INTRODUCTION: The SITS-UTMOST (Safe Implementation of Thrombolysis in Upper Time window Monitoring Study) was a registry-based prospective study of intravenous alteplase used in the extended time window (3-4.5 h) in acute ischaemic stroke to evaluate the impact of the approval of the extended time window on routine clinical practice. PATIENTS AND METHODS: Inclusion of at least 1000 patients treated within 3-4.5 h according to the licensed criteria and actively registered in the SITS-International Stroke Thrombolysis Registry was planned. Prospective data collection started 2 May 2012 and ended 2 November 2014. A historical cohort was identified for 2 years preceding May 2012. Clinical management and outcome were contrasted between patients treated within 3 h versus 3-4.5 h in the prospective cohort and between historical and prospective cohorts for the 3 h time window. Outcomes were functional independency (modified Rankin scale, mRS) 0-2, favourable outcome (mRS 0-1), and death at 3 months and symptomatic intracerebral haemorrhage (SICH) per SITS. RESULTS: 4157 patients from 81 centres in 12 EU countries were entered prospectively (N = 1118 in the 3-4.5 h, N = 3039 in the 0-3 h time window) and 3454 retrospective patients in the 0-3 h time window who met the marketing approval conditions. In the prospective cohort, median arrival to treatment time was longer in the 3-4.5 h than 3 h window (79 vs. 55 min). Within the 3 h time window, treatment delays were shorter for prospective than historical patients (55 vs. 63). There was no significant difference between the 3-4.5 h versus 3 h prospective cohort with regard to percentage of reported SICH (1.6 vs. 1.7), death (11.6 vs. 11.1), functional independency (66 vs. 65) at 3 months or favourable outcome (51 vs. 50). DISCUSSION: Main weakness is the observational design of the study. CONCLUSION: This study neither identified negative impact on treatment delay, nor on outcome, following extension of the approved time window to 4.5 h for use of alteplase in stroke.

Biostatistics Boehringer Ingelheim Pharma GmbH and Co KG Biberach an der Riss Germany

Boehringer Ingelheim Medical Department Boehringer Ingelheim AB Stockholm Sweden

Department of Clinical Neuroscience Karolinska Institutet and Department of Neurology Karolinska University Hospital Stockholm Sweden

Department of Neurology and Psychiatry Sapienza University of Rome Italy

Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow UK

International Clinical Research Center and Neurology Department St Anne's Hospital in Brno Czech Republic and Masaryk University Brno Czech Republic

Luton and Dunstable NHSFT University Hospital Lewsey Road Luton UK

Medical Department Boehringer Ingelheim France S A S Reims France

Medical Sciences Division University of Oxford and Oxford University Hospitals NHS Foundation Trust Oxford UK

Unidade CerebroVascular Hospital de São José Centro Hospitalar de Lisboa Central Lisbon Portugal

University Hospitals Coventry and Warwickshire NHS Trust UK

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