BACKGROUND In patients with ischemic stroke, endovascular treatment results in a higher rate of recanalization of the affected cerebral artery than systemic intravenous thrombolytic therapy. However, comparison of the clinical efficacy of the two approaches is needed. METHODS We randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours after onset, to endovascular therapy (intraarterial thrombolysis with recombinant tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a combination of these approaches) or intravenous t-PA. Treatments were to be given as soon as possible after randomization. The primary outcome was survival free of disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability despite symptoms, and 6 death) at 3 months. RESULTS A total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous t-PA. The median time from stroke onset to the start of treatment was 3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001). At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence interval, 0.44 to 1.14; P = 0.16). Fatal or nonfatal symptomatic intracranial hemorrhage within 7 days occurred in 6% of the patients in each group, and there were no significant differences between groups in the rates of other serious adverse events or the case fatality rate. CONCLUSIONS The results of this trial in patients with acute ischemic stroke indicate that endovascular therapy is not superior to standard treatment with intravenous t-PA. (Funded by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.)
BACKGROUND AND PURPOSE:Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study.
Parent artery reconstruction using flow diverter devices is a feasible, safe, and successful technique for the treatment of endovascular treatment of cerebral aneurysms.
Objective To assess the feasibility, safety and preliminary efficacy of intra-arterial thrombolysis (IAT) compared with standard intravenous thrombolysis (IVT) for acute ischemic stroke. Methods Eligible patients with ischemic stroke, who were devoid of contraindications, started IVT within 3 h or IAT as soon as possible within 6 h. Patients were randomized within 3 h of onset to receive either intravenous alteplase, in accordance with the current European labeling, or up to 0.9 mg/kg intra-arterial alteplase (maximum 90 mg), over 60 min into the thrombus, if necessary with mechanical clot disruption and/or retrieval. The purpose of the study was to determine the proportion of favorable outcome at 90 days. Safety endpoints included symptomatic intracranial hemorrhage (SICH), death and other serious adverse events. Results 54 patients (25 IAT) were enrolled. Median time from stroke onset to start to treatment was 3 h 15 min for IAT and 2 h 35 min for IVT (p,0.001). Almost twice as many patients on IAT as those on IVT survived without residual disability (12/25 vs 8/29; OR 3.2; 95% CI 0.9 to 11.4; p50.067). SICH occurred in 2/25 patients on IAT and in 4/29 on IVT (OR 0.5; CI 0.1 to 3.3; p50.675). Mortality at day 7 was 5/25 (IAT) compared with 4/29 (IVT) (OR 1.6; CI 0.4 to 6.7; p50.718). There was no significant difference in the rate of other serious adverse events. Conclusions Rapid initiation of IAT is a safe and feasible alternative to IVT in acute ischemic stroke. Trial registration number NCT00540527.Although intravenous alteplase administered within 3 h of symptom onset is the only approved medication for the treatment of acute ischemic stroke, 1 this approach has known limitations. A major issue is that intravenous alteplase may be ineffective in patients with occlusions of the large arteries, such as the internal carotid artery, 2 3 carotid T segment 4 and the proximal (M1) segment of the middle cerebral artery. Intra-arterial thrombolysis (IAT) offers some theoretical advantages over intravenous thrombolysis (IVT) 7 : (a) angiographic planning allows customization of treatment strategy; (b) locoregional injection allows a much higher concentration of the drug where needed and the overall dosage administered to the patient is limited to the minimum necessary; (d) mechanical devices may either speed up the recanalization process or make it possible in drug resistant cases.Recanalization rates have been related to improved clinical outcome 8 and there are data suggesting that in patients with large vessel occlusions reperfusion rates with IAT are superior to those obtained with IVT. However, compared with IVT, intra-arterial treatment requires more time consuming and invasive procedures, and expensive techniques that are available only in highly specialized centers with a neurointerventional team. Although previous randomized controlled trials (RCTs) on IAT provided promising results, 6 9 10 their generalization remains questionable as they were performed in highly selected patients. 11As a result, ...
BACKGROUND AND PURPOSE:Aneurysms of the cavernous segment of the ICA are difficult to treat with standard endovascular techniques, and ICA sacrifice achieves a high rate of occlusion but carries an elevated level of surgical complications and risk of de novo aneurysm formation. We report rates of occlusion and treatment-related data in 44 patients with cavernous sinus aneurysms treated with flow diversion.
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