FROM THE NEW ENGLAND JOURNAL OF MEDICINE
For patients with proximal large-vessel anterior stroke, neurovascular thrombectomy with a stent retriever plus medical therapy in the REVASCAT trial reduced the severity of poststroke disability and raised the rate of functional independence, compared with medical therapy alone, according to a report in the New England Journal of Medicine.
To assess the efficacy and safety of thrombectomy with a stent retriever, investigators performed a prospective, open-label, phase III clinical trial involving 206 adults up to 85 years of age treated at four designated comprehensive stroke centers in Catalonia, Spain.
All the participants in 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) had either not responded to intravenous alteplase administered within 4.5 hours of symptom onset or had contraindications to alteplase therapy. They were randomly assigned in equal numbers to undergo endovascular treatment with a stent retriever or medical therapy alone, said Dr. Tudor G. Jovin , director of the Stroke Institute, University of Pittsburgh Medical Center, and his associates.
The trial was halted early when the first interim analysis showed “lack of equipoise” between the two study groups, and because emerging results from three other studies demonstrated the superior efficacy of thrombectomy. The primary efficacy outcome measure – severity of disability at 90 days, as measured by expert assessors blinded to treatment assignment – significantly favored thrombectomy over medical therapy. The proportion of patients who achieved functional independence by day 90 on the modified Rankin scale also demonstrated the clear superiority of thrombectomy (43.7%) over medical therapy (28.2%).
Only 6.5 patients would need to be treated with thrombectomy to prevent 1 case of functional dependency or death. In addition, “thrombectomy was associated with a shift toward better outcomes across the entire spectrum of disability,” Dr. Jovin and his associates said (N. Engl. J. Med. 2015 [doi:10.1056/NEJMoa1503780]).
Regarding safety, the rate of death at 90 days did not differ significantly between patients who underwent thrombectomy (18.4%) and control subjects (15.5%). Rates of intracranial hemorrhage were the same, 1.9%, in both groups, and rates of other serious adverse events also were similar.
These findings are consistent with those of several other recently reported clinical trials and show that “in patients with acute stroke caused by a proximal large-vessel occlusion and an absence of a large infarct on baseline imaging, mechanical thrombectomy with [a] stent retriever was safe and led to improved clinical outcomes, as compared with medical therapy alone,” the investigators said.
REVASCAT was funded by an unrestricted grant from Covidien, maker of the stent retriever, and by grants from several Spanish research institutes. Dr. Jovin reported ties to Covidien, Silk Road Medical, Air Liquide, Medtronic, and Stryker Neurovascular.
