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缺血性卒中快速血管内治疗的随机评估
Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke


Mayank Goyal ... 心脑血管疾病 • 2015.03.12
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• 溶栓治疗轻度卒中的益处尚不清楚 • MRI引导下阿替普酶静脉给药治疗卒中——仍然卡在时间上

摘要


背景

在前循环近端血管阻塞的患者中,尽管使用了阿替普酶治疗,仍有60%~80%的患者在卒中发生后90天内死亡或不能重获功能独立性。我们在有小梗死核心、颅内动脉近端阻塞且侧支循环中度至良好的急性缺血卒中患者中,评估了接受标准治疗外加快速血管内治疗的效果。

 

方法

我们将参与者随机分配接受标准治疗(对照组)或标准治疗加采用可获得的血栓切除装置进行的血管内治疗(介入组)。前循环颅内动脉近端阻塞的患者在症状出现后最多12小时入组。计算机断层扫描(CT)及CT血管造影显示大梗死灶或侧支循环不良的患者被排除。对照预定目标对工作流程进行了评估。主要结局为90天时改良Rankin量表的评分(范围为0分[无症状]至6分[死亡])。采用比例优势模型计算共同比值比,作为评估干预会导致改良Rankin量表评分低于对照治疗可能性的一个指标(偏移分析)。

 

结果

因其有效性,试验被提前终止。在全世界22个研究中心,入组了316名参与者,其中238名接受了静脉内阿替普酶(介入组120名,对照组118名)。在介入组,从读取头颅CT至首次再灌注的中位时间为84分钟。介入提高了功能独立性(90天改良Rankin评分为0~2分)的比率(53.0%对对照组的29.3%;P<0.001)。主要结局表明介入组获益(共同比值比为2.6;95%可信区间,1.7~3.8;P<0.001),并且介入与死亡率降低相关(10.4%对对照组的19.0%;P=0.04)。3.6%的介入组参与者以及2.7%的对照组参与者发生了有症状的脑内出血(P=0.75)。

 

结论

在近端血管阻塞、小梗死灶且侧支循环中度至良好的急性缺血性卒中患者中,快速血管内治疗可改善功能结局并降低死亡率(由Covidien等资助;ESCAPE在ClinicalTrials.gov注册号为NCT01778335)。





作者信息

Mayank Goyal, M.D., Andrew M. Demchuk, M.D., Bijoy K. Menon, M.D., Muneer Eesa, M.D., Jeremy L. Rempel, M.D., John Thornton, M.D., Daniel Roy, M.D., Tudor G. Jovin, M.D., Robert A. Willinsky, M.D., Biggya L. Sapkota, M.B., B.S., Dar Dowlatshahi, M.D., Ph.D., Donald F. Frei, M.D., Noreen R. Kamal, M.D., Walter J. Montanera, M.D., Alexandre Y. Poppe, M.D., C.M., Karla J. Ryckborst, R.N., Frank L. Silver, M.D., Ashfaq Shuaib, M.D., Donatella Tampieri, M.D., David Williams, M.B., Ph.D., Oh Young Bang, M.D., Ph.D., Blaise W. Baxter, M.D., Paul A. Burns, M.B., Ch.B., M.D., Hana Choe, M.D., Ji-Hoe Heo, M.D., Ph.D., Christine A. Holmstedt, D.O., Brian Jankowitz, M.D., Michael Kelly, M.D., Ph.D., Guillermo Linares, M.D., Jennifer L. Mandzia, M.D., Ph.D., Jai Shankar, M.D., Sung-Il Sohn, M.D., Richard H. Swartz, Ph.D., Philip A. Barber, M.B., Ch.B., M.D., Shelagh B. Coutts, M.B., Ch.B., M.D., Eric E. Smith, M.D., M.P.H., William F. Morrish, M.D., Alain Weill, M.D., Suresh Subramaniam, M.D., Alim P. Mitha, M.D., John H. Wong, M.D., Mark W. Lowerison, M.Sc., Tolulope T. Sajobi, Ph.D., and Michael D. Hill, M.D., for the ESCAPE Trial Investigators*
The authors' affiliations are listed in the Appendix. Address reprint requests to Dr. Hill at the Calgary Stroke Program, Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Foothills Hospital, Rm. 1242A, 1403 29th Street NW, Calgary, AB T2N 2T9, Canada, or at michael.hill@ucalgary.ca. *A complete list of sites and investigators in the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial is provided in the Supplementary Appendix, available at NEJM.org.

 

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