A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated Balloon Versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis: Results From the PEPCAD China ISR Trial

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• 作者：Bo Xu ; Runlin Gao ; Jian'an Wang ; Yuejin Yang ; Shaoliang Chen ; Bin Liu ; Fang Chen ; Zhanquan Li ; Yaling Han ; Guosheng Fu ; Yelin Zhao ; Junbo Ge ; PEPCAD China ISR Trial Investigators
• 关键词：in-stent restenosis ; paclitaxel-coated balloon(s) ; paclitaxel-eluting stent(s)
• 刊名：JACC: Cardiovascular Interventions
• 出版年：February, 2014
• 年：2014
• 卷：7
• 期：2
• 页码：204-211
• 全文大小：396 K

文摘

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Objectives

The intention of the PEPCAD China ISR (A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis) was to demonstrate the efficacy of paclitaxel-coated balloon (PCB) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).

Background

The treatment of DES-ISR is still challenging with no established best strategy. Moreover, there is no study on the effect of PCB in the treatment of ISR in the Chinese population.

Methods

PEPCAD China ISR was a 220-patient randomized (1:1), single-blind prospective multicenter trial conducted in China. Patients with coronary DES-ISR received either PCB (SeQuent Please, B. Braun Melsungen AG, Melsungen, Germany) or paclitaxel-eluting stent (Taxus Libert茅, Boston Scientific, Natick, Massachusetts) treatment. The primary endpoint was in-segment late lumen loss at 9 months.

Results

There were no significant baseline differences between both treatment groups in terms of patient, lesion, or procedural characteristics. At 9 months, in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group (0.46 卤 0.51 mm vs. 0.55 卤 0.61 mm; difference: 鈭?.06 mm with 95% confidence interval: 鈭?.23 to 0.10; p for noninferiority聽= 0.0005). The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups.

Conclusions

In a randomized trial of 220 patients, angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR. On the basis of these, as well as previous randomized trial data, PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release. (A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [PEPCAD]; )