Positive Result After Reanalysis Using Baseline Diffusion-Weighted Imaging/Perfusion-Weighted Imaging Co-Registration

Yoshinari Nagakane, Soren Christensen, Caspar Brekenfeld, Henry Ma, Leonid Churilov, Mark Parsons, Christopher Levi, Kenneth Butcher, Andre Peeters, Alan Barber, Christopher Bladin, Diedre De Silva, John Fink, Thomas Kimber, David Schultz, Keith Muir, Brian Tress, Patricia Desmond, Stephen Davis, Geoffrey Donnan

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    75 Citations (Scopus)

    Abstract

    Background and Purpose-The Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) was a prospective, randomized, double-blinded, placebo-controlled, phase II trial of alteplase between 3 and 6 hours after stroke onset. The primary outcome of infarct growth attenuation on MRI with alteplase in mismatch patients was negative when mismatch volumes were assessed volumetrically, without coregistration, which underestimates mismatch volumes. We hypothesized that assessing the extent of mismatch by coregistration of perfusion and diffusion MRI maps may more accurately allow the effects of alteplase vs placebo to be evaluated. Methods-Patients were classified as having mismatch if perfusion-weighted imaging divided by coregistered diffusionweighted imaging volume ratio was >1.2 and total coregistered mismatch volume was >10 mL. The primary outcome was a comparison of infarct growth in alteplase vs placebo patients with coregistered mismatch. Results-Of 99 patients with baseline diffusion-weighted imaging and perfusion-weighted imaging, coregistration of both images was possible in 95 patients. Coregistered mismatch was present in 93% (88/95) compared to 85% (81/95) with standard volumetric mismatch. In the coregistered mismatch patients, of whom 45 received alteplase and 43 received placebo, the primary outcome measure of geometric mean infarct growth was significantly attenuated by a ratio of 0.58 with alteplase compared to placebo (1.02 vs 1.77; 95% CI, 0.33- 0.99; P=0.0459). Conclusions-When using coregistration techniques to determine the presence of mismatch at study entry, alteplase significantly attenuated infarct growth. This highlights the necessity for a randomized, placebo-controlled, phase III clinical trial of alteplase using penumbral selection beyond 3 hours.

    Original languageEnglish
    Pages (from-to)59-64
    Number of pages6
    JournalStroke
    Volume42
    Issue number1
    DOIs
    Publication statusPublished - 1 Jan 2011

    Keywords

    • Magnetic resonance imaging
    • Mismatch
    • Penumbra
    • Tissue plasminogen activator

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