HONOLULU—The Solitaire FR device is associated with high rates of recanalization and good clinical outcomes in patients with acute ischemic stroke, researchers reported at the 2013 International Stroke Conference. According to researchers, the device may entail a low risk of clinically relevant complications and a low rate of mortality.
Approximately 79% of patients treated with Solitaire FR achieved a thrombolysis in cerebral infarction (TICI) score of 2b within three passes, said Vitor Mendes Pereira, MD, Head of Interventional Neuroradiology at the University Hospital of Geneva. About 9% of patients received rescue therapy, including combined mechanical and medical treatment. When individuals who received rescue therapy were included, nearly 85% of patients achieved a TICI score of 2b or 3.
A Single-Arm Study of Patients With Ischemic Stroke
Dr. Pereira and his colleagues studied the Solitaire FR device in a single-arm, prospective, observational trial conducted at several dedicated, high-volume stroke centers with experience in mechanical thrombectomy. The primary end point was successful recanalization (ie, a TICI score of 2b or greater) of the occluded target territory using the study device within three passes. Secondary end points included time to revascularization, NIH Stroke Scale (NIHSS) score, modified Rankin Scale (mRs) score, symptomatic intracranial hemorrhage, and mortality.
The final analysis was based on 90-day follow-up of 202 patients with acute ischemic stroke. The population’s median age was 72, and 40% of patients were male. Patients’ median baseline NIHSS score was 17. Occlusions were in the internal carotid artery for 18% of subjects and in the middle cerebral artery for 82% of subjects. Most of the patients (59%) had received IV t-PA before mechanical thrombectomy, and the others received only mechanical thrombectomy.
Solitaire FR Was Associated With Decreased Disability
Nearly 26% of the subjects received endovascular treatment less than three hours after stroke onset. Approximately 38% of patients received the treatment between three and four and a half hours after stroke onset, and about 36% received thrombectomy after four and a half hours from stroke onset.
The mean number of passes that the physicians performed was 1.5. The median time from stroke onset to groin puncture was 238 minutes, and the median time from groin puncture to placement of the balloon-guided catheter was 12 minutes. The mean procedure duration was 20 minutes.
Patients’ NIHSS scores decreased from 17 at baseline to 7 immediately after the procedure. NIHSS scores decreased to 4 at discharge, which occurred at seven to 10 days after the procedure. At 90 days, the mean NIHSS was 1. At the final follow-up, 17% of individuals had an mRs score of 0, 26% had an mRs score of 1, and 15% had an mRs score of 2. Nearly 58% of the population had a favorable outcome.
About 19% of patients had a hemorrhage. One patient had microcatheter perforation, two had vessel dissections, and two had embolic events. The study’s mortality rate was 6.9%.
“Treatment with the stent-retriever Solitaire device in arterial circulation results in a low risk of clinically relevant procedure and device complications, high rates of recanalization and good clinical outcomes, and low mortality at 90 days,” said Dr. Pereira. “This study demonstrated that when you select comprehensive stroke centers with experienced physicians, there is a direct impact on the results: better patient selection, optimized intrahospital workflow, faster procedures, faster revascularization, and overall improvement. These data support the further investigation of this device in a randomized controlled trial against best medical treatment,” he concluded.
—Erik Greb
Senior Associate Editor
Suggested Reading
Dávalos A, Pereira VM, Chapot R, et al. Retrospective multicenter study of Solitaire FR for revascularization in the treatment of acute ischemic stroke. Stroke. 2012;43(10):2699-2705.
Frei D, Gerber J, Turk A, et al. The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter. J Neurointerv Surg. 2013 Jan 7 [Epub ahead of print].