and randomised to rhTNK-tPA 0.25mg/kg(single bolus)to a maximum of 25mg or standard medical ***,we will exclude patients who are intended for direct *** will be followed up for 90 *** outcomes Primary efficacy outcome is modified Rankin Scale(mRS)score≤1 at 90 *** efficacy outcomes include ordinal distribution of mRS at 90 days,major neurological improvement defined by a decrease≥8 points compared with the initial deficit or a score≤1 on the National Institutes of health Stroke Scale(NIhSS)at 72 hours,mRS score≤2 at 90 days,the rate of improvement on Tmax>6s at 24 hours and NIhSS score change from baseline at *** outcomes are symptomatic intracerebral haemorrhage within 36 hours and mortality at 90 *** TRACE III will provide evidence for the efficacy and safety of rhTNK-tPA in patients who had an ischaemic strokes due to anterior circulation LVO beyond *** registration number NCT05141305.

关键词： Therapy random Rational

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Trends in characteristics of neurologists who provide stroke consultations in the USA,2008-2021

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Stroke & Vascular Neurology 2023年第1期8卷 86-88页

作者： Carter h Nakamoto Andrew D Wilcock lee h schwamm Jennifer J Majersik Kori S Zachrison Ateev Mehrotra Department of health Care Policy Harvard Medical SchoolBostonMassachusettsUSA Department of Family Medicine University of Vermont Larner College of MedicineBurlingtonVermontUSA Department of Neurology Massachusetts General HospitalBostonMassachusettsUSA Department of Neurology University of UtahSalt Lake CityUtahUSA Department of Emergency Medicine Massachusetts General HospitalBostonMassachusettsUSA Division of General Medicine and Primary Care Beth Israel Deaconess Medical CenterBostonMassachusettsUSA

Introduction Patients with acute ischaemic strokes(AIS),on average,fare better with timely neurologist consultation,and a growing proportion of them receive ***,little is known about trends in the characteristics of neurologists who treat *** We identified AIS and transient ischaemic attack(TIA)episodes with neurologist consults in fee-for service Medicare from January 2008 to September *** each episode,we determined whether the neurologist was a vascular neurologist,was a high-volume provider,whether the patient was transferred between hospitals and the distance between the patient’s home and physician’s *** From 2008 to 2021,the share of AIS/TIA episodes(n=5073294)with neurologist consults increased(52.9%to 61.7%).Among episodes with consults,the fraction conducted by a vascular neurologist(5.2%to 13.7%)or by a high-volume neurologist(13.2%to 14.9%)also *** fraction with the patient’s home and neurologist greater than 100 miles apart(4.8%to 9.6%)or in different states(5.1%to 8.1%)increased,as did the fraction with transfers(4.2%to 8.5%).Discussion Over the study period,the proportion of AIS/TIA episodes with consultations from neurologists with either vascular neurology certifications or high volumes increased substantially.

关键词： acute characteristics consultation

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Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-Ⅱ (TRACE Ⅱ): rationale and design

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Stroke & Vascular Neurology 2022年第1期7卷 71-76页

作者： Shuya Li Bruce C V Campbell lee h schwamm Marc Fisher Mark Parsons hao Li Yuesong Pan Yongjun Wang China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Medicine and Neurology University of MelbourneMelbourneVictoriaAustralia Department of Neurology and Comprehensive Stroke Center Massachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA Neurology Beth Israel Deaconess Medical CenterBostonMassachusettsUSA Department of Neurology Liverpool HospitalSouth Western Sydney Clinical SchoolSydneyNew South WalesAustralia

Background and purpose Tenecteplase(TNK)is a promising agent for treatment of acute ischaemic stroke(AIS).We hypothesised that recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)is non-inferior to rt-PA in achieving excellent functional outcome at 90 days,when administered within 4.5 hours of ischaemic stroke *** and design Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events(TRACE)is a phase Ⅲ,multicentre,prospective,randomised,open-label,blinded-end point non-inferiority *** eligible for intravenous thrombolysis therapy are randomised to rhTNK-tPA 0.25 mg/kg(single bolus)to a maximum of 25 mg or rt-PA 0.9 mg/kg(10%bolus+90%infusion/1 hour)to a maximum of 90 *** considered necessary for the patient’s health may be given at the discretion of the investigator during 90-day *** outcomes The primary study outcome is excellent functional outcome defined as modified Rankin Scale(mRS)0–1 at 90 *** efficacy outcomes include favourable functional outcome defined as mRS≤2 at 90 days,ordinal distribution of mRS and major neurological improvement on the National Institutes of health Stroke *** outcomes are symptomatic intracranial haemorrhage within 36 hours and death from any *** There is no completed registration study of TNK in AIS *** Ⅱ strives to provide evidence for a new drug application for rhTNK-tPA in AIS within 4.5 hours through a well-designed and rigorously executed randomised trial in China.

