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ToolsTunnage, 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 and Bath, Philip M. (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). ISSN 1471-227X
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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. Trial registration: This trial is registered with International Standard Randomised Controlled Trials Number ISRCTN 26986053.
| Item Type: | Article |
|---|---|
| Additional Information: | Funding Information: This work was supported by the British Heart Foundation [grant number CS/14/4/30972] and sponsored by the University of Nottingham. There was no commercial support for the trial, and GTN patches and sham dressings were sourced by the Pharmacy Department at Nottingham University Hospitals NHS Trust. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author and two statisticians (LJW, PS) had full access to all the data in the study and the corresponding author had final responsibility for the decision to submit for publication. |
| Uncontrolled Keywords: | ambulance,functional stroke,glyceryl trinitrate,migraine,mimic,nitroglycerin,paramedic,seizures,stroke,emergency medicine ,/dk/atira/pure/subjectarea/asjc/2700/2711 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health Faculty of Medicine and Health Sciences > Research Groups > Nutrition and Preventive Medicine |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 27 Jan 2022 13:30 |
| Last Modified: | 23 Oct 2022 03:29 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/83185 |
| DOI: | 10.1186/s12873-021-00560-x |
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