Dataset Information

EndoVAscular treatment and ThRombolysis for Ischemic Stroke Patients (EVA-TRISP) registry: basis and methodology of a pan-European prospective ischaemic stroke revascularisation treatment registry.

ABSTRACT:

Purpose

The Thrombolysis in Ischemic Stroke Patients (TRISP) collaboration was a concerted effort initiated in 2010 with the purpose to address relevant research questions about the effectiveness and safety of intravenous thrombolysis (IVT). The collaboration also aims to prospectively collect data on patients undergoing endovascular treatment (EVT) and hence the name of the collaboration was changed from TRISP to EVA-TRISP. The methodology of the former TRISP registry for patients treated with IVT has already been published. This paper focuses on describing the EVT part of the registry.

Participants

All centres committed to collecting predefined variables on consecutive patients prospectively. We aim for accuracy and completeness of the data and to adapt local databases to investigate novel research questions. Herein, we introduce the methodology of a recently constructed academic investigator-initiated open collaboration EVT registry built as an extension of an existing IVT registry in patients with acute ischaemic stroke (AIS).

Findings to date

Currently, the EVA-TRISP network includes 20 stroke centres with considerable expertise in EVT and maintenance of high-quality hospital-based registries. Following several successful randomised controlled trials (RCTs), many important clinical questions remain unanswered in the (EVT) field and some of them will unlikely be investigated in future RCTs. Prospective registries with high-quality data on EVT-treated patients may help answering some of these unanswered issues, especially on safety and efficacy of EVT in specific patient subgroups.

Future plans

This collaborative effort aims at addressing clinically important questions on safety and efficacy of EVT in conditions not covered by RCTs. The TRISP registry generated substantial novel data supporting stroke physicians in their daily decision making considering IVT candidate patients. While providing observational data on EVT in daily clinical practice, our future findings may likewise be hypothesis generating for future research as well as for quality improvement (on EVT). The collaboration welcomes participation of further centres willing to fulfill the commitment and the outlined requirements.

SUBMITTER: Nordanstig A

PROVIDER: S-EPMC8354282 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

EndoVAscular treatment and ThRombolysis for Ischemic Stroke Patients (EVA-TRISP) registry: basis and methodology of a pan-European prospective ischaemic stroke revascularisation treatment registry.

Nordanstig Annika A Curtze Sami S Gensicke Henrik H Zinkstok Sanne M SM Erdur Hebun H Karlsson Camilla C Karlsson Jan-Erik JE Martinez-Majander Nicolas N Sibolt Gerli G Lyrer Philippe P Traenka Christopher C Baharoglu Merih I MI Scheitz Jan F JF Bricout Nicolas N Hénon Hilde H Leys Didier D Eskandari Ashraf A Michel Patrik P Hametner Christian C Ringleb Peter Arthur PA Arnold Marcel M Fischer Urs U Sarikaya Hakan H Seiffge David J DJ Pezzini Alessandro A Zini Andrea A Padjen Visnja V Jovanovic Dejana R DR Luft Andreas A Wegener Susanne S Kellert Lars L Feil Katharina K Kägi Georg G Rentzos Alexandros A Lappalainen Kimmo K Leker Ronen R RR Cohen Jose E JE Gomori John J Brehm Alex A Liman Jan J Psychogios Marios M Kastrup Andreas A Papanagiotou Panagiotis P Gralla Jan J Magoni Mauro M Majoie Charles B L M CBLM Bohner Georg G Vukasinovic Ivan I Cvetic Vladimir V Weber Johannes J Kulcsar Zsolt Z Bendszus Martin M Möhlenbruch Markus M Ntaios George G Kapsalaki Eftychia E Jood Katarina K Nolte Christian H CH Nederkoorn Paul J J PJJ Engelter Stefan S Strbian Daniel D Tatlisumak Turgut T

BMJ open 20210809 8

<h4>Purpose</h4>The Thrombolysis in Ischemic Stroke Patients (TRISP) collaboration was a concerted effort initiated in 2010 with the purpose to address relevant research questions about the effectiveness and safety of intravenous thrombolysis (IVT). The collaboration also aims to prospectively collect data on patients undergoing endovascular treatment (EVT) and hence the name of the collaboration was changed from TRISP to EVA-TRISP. The methodology of the former TRISP registry for patients treat ...[more]

PMID: 34373287

Similar Datasets

Project description:ObjectiveTo determine outcomes and safety of endovascular treatment for acute ischaemic stroke, due to proximal intracranial vessel occlusion in the anterior circulation, in routine clinical practice.DesignOngoing, prospective, observational cohort study.Setting16 centres that perform endovascular treatment in the Netherlands.Participants1488 patients included in the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands (MR CLEAN) Registry who had received endovascular treatment, including stent retriever thrombectomy, aspiration, and all alternative methods for acute ischaemic stroke within 6.5 hours from onset of symptoms between March 2014 and June 2016.Main outcome measuresThe primary outcome was the modified Rankin Scale (mRS) score, ranging from 0 (no symptoms) to 6 (death) at 90 days after the onset of symptoms. Secondary outcomes were excellent functional outcome (mRS score 0-1), good functional outcome (mRS score 0-2), and favourable functional outcome (mRS score 0-3) at 90 days; score on the extended thrombolysis in cerebral infarction scale at the end of the intervention procedure; National Institutes of Health Stroke Scale score 24-48 hours after intervention; and complications that occurred during intervention, hospital admission, or three months' follow up period. Outcomes and safety variables in the MR CLEAN Registry were compared with the MR CLEAN trial intervention and control arms.ResultsA statistically significant shift was observed towards better functional outcome in patients in the MR CLEAN Registry compared with the MR CLEAN trial intervention arm (adjusted common odds ratio 1.30, 95% confidence interval 1.02 to 1.67) and the MR CLEAN trial control arm (1.85, 1.46 to 2.34). The reperfusion rate, with successful reperfusion defined as a score of 2B-3 on the extended thrombolysis in cerebral infarction score, was 58.7%, the same as for patients in the MR CLEAN trial. Duration from onset of stroke to start of endovascular treatment and from onset of stroke to successful reperfusion or last contrast bolus was one hour shorter for patients in the MR CLEAN Registry. Symptomatic intracranial haemorrhage occurred in 5.8% of patients in the MR CLEAN Registry compared with 7.7% in the MR CLEAN trial intervention arm and 6.4% in the MR CLEAN trial control arm.ConclusionIn routine clinical practice, endovascular treatment for patients with acute ischaemic stroke is at least as effective and safe as in the setting of a randomised controlled trial.

