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In this trial involving 543 patients with stroke due to occlusion of medium or distal vessels, endovascular treatment within 24 hours after the onset of symptoms was not effective in improving functional outcome at 90 days.

Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.).

In a trial conducted in China, patients with large cerebral infarctions as determined by imaging criteria within 24 hours after onset had better outcomes with endovascular therapy than with medical therapy alone.

In acute ischemic stroke, thrombectomy with a stent retriever plus intravenous t-PA was more effective than t-PA in improving functional outcomes. At 90 days, 60% of patients in the intervention group were functionally independent, as compared with 35% in the control group. Intravenous tissue plasminogen activator (t-PA) administered within 4.5 hours after the onset of acute ischemic stroke improves outcomes. 1 – 3 However, intravenous t-PA has multiple constraints, including unresponsiveness of large thrombi to rapid enzymatic digestion, a narrow time window for administration, and the risk of cerebral and systemic hemorrhage. Among patients with occlusions of the intracranial internal carotid artery or the first segment of the middle cerebral artery (or both), intravenous t-PA results in early reperfusion in only 13 to 50%. 4 – 7 Neurovascular thrombectomy is a reperfusion strategy that is distinct from pharmacologic fibrinolysis. Endovascular mechanical treatments can remove large, proximal . . .

In this randomized trial involving patients with acute ischemic stroke with proximal anterior circulation occlusion, endovascular treatment with a Solitaire stent retriever was more effective than medical therapy alone in improving functional outcomes at 90 days. Recently completed prospective, randomized trials involving patients with acute stroke have consistently shown a clinical benefit for mechanical thrombectomy. 1 – 4 Our study, called the Randomized Trial of Revascularization with Solitaire FR Device versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset (REVASCAT), shares the following four features with the previously cited trials: enrollment limited to patients with imaging-based evidence of proximal occlusion of the M1 segment (main trunk) of the middle cerebral artery with or without concomitant occlusion of the internal carotid artery, imaging-based exclusion . . .

In 340 Chinese patients with basilar-artery occlusion, endovascular treatment resulted in better neurologic outcomes than medical care. Approximately one third of patients underwent intravenous thrombolysis.

In a Chinese trial, endovascular thrombectomy at 6 to 24 hours led to more good outcomes than standard care but also to more cerebral hemorrhages. Approximately 20% of patients received intravenous thrombolysis.

In a trial involving patients with ischemic stroke due to medium-vessel occlusion, thrombectomy within 12 hours did not lead to a better functional outcome and lower mortality at 90 days than usual care.

Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line. We did a multicentre, randomised, open label, blinded outcome, core lab adjudicated non-inferiority trial at 15 sites (ten hospitals and four specialty clinics in the USA and one hospital in Canada). Eligible participants were patients presenting with acute ischaemic stroke from anterior circulation large-vessel occlusion within 6 h of onset and an Alberta Stroke Program Early CT Score of greater than 6. We randomly assigned participants (1:1) via a central web-based system without stratification to either direct aspiration first pass or stent retriever first line thrombectomy. Those assessing primary outcomes via clinical examinations were masked to group assignment as they were not involved in the procedures. Physicians were allowed to use adjunctive technology as was consistent with their standard of care. The null hypothesis for this study was that patients treated with aspiration as first pass achieve inferior outcomes compared with those treated with a stent retriever first line approach. The primary outcome was non-inferiority of clinical functional outcome at 90 days as measured by the percentage of patients achieving a modified Rankin Scale score of 0–2, analysed by intent to treat; non-inferiority was established with a margin of 0·15. All randomly assigned patients were included in the safety analyses. This trial is registered at ClinicalTrials.gov, number: NCT02466893. Between June 1, 2015, and July 5, 2017, we assigned 270 patients to treatment: 134 to aspiration first pass and 136 to stent retriever first line. A modified Rankin score of 0–2 at 90 days was achieved by 69 patients (52%; 95% CI 43·8–60·3) in the aspiration group and 67 patients (50%; 41·6–57·4) in the stent retriever group, showing that aspiration as first pass was non-inferior to stent retriever first line (pnon-inferiority=0·0014). Intracranial haemorrhage occurred in 48 (36%) of 134 in the aspiration first pass group, and 46 (34%) of 135 in the stent retriever first line group. All-cause mortality at 3 months occurred in 30 patients (22%) in both groups. A direct aspiration as first pass thrombectomy conferred non-inferior functional outcome at 90 days compared with stent retriever first line thrombectomy. This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy. Penumbra.

Tenecteplase for thrombolysis in a 4.5-to-24-hour window did not improve disability outcomes at 90 days in patients with ischemic stroke who had been chosen on the basis of imaging. Most patients had endovascular thrombectomy.