Thrombectomy within 8 hours after symptom onset in ischemic stroke.

Abstract

BACKGROUND:

We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry.

METHODS:

During a 2-year period at four centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy (including intravenous alteplase when eligible) and endovascular therapy with the Solitaire stent retriever (thrombectomy group) or medical therapy alone (control group). All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging. In all study patients, the use of alteplase either did not achieve revascularization or was contraindicated. The primary outcome was the severity of global disability at 90 days, as measured on the modified Rankin scale (ranging from 0 [no symptoms] to 6 [death]). Although the maximum planned sample size was 690, enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials.

RESULTS:

Thrombectomy reduced the severity of disability over the range of the modified Rankin scale (adjusted odds ratio for improvement of 1 point, 1.7; 95% confidence interval [CI], 1.05 to 2.8) and led to higher rates of functional independence (a score of 0 to 2) at 90 days (43.7% vs. 28.2%; adjusted odds ratio, 2.1; 95% CI, 1.1 to 4.0). At 90 days, the rates of symptomatic intracranial hemorrhage were 1.9% in both the thrombectomy group and the control group (P=1.00), and rates of death were 18.4% and 15.5%, respectively (P=0.60). Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals.

CONCLUSIONS:

Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset, stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence. (Funded by Fundació Ictus Malaltia Vascular through an unrestricted grant from Covidien and others; REVASCAT ClinicalTrials.gov number, NCT01692379.).

• Authors: Tudor G Jovin, Angel Chamorro, Erik Cobo, María A de Miquel, Carlos A Molina, Alex Rovira, Luis San Román, Joaquín Serena, Sonia Abilleira, Marc Ribó, Mònica Millán, Xabier Urra, Pere Cardona, Elena López-Cancio, Alejandro Tomasello, Carlos Castaño, Jordi Blasco, Lucía Aja, Laura Dorado, Helena Quesada, Marta Rubiera, María Hernandez-Pérez, Mayank Goyal, Andrew M Demchuk, Rüdiger von Kummer, Miquel Gallofré, Antoni Dávalos, REVASCAT Trial Investigators
• Journal: The New England journal of medicine (N Engl J Med) Vol. 372 Issue 24 Pg. 2296-306 (Jun 11 2015) ISSN: 1533-4406 [Electronic] United States
• PMID: 25882510 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrinolytic Agents
• Tissue Plasminogen Activator

Topics

• Acute Disease
• Administration, Intravenous
• Aged
• Brain Ischemia (therapy)
• Combined Modality Therapy
• Contraindications
• Endovascular Procedures
• Female
• Fibrinolytic Agents (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Stents
• Stroke (drug therapy, therapy)
• Thrombectomy (adverse effects, instrumentation, methods)
• Time-to-Treatment
• Tissue Plasminogen Activator (adverse effects, therapeutic use)