451. Diffusion-weighted imaging lesion growth occurs despite recanalization in acute ischemic stroke: Implications for future treatment trials.
- Author
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Sah RG, d'Esterre CD, Hill MD, Hafeez M, Tariq S, Forkert ND, Frayne R, Demchuk AM, Goyal M, and Barber PA
- Subjects
- Aged, Aged, 80 and over, Brain pathology, Brain Ischemia epidemiology, Canada epidemiology, Diffusion Magnetic Resonance Imaging, Female, Follow-Up Studies, Humans, Infarction etiology, Male, Middle Aged, Stroke epidemiology, Thrombolytic Therapy, Treatment Outcome, Brain diagnostic imaging, Brain Ischemia therapy, Cerebral Revascularization, Infarction epidemiology, Postoperative Complications epidemiology, Stroke therapy
- Abstract
Background: A proportion of patients presenting with acute small ischemic strokes have poor functional outcomes, even following rapid recanalization treatment., Aims: Infarct growth may occur even after successful recanalization and could represent an appropriate endpoint for future stroke therapy trials., Methods: Magnetic resonance diffusion-weighted imaging lesion volumes were obtained at 5 h (initial posttreatment) and 24 h (follow-up) after acute stroke treatment for n = 33 in ischemic stroke patients. Sample sizes per arm (90% power, 30% effect size) for diffusion-weighted imaging lesion growth between initial and 24 h, early change in the National Institutes of Health Stroke Scale between pre- and 24 h, National Institutes of Health Stroke Scale at 24 h, and diffusion-weighted imaging lesion volume at 24 h were estimated to power a placebo-controlled stroke therapy trial., Results: For patients with poor recanalization (modified thrombolysis in cerebral infarction <2 a; modified arterial occlusion lesion = 0-2) (n = 11), the median diffusion-weighted imaging lesion growth was 8.1 (interquartile range: 4.5, 22.4) ml and with good recanalization (modified thrombolysis in cerebral infarction =2 b or 3; modified arterial occlusion lesion = 3) (n = 22), the median diffusion-weighted imaging lesion growth was 10.0 (interquartile range: 6.0, 28.2) ml ( P = 0.749). When considering a 30% effect size, the sample size required per arm to achieve significance in an acute stroke study would be: (1) N = 49 for the diffusion-weighted imaging lesion growth between initial posttreatment and follow-up time points, (2) N = 65 for the change in the National Institutes of Health Stroke Scale between admission and 24 h, (3) N = 259 for the National Institutes of Health Stroke Scale at 24 h, and (4) N = 256 for diffusion-weighted imaging volume at 24 h., Conclusion: Despite best efforts to recanalize the ischemic brain, early diffusion-weighted imaging lesion growth still occurs. Treatment trials in stroke should consider early diffusion-weighted imaging lesion growth as a surrogate outcome measure to significantly reduce sample sizes.
- Published
- 2019
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