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Prospective, Multicenter, Controlled Trial of Mobile Stroke Units
James C Grotta1, Jose-Miguel Yamal1, Stephanie A Parker1
1From the Mobile Stroke Unit, Memorial Hermann Hospital-Texas Medical Center (J.C.G., J. McCarthy, T.F.), the Departments of Biostatistics and Data Science (J.-M.Y., A.P.J., M.W., N.S., M.G.) and Management, Policy, and Community Heath (S.S.R.), University of Texas School of Public Health, the Departments of Neurology (S.A.P., N.R.G., P.L.B., N.R.-G., E.L., J.S., K.P., Y.S., E.A.N., R.B.) and Emergency Medicine (D.P.), University of Texas McGovern Medical School, the Departments of Emergency Medicine (D.P.) and Neurology (C.P.V.R.), Baylor College of Medicine, the Department of Neurology, Houston Methodist Hospital (D.C., J.V., V.M.), the Department of Neurology, Harris Health-Ben Taub General Hospital (J.S.K.), and HCA Houston Healthcare (L.G.) - all in Houston; the Department of Neurology, University of Colorado, UCHealth Anschutz Medical Campus, Aurora (W.J.J., B.D.S., K.A., M.E., D.O.), and the Department of Neurology, UCHealth Memorial Hospital, Colorado Springs (J. Miller) - both in Colorado; the Department of Neurology, University of Tennessee Health Science Center, Memphis (A.W.A., A.V.A., J.P.R.); the Department of Neurology, Weill Cornell Medicine (B.B.N., M.E.F., C.S., M.L., S.M.), and the Department of Neurology, Columbia University Irving Medical Center (J.Z.W.) - both in New York; the Department of Neurology, Ronald Reagan UCLA Medical Center, Los Angeles (M.N., J.L.S., K.M.B., B.M.V.), the Department of Neurology, Mills Peninsula Medical Center, Burlingame (I.S., J.E., N. Barazangi, J.I.), Los Angeles County Emergency Medical Services, Santa Fe Springs (M.G.-H., N. Bosson), and San Mateo County Emergency Medical Services, South San Francisco (G.G.) - all in California; and the Department of Neurology, Indiana University School of Medicine, Indianapolis (J. Mackey, S.Q.C., K.S.).
Background:
Mobile stroke units (MSUs) are ambulances with staff and a computed tomographic scanner that may enable faster treatment with tissue plasminogen activator (t-PA) than standard management by emergency medical services (EMS). Whether and how much MSUs alter outcomes has not been extensively studied.
Methods:
In an observational, prospective, multicenter, alternating-week trial, we assessed outcomes from MSU or EMS management within 4.5 hours after onset of acute stroke symptoms. The primary outcome was the score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes according to a patient value system, derived from scores on the modified Rankin scale of 0 to 6, with higher scores indicating more disability). The main analysis involved dichotomized scores on the utility-weighted modified Rankin scale (≥0.91 or <0.91, approximating scores on the modified Rankin scale of ≤1 or >1) at 90 days in patients eligible for t-PA. Analyses were also performed in all enrolled patients.
Results:
We enrolled 1515 patients, of whom 1047 were eligible to receive t-PA; 617 received care by MSU and 430 by EMS. The median time from onset of stroke to administration of t-PA was 72 minutes in the MSU group and 108 minutes in the EMS group. Of patients eligible for t-PA, 97.1% in the MSU group received t-PA, as compared with 79.5% in the EMS group. The mean score on the utility-weighted modified Rankin scale at 90 days in patients eligible for t-PA was 0.72 in the MSU group and 0.66 in the EMS group (adjusted odds ratio for a score of ≥0.91, 2.43; 95% confidence interval [CI], 1.75 to 3.36; P<0.001). Among the patients eligible for t-PA, 55.0% in the MSU group and 44.4% in the EMS group had a score of 0 or 1 on the modified Rankin scale at 90 days. Among all enrolled patients, the mean score on the utility-weighted modified Rankin scale at discharge was 0.57 in the MSU group and 0.51 in the EMS group (adjusted odds ratio for a score of ≥0.91, 1.82; 95% CI, 1.39 to 2.37; P<0.001). Secondary clinical outcomes generally favored MSUs. Mortality at 90 days was 8.9% in the MSU group and 11.9% in the EMS group.
Conclusions:
In patients with acute stroke who were eligible for t-PA, utility-weighted disability outcomes at 90 days were better with MSUs than with EMS. (Funded by the Patient-Centered Outcomes Research Institute; BEST-MSU ClinicalTrials.gov number, NCT02190500.).
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