April 20, 2015
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REVASCAT: Stent retriever thrombectomy reduces poststroke disability, increases functional independence

In patients with anterior circulation stroke treated within 8 hours of symptom onset, stent retriever thrombectomy was associated with reduced poststroke disability and increased functional independence, according to results of the REVASCAT trial.

Researchers randomly assigned 206 patients who could be treated within 8 hours of onset of acute ischemic stroke to medical therapy (including IV alteplase if eligible) plus endovascular therapy with a stent retriever (Solitaire, Covidien) or medical therapy alone. The findings were presented at the European Stroke Organisation Conference and simultaneously published in The New England Journal of Medicine.

According to the researchers, all patients had confirmed proximal anterior circulation occlusion and no large infarct on neuroimaging.

The primary outcome was modified Rankin scale score at 90 days. Secondary outcomes included death and symptomatic intracranial hemorrhage at 90 days.

Trial stopped early

Enrollment was planned for a maximum of 690 patients, but was halted early after loss of equipoise after positive results for thrombectomy were reported from similar trials, including MR CLEAN, EXTEND-IA, ESCAPE and SWIFT PRIME.

“After an interim analysis once 25% of the original participant sample size were enrolled, the data safety monitoring board of the study recommended stopping the trial, as it became clear that it was no longer ethically justified to randomly assign patients to receive only conventional therapy,” Tudor Jovin, MD, associate professor of neurology and neurological surgery at the University of Pittsburgh and director of the University of Pittsburgh Medical Center Stroke Institute, said in a press release.

Better outcomes for thrombectomy

Jovin and colleagues found that thrombectomy was associated with reduction in severity of disability over the range of the modified Rankin scale at 90 days (adjusted OR for improvement of 1 point = 1.7; 95% CI, 1.05-2.8).

The thrombectomy group had a higher rate of functional independence, defined as a modified Rankin scale score of 0 to 2, at 90 days (43.7% vs. 28.2%; adjusted OR = 2.1; 95% CI, 1.1-4) compared with controls.

The researchers reported no difference in the rate of symptomatic intracranial hemorrhage (1.9% vs. 1.9%) or death (thrombectomy group, 18.4%; control group, 15.5%) between the groups.

“This is a giant step forward that will change the way we approach triage and treatment of stroke patients,” Jovin said in the release. “And, as other studies found, removing blood clots from the brain did indeed lead to better outcomes for patients.” – by Erik Swain

References:

Dávalos A. Official Welcome and New Large Clinical Trials and Hot Results. Presented at: European Stroke Organisation Conference; April 17-19, 2015; Glasgow, Scotland.

Jovin TG, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1503780.

Disclosures: The study was funded by Fundació Ictus Malaltia Vascular through an unrestricted grant from Covidien and others. Jovin reports receiving grant, nonfinancial and other support from Fundació Ictus Malaltia Vascular and nonfinancial support from Covidien during the course of the study, receiving personal fees from Air Liquide and Silk Road Medical, and receiving nonfinancial support from Covidien/Medtronic and Stryker Neurovascular outside the submitted work.