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Stroke. 2016 Mar;47(3):798-806. doi: 10.1161/STROKEAHA.115.012360.

Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials.

Author information

1
From the Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia (B.C.V.C., S.M.D.); Department of Clinical Neurosciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Foothills Hospital, Calgary AB, Canada (M.D.H., B.K.M., A.D.); Neurology Department, Hospital Vall d'Hebron, Barcelona, Spain (M.R.); The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia (G.A.D.); Department of Radiology, CHUM-Hopital Notre Dame, University of Montreal, Montreal, Canada (D.R.); Department of Radiology, Beaumont Hospital, Dublin, Ireland (J.T.); Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain (L.D., M.H.-P.); Department of Neuroradiology, Hôpital Gui-de Chauliac, Montpellier, France (A.B.); Department of Neurosurgery, State University of New York at Buffalo, Buffalo, New York (E.I.L.); Department of Neurology, University Hospital of University Duisburg-Essen, Essen, Germany (H.-C.D.); Division of Neuroradiology and Division of Neurosurgery, Departments of Medical Imaging and Surgery, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Canada (V.M.P.); Department of Radiology, Hospital Clínic, Barcelona, Spain (J.B.); Department of Neurology, Hospital de Bellvitge, Barcelona, Spain (H.Q.); Department of Radiology, University of Alberta, Edmonton, Canada (J.R.); Division of Interventional Neuroradiology, Department of Radiology and Neurosurgery, David Geffen School of Medicine, University of California, Los Angeles (UCLA) (R.J.); Department of Biostatistics and Clinical Epidemiology, The Philadelphia College of Osteopathic Medicine, PA (B.C.S.); Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Parkville, Australia (P.J.M.); Stroke Institute, Department of Neurology, University of Pittsburgh Medical C

Abstract

BACKGROUND AND PURPOSE:

Recent positive randomized trials of endovascular therapy for ischemic stroke used predominantly stent retrievers. We pooled data to investigate the efficacy and safety of stent thrombectomy using the Solitaire device in anterior circulation ischemic stroke.

METHODS:

Patient-level data were pooled from trials in which the Solitaire was the only or the predominant device used in a prespecified meta-analysis (SEER Collaboration): Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME), Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE), Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial (EXTEND-IA), and 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). The primary outcome was ordinal analysis of modified Rankin Score at 90 days. The primary analysis included all patients in the 4 trials with 2 sensitivity analyses: (1) excluding patients in whom Solitaire was not the first device used and (2) including the 3 Solitaire-only trials (excluding ESCAPE). Secondary outcomes included functional independence (modified Rankin Score 0-2), symptomatic intracerebral hemorrhage, and mortality.

RESULTS:

The primary analysis included 787 patients: 401 randomized to endovascular thrombectomy and 386 to standard care, and 82.6% received intravenous thrombolysis. The common odds ratio for modified Rankin Score improvement was 2.7 (2.0-3.5) with no heterogeneity in effect by age, sex, baseline stroke severity, extent of computed tomography changes, site of occlusion, or pretreatment with alteplase. The number needed to treat to reduce disability was 2.5 and for an extra patient to achieve independent outcome was 4.25 (3.29-5.99). Successful revascularization occurred in 77% treated with Solitaire device. The rate of symptomatic intracerebral hemorrhage and overall mortality did not differ between treatment groups.

CONCLUSIONS:

Solitaire thrombectomy for large vessel ischemic stroke was safe and highly effective with substantially reduced disability. Benefits were consistent in all prespecified subgroups.

KEYWORDS:

endovascular treatment; intra-arterial therapy; ischemic stroke; mechanical thrombectomy; meta-analysis; randomized controlled trial; stent retriever device; thrombolysis

PMID:
26888532
PMCID:
PMC4760381
DOI:
10.1161/STROKEAHA.115.012360
[Indexed for MEDLINE]
Free PMC Article

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