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Pre-hospital Transdermal Glyceryl Trinitrate in Patients With Stroke Mimics: Data From the Right-2 Randomised-controlled Ambulance Trial

Tunnage, Bronwyn; Woodhouse, Lisa J.; Dixon, Mark; Anderson, Craig; Ankolekar, Sandeep; Appleton, Jason; Cala, Lesley; England, Timothy; Krishnan, Kailash; Havard, Diane; Mair, Grant; Muir, Keith; Phillips, Steve; Potter, John; Price, Christopher; Randall, Marc; Robinson, Thompson G.; Roffe, Christine; Sandset, Else; Siriwardena, Niro; Scutt, Polly; Wardlaw, Joanna M.; Sprigg, Nikola; Bath, Philip M.; Investigators, RIGHT-2

Pre-hospital Transdermal Glyceryl Trinitrate in Patients With Stroke Mimics: Data From the Right-2 Randomised-controlled Ambulance Trial Thumbnail


Authors

Bronwyn Tunnage

Lisa J. Woodhouse

Mark Dixon

Craig Anderson

Sandeep Ankolekar

Jason Appleton

Lesley Cala

Timothy England

Kailash Krishnan

Diane Havard

Grant Mair

Keith Muir

Steve Phillips

John Potter

Christopher Price

Marc Randall

Thompson G. Robinson

Else Sandset

Niro Siriwardena

Polly Scutt

Joanna M. Wardlaw

Nikola Sprigg

Philip M. Bath

RIGHT-2 Investigators



Abstract

Background: Prehospital stroke trials will inevitably recruit patients with non-stroke conditions, so called stroke mimics. We undertook a pre-specified analysis to determine outcomes in patients with mimics in the second Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial (RIGHT-2). Methods: RIGHT-2 was a prospective, multicentre, paramedic-delivered, ambulance-based, sham-controlled, participant-and outcome-blinded, randomised-controlled trial of transdermal glyceryl trinitrate (GTN) in adults with ultra-acute presumed stroke in the UK. Final diagnosis (intracerebral haemorrhage, ischaemic stroke, transient ischaemic attack, mimic) was determined by the hospital investigator. This pre-specified subgroup analysis assessed the safety and efficacy of transdermal GTN (5 mg daily for 4 days) versus sham patch among stroke mimic patients. The primary outcome was the 7-level modified Rankin Scale (mRS) at 90 days. Results Among 1149 participants in RIGHT-2, 297 (26%) had a final diagnosis of mimic (GTN 134, sham 163). The mimic group were younger, mean age 67 (SD: 18) vs 75 (SD: 13) years, had a longer interval from symptom onset to randomisation, median 75 [95% CI: 47,126] vs 70 [95% CI:45,108] minutes, less atrial fibrillation and a lower systolic blood pressure and Face-Arm-Speech-Time tool score than the stroke group. The three most common mimic diagnoses were seizure (17%), migraine or primary headache disorder (17%) and functional disorders (14%). At 90 days, the GTN group had a better mRS score as compared to the sham group (adjusted common odds ratio 0.54; 95% confidence intervals 0.34, 0.85; p = 0.008), a difference that persisted at 365 days. There was no difference in the proportion of patients who died in hospital, were discharged to a residential care facility, or suffered a serious adverse event. Conclusions One-quarter of patients suspected by paramedics to have an ultra-acute stroke were subsequently diagnosed with a non-stroke condition. GTN was associated with unexplained improved functional outcome observed at 90 days and one year, a finding that may represent an undetected baseline imbalance, chance, or real efficacy. GTN was not associated with harm.

Journal Article Type Article
Acceptance Date Nov 28, 2021
Online Publication Date Jan 10, 2022
Publicly Available Date Mar 29, 2024
Journal BMC Emergency Medicine
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 22
Article Number 2
DOI https://doi.org/10.1186/s12873-021-00560-x
Publisher URL https://bmcemergmed.biomedcentral.com/articles/10.1186/s12873-021-00560-x#article-info
Related Public URLs https://www.researchsquare.com/article/rs-147007/v1