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西罗莫司与紫杉醇洗脱支架治疗冠状动脉支架内再狭窄的比较。

Comparison of sirolimus versus paclitaxel eluting stents for treatment of coronary in-stent restenosis.

作者信息

Airoldi Flavio, Briguori Carlo, Iakovou Ioannis, Stankovic Goran, Biondi-Zoccai Giuseppe, Carlino Mauro, Chieffo Alaide, Montorfano Matteo, Cosgrave John, Michev Iassen, Rogacka Renata, Sangiorgi Giuseppe Massimo, Colombo Antonio

机构信息

San Raffaele Hospital IRCCS, Milan, Italy.

出版信息

Am J Cardiol. 2006 Apr 15;97(8):1182-7. doi: 10.1016/j.amjcard.2005.11.034. Epub 2006 Mar 9.

Abstract

In patients with in-stent restenosis (ISR) inside bare metal stents, drug-eluting stents reduce the recurrence of restenosis compared with balloon angioplasty. However, few data are available about this therapeutic modality in the case of diffuse restenosis. The aim of this study was to evaluate the immediate and mid-term outcome of sirolimus- and paclitaxel-eluting stent implantation in diffuse ISR and determine the predictors of clinical and angiographic restenosis recurrence. A series of 161 consecutive patients with 194 diffuse ISR lesions (>10 mm) treated with drug-eluting stent implantation were evaluated. Major adverse cardiac events were defined as death, myocardial infarction, and the need for target lesion revascularization. During a mean follow-up of 8.2 +/- 3.4 months, the cumulative incidence of major adverse cardiac events was 19% in the SES group and 24% in the PES group (p = 0.56). Angiographic follow-up was performed in 80% of the lesions. The overall restenosis rate was 22% and was not significantly different between lesions treated with sirolimus-eluting (20%) or paclitaxel-eluting (25%, p = 0.55) stents. The incidence of restenosis was higher in diabetics (32%) than in nondiabetics (16%, odds ratio 2.5, 95% confidence interval 1.1 to 5.5, p = 0.02). By multivariate analysis, diabetes was confirmed to be the only independent predictor of recurrent restenosis (odds ratio 3.53, 95% confidence interval 1.39 to 9.02, p = 0.008). In conclusion, drug-eluting stent implantation for diffuse ISR is associated with acceptable clinical and angiographic results. The association of diffuse restenosis and diabetes mellitus is an unfavorable condition leading to a high risk of recurrence.

摘要

在接受裸金属支架植入后发生支架内再狭窄(ISR)的患者中,与球囊血管成形术相比,药物洗脱支架可降低再狭窄的复发率。然而,关于弥漫性再狭窄情况下这种治疗方式的数据很少。本研究的目的是评估西罗莫司和紫杉醇洗脱支架植入弥漫性ISR的即刻和中期结果,并确定临床和血管造影再狭窄复发的预测因素。对连续161例接受药物洗脱支架植入治疗194处弥漫性ISR病变(>10mm)的患者进行了评估。主要不良心脏事件定义为死亡、心肌梗死以及靶病变血管重建的需求。在平均8.2±3.4个月的随访期间,西罗莫司洗脱支架组主要不良心脏事件的累积发生率为19%,紫杉醇洗脱支架组为24%(p=0.56)。80%的病变进行了血管造影随访。总体再狭窄率为22%,接受西罗莫司洗脱(20%)或紫杉醇洗脱(25%,p=0.55)支架治疗的病变之间无显著差异。糖尿病患者的再狭窄发生率(32%)高于非糖尿病患者(16%,比值比2.5,95%置信区间1.1至5.5,p=0.02)。通过多变量分析,糖尿病被确认为再狭窄复发的唯一独立预测因素(比值比3.53,95%置信区间1.39至9.02,p=0.008)。总之,弥漫性ISR的药物洗脱支架植入与可接受的临床和血管造影结果相关。弥漫性再狭窄与糖尿病的关联是导致复发高风险的不利情况。

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