A pair of clinical trials comparing treatment with anti-stroke drugs and stent thrombectomy with drug therapy alone showed reduced disability in stoke patients, bringing more good news for stent thrombectomy device makers.
The studies, sponsored by Medtronic (NYSE:MDT), used the Solitaire stent thrombectomy device it acquired along with Covidien earlier this year. The results were published online today in the New England Journal of Medicine.
The results of the Swift Prime and Revascat trials echo data from the Mr. Clean trial published last December in NEJM showing that new-generation thrombectomy devices were superior in treating severe ischemic strokes than standard medical care with an anti-thrombosis drug.
The 196-patient Swift Prime trial, which was stopped early because of efficacy, showed reduced disability at 90 days over all scores on the Rankin scale for the cohort treated with the Solitaire device; the rate of functional independence was 60% for the intervention arm, compared with 35% for the control arm. There were no significant differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12), according to the study.
Revascat enrolled 206 patients who were randomly assigned to either drug therapy or drug therapy plus stent thrombectomy with the Solitaire device. The study showed a reduction in the severity of disability over a modified Rankin scale. The rate of functional independence at 90 days for the intervention group was 43.7%, compared with 28.2% for the control group. The rate of symptomatic intracranial hemorrhage was 1.9% in both groups; the rate of death was 18.4% for the Solitaire cohort and 15.5% for the control group.
"These findings are bringing the global stroke treatment community together to rethink how we provide stroke care," neurovascular president Brett Wall said in prepared remarks. "Improving patient access to the proven Solitaire device stent thrombectomy procedure is an important objective for all of us who are committed to fighting stroke. We support the revision of guidelines and the benefit that this will drive to patients, health systems and our broader society."
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