Background and Purpose-Thrombectomy, primarily with stent retrievers with or without adjunctive aspiration, provided clinical benefit across multiple prospective randomized trials. Whether this benefit is exclusive to stent retrievers is unclear. Methods-THERAPY (The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke; NCT01429350) was an international, multicenter, prospective, randomized (1:1), open label, blinded end point evaluation, concurrent controlled clinical trial of aspiration thrombectomy after intravenous alteplase (IAT) administration compared with intravenous-alteplase alone in patients with large vessel ischemic stroke because of a thrombus length of ≥8 mm. The primary efficacy end point was the percent of patients achieving independence at 90 days (modified Rankin Scale score, 0-2; intention-to-treat analysis). The primary safety end point was the rate of severe adverse events (SAEs) by 90 days (as treated analysis). Patients were randomized 1:1 across 36 centers in 2 countries (United States and Germany). Results-Enrollment was halted after 108 (55 IAT and 53 intravenous) patients (of 692 planned) because of external evidence of the added benefit of endovascular therapy to intravenous-alteplase alone. Functional independence was achieved in 38% IAT and 30% intravenous intention-to-treat groups (P=0.52). Intention-to-treat ordinal modified Rankin Scale odds ratio was 1.76 (95% confidence interval, 0.86-3.59; P=0.12) in favor of IAT. Secondary efficacy analyses all demonstrated a consistent direction of effect toward benefit of IAT. No differences in symptomatic intracranial hemorrhage rates (9.3% IAT versus 9.7% intravenous, P=1.0) or 90-day mortality (IAT: 12% versus intravenous: 23.9%, P=0.18) were observed. Conclusions-THERAPY did not achieve its primary end point in this underpowered sample. Directions of effect for all prespecified outcomes were both internally and externally consistent toward benefit. It is possible that an alternate method of thrombectomy, primary aspiration, will benefit selected patients harboring large vessel occlusions. Further study on this topic is indicated. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01429350.
A prospective study was designed to evaluate clinical outcome in a series of 100 consecutively treated patients who underwent endovascular embolization of 104 intracranial aneurysms using Guglielmi detachable coils (GDCs). Midterm clinical outcome (2-6 years, average 3.5 years) was obtained for 94 patients and was classified according to a modified Glasgow Outcome Scale. Of nine patients treated in the acute phase of severe subarachnoid hemorrhage (Grade IV or V), seven died from the initial hemorrhage, one had a poor outcome, and one had a fair midterm outcome, with no post-GDC embolization hemorrhages. Twenty patients underwent subsequent surgical or endovascular procedures that did not include the use of GDCs. These included aneurysm clipping in nine patients and parent vessel sacrifice in 11 patients. None of these 20 patients experienced post-GDC embolization hemorrhage. The postoperative midterm clinical outcomes of these 20 patients did not significantly differ from the outcomes of patients who underwent GDC embolization as their definitive treatment. Six patients died of unrelated causes prior to reaching the 2-year survival point, with no post-GDC embolization hemorrhage. The midterm outcomes of the remaining 61 patients who underwent GDC embolization as their definitive treatment were classified as excellent (46 patients [75%]), good (seven patients [11%]), fair (three patients [5%]), poor (one patient [2%]), or dead (four patients [7%]). All four patients died from giant lesions. At midterm follow up, the surviving 57 patients' neurological statuses were unchanged or improved in 54 cases and worsened in three cases. The midterm post-GDC embolization hemorrhage rate was 0% for small aneurysms, 4% (one case) for large aneurysms, and 33% (five cases) for giant lesions. The GDC procedure is a safe, effective, and reliable means of preventing aneurysm hemorrhage in patients with small and large intracranial aneurysms. Results, however, are less satisfactory in cases involving giant lesions. Further follow-up review is necessary to establish durability in the longer term. Patients with Grade IV or V subarachnoid hemorrhage in this series generally had poor outcomes even if the GDC procedure was successful in occluding the aneurysm.
Background and Purpose-Efficient and timely recanalization is an important goal in acute stroke endovascular therapy.Several studies demonstrated improved recanalization and clinical outcomes with the stent retriever devices compared with the Merci device. The goal of this study was to evaluate the role of the balloon guide catheter (BGC) and recanalization success in a substudy of the North American Solitaire Acute Stroke (NASA) registry. Methods-The
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