溶栓相关试验及进展课件

1、急性缺血性脑卒中血管再通 临床证据与进展,首都医科大学宣武医院神经外科 王亚冰,缺血性脑卒中溶栓治疗循证,静脉溶栓（NINDS， ECASS III ） 动脉溶栓（PROACT） 动静脉溶栓（IMS） 机械取栓（MERCI，SEIS） 指南 其他证据,静脉溶栓治疗,美国FDA批准临床应用 -1995年NINDS研究证明3h内静脉注射重组组织纤溶酶原激活剂（rtPA）溶栓治疗的有效性 AHA: -2008年欧洲急性卒中协作ECASS III研究表明静脉rtPA溶栓治疗的时间窗可延长至4.5h,静脉rtPA溶栓的不足,受益患者少 - 仅1-3%的患者能够在发病3h内接受治疗 血管再通率较低 - 仅约6%的颈内动脉、30%大脑中动脉和30%椎基底动脉可获得血管再通,39岁女性，意识障碍2小时 A：T2相正常 B、C：DWI显示右侧MCA分布区细胞毒性水肿，以右侧放射冠明显 动脉内溶栓治疗3天后复查 D：病变范围无增大，仅皮层及放射冠有小梗塞灶。,Dismatch,未行溶栓治疗的病例,缺血性脑卒中的早期治疗,血管再通,临床有效,发现新策略!,缺血区的血流灌注,缺血性脑卒中,血管再通：早期治疗关

2、键 -NINDS：1995年，静脉溶栓，3h -ECASS-：2008年，静脉溶栓，4.5h -大血管闭塞（ICA T-6%，TCD） 发展： -大血管闭塞（ICA，MCA，VA，BA） -Real-time window 至 病理生理时间窗 -多模式的血管内治疗（单纯/合并）,有效 快速 容易,复杂,血管内机械再通治疗,The Impact of Recanalization on Ischemic Stroke Outcome A Meta-Analysis,spontaneous (24.1%), intravenous fibrinolytic (46.2%), intra-arterial fibrinolytic (63.2%), combined intravenousintra-arterial (67.5%), and mechanical (83.6%) recanalized versus nonrecanalized: odds ratio of 4.43 (95% CI, 3.32 to 5.91) mortality was reduced in recan

3、alized patients (odds ratio, 0.24; 95% CI, 0.16 to 0.35) SICH: did not differ between the 2 groups,Stroke. 2007;38:967-973;,Anterior circulation: randomized thrombolysis trials in hemispheric stroke,NINDS: National Institute of Neurological Disorders and Stroke; ECASS: European Cooperative Acute Stroke Study PROACT:Prolyse in Acute Cerebral Thromboembolism,Posterior circulation: Major treatment studies in acute vertebrobasilar occlusion,IVT: intravenous thrombolysis; LIT: local intraarterial thr

4、ombolysis;,Guidelines for the Early Management of Patients With Acute Ischemic Stroke,Intravenous rtPA 推荐对起病3小时内符合标准的缺血性卒中患者静脉输注rtPA（0.9mg/kg，最大剂量90mg），I级推荐，A级证据。 推荐有适应征、起病后3-4.5小时的卒中患者使用静脉用rtPA（0.9mg/kg，最大剂量90mg），I级推荐，B级证据。,AHA/ASA Guideline,Guidelines for the Early Management of Patients With Acute Ischemic Stroke,Endovascular Interventions 时间窗内：静脉优先于动脉（I级推荐，A级证据） 对于大脑中动脉大面积缺血性卒中患者，病程小于6小时的，动脉内溶栓治疗审慎选择的患者（他们不适合使用rtPA治疗）可以获益。（I级推荐，B级证据）。 机械取栓方面，支架取栓器（如Solitaire FR和Trevo）总体上优于弹簧圈取栓器（如Merci）。Penu

5、mbra系统相较支架取栓器的相对效果尚不明确。I级推荐，A级证据。 联合溶栓：对于大动脉梗死静脉溶栓没有出现应答的患者进行补救性动脉内溶栓或机械取栓术是合理的。需要更多的随机试验结果（IIb级推荐，B级证据）。 急诊颅内血管成形术和/或支架置入的效果尚不肯定。,AHA/ASA Guideline,SWIFT Trial：SolitaireMerci,Merci Retrieval Device,X6、X5；L5；Kmini、V,Penumbra System,Thrombus aspiration and proximal thrombectomy,FDA 2007,Penumbra System,支架回收机械取栓,支架回收机械取栓,Castano et al. Stroke 2010;41:1836-40,Endovascular treatment of acute ischemic stroke the end or the beginning?,IMS IIII: interventional Management of Stroke MR RESCUE: Mechanical

6、 Retrieval and Recanalization of Stroke Clots Using Embolectomy SYNTHESIS Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke,Neurosurg Focus 36 (1):E5, 2014,Bridging Therapy,Bridging Therapy in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis,Systematic review of all studies using bridging therapy published between January 1966 and March 2011 The literature search identified 15 studies. In this meta-analysis, pooled est

7、imates associated with bridging therapy were 69.6% for recanalization rates, 48.9% for favorable outcome, 17.9% for mortality, and 8.6% for sICH.,Stroke. 2012;43:1302-1308,Pooled Rates of Recanalization and Clinical Outcomes,ConclusionsBridging therapy is associated with acceptable safety and efficacy in stroke patients. Time to intravenous treatment is critical to improve recanalization rates and favorable outcomes.,IMS III trial,Endovascular Therapy after Intravenous t-PA versus t-PA Alone for

8、 Stroke within 3 hours Stopped early because of futility after 656 participants had undergone randomization (434 patients to endovascular therapy and 222 to intravenous t-PA alone),N Engl J Med. 2013 March 7; 368(10): 893903.,IMS III trial,IMS III trial,CONCLUSIONSSimilar safety outcomes and no significant difference in functional independence with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone,N Engl J Med. 2013 March 7; 368(10): 893903.,Endovascular treatm

9、ent of acute ischemic stroke the end or the beginning?,IMS IIII: interventional Management of Stroke MR RESCUE: Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy SYNTHESIS Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke,Neurosurg Focus 36 (1):E5, 2014,MR RESCUE A Trial of Imaging Selection and Endovascular Treatment for Ischemic Stroke,A favorable penumbral pattern on neuroimaging did not identify patients who would differentially benefit from endovascular therapy for acute ischemic stroke, nor was embolectomy shown to be superior to standard care.,SWIFT Trial,美国多中心、随机对照研究 血管内机械再通治疗颅内大血管闭塞 Solitaire Retriever vs Merci Retriever 主要疗效终点：成功血管再通、无症状性出血 次要疗效终点：良好临床结局、死亡率和严重并发症,Saver et al. ISC 2012 Feb,SWIFT Trial: Randomized,All P0.001,Endovascular treatment of acute ischemic stroke the end or the beginning?,IMS IIII: interventional Management of Stroke M

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