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Endovascular treatment for acute ischemic stroke.

ABSTRACT: 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.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.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.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.).

SUBMITTER: Ciccone A

PROVIDER: S-EPMC3708480 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Endovascular treatment for acute ischemic stroke.

Ciccone Alfonso A Valvassori Luca L Nichelatti Michele M Sgoifo Annalisa A Ponzio Michela M Sterzi Roberto R Boccardi Edoardo E

The New England journal of medicine 20130206 10

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 23387822

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Project description:Background Patients aged ≥90 were excluded or under-represented in past thrombectomy trials; thus, uncertainty remains whether treatment benefits can be expected regardless of age. This study investigates outcome and safety of thrombectomy in nonagenarians to improve decision making in a real-world setting. Methods and Results All currently available data of patients aged ≥90 enrolled in the GSR-ET (German Stroke Registry-Endovascular Treatment) were combined with a smaller cohort from 3 tertiary stroke centers. Baseline characteristics, procedural (Thrombolysis in Cerebral Infarction scale) and functional outcomes (modified Rankin Scale; mRS), as well as complications (symptomatic intracranial hemorrhage, serious adverse events; SAEs) were analyzed. Good functional outcome was defined as mRS ≤3 at 90-days. 203 patients with anterior circulation stroke and prestroke mRS ≤3 were included. The rate of successful recanalization (Thrombolysis in Cerebral Infarction scale ≥2b) was 75.9% (154/203). Good functional outcome (mRS ≤3) was observed in 21.6% (41 of 193) at 90-days. In-hospital mortality was 27.1% (55 of 203) and increased significantly at 90 days to 48.9% (93 of 190; P<0.001). Symptomatic intracranial hemorrhage occurred in 3% (6 of 203) of patients. Logistic regression analysis identified Alberta Stroke Program Early CT Score (adjusted odds ratio, 1.93; 95% CI, 1.01-3.70; P=0.046) and initial National Institute of Health Stroke Scale (adjusted odds ratio, 0.85; 95% CI, 0.76-0.97; P=0.014) as independent predictors for good outcome. Patients with successful recanalization had a significant (P=0.001) shift of mRS distribution with higher rates of good functional outcomes (23.8% [34 of 143] versus 14.9% [7 of 47]) and lower mortality at 90-days (46.8% [67 of 143] versus 55.3% [26 of 47]). Conclusions Despite high mortality and less frequent favorable outcome, our data suggest that thrombectomy is still effective and safe for nonagenarians. Decision making for thrombectomy in patients aged ≥90 should be based on a case-by-case basis with regard to initial National Institute of Health Stroke Scale and Alberta Stroke Program Early CT Score.

Project description:ObjectiveTo compare the outcomes between endovascular and medical management of acute ischemic stroke in recent randomized controlled trials (RCT).MethodsA systematic literature review was performed, and multicenter, prospective RCTs published from January 1, 2013, to May 1, 2015, directly comparing endovascular therapy to medical management for patients with acute ischemic stroke were included. Meta-analyses of modified Rankin Scale (mRS) and mortality at 90 days and symptomatic intracranial hemorrhage (sICH) for endovascular therapy and medical management were performed.ResultsEight multicenter, prospective RCTs (Interventional Management of Stroke [IMS] III, Local Versus Systemic Thrombolysis for Acute Ischemic Stroke [SYNTHESIS] Expansion, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy [MR RESCUE], Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands [MR CLEAN], Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness [ESCAPE], Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial [EXTEND-IA], Solitaire With the Intention For Thrombectomy as Primary Endovascular Treatment [SWIFT PRIME], and Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours [REVASCAT]) comprising 2,423 patients were included. Meta-analysis of pooled data demonstrated functional independence (mRS 0-2) at 90 days in favor of endovascular therapy (odds ratio [OR] = 1.71; p = 0.005). Subgroup analysis of the 6 trials with large vessel occlusion (LVO) criteria also demonstrated functional independence at 90 days in favor of endovascular therapy (OR = 2.23; p < 0.00001). Subgroup analysis of the 5 trials that primarily utilized stent retriever devices (≥70%) in the intervention arm demonstrated functional independence at 90 days in favor of endovascular therapy (OR = 2.39; p < 0.00001). No difference was found for mortality at 90 days and sICH between endovascular therapy and medical management in all analyses and subgroup analyses.ConclusionsThis meta-analysis provides strong evidence that endovascular intervention combined with medical management, including IV tissue plasminogen activator for eligible patients, improves the outcomes of appropriately selected patients with acute ischemic stroke in the setting of LVO.

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Endovascular treatment for acute ischemic stroke.

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Endovascular treatment for acute ischemic stroke.

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