Prospective, Multicenter, Single-Arm Study of Mechanical Thrombectomy Using Solitaire Flow Restoration in Acute Ischemic Stroke

• Authors: Vitor M Pereira, University Hospital of Geneva; Jan Gralla, University of Bern; Antoni Davalos, Universitary Hospital Germans Trias i Pujol; Alain Bonafe, CHU Montpellier Guy Chauliac; Rene Castano, Universitary Hospital Germans Trias i Pujol; Rene Chapot, Alfred Krupp Krankenhaus; David S Liebeskind, UCLA; Raul Nogueira, Emory University; Marcel Arnold, University of Bern; Roman Sztajzel, University Hospital of Geneva; Thomas Liebig, University Hospital of Cologne; Mayank Goyal, University of Calgary; Michael Besselmann, Klinikum Osnabrueck; Alfredo Moreno, Hospital Virgen de la Arrixaca; Gerhard Schroth, University of Bern
• Journal Title: Stroke
• Volume: Volume 44, Number 10
• Publisher: American Heart Association | 2013-10-01, Pages 2802-2807
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1161/STROKEAHA.113.001232
• Subjects: Health Sciences, Epidemiology; Health Sciences, Medicine and Surgery; Biology, Neuroscience
• Keywords: Science & Technology; Life Sciences & Biomedicine; Clinical Neurology; Peripheral Vascular Disease; Neurosciences & Neurology; Cardiovascular System & Cardiology; mechanical embolectomy; stroke treatment; MERCI TRIAL; REVASCULARIZATION; PROUROKINASE; SAFETY; TISSUE

Abstract

Background and Purpose-Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke. Methods-Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction ≥2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0-2). Results-A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada, and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, and the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and procedure-related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions-In this single-arm study, treatment with the Solitaire Flow Restoration device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days.