Solitaire器械可有效治疗大动脉卒中

圣迭戈——在神经介入外科学会(SNIS)年会上报告的一项多中心研究显示，Solitaire FR血运重建器械用于大动脉阻塞继发急性缺血性卒中(AIS)的一线治疗不仅安全，而且再通率和临床结局良好。

Solitaire FR器械可机械性去除被阻塞血管中的血栓，已经获得欧洲CE认证，Covidien公司于2009年11月将该产品投向国际市场，并于2012年3月获得美国食品药品管理局(FDA)上市批准。
 

Solitaire FR 血运重建器械

日内瓦大学医院介入神经放射科主任Vitor Mendes Pereira博士报告称，这项以Solitaire FR作为AIS患者血运重建一线治疗的多中心研究招募了2009年3月~2010年7月在日内瓦、巴塞罗那、埃森、蒙彼利埃、斯德哥尔摩和伯尔尼等地临床中心接受治疗的141例连续患者。研究者利用独立临床实验室评价术前和术后血管造影脑梗死溶栓(TICI)评分情况，完全再通定义为治疗后TICI为2b或3，良好神经结局为国立卫生研究院卒中量表(NIHSS)评分改善≥10分或出院时NIHSS评分为0或1，良好结局为90天改良Rankin量表评分≤2。

患者平均年龄66岁，44%为女性，中位NIHSS评分为18，52%的患者在治疗前接受组织型纤溶酶原激活物(TPA)静脉治疗。多数阻塞位于前循环(86%)，46%属于M1阻塞。

研究显示，85%的患者血运重建成功，TICI≥2b，其中96%的患者心肌梗死溶栓(TIMI)评分≥2，83%的患者动脉阻塞性损伤(AOL)评分为3。近3/4的患者(74%)采用气囊引导导管，技术成功率为97.8%，中位股动脉穿刺时间为40分钟，平均血管再通数为1.8，77%的再通成功患者血管再通数最高为2。7例(4.9%)患者需要挽救治疗。近1/3的患者(32%)出院时神经结局良好，55%的患者90天改良Rankin量表评分≤2。90天死亡率为26%， 6%的患者发生颅内出血。

该研究由Covidien公司资助，Pereira博士报告他担任该公司顾问，并且是该公司资助的两项研究的主要研究者。


Vitor Mendes Pereira博士

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By: DOUG BRUNK, Cardiology News Digital Network

SAN DIEGO  – When used as a first-line choice for the treatment of acute ischemic stroke secondary to large artery occlusion, the Solitaire FR revascularization device was safe and offered good recanalization rates and clinical outcomes, a multicenter study showed.

The Solitaire FR device, which mechanically removes blood clots from blocked vessels, received CE Mark approval in Europe and has been commercialized internationally by Covidien since November 2009. The Solitaire FR device was cleared in March of 2012 by the Food and Drug Administration.

The Solitaire FR revascularization device.
 
At the annual meeting of the Society of Neurointerventional Surgery, Dr. Vitor Mendes Pereira presented findings from 141 consecutive patients with acute ischemic stroke who were treated with the Solitaire FR device as first-line treatment to restore blood flow at clinical centers located in Geneva; Barcelona; Essen, Germany; Montpellier, France; Stockholm; and Bern, Switzerland, between March 2009 and July 2010. The researchers used an independent clinical lab to evaluate Thrombolysis in Cerebral Infarction (TICI) scores on pre- and postprocedural angiograms.

Dr. Pereira, one of the investigators who heads the section of interventional neuroradiology at University Hospital of Geneva, said that complete recanalization was defined as TICI 2b or 3 post treatment. He and his associates defined good early neurologic outcome as a National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 or more points or a NIHSS score of 0 or 1 at hospital discharge. They defined favorable outcome as a modified Rankin Scale score of 2 or less at day 90.

The mean age of the 141 patients was 66 years; 44% were women. Their median NIHSS score was 18, and 52% of patients were treated after previous treatment using intravenous tissue plasminogen activator (TPA). Most of the occlusions were located in the anterior circulation (86%), and 46% corresponded to M1 occlusions.

Dr. Pereira reported successful revascularization in 85% of patients with a TICI of 2b or greater, 96% for those with a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or greater, and 83% for those with an Arterial Occlusive Lesion (AOL) score of 3.
 
Nearly three-quarters of cases (74%) were performed using a balloon-guided catheter. Technical success was achieved in 97.8% of patients, and the median time to groin puncture was 40 minutes. The mean number of passes was 1.8, and 77% of patients achieved recanalization success with up to two passes. Rescue therapy was required in seven cases (4.9%).

Nearly one-third of patients (32%) achieved a good neurologic outcome at hospital discharge and 55% had a modified Rankin Scale score of 2 or less at 90 days. The rate of death at 90 days was 26%, and 6% experienced intracranial hemorrhage.

The study was funded by Covidien. Dr. Pereira disclosed that he is a consultant for Covidien and is the principal investigator for two studies funded by the company.