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严重症状性颅内狭窄支架植入与药物治疗的比较:一项对照临床试验

A Comparison of Stent Implant versus Medical Treatment for Severe Symptomatic Intracranial Stenosis: A Controlled Clinical Trial.

作者信息

Mohammadian Rezao, Pashapour Ali, Sharifipour Ehsan, Mansourizadeh Reza, Mohammadian Farideh, Taher Aghdam Ali Akbar, Mousavi Mohammad, Dadras Farhad

机构信息

Neuroscience Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Cerebrovasc Dis Extra. 2012 Nov 1;2(1):108-20. doi: 10.1159/000344004. Print 2012 Jan.

Abstract

BACKGROUND

Atherosclerotic stenosis of the major intracranial arteries is the most common cause of ischemic stroke. There are limited treatments for severe intracranial stenosis, and stent placement versus medical treatment remains controversial. The aim of this study was to compare functional outcomes of these two modalities in patients with severe symptomatic intracranial stenosis.

METHODS

At a single center, between 2008 and 2011, patients with angiographically demonstrated severe (70-90%) symptomatic intracranial atherosclerosis were divided into two groups: group A, which received only medical treatment, and group B, which underwent endovascular stent implant treatment. The severity and location of the stenosis was determined by digital subtraction angiography and the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial criteria in all patients. The exclusion criteria were: specific causes other than atherosclerosis, such as artery dissection, fibromuscular dysplasia, vasculitis, radiation and intracranial hemorrhage, focal neurological deficit that did not correlate to internal carotid artery or middle cerebral artery stenosis. All procedures were done under light anesthesia. Technical success was defined as the reduction of stenosis to <30% with complete enveloping of the lesion after the procedure. Early and late adverse events and functional outcomes were compared between the groups using the modified Rankin Scale (mRS).

RESULTS

Overall, 63 patients (29 in group A and 34 in group B) were evaluated and followed for a mean period of 15.22 months (range 6-25). The technical success rate was 97% in a total of 34 stents in 34 patients. There was no difference between the early (within 30 days) adverse event rates of the two groups. The median follow-up duration for the stent implant patients was 15 months (range 6-25), and for the medically treated cohort it was 14 months (range 8-25). The re-stenosis rate was 5.8% and the total number of late (>30 days) adverse events, including stroke, myocardial infarction and death, was 1 (2.9%) and 6 (20.7%) in the stent implant and medical groups, respectively (p = 0.042). The stent implant group had significantly better favorable functional outcomes according to the mRS than the medical group (93.9 vs. 63.0%). The cumulative secondary adverse event-free survival was significantly lower in the stent implant group.

CONCLUSION

Stent implants can be considered more durable and safe for patients with symptomatic severe stenosis of the internal carotid artery or middle cerebral artery, despite optimal medical therapy. Randomized, multicenter trials are required to confirm these results.

摘要

背景

主要颅内动脉的动脉粥样硬化性狭窄是缺血性卒中最常见的病因。针对严重颅内狭窄的治疗方法有限,支架置入术与药物治疗仍存在争议。本研究的目的是比较这两种治疗方式对有症状的严重颅内狭窄患者的功能结局。

方法

在2008年至2011年期间,于单一中心,将血管造影显示有严重(70 - 90%)症状性颅内动脉粥样硬化的患者分为两组:A组仅接受药物治疗,B组接受血管内支架植入治疗。所有患者均通过数字减影血管造影及华法林 - 阿司匹林症状性颅内疾病(WASID)试验标准确定狭窄的严重程度和部位。排除标准为:动脉粥样硬化以外的特定病因,如动脉夹层、纤维肌发育不良、血管炎、放疗及颅内出血;与颈内动脉或大脑中动脉狭窄无关的局灶性神经功能缺损。所有操作均在浅麻醉下进行。技术成功定义为术后狭窄程度降至<30%且病变完全被覆盖。使用改良Rankin量表(mRS)比较两组的早期和晚期不良事件及功能结局。

结果

总体而言,63例患者(A组29例,B组34例)接受了评估并平均随访15.22个月(范围6 - 25个月)。34例患者共植入了34枚支架,技术成功率为97%。两组早期(30天内)不良事件发生率无差异。支架植入患者的中位随访时间为15个月(范围6 - 25个月),药物治疗队列的中位随访时间为14个月(范围8 - 25个月)。支架植入组和药物治疗组的再狭窄率分别为5.8%和20.7%,晚期(>30天)不良事件总数分别为1例(2.9%)和6例(20.7%)(p = 0.042)。根据mRS,支架植入组的良好功能结局显著优于药物治疗组(93.9%对63.0%)。支架植入组累积无继发不良事件生存率显著更低。

结论

对于有症状的颈内动脉或大脑中动脉严重狭窄患者,尽管进行了最佳药物治疗,支架植入可能更持久且安全。需要进行随机、多中心试验来证实这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/323f/3567882/c672387847ac/cee-0002-0108-g01.jpg

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