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急性缺血性脑卒中神经血栓切除术治疗患者的系统评价:STRATIS 登记研究的主要结果。

Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry.

机构信息

From the Advanced Neuroscience Network/Tenet South Florida (N.H.M.-K., R.K.); St Vincent Mercy Hospital, Toledo, OH (O.O.Z.); Vanderbilt University Medical Center, Nashville, TN (M.T.F., R.C.); University of California Los Angeles (R.J., J.L.S., D.S.L., S. Starkman); Brigham and Women's Hospital, Boston, MA (M.A.A.-S.); Methodist Hospital, Houston, TX (R.P.K.); Florida Hospital Neuroscience Institute, Winter Park (F.R.H., R.H.G.); University of Miami Miller School of Medicine/Jackson Memorial Hospital, FL (D.R.Y., E.C.P.); Norton Neuroscience Institute, Norton Healthcare, Louisville, KY (T.L.Y., S.R.D.); University of Pittsburgh Medical Center, PA (A.P.J.); WellStar Neurosciences Network, WellStar Kennestone Regional Medical Center, Marietta, GA (R.G.); Valley Baptist Medical Center, Harlingen, TX (A.E.H.); St Luke's Hospital of Kansas City, MO (C.O.M.); Oregon Health and Science University Hospital, Portland, OR (H.B.); Emory University School of Medicine, Grady Memorial Hospital, Atlanta, GA (R.G.N., D.C.H.); Baptist Health Lexington/Central Baptist, KY (C.A.G.); South Broward Hospital, Hollywood, FL (B.P.M.); Providence St Vincent Medical Center, Portland, OR (V.D.); Baptist Hospital of Miami, FL (I.L.); St Dominic's-Jackson Memorial Hospital, MS (S.H.M.); University of Tennessee Medical Center, Knoxville (P.K.); Advocate Christ Medical Center, Oak Lawn, IL (T.J.G.); Cleveland Clinic, OH (M.S.H.); Baylor University Medical Center, Dallas, TX (I.T.); OhioHealth Riverside Methodist Hospital, Columbus (N.V.); Memorial Hermann Texas Medical Center, Houston (P.R.C.); Swedish Medical Center First Hill Campus, Seattle, WA (S.J.M.); Maine Medical Center, Portland (R.D.E.); Geisinger Clinic, Danville, PA (C.M.S.); Baptist Medical Center-Jacksonville, FL (E.S.); Baptist Hospital Louisville, KY (A.A.-C.); Barnes Jewish Hospital, St Louis, MO (C.P.D.); Mercy San Juan Medical Center and Mercy General, Carmichael, CA (L.M.); Presence St Joseph Medical Center, Joliet, IL (A. Badruddin); Buffalo General Medical Center, NY (A.H.S.); University of Arizona Medical Center, Tucson (T.M.D.); University of Kentucky Hospital, Lexington (A.A.); Los Robles Medical Center, Thousand Oaks, CA (M.A.T.); Aurora Hospital, Milwaukee, WI (K.A.); West Virginia University/Ruby Memorial Hospital, Morgantown, WV (J.C.); Albany Medical Center, NY (A. Boulos); University of Maryland Medical Center, Baltimore (G.J.); University of Massachusetts Memorial Medical Center, Worcester (A.S.P.); Crouse Hospital, Syracuse, NY (E.M.D.); Virginia Mason Medical Center, Seattle, WA (D.H.R.); Mayo Clinic-Rochester, MN (D.F.K.); Erlanger Medical Center, Chattanooga, TN (B.W.B.); ProMedica Toledo Hospital, OH (M.A.J.); Banner University Medical Center, Phoenix, AZ (P.S.); McLaren Flint, MI (A.M.); California Pacific Medical Center, San Francisco (J.D.E.); University of California, Irvine, Orange (S. Suzuki); St John Providence Hospital, Detroit, MI (R.D.F.); Abbott Northwestern Hospital, Minneapolis, MN (J.E.D.A.); and Carolinas Medical Center, Charlotte, NC (J.C.M.).

出版信息

Stroke. 2017 Oct;48(10):2760-2768. doi: 10.1161/STROKEAHA.117.016456. Epub 2017 Aug 22.

DOI:10.1161/STROKEAHA.117.016456
PMID:28830971
Abstract

BACKGROUND AND PURPOSE

Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials.

METHODS

STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis.

RESULTS

A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2.

CONCLUSIONS

This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

摘要

背景与目的

机械血栓切除术联合支架取栓术已成为治疗急性缺血性脑卒中患者大血管闭塞的标准治疗方法。STRATIS 登记研究(急性缺血性脑卒中患者接受神经血栓切除术装置治疗的系统评估)旨在评估在随机试验中是否可以在大型真实世界队列中实现类似的流程时间、技术和功能结果。

方法

STRATIS 旨在前瞻性纳入在美国接受 Solitaire 再通装置和 Mindframe Capture 低轮廓再通装置治疗的患者,发病后 8 小时内。STRATIS 队列与之前发表的 SEER 患者水平荟萃分析的介入队列进行比较。

结果

共分析了 55 个中心的 984 例患者。平均 NIHSS 评分为 17.3。静脉注射组织型纤溶酶原激活剂的使用率为 64.0%。从发病到入组医院、入医院到穿刺、穿刺到再灌注的中位时间分别为 138、72 和 36 分钟。核心实验室判定的改良脑梗死溶栓(TICI)≥2b 的比例为 87.9%。90 天时,56.5%的患者改良 Rankin 量表评分为 0-2,全因死亡率为 14.4%,症状性颅内出血发生率为 1.4%。从急救医疗服务现场到达至穿刺的中位时间为 152 分钟,该时间间隔每延迟 1 小时,实现改良 Rankin 量表评分为 0-2 的可能性就会降低 5.5%。

结论

这是迄今为止最大的 Solitaire 登记研究,证明了随机试验的结果可以在社区中重现。随着时间的推移,临床获益的下降需要优化护理系统。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT02239640。

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