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

被引：194

作者：

Campbell, Bruce C. V. ^{[1
]}

Hill, Michael D. ^{[2
]}

Rubiera, Marta ^{[3
]}

Menon, Bijoy K. ^{[2
]}

Demchuk, Andrew ^{[2
]}

Donnan, Geoffrey A. ^{[4
]}

Roy, Daniel ^{[5
]}

Thornton, John ^{[6
]}

Dorado, Laura ^{[7
]}

Bonafe, Alain ^{[8
]}

Levy, Elad I. ^{[9
]}

Diener, Hans-Christoph ^{[10
]}

Hernandez-Perez, Maria ^{[7
]}

Pereira, Vitor Mendes ^{[11
,12
]}

Blasco, Jordi ^{[13
]}

Quesada, Helena ^{[14
]}

Rempel, Jeremy ^{[15
]}

Jahan, Reza ^{[16
]}

Davis, Stephen M. ^{[1
]}

Stouch, Bruce C. ^{[17
]}

Mitchell, Peter J. ^{[18
]}

Jovin, Tudor G. ^{[19
]}

Saver, Jeffrey L. ^{[20
,21
]}

Goyal, Mayank ^{[22
]}

机构：

[1] Univ Melbourne, Royal Melbourne Hosp, Dept Med & Neurol, Melbourne Brain Ctr, Parkville, Vic, Australia

[2] Univ Calgary, Foothills Hosp, Cumming Sch Med, Dept Clin Neurosci,Hotchkiss Brain Inst, Calgary, AB, Canada

[3] Hosp Valle De Hebron, Dept Neurol, Barcelona, Spain

[4] Univ Melbourne, Florey Inst Neurosci & Mental Hlth, Parkville, Vic 3052, Australia

[5] Univ Montreal, Dept Radiol, CHUM Hop Notre Dame, Montreal, PQ, Canada

[6] Beaumont Hosp, Dept Radiol, Dublin 9, Ireland

[7] Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Dept Neurosci, E-08193 Barcelona, Spain

[8] Hop Gui de Chauliac, Dept Neuroradiol, Montpellier, France

[9] SUNY Buffalo, Dept Neurosurg, Buffalo, NY 14260 USA

[10] Univ Duisburg Essen, Dept Neurol, Univ Hosp, Essen, Germany

[11] Univ Toronto, Toronto Western Hosp, Univ Hlth Network, Div Neuroradiol,Div Dept Med Imaging, Toronto, ON M5T 2S8, Canada

[12] Univ Toronto, Toronto Western Hosp, Univ Hlth Network, Div Neurosurg,Dept Surg, Toronto, ON M5T 2S8, Canada

[13] Hosp Clin Barcelona, Dept Radiol, Barcelona, Spain

[14] Bellvitge Hosp, Dept Neurol, Barcelona, Spain

[15] Univ Alberta, Dept Radiol, Edmonton, AB, Canada

[16] Univ Calif Los Angeles, David Geffen Sch Med, Div Intervent Neuroradiol, Dept Radiol & Neurosurg, Los Angeles, CA 90095 USA

[17] Philadelphia Coll Osteopath Med, Dept Biostat & Clin Epidemiol, Philadelphia, PA USA

[18] Univ Melbourne, Royal Melbourne Hosp, Dept Radiol, Parkville, Vic, Australia

[19] Univ Pittsburgh, Med Ctr, Dept Neurol, Stroke Inst, Pittsburgh, PA 15260 USA

[20] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA 90095 USA

[21] Univ Calif Los Angeles, David Geffen Sch Med, Comprehens Stroke Ctr, Los Angeles, CA 90095 USA

[22] Univ Calgary, Foothills Hosp, Dept Radiol, Calgary, AB, Canada

来源：

STROKE | 2016年 / 47卷 / 03期

关键词：

thrombolysis; randomized controlled trial; mechanical thrombectomy; endovascular treatment; stent retriever device; intra-arterial therapy; meta-analysis; ischemic stroke; ACUTE ISCHEMIC-STROKE; INTRAVENOUS T-PA; ENDOVASCULAR TREATMENT; THERAPY; WINDOW; TIME; CARE; GUIDELINES; MANAGEMENT; BENEFIT;

D O I：

10.1161/STROKEAHA.115.012360

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：798 / 806

页数：9

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