Restenosis in gold-coated renal artery stents

Restenosis in gold-coated renal artery stents
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DOI:
10.1016/j.jvs.2005.03.038
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发表时间:
2005-07-01
影响因子:
4.3
通讯作者:
Cronenwett, JL
Cronenwett, JL
中科院分区:
医学2区
文献类型:
--
作者:
Nolan, BW;Schermerhorn, ML;Cronenwett, JL

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背景:在透视下,镀金可提高支架的可见度。这对于在肾动脉支架置入术(RAS)中精确放置支架特别有价值。关于金涂层支架的再狭窄,有相互矛盾的证据。为了评价镀金对肾支架术后再狭窄的影响,我们回顾了我们实践中所有接受RAS的患者的结果。对2000年6月至2003年9月间所有接受RAS手术的患者进行了回顾性队列研究。在此期间,使用了镀金和不锈钢支架。再狭窄(>60%直径)由系列双功检查确定(收缩峰值速度>180 cm/S和肾主动脉比>3.5)。采用Kaplan-Meier寿命表法计算再狭窄率。采用对数等级检验和Cox比例风险模型对可能影响再狭窄的变量进行评估。对78例患者的97条动脉进行了血管内支架成形术。在48例患者的59条动脉中放置了金涂层(NIRoyal)支架。在34例患者的38支动脉中放置了不锈钢支架(Corinthian、Genesis和Herculink)。患者的人口统计学、治疗适应症、技术成功和并发症在黄金和不锈钢支架组之间没有差别。平均随访时间:镀金支架为15个月,不锈钢支架为18个月。根据寿命表法,不锈钢支架组1年和2年无再狭窄率分别为84%和78%,而金涂层支架组分别为69%和39%(P=0.012,log-ranch检验)。多变量分析显示,只有使用金涂层支架(P=0.018;危险比[HR],3.3;95%可信区间[CI],1.2至8.7)和双侧病变(P=0.046;心衰,2.3;95%可信区间,1.02至5.2)才能预测再狭窄。单因素分析显示,支架直径、患者人口统计和RAS适应症对再狭窄无影响。根据美国心脏协会的标准,不锈钢组有87%的患者在1年后血压有所改善,而金涂层支架组的这一比例为77%(Kaplan-Meier;P=0.042,LOG-RANK检验)。RAS对两组患者血肌酐水平的影响差异无统计学意义。结论:在本组患者中,镀金肾支架的再狭窄率明显高于钢制支架。这些发现导致我们放弃了对RAS使用金涂层支架。接受金涂层支架治疗动脉粥样硬化性肾动脉狭窄的患者应密切关注是否有再狭窄的证据。
Background: Gold coating improves stent visibility under fluoroscopy. This is particularly valuable for precise stent placement during renal artery stenting (RAS). There is conflicting evidence regarding restenosis with gold-coated stents. To evaluate the effect of gold coating on restenosis after renal stenting, we reviewed the results of all patients undergoing RAS in our practice.Methods. A retrospective cohort study of all patients undergoing RAS between June 2000 and September 2003 was performed. During this time, both gold-coated and stainless steel stents were used. Restenosis (>60% diameter) was determined by serial follow-up duplex exams (peak systolic velocity > 180cm/s and renal-aortic ratio > 3.5). Restenosis rates were determined by using the Kaplan-Meier life-table method. Variables potentially affecting restenosis were evaluated with the log-rank test and Cox proportional hazards modeling.Results. RAS was performed in 97 arteries (78 patients). Gold-coated (NIRoyal) stents were placed in 59 arteries (48 patients). Stainless steel stents (Corinthian, Genesis, and Herculink) were placed in 38 arteries (34 patients). Patient demographics, indication for treatment, technical success, and complications did not differ between gold and stainless steel stent groups. Mean follow-up was 15 months for gold-coated stents and 18 months for stainless steel stents (NS). By life-table method, 1-year and 2-year freedom from restenosis rates were 84% and 78% in arteries treated with stainless steel stents versus 69% and 39% in those treated with gold-coated stents (P =.012, log-rank test). By multivariate analysis, only the use of gold-coated stents (P =.018; hazard ratio [HR], 3.3; 95% confidence interval [CI], 1.2 to 8.7) and bilateral disease (P =.046; HF, 2.3; 95% CI, 1.02 to 5.2) predicted restenosis. Stent diameter, patient demographics, and indication for RAS had no effect on restenosis by univariate analysis. According to American Heart Association criteria, 87% of patients in the stainless steel group had improved blood pressure at 1 year, compared with 77% in the gold-coated stent group (Kaplan-Meier; P =.042, log-rank test). There were no significant differences in the effect of RAS on serum creatinine levels between the two groups.Conclusion: Gold-coated renal stents had a substantially higher rate of restenosis than stainleiss steel stents in our series. These findings have led us to abandon the use of gold-coated stents for RAS. Patients who have received gold-coated stents for the treatment of atherosclerotic renal artery stenosis should be followed closely for evidence of restenosis.