Stenting of symptomatic atherosclerotic lesions in the vertebral or intracranial arteries (SSYLVIA) study results

Stenting of symptomatic atherosclerotic lesions in the vertebral or intracranial arteries (SSYLVIA) study results
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DOI:
10.1161/01.str.0000128708.86762.d6
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发表时间:
2004-06-01
期刊:
影响因子:
8.3
通讯作者:
King, P
King, P
中科院分区:
医学1区
文献类型:
--
作者:
Lutsep, HL;Barnwell, S;King, P

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背景和目的:有症状的颅内动脉狭窄患者接受药物治疗时,卒中发生率可能高达每年10%-24%。本多中心、非随机、前瞻性可行性研究评价了NEUROLINK系统治疗椎动脉或颅内动脉狭窄的效果。方法:患者年龄18 - 80岁,症状归因于单个靶病变狭窄大于或等于50%。患者在术前和术后一年接受了5次神经系统检查,并在6个月时接受了另一次血管造影。(70.5%)颅内动脉(颈内动脉15例,大脑中动脉5例,大脑后动脉1例,基底动脉17例,椎动脉5例)和18例颅外段椎动脉(6个开口,12个小脑后下动脉近端)治疗率为29.5%。在前30天,4例患者(6.6%)发生卒中,无死亡。58/61例(95%)成功置入支架。6个月时,颅内动脉狭窄>50%者12/37(32.4%),颅外椎动脉狭窄> 50%者6/14(42.9%),椎动脉开口狭窄4例。7例(39%)复发性狭窄有症状。55例患者中有4例(7.3%)在30天后发生卒中,其中1例为唯一未植入支架的患者。6.6%的患者在30天内发生卒中,7.3%的患者在30天至1年内发生卒中。虽然35%的患者发生再狭窄,但61%的患者无症状。需要进行涉及NEUROLINK系统的进一步试验。
Background and Purpose-Stroke rates in patients with symptomatic intracranial stenosis may be as high as 10% to 24% per year on medical therapy. This multicenter, nonrandomized, prospective feasibility study evaluated the NEUROLINK System for treatment of vertebral or intracranial artery stenosis.Methods-Patients were 18 to 80 years old with symptoms attributed to a single target lesion of greater than or equal to50% stenosis. Patients received 5 neurological examinations before and in the year after the procedure, and another angiogram at 6 months.Results-In 61 patients enrolled, 43 (70.5%) intracranial arteries (15 internal carotid, 5 middle cerebral, 1 posterior cerebral, 17 basilar, 5 vertebral) and 18 (29.5%) extracranial vertebral arteries (6 ostia, 12 proximal to the posterior inferior cerebellar artery [PICA]) were treated. In the first 30 days, 4 patients (6.6%) had strokes and no deaths occurred. Successful stent placement was achieved in 58/61 cases (95%). At 6 months, stenosis of >50% occurred in 12/37 (32.4%) intracranial arteries and 6/14 (42.9%) extracranial vertebrals, 4 in the vertebral ostia. Seven (39%) recurrent stenoses were symptomatic. Four of 55 patients (7.3%) had strokes later than 30 days, 1 of which was in the only patient not stented.Conclusions-The NEUROLINK System is associated with a high rate of successful stent deployment. Strokes occurred in 6.6% of patients within 30 days and in 7.3% between 30 days and 1 year. Although restenoses occurred in 35% of patients, 61% were asymptomatic. Further trials involving the NEUROLINK System are warranted.