Meta-analysis published in Stroke shows that addition of Solitaire stent retriever to current pharmaceutical treatment (IV-tPA) significantly improves functional outcomes in patients suffering stroke.- Medtronic

A meta-analysis published online in Stroke and presented at the International Stroke Conference (ISC) in Los Angeles, Calif., found that the addition of Medtronic plc's Solitaire stent retriever to current pharmaceutical treatment (IV-tPA) significantly improves functional outcomes in patients suffering stroke. Safety and Efficacy of Solitaire Stent Thrombectomy - Individual Patient Data Meta-analysis of Randomized Trials (SEER) also showed a significant reduction (20% vs. 40%, adjusted OR 3.7(1.3-10.6), p=0.01) in mortality for patients over the age of 80.

SEER assessed four global clinical trials published last year in the New England Journal of Medicine (NEJM): SOLITAIRE FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME), Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT), EXtending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (EXTEND-IA) and Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE). SEER is the first patient-level global meta-analysis of the four randomized trials and examined data from a total of 787 patients. The analysis showed that patients experiencing an acute ischemic stroke and treated with the Solitaire stent retriever, when eligible, had significantly improved independent functional outcomes (mRS 0-2) at 90 days than patients treated with IV-tPA alone (54% vs. 31.5%, p<0.0001). The analysis also found that patients over the age of 80 and in good health had a clinically and statistically significant 20 percent absolute reduction in mortality. Further, the analysis showed a strong significance in the numbers needed to treat (2.5) to reduce disability (i.e., for every 2.5 patients treated with the Solitaire device plus IV-tPA, 1 patient showed improved functional outcomes).

Comment:The Solitaire device uses a micro-sized catheter to access arteries in the brain affected by stroke through an incision in the leg. Once delivered, the Solitaire device helps to immediately restore blood flow and remove the blood clots causing the stroke.

Comment: In June 2015, the American Heart Association/American Stroke Association (AHA/ASA) published new stroke treatment guidelines that recommended the use of stent retriever technology - such as the Solitaire stent retriever device - in conjunction with IV-tPA as a first-line treatment for eligible patients.