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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

S Anderson, Craig; Robinson, Thompson G.; Bray, Benjamin D.; Paley, Lizz; Sprigg, Nikola; Wang, Xia; Arima, Hisatomi; Bath, Philip M.; Broderick, Joseph P.; Durham, Alice C.; Kim, Jong S.; Lavados, Pablo M.; Lee, Tsong Hai; Martins, Sheila; Nguyen, Thang H.; Pandian, Jeyaraj D.; Parsons, Mark W.; Pontes-Neto, Octavio M.; Ricci, Stefano; Sharma, Vijay K.; Wang, Jiguang; Woodward, Mark; Rudd, Anthony G.; Chalmers, John; Anderson, Craig S.; for the ENCHANTED Investigators and the SSNAP Collaboration

Authors

Craig S Anderson

Thompson G. Robinson

Benjamin D. Bray

Lizz Paley

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

Xia Wang

Hisatomi Arima

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

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

for the ENCHANTED Investigators and the SSNAP Collaboration



Abstract

© 2019 World Stroke Organization. Background: Randomized controlled trials provide high-level evidence, but the necessity to include selected patients may limit the generalisability of their results. Methods: 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. Results: 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. Conclusions: 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. Clinical trial registration: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616.

Journal Article Type Article
Publication Date Oct 1, 2019
Journal International Journal of Stroke
Print ISSN 1747-4930
Electronic ISSN 1747-4949
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 14
Issue 7
Pages 678-685
APA6 Citation S Anderson, C., Robinson, T. G., Bray, B. D., Paley, L., Sprigg, N., Wang, X., …for the ENCHANTED Investigators and the SSNAP Collaboration, . (2019). 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. International Journal of Stroke, 14(7), 678-685. https://doi.org/10.1177/1747493019841246
DOI https://doi.org/10.1177/1747493019841246
Keywords Neurology
Publisher URL https://journals.sagepub.com/doi/10.1177/1747493019841246

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