SAN DIEGO--(BUSINESS WIRE)--
The Society of NeuroInterventional Surgerys (SNIS) 9th Annual Meeting in San Diego announced today notable trial results that show scientific advancement in predicting which patients suffering from ischemic stroke will benefit from endovascular therapy--a technique that accomplishes treatment through clot-busting drugs or devices delivered through the arteries directly to the problem area in the brain. The Stroke Treatment and Revascularization Therapy (START) trial, sponsored by Penumbra, Inc., is one of the first prospective, core-lab adjudicated, multicenter studies to show a correlation between an image of the patients brain before treatment and their recovery after clot aspiration. Specifically, the study evaluated information from a brain scan about the amount of tissue affected by a stroke prior to treatment, and showed that it can be used to predict outcomes in patients undergoing endovascular care with the Penumbra System, an aspiration thrombectomy device used to remove clots from large vessels of the brain.
Currently, there is no standard imaging technique to suggest which patients suffering from acute ischemic stroke should receive endovascular therapy. The CAT Scan (CT) remains the most widely used modality for stroke evaluation, but is primarily used to rule out bleeding. Changes on a non-contrast CT as measured by the ASPECTS score, a way of evaluating early effects of a stroke, have been shown to predict response to endovascular therapy. To date, however, definitive studies proving the value of CT-Angiography Source Images (CTA-SI) in assessing stroke treatment outcomes are lacking. This study provides initial answers to fill that void, especially considering the often complicated process involved in evaluating stroke patients beyond the traditional 3 to 4.5 hour window when clot-busting drugs cannot be used and treatment utilizing devices may be optimal.
Aside from the value of this study to the individual practitioner, these results have significant implications for the collective neurointerventional community, said Don Frei, MD, Director of Neurointerventional Surgery, Radiology Imaging Associates/Swedish Medical Center in Denver, Colorado, and a Principal Investigator of the START Trial. Stroke is a devastating condition which requires a quick but accurate assessment of the best treatment options for the patient. This study helps to more rigorously define techniques that can begin to give us some of those answers.
A total of 77 patients at 15 centers met study criteria which required that patients show evidence of large vessel occlusion within 8 hours of symptom onset and a NIH Stroke Scale (NIHSS) score 10. Those who presented within 3 hours must have been ineligible or not responsive to intravenous drug therapy. The imaging method included in the study was at each centers discretion and included non-contrast CT, CTA-SI, CT perfusion, or MRI diffusion imaging. This analysis focused on the preliminary CTA-SI results. Overall results showed a positive neurological outcome rate (modified Rankin Score 2 at 90 days) of 48.1% (37/77). This is the highest rate of positive neurological outcomes in any prospective, multicenter, core-lab adjudicated study of interventional stroke treatment with any device to date.
Moreover, when the pre-specified ASPECTS classifications, 0-4 (large infarct), 5-7 (medium infarct), and 8-10 (small infarct) are used, the outcomes become differentiated. The rate of good outcomes is only 20.0% for patients with ASPECTS 0-4, but 55.8% for 5-7, and an exceptionally high 64.3% for 8-10 (p=0.08). Adjusting for age and stroke severity and comparing ASPECTS 0-4 with the ASPECTS 5-10 group, pre-ASPECTS 5-10 was an independent predictor of good outcome (Odds Ratio 6.8, p=0.006).
Modified Rankin Score 2 at 90 days (Good Clinical Outcome)
All Patients
ASPECTS 0-4
ASPECTS 5-7
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The Penumbra START Trial Points to Imaging Technique That Could Predict Good Outcome for Acute Ischemic Stroke Patients