Project description:ObjectivesEndovascular therapy (EVT) has proven to be clinically effective in treating large vessel occlusion acute ischaemic stroke (AIS), either alone or in combination with intravenous alteplase. Despite this, there is a limited evidence on the cost-effectiveness of EVT in Thailand and other low-income and middle-income countries. This study aims to assess whether EVT is a cost-effective therapy for AIS, and to estimate the fiscal burden to the Thai government through budget impact analysis.MethodsAn economic evaluation was performed to compare AIS therapy with and without EVT from a societal perspective. The primary outcome was incremental cost-effectiveness per quality-adjusted life year (QALY) gained. Clinical parameters were derived from both national and international literature, while cost and utility data were collected locally. The analysis applied a cost-effectiveness threshold of 160 000 Baht (~$5000) per QALY, as set by the Thai government.ResultsBoth EVT alone and EVT combined with intravenous alteplase, among patients who are ineligible and eligible for intravenous alteplase, respectively, improved health outcomes but incurred additional cost. The combination of EVT and intravenous alteplase was associated with an incremental cost-effectiveness ratio (ICER) of 146 800 THB per QALY gained compared with intravenous alteplase alone, and the ICER of EVT alone compared with supportive care among patients ineligible for intravenous alteplase was estimated at 115 000 THB per QALY gained. Sensitivity analysis showed that the price of EVT has the greatest impact on model outcomes. Over a time horizon of 5 years, the introduction of EVT into the Thai health benefit package would require an additional budget of 887 million THB, assuming 2000 new cases per year.ConclusionsEVT represents good value for money in the Thai context, both when provided to patients eligible for intravenous alteplase, and when provided alone to those who are ineligible for intravenous alteplase.

Project description:IntroductionIn patients with stroke attributable to cervical artery dissection, we compared endovascular therapy to intravenous thrombolysis regarding three-month outcome, recanalisation and complications.Materials and methodsIn a multicentre intravenous thrombolysis/endovascular therapy-register-based cohort study, all consecutive cervical artery dissection patients with intracranial artery occlusion treated within 6 h were eligible for analysis. Endovascular therapy patients (with or without prior intravenous thrombolysis) were compared to intravenous thrombolysis patients regarding (i) excellent three-month outcome (modified Rankin Scale score 0-1), (ii) symptomatic intracranial haemorrhage, (iii) recanalisation of the occluded intracranial artery and (iv) death. Upon a systematic literature review, we performed a meta-analysis comparing endovascular therapy to intravenous thrombolysis in cervical artery dissection patients regarding three-month outcome using a random-effects Mantel-Haenszel model.ResultsAmong 62 cervical artery dissection patients (median age 48.8 years), 24 received intravenous thrombolysis and 38 received endovascular therapy. Excellent three-month outcome occurred in 23.7% endovascular therapy and 20.8% with intravenous thrombolysis patients. Symptomatic intracranial haemorrhage occurred solely among endovascular therapy patients (5/38 patients, 13.2%) while four (80%) of these patients had bridging therapy; 6/38 endovascular therapy and 0/24 intravenous thrombolysis patients died. Four of these 6 endovascular therapy patients had bridging therapy. Recanalisation was achieved in 84.2% endovascular therapy patients and 66.7% intravenous thrombolysis patients (odds ratio 3.2, 95% confidence interval [0.9-11.38]). Sensitivity analyses in a subgroup treated within 4.5 h revealed a higher recanalisation rate among endovascular therapy patients (odds ratio 3.87, 95% confidence interval [1.00-14.95]), but no change in the key clinical findings. In a meta-analysis across eight studies (n = 212 patients), cervical artery dissection patients (110 intravenous thrombolysis and 102 endovascular therapy) showed identical odds for favourable outcome (odds ratio 0.97, 95% confidence interval [0.38-2.44]) among endovascular therapy patients and intravenous thrombolysis patients.Discussion and conclusionIn this cohort study, there was no clear signal of superiority of endovascular therapy over intravenous thrombolysis in cervical artery dissection patients, which - given the limitation of our sample size - does not prove that endovascular therapy in these patients cannot be superior in future studies. The observation that symptomatic intracranial haemorrhage and deaths in the endovascular therapy group occurred predominantly in bridging patients requires further investigation.

Dataset Information

EndoVAscular treatment and ThRombolysis for Ischemic Stroke Patients (EVA-TRISP) registry: basis and methodology of a pan-European prospective ischaemic stroke revascularisation treatment registry.

Purpose

Participants

Findings to date

Future plans

Publications

EndoVAscular treatment and ThRombolysis for Ischemic Stroke Patients (EVA-TRISP) registry: basis and methodology of a pan-European prospective ischaemic stroke revascularisation treatment registry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets