Pre-hospital transdermal glyceryl trinitrate in patients with stroke mimics: data from the RIGHT-2 randomised-controlled ambulance trial

Tunnage, B. et al. (2022) Pre-hospital transdermal glyceryl trinitrate in patients with stroke mimics: data from the RIGHT-2 randomised-controlled ambulance trial. BMC Emergency Medicine, 22(1), 2. (doi: 10.1186/s12873-021-00560-x) (PMID:35012462) (PMCID:PMC8744321)

Abstract

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. Trial registration: This trial is registered with International Standard Randomised Controlled Trials Number ISRCTN 26986053.

• Item Type: Articles
• Additional Information: This work was supported by the British Heart Foundation [grant number CS/ 14/4/30972] and sponsored by the University of Nottingham.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Muir, Professor Keith
• Authors: Tunnage, B., Woodhouse, L. J., Dixon, M., Anderson, C., Ankolekar, S., Appleton, J., Cala, L., England, T., Krishnan, K., Havard, D., Mair, G., Muir, K., Phillips, S., Potter, J., Price, C., Randall, M., Robinson, T. G., Roffe, C., Sandset, E., Siriwardena, N., Scutt, P., Wardlaw, J. M., Sprigg, N., and Bath, P. M.
• College/School: College of Medical Veterinary and Life Sciences > School of Psychology & Neuroscience
• Journal Name: BMC Emergency Medicine
• Publisher: BioMed Central
• ISSN: 1471-227X
• ISSN (Online): 1471-227X
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in BMC Emergency Medicine 22(1):2
• Publisher Policy: Reproduced under a Creative Commons License