关键词： infusion acute rational

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Linking the Paul Coverdell National Acute Stroke Program to commercial claims to establish a framework for real-world longitudinal stroke research

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Stroke & Vascular Neurology 2022年第2期7卷 114-123页

作者： Elisabetta Patorno Sebastian Schneeweiss Mary G George Xin Tong Jessica M Franklin Ajinkya Pawar helen Mogun Lidia M V R Moura lee h schwamm Division of Pharmacoepidemiology and Pharmacoeconomics Department of MedicineBrigham and Women's HospitalHarvard Medical SchoolBostonMassachusettsUSA Division for heart Disease and Stroke Prevention NCCDPHPCenters for Disease Control and PreventionAtlantaGeorgiaUSA Epilepsy and Neurophysiology Division Department of NeurologyMassachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA Fireman Vascular Center and Stroke Division Department of NeurologyMassachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA

Background Non-interventional large-scale research on real-world patients who had a stroke requires the use of multiple data sources ensuring access to longitudinal data from large populations with clinically-detailed *** sought to establish a framework for longitudinal research on patients hospitalised with stroke by linking information-rich,deidentified inpatient data from the Paul Coverdell National Acute Stroke Program(PCNASP)to commercial and Medicare Advantage longitudinal claims *** All stroke admissions in PCNASP between 2008 and 2015 were evaluated for linkage to longitudinal claims from a commercial insurer using an algorithm based on six available common data fields(patient age,gender,admission date,discharge date,discharge diagnosis and state)and a hospital *** evaluated the linkage quality(via the percentage of unique records in the linked dataset)and the representativeness of the linked *** also described medical history,stroke severity and patterns of medication use among the PCNASP-claims linked *** The linkage produced uniqueness equal to 99.1%.We identified 5644 linked and 98896 unlinked patients who had an ischaemic stroke hospitalisation in claims *** patients were younger than unlinked(69.7 vs 72.5 years),but otherwise similar by medical history,prestroke medication use or lab *** severity was mild and most patients were discharged *** and discharge use of antihypertensive and statins in the PCNASP were greater than their use as measured by filled prescriptions in *** high-quality linkage between the PCNASP and commercial claims data is *** linkage identified differences between reported or recommended versus actual out-of-hospital medication utilisation,highlighting the importance of longitudinal data availability for research aimed to improve the care of patients who had a stroke.

关键词： linkage claims younger

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Prestroke selective serotonin reuptake inhibitor use and functional outcomes after ischaemic stroke

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Stroke & Vascular Neurology 2018年第1期3卷 9-16页

作者： Mark R Etherton Khawja A Siddiqui lee h schwamm Department of Neurology Harvard Medical SchoolBostonMassachusettsUSA Department of Neurology Massachusetts General HospitalBostonMassachusettsUSA

background Selective serotonin reuptake inhibitors(SSRIs)have been implicated in contributing to recovery after acute ischaemic *** particular,poststroke initiation of an SSRI has been demonstrated to improve motor *** role of prestroke SSRI use on functional outcomes and stroke recovery is less *** aimed to examine the effect of prestroke SSRI use on metrics of hospitalisation and functional *** We included 4968 consecutive patients from January 2006 to June 2015 in our local Get With The Guidelines-Stroke registry in whom a preadmission drug list could be extracted from an administrative research data *** and multivariate analyses were performed to identify predictors of functional *** On univariate analysis,among 4698 ischaemic strokes(740 SSRI users and 3948 non-users),SSRI use before acute ischaemic stroke did not impact the National Institutes of health Stroke Scale(NIhSS)admission score,length of stay or rate of symptomatic *** using SSRIs prior to their stroke were more likely to present with weakness(57% vs 47.3%;Phave hospitalisations complicated by pneumonia(7.6% vs 5.7%;Ph a negative impact on ambulatory status at discharge and discharge to *** multivariate regression analysis,SSRI use was associated with lower likelihood of discharge to home(adjusted OR 0.79,95% CI 0.62 to 0.997,Phaemic stroke is associated with lower rates of discharge to home despite no significant increase in length of stay or NIhSS score.

关键词： functional likely stroke

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Improving detection of cerebral small vessel disease aetiology in patients with isolated lobar intracerebral haemorrhage

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Stroke & Vascular Neurology 2023年第1期8卷 26-33页

作者： Alvin S Das Elif Gokcal Robert W Regenhardt Mitchell J horn Kristin Schwab Nader Daoud Anand Viswanathan W Taylor Kimberly Joshua N Goldstein Alessandro Biffi Natalia Rost Jonathan Rosand lee h schwamm Steven M Greenberg M Edip Gurol Department of Neurology Beth Israel Deaconess Medical CenterHarvard Medical SchoolBostonMassachusettsUSA Department of Neurology Massachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA Department of Neurosurgery Massachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA Department of Emergency Medicine Massachusetts General HospitalHarvard Medical SchoolBostonMassachusettsUSA

Background and purpose We evaluate whether non-haemorrhagic imaging markers(NhIM)(white matter hyperintensity patterns,lacunes and enlarged perivascular spaces(EPVS))can discriminate cerebral amyloid angiopathy(CAA)from hypertensive cerebral small vessel disease(hTN-cSVD)among patients with isolated lobar intracerebral haemorrhage(isolated-LICh).Methods In patients with isolated-LICh,four cSVD aetiologic groups were created by incorporating the presence/distribution of NhIM:hTN-cSVD pattern,CAA pattern,mixed NhIM and no *** pattern consisted of patients with any combination of severe centrum semiovale EPVS,lobar lacunes or multiple subcortical spots ***-cSVD pattern consisted of any hTN-cSVD markers:severe basal ganglia PVS,deep lacunes or peribasal ganglia white matter hyperintensity *** NhIM consisted of at least one imaging marker from either *** hypothesis was that patients with hTN-cSVD pattern/mixed NhIM would have a higher frequency of left ventricular hypertrophy(LVh),which is associated with *** In 261 patients with isolated-LICh,CAA pattern was diagnosed in 93 patients,hTN-cSVD pattern in 53 patients,mixed NhIM in 19 patients and no NhIM in 96 *** frequency of LVh was similar among those with hTN-cSVD pattern and mixed NhIM(50%vs 39%,p=0.418)but was more frequent in hTN-cSVD pattern compared with CAA pattern(50%vs 20%,phTN-cSVD pattern(OR:7.38;95%CI 2.84 to 19.20)and mixed NhIM(OR:4.45;95%CI 1.25 to 15.90)were found to be independently associated with *** Among patients with isolated-LICh,NhIM may help differentiate hTN-cSVD from CAA,using LVh as a marker for hTN-cSVD.

关键词： patients cerebral hypertensive

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The American heart Association’s Get With the Guidelines(GWTG)-Stroke development and impact on stroke care

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Stroke & Vascular Neurology 2017年第2期2卷 94-105页

作者： Cora h Ormseth Kevin N Sheth Jeffrey L Saver Gregg C Fonarow lee h schwamm Neurology Yale University School of MedicineNew HavenConnecticutUSA Department of Neurology UCLA Medical CenterLos AngelesCaliforniaUSA Department of Cardiology UCLA Medical CenterLos AngelesCaliforniaUSA Department of Neurology Massachusetts General HospitalBostonMassachusettsUSA

The American heart Association’s Get With the Guidelines(GWTG)-Stroke programme has changed stroke care delivery in the USA since its establishment in *** is a voluntary registry and continuous quality improvement initiative that collects data on patient characteristics,hospital adherence to guidelines and inpatient *** of the programme saw increased provision of evidence-based care and improved patient *** review will describe the development of the programme and discuss the impact on stroke outcomes and transformation of stroke care delivery that followed its implementation.

关键词： impact programme

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Strategy for reliable identification of ischaemic stroke, thrombolytics and thrombectomy in large administrative databases

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Stroke & Vascular Neurology 2021年第2期6卷 194-200页

作者： Kori S Zachrison Sijia Li Mathew J Reeves Opeolu Adeoye Carlos A Camargo lee h schwamm Renee Y hsia Department of Emergency Medicine Massachusetts General HospitalBostonMassachusettsUSA Department of Emergency Medicine Harvard Medical SchoolBostonMassachusettsUSA Department of Epidemiology and Biostatistics Michigan State UniversityEast LansingMichiganUSA University of Cincinnati CincinnatiOhioUSA Massachusetts General hospital BostonMassachusettsUSA Department of Emergency Medicine University of California San FranciscoSan FranciscoCaliforniaUSA

Background Administrative data are frequently used in stroke *** accurate identification of patients who had an ischaemic stroke,and those receiving thrombolysis and endovascular thrombectomy(EVT)is critical to ensure representativeness and *** examined differences in patient samples based on mode of identification,and propose a strategy for future patient and procedure identification in large administrative *** We used non-public administrative data from the state of California to identify all patients who had an ischaemic stroke discharged from an emergency department(ED)or inpatient hospitalisation from 2010 to 2017 based on International Classification of Disease(ICD-9)(2010-2015),ICD-10(2015-2017)and Medicare Severity-Diagnosis-related Group(MS-DRG)discharge *** identified patients with interhospital transfers,patients receiving thrombolytics and patients treated with EVT based on ICD,Current Procedural Terminology(CPT)and MS-DRG *** determined what proportion of these transfers and procedures would have been identified with ICD versus MS-DRG discharge *** Of 365099 ischaemic stroke encounters,most(87.70%)had both a stroke-related ICD-9 or ICD-10 code and stroke-related MS-DRG code;12.28% had only an ICD-9 or ICD-10 code and 0.02% had only an MS-DRG *** all transfers(99.99%)were identified using ICD *** identified 32433 thrombolytic-treated patients(8.9% of total)using ICD,CPT and MS-DRG codes;the combination of ICD and CPT codes identified nearly all(98%).We identified 7691 patients treated with EVT(2.1%of total)using ICD and MS-DRG codes;both MS-DRG and ICD-9/ICD-10 codes were necessary because ICD codes alone missed 13.2%of *** codes only pertain to outpatient/ED patients and are not useful for EVT *** ICD-9/ICD-10 diagnosis codes capture nearly all ischaemic stroke encounters and transfers,while the combination of ICD-9/ICD-10 and CPT codes are adequate

关键词： thrombolytic diagnosis administrative

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Resource utilisation among patients transferred for intracerebral haemorrhage

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Stroke & Vascular Neurology 2019年第4期4卷 223-226页

作者： Kori Sauser Zachrison Emily Aaronson Sadiqa Mahmood Jonathan Rosand Anand Viswanathan lee h schwamm Joshua N Goldstein Department of Emergency Medicine Massachusetts General HospitalBostonMassachusettsUSA Department of Emergency Medicine Harvard Medical SchoolBostonMassachusettsUSA health Catalyst CambridgeMassachusettsUSA Department of Neurology Massachusetts General HospitalBostonMassachusettsUSA Department of Neurology Harvard Medical SchoolBostonMassachusettsUSA

background Patients with intracerebral haemorrhage(ICh)are frequently transferred between hospitals for higher level of *** aimed to identify factors associated with resource utilisation among patients with ICh admitted to a single academic *** We used a prospectively collected registry of consecutive patients with primary ICh at an urban academic hospital between 1 January 2005 and 31 December *** primary outcome was use of either intensive care unit(ICU)admission or surgical *** regression examined factors associated with the outcome,controlling for age,sex,Glasgow coma score(GCS)and ICh *** Of the 2008 patients included,887(44.2%)received ICU stay or surgical *** patients were younger(71 vs 74 years,phite(83.9% vs 89.3%,phad lower baseline GCS(12 vs 14,phad intraventricular haemorrhage(58.6%vs 43.4%,ph ICU stay or surgical intervention were age>65 years(OR 0.38,95% CI 0.21 to 0.69),GCSh score>0(OR 2.23,95% CI 1.70 to 2.91).Conclusion Among this cohort of primary patients with ICh,GCS of 15 and ICh score of 0 were associated with less frequent use of ICU or *** results should be validated in a larger sample but may be valuable for hospitals considering which patients with ICh could safely remain at the referring facility.

