Applicability of ENCHANTED trial results to current acute ischemic stroke patients eligible for intravenous thrombolysis in England and Wales: Comparison with the Sentinel Stroke National Audit Programme registry
Journal
International Journal of Stroke
ISSN
1747-4930
1747-4949
Date Issued
2019
Author(s)
Thompson G Robinson
Benjamin D Bray
Lizz Paley
Nikola Sprigg
Xia Wang
Hisatomi Arima
Philip M Bath
Joseph P Broderick
Alice C Durham
Jong S Kim
Pablo M Lavados
Tsong-Hai Lee
Sheila Martins
Thang H Nguyen
Jeyaraj D Pandian
Mark W Parsons
Octavio M Pontes-Neto
Stefano Ricci
Vijay K Sharma
Jiguang Wang
Mark Woodward
Anthony G Rudd
John Chalmers
Craig S Anderson
Type
Resource Types::text::journal::journal article
URL Institutional Repository
Abstract
<jats:sec><jats:title>Background</jats:title><jats:p> Randomized controlled trials provide high-level evidence, but the necessity to include selected patients may limit the generalisability of their results. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Comparisons were made of baseline and outcome data between patients with acute ischemic stroke (AIS) recruited into the alteplase-dose arm of the international, multi-center, Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) in the United Kingdom (UK), and alteplase-treated AIS patients registered in the UK Sentinel Stroke National Audit Programme (SSNAP) registry, over the study period June 2012 to October 2015. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> There were 770 AIS patients (41.2% female; mean age 72 years) included in ENCHANTED at sites in England and Wales, which was 19.5% of alteplase-treated AIS patients registered in the SSNAP registry. Trial participants were significantly older, had lower baseline neurological severity, less likely Asian, and had more premorbid symptoms, hypertension and atrial fibrillation. Although ENCHANTED participants had higher rates of symptomatic intracerebral hemorrhage than those in SSNAP, there were no differences in onset-to-treatment time, levels of disability (assessed by the modified Rankin scale) at hospital discharge, and mortality over 90 days between groups. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Despite the high level of participation, equipoise over the dose of alteplase among UK clinician investigators favored the inclusion of older, frailer, milder AIS patients in the ENCHANTED trial. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616 </jats:p></jats:sec>
Subjects
acute ischemic stroke
;
alteplase
;
thrombolysis
;
clinical trial
;
health outcomes
;
adult
;
aged
;
aged, 80 and over
;
female
;
fibrinolytic agents
;
humans
;
male
;
middle aged
;
patient selection
;
randomized controlled trials as topic
;
registries
;
stroke
;
tissue plasminogen activator
;
alteplase
;
fibrinolytic agent
;
tissue plasminogen activator
;
aged
;
article
;
asian
;
blood clot lysis
;
blood pressure regulation
;
brain hemorrhage
;
brain ischemia
;
controlled study
;
disease registry
;
disease severity
;
drug dose comparison
;
england
;
ethnic difference
;
evidence based medicine
;
factor analysis
;
female
;
human
;
low drug dose
;
major clinical study
;
male
;
multicenter study
;
national institutes of health stroke scale
;
open study
;
priority journal
;
randomized controlled trial
;
rankin scale
;
treatment outcome
;
united kingdom
;
wales
;
adult
;
cerebrovascular accident
;
comparative study
;
middle aged
;
patient selection
;
randomized controlled trial (topic)
;
register
;
very elderly