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Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial

Appleton, Jason Philip; Woodhouse, Lisa J.; Anderson, Craig S.; Ankolekar, Sandeep; Cala, Lesley; Dixon, Mark; England, Timothy J.; Krishnan, Kailash; Mair, Grant; Muir, Keith W.; Potter, John; Price, Christopher I.; Randall, Marc; Robinson, Thompson G.; Roffe, Christine; Sandset, Else C.; Saver, Jeffrey L.; Shone, Angela; Siriwardena, Aloysius Niroshan; Wardlaw, Joanna M.; Sprigg, Nikola; Bath, Philip M.

Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial Thumbnail


Authors

Jason Philip Appleton

Craig S. Anderson

Sandeep Ankolekar

Lesley Cala

Mark Dixon

Kailash Krishnan

Grant Mair

Keith W. Muir

John Potter

Christopher I. Price

Marc Randall

Thompson G. Robinson

Christine Roffe

Else C. Sandset

Jeffrey L. Saver

Angela Shone

Aloysius Niroshan Siriwardena

Joanna M. Wardlaw

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

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



Abstract

Background The effect of transdermal glyceryl trinitrate (GTN, a nitrovasodilator) on clinical outcome when administered before hospital admission in suspected stroke patients is unclear. Here, we assess the safety and efficacy of GTN in the prespecified subgroup of patients who had an ischaemic stroke within the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2).

Methods RIGHT-2 was an ambulance-based multicentre sham-controlled blinded-endpoint study with patients randomised within 4 hours of onset. The primary outcome was a shift in scores on the modified Rankin scale (mRS) at day 90. Secondary outcomes included death; a global analysis (Wei-Lachin test) containing Barthel Index, EuroQol-5D, mRS, telephone interview for cognitive status-modified and Zung depression scale; and neuroimaging-determined ‘brain frailty’ markers. Data were reported as n (%), mean (SD), median [IQR], adjusted common OR (acOR), mean difference or Mann-Whitney difference (MWD) with 95% CI.

Results 597 of 1149 (52%) patients had a final diagnosis of ischaemic stroke; age 75 (12) years, premorbid mRS>2 107 (18%), Glasgow Coma Scale 14 (2) and time from onset to randomisation 67 [45, 108] min. Neuroimaging ‘brain frailty’ was common: median score 2 [2, 3] (range 0–3). At day 90, GTN did not influence the primary outcome (acOR for increased disability 1.15, 95% CI 0.85 to 1.54), death or global analysis (MWD 0.00, 95% CI −0.10 to 0.09). In subgroup analyses, there were non-significant interactions suggesting GTN may be associated with more death and dependency in participants randomised within 1 hour of symptom onset and in those with more severe stroke.

Conclusions In patients who had an ischaemic stroke, ultra-acute administration of transdermal GTN in the ambulance did not improve clinical outcomes in a population with more clinical and radiological frailty than seen in previous in-hospital trials.

Citation

Appleton, J. P., Woodhouse, L. J., Anderson, C. S., Ankolekar, S., Cala, L., Dixon, M., …Bath, P. M. (2023). Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial. Stroke and Vascular Neurology, 9(1), https://doi.org/10.1136/svn-2022-001634

Journal Article Type Article
Acceptance Date Aug 12, 2022
Online Publication Date Jun 8, 2023
Publication Date Jun 8, 2023
Deposit Date Jun 21, 2023
Publicly Available Date Jun 21, 2023
Journal Stroke and Vascular Neurology
Electronic ISSN 2059-8696
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Issue 1
DOI https://doi.org/10.1136/svn-2022-001634
Keywords Stroke, Clinical Trial, Cerebral Infarction, Blood Pressure
Public URL https://nottingham-repository.worktribe.com/output/21646408
Publisher URL https://svn.bmj.com/content/early/2023/06/08/svn-2022-001634

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