• Nils Wahlgren, Niaz Ahmed, Niclas Eriksson, Franz Aichner, Erich Bluhmki, Antoni Dávalos, Terttu Erilä, Gary A Ford, Martin Grond, Werner Hacke, Michael G Hennerici, Markku Kaste, Martin Köhrmann, Vincent Larrue, Kennedy R Lees, Thomas Machnig, Risto O Roine, Danilo Toni, Geert Vanhooren, and Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy Investigators.
• Department of Neurology, Karolinska University Hospital-Solna, Karolinska Institutet, Stockholm, Sweden. nils.wahlgren@karolinska.se
• Stroke. 2008 Dec 1;39(12):3316-22.

Background And PurposeThe Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy (SITS-MOST) unadjusted results demonstrated that intravenous alteplase is well tolerated and that the effects were comparable with those seen in randomized, controlled trials (RCTs) when used in routine clinical practice within 3 hours of ischemic stroke onset. We aimed to identify outcome predictors and adjust the outcomes of the SITS-MOST to the baseline characteristics of RCTs.MethodsThe study population was SITS-MOST (n=6483) and pooled RCTs (n=464) patients treated with intravenous alteplase within 3 hours of stroke onset. Multivariable, backward stepwise regression analyses (until Por=1 within 7 days with any hemorrhage (RCT definition), mortality, and independency as defined by modified Rankin Score of 0 to 2 at 3 months.ResultsThe adjusted proportion of symptomatic intracerebral hemorrhage for SITS-MOST was 8.5% (95% CI, 7.9 to 9.0) versus 8.6% (6.3 to 11.6) for pooled RCTs; mortality was 15.5% (14.7 to 16.2) versus 17.3% (14.1 to 21.1); and independency was 50.4% (49.6 to 51.2) versus 50.1% (44.5 to 54.7), respectively. In the multivariable analysis, older age, high blood glucose, high National Institutes of Health Stroke Scale score, and current infarction on imaging scans were related to poor outcome in all parameters. Systolic blood pressure, atrial fibrillation, and weight were additional predictors of symptomatic intracerebral hemorrhage. Current smokers had a lower rate of symptomatic intracerebral hemorrhage. Disability before current stroke (modified Rankin Score 2 to 5), diastolic blood pressure, antiplatelet other than aspirin, congestive heart failure, patients treated in new centers, and male sex were related to high mortality at 3 months.ConclusionsThe adjusted outcomes from SITS-MOST were almost identical to those in relevant RCTs and reinforce the conclusion drawn previously in the unadjusted analysis. We identified several important outcome predictors to better identify patients suitable for thrombolysis.

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