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急性缺血性卒中中机械取栓术与静脉注射组织型纤溶酶原激活剂的安全性。脑缺血多模式机械性栓子清除术(MERCI)试验第一部分的结果

Safety of mechanical thrombectomy and intravenous tissue plasminogen activator in acute ischemic stroke. Results of the multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial, part I.

作者信息

Smith W S

机构信息

Department of Neurology, University of California-San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143, USA.

出版信息

AJNR Am J Neuroradiol. 2006 Jun-Jul;27(6):1177-82.

Abstract

BACKGROUND

The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) trial reported efficacy of the Merci Retriever for opening intracranial vessels in patients ineligible for intravenous (IV) tissue plasminogen activator (tPA). Patients who receive IV tPA but do not recanalize may also benefit from thrombectomy, but the revascularization efficacy and safety of this strategy has not been reported.

METHODS

Multi MERCI is an ongoing international, multicenter, prospective, single-arm trial of patients with large vessel stroke treated within 8 hours of symptom onset. Patients were enrolled who had received IV tPA but did not recanalize or who were ineligible for IV tPA. Primary outcome was vascular recanalization (Thrombolysis in Myocardial Infarction [TIMI] score II/III) and safety.

RESULTS

One hundred eleven patients received the thrombectomy procedure. Mean age +/- SD was 66.2 +/- 17.0 years, and baseline National Institutes of Health Stroke Scale (NIHSS) score was 19 +/- 6.3. Thirty patients (27%) received IV tPA before intervention. Treatment with the Retriever alone resulted in successful recanalization in 60 of 111 (54%) treatable vessels and in 77 of 111 (69%) after adjunctive therapy (IA tPA, mechanical). Symptomatic intracranial hemorrhage (ICH) occurred in 10 of 111 (9.0%). Clinically significant procedural complications occurred in 5 of 111 (4.5%) patients. The symptomatic ICH rate was 2 of 30 (6.7%) in patients pretreated with IV tPA and 8 of 81 (9.9%) in those without (P > .99).

CONCLUSIONS

Mechanical thrombectomy after IV tPA seems as safe as mechanical thrombectomy alone. Mechanical thrombectomy with both first- and second-generation Merci devices is efficacious in opening intracranial vessels during acute ischemic stroke in patients who are either ineligible for IV fibrinolytic therapy or have failed IV fibrinolytic therapy.

摘要

背景

MERCI(脑缺血机械性血栓清除)试验报告了Merci取栓器在不符合静脉注射(IV)组织纤溶酶原激活剂(tPA)条件的患者中开通颅内血管的疗效。接受静脉注射tPA但未实现再通的患者也可能从血栓切除术获益,但该策略的血管再通疗效和安全性尚未见报道。

方法

多中心MERCI试验是一项正在进行的国际多中心前瞻性单臂试验,纳入症状发作8小时内接受治疗的大动脉卒中患者。纳入已接受静脉注射tPA但未实现再通或不符合静脉注射tPA条件的患者。主要结局为血管再通(心肌梗死溶栓[TIMI]评分II/III级)及安全性。

结果

111例患者接受了血栓切除手术。平均年龄±标准差为66.2±17.0岁,基线美国国立卫生研究院卒中量表(NIHSS)评分为19±6.3。30例患者(27%)在干预前接受了静脉注射tPA。单纯使用取栓器治疗使111条可治疗血管中的60条(54%)成功再通,辅助治疗(动脉内tPA、机械治疗)后111条血管中的77条(69%)成功再通。111例患者中有10例(9.0%)发生有症状性颅内出血(ICH)。111例患者中有5例(4.5%)发生具有临床意义的手术并发症。静脉注射tPA预处理患者的有症状性ICH发生率为30例中的2例(6.7%),未接受预处理患者为81例中的8例(9.9%)(P>.99)。

结论

静脉注射tPA后进行机械性血栓切除术似乎与单纯机械性血栓切除术一样安全。使用第一代和第二代Merci装置进行机械性血栓切除术,对于不符合静脉纤溶治疗条件或静脉纤溶治疗失败的急性缺血性卒中患者,在开通颅内血管方面是有效的。

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