关键词： patients admitted Glasgow

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Temporal trends and rural-urban disparities in cerebrovascular risk factors,in-hospital management and outcomes in ischaemic strokes in China from 2005 to 2015:a nationwide serial cross-sectional survey

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Stroke & Vascular Neurology 2023年第1期8卷 34-50页

作者： Chun-Juan Wang hong-Qiu Gu Xin-Miao Zhang Yong Jiang hao Li Janet Prvu Bettger Xia Meng Ke-hui Dong Run-Qi Wangqin Xin Yang Meng Wang Chelsea Liu Li-Ping Liu Bei-Sha Tang Guo-Zhong Li Yu-Ming Xu Zhi-Yi he Yi Yang Winnie Yip Gregg C Fonarow lee h schwamm Ying Xian Xing-Quan Zhao Yi-Long Wang Yongjun Wang Zixiao Li China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina National Center for healthcare Quality Management in Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Vascular Neurology Department of NeurologyBeijing Tiantan HospitalCapital Medical UniversityBeiingChina Center of Stroke Beijing Institute for Brain DisordersBeijngChina Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease BeijingChina Duke Clinical Research Institute Duke UniversityDurhamNorth CarolinaUSA Department of Neurology Duke Univeristy Medical CenterDurhamNorth CarolinaUSA Department of Epidemiology Harvard T H Chan School of Public HealthBostonMassachusettsUSA Neuro-intensive Care Unit Department of NeurologyBeijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology Xiangya HospitalCentral South UniversityChangshaHunanChina Department of Neurology The First Affiliated Hospital of Harbin Medical UniversityHarbinHeilongjiangChina Department of Neurology The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanChina Key Laboratory of Cerebrovascular Disease Prevention and Treatment National Health Commission(Province and Ministry Co-constructed)ZhengzhouHenanChina Department of Neurology The First Affiliated Hospital of China Medical UniversityShenyangLiaoningChina Department of Neurology The First Hospital of Jilin UniversityChangchunJilinChina Department of Global health and Population Harvard T.H.Chan School of Public HealthBostonMAUSA Ahmanson-UCLA Cardiomyopathy Center Ronald Reagan-UCLA Medical CenterLos AngelesCAUSA Department of Neurology Massachusetts General HospitalHarvard Medical SchoolBostonMAUSA Department of Neurology The University of Texas Southwestern Medical CenterDallasTexasUSA Research Unit of Artificial Intelligence in Cerebrovascular Disease Chinese Academy of Medical SciencesBeijingChina Chinese Inst

Background Stroke is the leading cause of mortality in China,with limited evidence of in-hospital burden obtained from nationwide *** aimed to monitor and track the temporal trends and rural-urban disparities in cerebrovascular risk factors,management and outcomes from 2005 to *** We used a two-stage random sampling survey to create a nationally representative sample of patients admitted for ischaemic stroke in 2005,2010 and *** sampled participating hospitals with an economic-geographical region-stratified random-sampling approach first and then obtained patients with a systematic sampling *** weighed our survey data to estimate the national-level results and assess changes from 2005 to *** We analysed 28277 ischaemic stroke admissions from 189 participating *** 2005 to 2015,the estimated national hospital admission rate for ischaemic stroke per 100000 people increased(from 75.9 to 402.7,Ptrendhe prevalence of risk factors,including hypertension,diabetes,dyslipidaemia and current smoking,*** composite score of diagnostic tests for stroke aetiology assessment(from 0.22 to 0.36,Ptrendharge against medical advice(DAMA)(from 15.2%(95%CI 13.7%to 16.7%)to 8.6%(8.1%to 9.0%);adjusted Ptrend=0.046),and decreases in in-hospital mortality(0.7%in 2015 vs 1.8%in 2005;adjusted OR(aOR)0.52;95%CI 0.32 to 0.85)and the composite outcome of in-hospital mortality or DAMA(8.4%in 2015 vs 13.9%in 2005;aOR 0.65;95%CI 0.47 to 0.89)were *** between rural and urban hospitals narrowed;however,disparities persisted in in-hospital management(brain MRI:rural-urban difference from−14.4%to−11.2%;cerebrovascular assessment:from−20.3%to−16.7%;clopidogrel:from−2.1%to−10.3%;anticoagulant for atrial fibrillation:from−10.9%to−8.2%)and in-hospital outcomes(DAMA:from 2.7%to 5.0%;composite outcome

关键词： admitted nationwide survey

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