Tunnage, B, Woodhouse, LJ, Dixon, M, Anderson, C, Ankolekar, S, Appleton, J, Cala, L, England, T, Krishnan, K, Harvard, D, Mair, K, Phillips, S, Potter, J, Price, C, Randall, M, Robinson, TG, Roffe, C ORCID: https://orcid.org/0000-0002-5259-6649, Sandset, E, Siriwardena, N, Scutt, P, Wardlaw, JM, Sprigg, N and Bath, PM (2021) Pre-hospital Transdermal Glyceryl Trinitrate in Patients With Stroke Mimics: Data From the Right-2 Randomised-controlled Ambulance Trial. BMC Emergency Medicine. (Submitted)

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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.

Item Type: Article
Additional Information: This has been submitted, and has yet to be accepted and published. If this changes, the correct amendments will be made.
Divisions: Faculty of Medicine and Health Sciences > School of Pharmacy and Bioengineering
Depositing User: Symplectic
Date Deposited: 06 May 2021 07:44
Last Modified: 06 May 2021 07:44
URI: https://eprints.keele.ac.uk/id/eprint/9494

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