uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Multivariable Analysis of Outcome Predictors and Adjustment of Main Outcome Results to Baseline Data Profile in Randomized Controlled Trials Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy (SITS-MOST)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm , UCR-Uppsala Clinical Research center.
Show others and affiliations
2008 (English)In: Stroke, ISSN 0039-2499, Vol. 39, no 12, 3316-3322 p.Article in journal (Refereed) Published
Abstract [en]

Background and Purpose-The 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.Methods-The 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 P <= 0.10) were performed to identify the outcome predictors for SITS-MOST. Variables appearing either in the final multivariable model or differing (P < 0.10) between SITS-MOST and RCTs were included in the prediction model for the adjustment of outcomes.Main outcome measures were symptomatic intracerebral hemorrhage, defined as National Institutes of Health Stroke Scale deterioration >= 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.Results-The 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.Conclusions-The 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.

Place, publisher, year, edition, pages
2008. Vol. 39, no 12, 3316-3322 p.
Keyword [en]
monitoring, multivariate, safety, stroke, thrombolysis
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-107010DOI: 10.1161/STROKEAHA.107.510768ISI: 000261224800028OAI: oai:DiVA.org:uu-107010DiVA: diva2:227558
Available from: 2009-07-15 Created: 2009-07-15 Last updated: 2009-07-16Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full text
By organisation
UCR-Uppsala Clinical Research center
In the same journal
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 154 hits
ReferencesLink to record
Permanent link

Direct link