碳涂层对动脉粥样硬化性肾动脉狭窄支架置入术后再狭窄率的影响。

Impact of carbon coating on the restenosis rate after stenting of atherosclerotic renal artery stenosis.

作者信息

Zeller Thomas, Rastan Aljoscha, Kliem Martin, Schwarzwälder Uwe, Frank Ulrich, Bürgelin Karlheinz, Schwarz Thomas, Amantea Pietro, Müller Christian, Neumann Franz-Josef

机构信息

Department of Angiology, Herz Zentrum Bad Krozingen, Germany.

出版信息

J Endovasc Ther. 2005 Oct;12(5):605-11. doi: 10.1583/05-1599MR.1.

DOI:10.1583/05-1599MR.1

PMID:16212462

Abstract

PURPOSE

To investigate the impact of carbofilm coating and low-profile rapid exchange stent devices on the restenosis rate after stent-angioplasty of atherosclerotic renal artery stenosis (RAS).

METHODS

During a 2-year period (7/2002-7/2004), 143 consecutive patients with 179 primary ostial atherosclerotic RAS>or=70% diameter stenosis were treated with stents selected at the discretion of the operator. Eighteen patients (32 lesions) treated with 9 different types of stents were excluded from the analysis, leaving 125 patients (69 men; mean age 67 years, range 42 to 90) with 147 lesions who received either a Radix carbofilm-coated stent in 78 (53%) lesions (68 [54%] patients) or a Palmaz Genesis bare stainless steel stent in 69 (47%) lesions (57 [46%] patients). The target vessel diameter ranged from 5 to 7 mm.

RESULTS

Baseline characteristics were similar in both groups except the mean stent diameter, which was larger in the bare stent cohort (6.4+/-0.7 versus 5.9+/-0.5 mm, p<0.001). Primary success was 100% in both groups; the initial mean diameter stenosis was reduced from 79%+/-14% and 80%+/-14% in the coated versus bare stent groups to 3+/-5% and 2+/-6%, respectively. After a mean follow-up of 22+/-5 months, the restenosis rate was 6.4% for the coated stent and 5.8% for the bare stent (p=0.87). For the entire cohort, restenosis rates varied significantly (p<0.05) according to stent diameter: 19% (5/26) for 5 mm, 4% (3/81) for 6 mm, and 2.5% (1/40) for 7 mm. In a binary logistic regression analysis including carbofilm coating, stent diameter, gender, diabetes, smoking status, and body mass index, stent diameter was the only independent predictor of restenosis (odds ratio 0.12, 95% CI 0.03 to 0.48 [p=0.003] for a 1-mm increase in vessel diameter).

CONCLUSIONS

Using modern low-profile stent devices, carbofilm coating does not significantly reduce the restenosis rate compared to a bare metal stent. With contemporary stent devices, the restenosis rate has been decreasing compared to earlier reports in the literature.

摘要

目的

研究碳膜涂层和低轮廓快速交换支架装置对动脉粥样硬化性肾动脉狭窄（RAS）支架血管成形术后再狭窄率的影响。

方法

在2年期间（2002年7月至2004年7月），143例连续患有179处原发性开口动脉粥样硬化性RAS且直径狭窄≥70%的患者接受了由操作者酌情选择的支架治疗。18例患者（32处病变）接受了9种不同类型的支架治疗，被排除在分析之外，剩下125例患者（69例男性；平均年龄67岁，范围42至90岁）有147处病变，其中78处（53%）病变（68例[54%]患者）接受了雷迪思碳膜涂层支架，69处（47%）病变（57例[46%]患者）接受了帕尔马兹吉尼西裸不锈钢支架。靶血管直径范围为5至7毫米。

结果

两组的基线特征相似，但裸支架组的平均支架直径较大（6.4±0.7对5.9±0.5毫米，p<0.001）。两组的主要成功率均为100%；涂层支架组和裸支架组的初始平均直径狭窄率分别从79%±14%和80%±14%降至3%±5%和2%±6%。平均随访22±5个月后，涂层支架的再狭窄率为6.4%，裸支架为5.8%（p = 0.87）。对于整个队列，再狭窄率根据支架直径有显著差异（p<0.05）：5毫米的为19%（5/26），6毫米的为4%（3/81），7毫米的为2.5%（1/40）。在一项包括碳膜涂层、支架直径、性别、糖尿病、吸烟状况和体重指数的二元逻辑回归分析中，支架直径是再狭窄的唯一独立预测因素（血管直径每增加1毫米，优势比为0.12，95%可信区间为0.03至0.48 [p = 0.003]）。