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Original Investigation |

Effect of the Use of Ambulance-Based Thrombolysis on Time to Thrombolysis in Acute Ischemic Stroke:  A Randomized Clinical Trial

Martin Ebinger, MD1,2; Benjamin Winter, MD1,2; Matthias Wendt, MD1; Joachim E. Weber, MD1; Carolin Waldschmidt, MD1; Michal Rozanski, MD1,2; Alexander Kunz, MD1,2; Peter Koch, MD1; Philipp A. Kellner, MD3; Daniel Gierhake, MD2; Kersten Villringer, MD2; Jochen B. Fiebach, MD2; Ulrike Grittner, PhD2,4; Andreas Hartmann, MD5; Bruno-Marcel Mackert, MD6; Matthias Endres, MD1,2,7,8,9; Heinrich J. Audebert, MD1,2 ; for the STEMO Consortium
[+] Author Affiliations
1Department of Neurology, Charité–Universitätsmedizin Berlin
2Center for Stroke Research Berlin (CSB), Charité–Universitätsmedizin Berlin
3Vivantes–Klinikum im Friedrichshain, Rettungsstelle, Berlin
4Department for Biostatistics and Clinical Epidemiology, Charité–Universitätsmedizin Berlin
5Rhön-Klinikum–Klinikum Frankfurt (Oder), Frankfurt (Oder)
6Vivantes–Auguste-Viktoria-Klinikum, Berlin
7ExcellenceCluster NeuroCure, Charité–Universitätsmedizin Berlin
8German Center for Neurodegenerative Diseases (DZNE), Berlin
9German Center for Cardiovascular Research (DZHK), Berlin
JAMA. 2014;311(16):1622-1631. doi:10.1001/jama.2014.2850.
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Published online

Importance  Time to thrombolysis is crucial for outcome in acute ischemic stroke.

Objective  To determine if starting thrombolysis in a specialized ambulance reduces delays.

Design, Setting, and Participants  In the Prehospital Acute Neurological Treatment and Optimization of Medical care in Stroke Study (PHANTOM-S), conducted in Berlin, Germany, we randomly assigned weeks with and without availability of the Stroke Emergency Mobile (STEMO) from May 1, 2011, to January 31, 2013. Berlin has an established stroke care infrastructure with 14 stroke units. We included 6182 adult patients (STEMO weeks: 44.3% male, mean [SD] age, 73.9 [15.0] y; control weeks: 45.2% male, mean [SD] age, 74.3 [14.9] y) for whom a stroke dispatch was activated.

Interventions  The intervention comprised an ambulance (STEMO) equipped with a CT scanner, point-of-care laboratory, and telemedicine connection; a stroke identification algorithm at dispatcher level; and a prehospital stroke team. Thrombolysis was started before transport to hospital if ischemic stroke was confirmed and contraindications excluded.

Main Outcomes and Measures  Primary outcome was alarm-to-thrombolysis time. Secondary outcomes included thrombolysis rate, secondary intracerebral hemorrhage after thrombolysis, and 7-day mortality.

Results  Time reduction was assessed in all patients with a stroke dispatch from the entire catchment area in STEMO weeks (3213 patients) vs control weeks (2969 patients) and in patients in whom STEMO was available and deployed (1804 patients) vs control weeks (2969 patients). Compared with thrombolysis during control weeks, there was a reduction of 15 minutes (95% CI, 11-19) in alarm-to-treatment times in the catchment area during STEMO weeks (76.3 min; 95% CI, 73.2-79.3 vs 61.4 min; 95% CI, 58.7-64.0; P < .001). Among patients for whom STEMO was deployed, mean alarm-to-treatment time (51.8 min; 95% CI, 49.0-54.6) was shorter by 25 minutes (95% CI, 20-29; P < .001) than during control weeks. Thrombolysis rates in ischemic stroke were 29% (310/1070) during STEMO weeks and 33% (200/614) after STEMO deployment vs 21% (220/1041) during control weeks (differences, 8%; 95% CI, 4%-12%; P < .001, and 12%, 95% CI, 7%-16%; P < .001, respectively). STEMO deployment incurred no increased risk for intracerebral hemorrhage (STEMO deployment: 7/200; conventional care: 22/323; adjusted odds ratio [OR], 0.42, 95% CI, 0.18-1.03; P = .06) or 7-day mortality (9/199 vs 15/323; adjusted OR, 0.76; 95% CI, 0.31-1.82; P = .53).

Conclusions and Relevance  Compared with usual care, the use of ambulance-based thrombolysis resulted in decreased time to treatment without an increase in adverse events. Further studies are needed to assess the effects on clinical outcomes.

Trial Registration  clinicaltrials.gov Identifier: NCT01382862

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Figure 1.
Map of Berlin, Germany, With Color-Coded STEMO Catchment Area Around STEMO Base

The Stroke Emergency Mobile (STEMO) catchment area (colored zones) is defined by a 75% probability of reaching the emergency site within 16 minutes from base (Fire Station 3400, Berlin-Wilmersdorf). Courtesy of the Berliner Feuerwehr.

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Figure 2.
Study Flowchart According to STEMO Weeks and Control Weeks

During Stroke Emergency Mobile (STEMO) weeks, there were 2027 patients with STEMO deployment; 1804 of these patients had in-hospital documentation. Patients without disabling neurological deficits at first assessment who received thrombolysis after a secondary worsening or recurrence of symptoms were excluded from primary outcome analysis. MRI indicates magnetic resonance imaging; tPA, tissue plasminogen activator.aOf these deployments, 349 were cancelled before STEMO arrival (6 of these patients received tPA in hospitals).

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