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Observational Study
. 2024 Dec 1;81(12):1250-1262.
doi: 10.1001/jamaneurol.2024.3659.

Mobile Stroke Unit Management in Patients With Acute Ischemic Stroke Eligible for Intravenous Thrombolysis

Brian Mac Grory  1   2 , Jie-Lena Sun  2 , Brooke Alhanti  2   3 , Jay Lusk  1 , Fan Li  3   4 , Opeolu Adeoye  5 , Karen Furie  6 , David Hasan  7 , Steven Messe  8 , Kevin N Sheth  9 , Lee H Schwamm  9 , Eric E Smith  10 , Deepak L Bhatt  11 , Gregg C Fonarow  12   13   14 , Jeffrey L Saver  15   16 , Ying Xian  17   18   19 , James Grotta  20
Affiliations
Observational Study

Mobile Stroke Unit Management in Patients With Acute Ischemic Stroke Eligible for Intravenous Thrombolysis

Brian Mac Grory et al. JAMA Neurol. .

Abstract

Importance: Clinical trials have suggested that prehospital management in a mobile stroke unit (MSU) improves functional outcomes in patients with acute ischemic stroke who are potentially eligible for intravenous thrombolysis, but there is a paucity of real-world evidence from routine clinical practice on this topic.

Objective: To determine the association between prehospital management in an MSU vs standard emergency medical services (EMS) management and the level of global disability at hospital discharge.

Design, setting, and participants: This was a retrospective, observational, cohort study that included consecutive patients with a final diagnosis of ischemic stroke who received either prehospital management in an MSU or standard EMS management between August 1, 2018, and January 31, 2023. Follow-up ended at hospital discharge. The primary analytic cohort included those who were potentially eligible for IV thrombolysis. A separate, overlapping cohort including all patients regardless of diagnosis was also analyzed. Patient data were obtained from the American Heart Association's Get With The Guidelines-Stroke (GWTG-Stroke) Program, a nationwide, multicenter quality assurance registry. This analysis was completed in May 2024.

Exposure: Prehospital management in an MSU (vs standard EMS management).

Main outcomes and measures: The primary efficacy end point was the utility-weighted modified Rankin Scale (UW-mRS) score. The secondary efficacy end point was independent ambulation status. The coprimary safety end points were symptomatic intracranial hemorrhage (sICH) and in-hospital mortality.

Results: Of 19 433 patients (median [IQR] age, 73 [62-83] years; 9867 female [50.8%]) treated at 106 hospitals, 1237 (6.4%) received prehospital management in an MSU. Prehospital management in an MSU was associated with a better score on the UW-mRS at discharge (adjusted mean difference, 0.03; 95% CI, 0.01-0.05) and a higher likelihood of independent ambulation at discharge (53.3% [468 of 878 patients] vs 48.3% [5868 of 12 148 patients]; adjusted risk ratio [aRR], 1.08; 95% CI, 1.03-1.13). There was no statistically significant difference in sICH (5.2% [57 of 1094] vs 4.2% [545 of 13 014]; aRR, 1.30; 95% CI, 0.94-1.75]) or in-hospital mortality (5.7% [70 of 1237] vs 6.2% [1121 of 18 196]; aRR, 1.03; 95% CI, 0.78-1.27) between the 2 groups.

Conclusions and relevance: Among patients with acute ischemic stroke potentially eligible for intravenous thrombolysis, prehospital management in an MSU compared with standard EMS management was associated with a significantly lower level of global disability at hospital discharge. These findings support policy efforts to expand access to prehospital MSU management.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Mac Grory reported receiving grants from National Institutes of Health (NIH) and American Heart Association (AHA) during the conduct of the study. Dr Sheth reported receiving advisory board fees from Bexorg, Brain Q, Astrocyte, and Rhaeos; grants from NIH, AHA, and Hyperfine; data safety monitoring board fees from Sense and Phillips; and having a patent for Alva issued. Dr Schwamm reported receiving data safety monitoring board fees from Penumbra, consultant fees from Medtronic, and committee member fees from Genentech (TIMELESS NCT03785678) outside the submitted work. Dr Bhatt reported receiving advisory board fees from Angiowave, Bayer, Boehringer Ingelheim, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Stasys; participating on the board of directors for the AHA of New York City; receiving stock options from Angiowave, Bristol Myers Squibb, DRS.LINQ, and High Enroll; receiving consultant fees from Broadview Ventures, GlaxoSmithKline, Hims, SFJ, and Youngene; serving on data monitoring committees for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic, Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical; for ALLAY-HF, funded by Alleviant Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); receiving honoraria from American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (AHA lecture), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), WebMD (CME steering committees), Wiley (steering committee); serving as deputy editor of Clinical Cardiology; having a patent for sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women’s Hospital who assigned to Lexicon; neither I nor Brigham and Women’s Hospital receive any income from this patent); receiving research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, 89Bio; receiving royalties from Elsevier (Editor, Braunwald’s Heart Disease); serving as site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; serving as trustee for the American College of Cardiology; and receiving unfunded research support from FlowCo. Dr Fonarow reported receiving grants from Patient-Centered Outcomes Research Institute, nonfinancial support from Get With The Guidelines Steering Committee, and being an employee of the University of California. Dr Saver reported receiving steering committee fees from Roche, Genentech, Medtronic, BrainQ, Ji-Xing, and Rapid Medical. Dr Xian reported receiving personal fees from Boehringer Ingelheim and grants from Genentech and the National Institute on Aging (R01AG062770 and R01AG066672) outside the submitted work. Dr Grotta reported receiving consulting fees from Frazer Ltd during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart of Patient Selection for Inclusion in the Study
Trained hospital personnel use a patient management tool to collect data on consecutive patients with acute ischemic stroke (AIS) admitted to each participating hospital. AMA indicates against medical advice; EMS, emergency medical services; GWTG, Get With The Guidelines; IV tPA, intravenous tissue plasminogen activator; MSU, mobile stroke unit; NIHSS, National Institutes of Health Stroke Scale.
Figure 2.
Figure 2.. Adjusted Association Between Time From Symptom Onset to Intravenous (IV) Thrombolysis and Key Study End Points
Logistic regression models were created to examine the association between time from symptom onset to IV thrombolysis and utility-weighted modified Rankin Scale (UW-mRS) (A), independent ambulation (B), and mortality (C). Time from symptom onset to IV thrombolysis was modeled as a restricted cubic spline with 4 knots. Adjustment covariates were age, biological sex, and admission National Institutes of Health Stroke Scale with site included as a random effect. EMS indicates emergency medical services; MSU, mobile stroke unit; tPA, intravenous tissue plasminogen activator.
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