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Short review of randomized controlled trials (RCTs) for Surgical Neurology International: Two important RCT articles for 2018 – Part I

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The DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) trial is a 38 center, open‐label trial utilizing blinded outcome assessment. This RCT compared thrombectomy versus medical therapy in… Click to show full abstract

The DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) trial is a 38 center, open‐label trial utilizing blinded outcome assessment. This RCT compared thrombectomy versus medical therapy in the management of 182 patients – 92 endovascular and 90 medical therapy. Patients included in the study had either internal carotid artery or middle cerebral artery (M1) thrombotic occlusions, with ictal onset between 6 and 16 hours prior to presentation. All patients had to exhibit radiologically defined salvageable ischemic brain tissue that had not yet infarcted, with infarcted volumes less than 70 mL, and ratio of volume of ischemic to infarct volume had to be greater than 1.8. Comparing the two groups, the DEFUSE 3 trial found significantly higher rates of survival post thrombectomy (77 out of 90 patients) versus 67 out of 90 patients receiving medical therapy alone. Furthermore, those undergoing thrombectomy exhibited significantly greater likelihoods of 90‐day functional independence (41 out of 90 post thrombectomy) versus just 15 out of 90 treated with medical therapy alone. Several statistically valid key points were emphasized by this methodologically strong RCT: (1) more wake up strokes (with potentially unclear exact time of stroke onset) were included in the thrombectomy group (n = 49) versus medical therapy group (n = 42), (2) thirteen heterogeneous patients (that is, small numbers per center) with internal carotid artery artherosclerotic plaques additionally received cervical angioplasty and stent placements, (3) thirty‐four thrombectomy patients versus 28 in the medical therapy group had atrial fibrillation. They, therefore, had potentially different underlying clot textures than those with atherosclerotic artery‐to‐artery thrombi,

Keywords: neurology; artery; medical therapy; therapy; thrombectomy; surgical neurology

Journal Title: Surgical Neurology International
Year Published: 2018

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