Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial

Yuko Y Palesch, Sharon D Yeatts, Thomas A Tomsick, Lydia D Foster, Andrew M Demchuk, Pooja Khatri, Michael D Hill, Edward C Jauch, Tudor G Jovin, Bernard Yan, Rüdiger von Kummer, Carlos A Molina, Mayank Goyal, Wouter J Schonewille, Mikael Mazighi, Stefan T Engelter, Craig Anderson, Judith Spilker, Janice Carrozzella, Karla J Ryckborst, L Scott Janis, Annie Simpson, Kit N Simpson, Joseph P Broderick, Interventional Management of Stroke III Investigators, Yuko Y Palesch, Sharon D Yeatts, Thomas A Tomsick, Lydia D Foster, Andrew M Demchuk, Pooja Khatri, Michael D Hill, Edward C Jauch, Tudor G Jovin, Bernard Yan, Rüdiger von Kummer, Carlos A Molina, Mayank Goyal, Wouter J Schonewille, Mikael Mazighi, Stefan T Engelter, Craig Anderson, Judith Spilker, Janice Carrozzella, Karla J Ryckborst, L Scott Janis, Annie Simpson, Kit N Simpson, Joseph P Broderick, Interventional Management of Stroke III Investigators

Abstract

Background and purpose: Randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at 3 months, but data regarding outcomes at 12 months are currently lacking.

Methods: We compared functional and quality-of-life outcomes at 12 months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the Interventional Management of Stroke III Trial. The key outcome measures were a modified Rankin Scale score ≤2 (functional independence) and the Euro-QoL EQ-5D, a health-related quality-of-life measure.

Results: 656 subjects with moderate-to-severe stroke (National Institutes of Health Stroke Scale ≥8) were enrolled at 58 centers in the United States (41 sites), Canada (7), Australia (4), and Europe (6). There was an interaction between treatment group and stroke severity in the repeated measures analysis of modified Rankin Scale ≤2 outcome (P=0.039). In the 204 participants with severe stroke (National Institutes of Health Stroke Scale ≥20), a greater proportion of the endovascular group had a modified Rankin Scale ≤2 (32.5%) at 12 months as compared with the intravenous tissue-type plasminogen activator group (18.6%, P=0.037); no difference was seen for the 452 participants with moderately severe strokes (55.6% versus 57.7%). In participants with severe stroke, the endovascular group had 35.2 (95% confidence interval: 2.1, 73.3) more quality-adjusted-days over 12 months as compared with intravenous tissue-type plasminogen activator alone.

Conclusions: Endovascular therapy improves functional outcome and health-related quality-of-life at 12 months after severe ischemic stroke.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Keywords: acute stroke; endovascular procedures; randomized trial; tPA.

© 2015 American Heart Association, Inc.

Figures

Figure 1
Figure 1
Proportion of mRS 0-2 Over Time by Stroke Severity Cohort
Figure 2
Figure 2
Distribution of mRS scores by Time of Assessment by Stroke Severity Cohort
Figure 3
Figure 3
Unadjusted* and Adjusted† Common Odds Ratio (95% CI) from Repeated Measures Analysis of the mRS 0-2 and Ordinal mRS, Overall and by Stroke Severity *Model includes time and treatment covariates †Model includes time, treatment, NIHSS cohort, time from onset to IV t-PA initiation, and age covariates
Figure 4
Figure 4
Repeated measures analysis by Pre-specified Subgroups for Severe Stroke Group *Model includes time, treatment, NIHSS cohort, time from onset to IV t-PA initiation, and age covariates ICA – internal carotid artery, M1 – first division of middle cerebral artery, ASPECTS – Alberta Stroke Program Early CT score

Source: PubMed

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