Campbell Bruce C V, Hill Michael D, Rubiera Marta, Menon Bijoy K, Demchuk Andrew, Donnan Geoffrey A, Roy Daniel, Thornton John, Dorado Laura, Bonafe Alain, Levy Elad I, Diener Hans-Christoph, Hernández-Pérez María, Pereira Vitor Mendes, Blasco Jordi, Quesada Helena, Rempel Jeremy, Jahan Reza, Davis Stephen M, Stouch Bruce C, Mitchell Peter J, Jovin Tudor G, Saver Jeffrey L, Goyal Mayank
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
Stroke. 2016 Mar;47(3):798-806. doi: 10.1161/STROKEAHA.115.012360.
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.
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.
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.
Solitaire thrombectomy for large vessel ischemic stroke was safe and highly effective with substantially reduced disability. Benefits were consistent in all prespecified subgroups.
近期缺血性卒中血管内治疗的阳性随机试验主要使用支架取栓器。我们汇总数据以研究使用Solitaire装置进行支架取栓术治疗前循环缺血性卒中的有效性和安全性。
患者水平的数据来自以下试验,在预先设定的荟萃分析(SEER协作组)中,Solitaire是唯一使用或主要使用的装置:以血栓切除术作为主要血管内治疗的Solitaire FR(SWIFT PRIME)、以小梗死核心和前循环近端闭塞为重点并尽量缩短CT至再通时间的血管内治疗(ESCAPE)、延长急性神经功能缺损动脉内溶栓时间(EXTEND-IA),以及Solitaire FR装置血管再通与最佳药物治疗对症状发作8小时内出现的前循环大血管闭塞所致急性卒中治疗效果的随机试验(REVASCAT)。主要结局是90天时改良Rankin量表评分的序贯分析。主要分析纳入了4项试验中的所有患者,并进行了2项敏感性分析:(1)排除未首先使用Solitaire装置的患者;(2)纳入仅使用Solitaire的3项试验(排除ESCAPE)。次要结局包括功能独立性(改良Rankin量表评分0 - 2)、症状性脑出血和死亡率。
主要分析纳入了787例患者:401例随机接受血管内血栓切除术,386例接受标准治疗,82.6%接受了静脉溶栓治疗。改良Rankin量表评分改善的共同优势比为2.7(2.0 - 3.5),年龄、性别、基线卒中严重程度、计算机断层扫描改变程度、闭塞部位或阿替普酶预处理对疗效无异质性影响。减少残疾所需治疗人数为2.5,额外增加1例患者实现独立结局所需人数为4.25(3.29 - 5.99)。使用Solitaire装置治疗的患者中77%实现了成功再通。治疗组之间症状性脑出血发生率和总体死亡率无差异。
Solitaire取栓术治疗大血管缺血性卒中安全且高效,可显著降低残疾率。在所有预先设定的亚组中获益一致。