Yu Simon Chun Ho, Leung Thomas Wai Hong, Lam Judy Suk Yee, Lam Wynnie Wai Man, Wong Lawrence Ka Sing
Department of Diagnostic Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, 30-32 Ngan Shing St, Shatin, New Territories, Hong Kong.
Radiology. 2009 Apr;251(1):224-32. doi: 10.1148/radiol.2511081057.
To evaluate the feasibility and preliminary results of using paclitaxel-eluting stents for angioplasty and to treat symptomatic atherosclerotic ostial vertebral artery (VA) stenosis.
Institutional review board approval and written informed consent were obtained for this prospective study. Nine men and one woman (average age, 65.9 years +/- 11.6 [standard deviation]) were included. Inclusion criteria were as follows: (a) Patients had angiographic evidence of VA ostial stenosis of 50% or more or stenosis of more than 45% if the contralateral VA was occluded. (b) Refractory vertebrobasilar ischemia, such as a stroke or transient ischemic attack, occurred while patients were taking one antiplatelet medication with optimal cardiovascular risk factor control. (c) Patients did not have another substantial vertebrobasilar stenotic lesion in the same territory. The primary end point was procedure safety, defined as mortality and permanent neurologic morbidity 30 days after stent placement. The secondary end point was clinical effectiveness, defined as recurrent vertebrobasilar ischemic symptoms within 12 months after stent placement and restenosis greater than or equal to 50% of the treated VA segment within 12 months after stent placement.
The degree of stenosis ranged from 46% to 83% (mean, 67.3% +/- 11.9). The technical success rate was 100%. Procedure-related complication rate, mortality rate, and permanent neurologic morbidity rate at 30-day follow-up were 0%. At 12-month follow-up, no patient reported recurrent vertebrobasilar ischemic symptoms or had VA restenosis.
This pilot study suggests that use of paclitaxel-eluting stents in angioplasty and to treat symptomatic atherosclerotic ostial VA stenosis are feasible and promising in terms of potential safety and effectiveness in prevention of recurrent ischemia and restenosis. These results could be helpful in the formulation of a larger prospective randomized controlled trial.
评估使用紫杉醇洗脱支架进行血管成形术治疗有症状的动脉粥样硬化性椎动脉开口狭窄的可行性和初步结果。
本前瞻性研究获得了机构审查委员会的批准并取得了书面知情同意书。纳入9名男性和1名女性（平均年龄65.9岁±11.6[标准差]）。纳入标准如下：(a) 患者有血管造影证据显示椎动脉开口狭窄达50%或以上，若对侧椎动脉闭塞则狭窄超过45%。(b) 在患者服用一种抗血小板药物且心血管危险因素得到最佳控制的情况下，发生难治性椎基底动脉缺血，如中风或短暂性脑缺血发作。(c) 患者在同一区域没有其他严重的椎基底动脉狭窄病变。主要终点是手术安全性，定义为支架置入后30天的死亡率和永久性神经功能障碍。次要终点是临床有效性，定义为支架置入后12个月内复发性椎基底动脉缺血症状以及支架置入后12个月内治疗的椎动脉节段再狭窄大于或等于50%。
狭窄程度为46%至83%（平均67.3%±11.9）。技术成功率为100%。30天随访时的手术相关并发症发生率、死亡率和永久性神经功能障碍发生率均为0%。在12个月随访时，没有患者报告复发性椎基底动脉缺血症状或椎动脉再狭窄。
这项初步研究表明，在血管成形术中使用紫杉醇洗脱支架治疗有症状的动脉粥样硬化性椎动脉开口狭窄在预防复发性缺血和再狭窄方面的潜在安全性和有效性方面是可行且有前景的。这些结果可能有助于制定更大规模的前瞻性随机对照试验。
