Drug-eluting Balloon Bests Angioplasty for In-stent Restenosis

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Paclitaxel-eluting balloons are more effective than conventional balloon angioplasty at treating bare-metal stent (BMS) or drug-eluting stent (DES) restenosis, according to the results of a randomized study published in the September 2013 issue of the American Heart Journal. 

Researchers led by Seiji Habara, MD, of Kurashiki Central Hospital (Kurashiki-shi, Japan), randomized 208 patients with 213 in-stent restenosis lesions (BMS = 123; DES = 90) at 13 Japanese centers to treatment with paclitaxel-eluting balloons (SeQuent Please; B. Braun Melsungen AG, Vascular Systems, Berlin, Germany) or conventional balloon angioplasty from October 2009 to February 2011. 

Clinical follow-up was available in almost all (99.5%) patients. Target vessel failure (TVF, primary endpoint), TVR, TLR, PCI, and MACE were all higher in the balloon angioplasty group (table 1). 

Table 1. Six-month Clinical Outcomes

  
On angiographic follow-up, late lumen loss was lower with paclitaxel-eluting balloons, as was percentage diameter stenosis, minimal lumen diameter (MLD), and binary restenosis (table 2). 

Table 2. Six-month QCA Results

  
In paclitaxel balloon-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS restenosis vs. 9.1% of patients with DES restenosis (P = 0.04). In addition, late loss was lower in patients with BMS restenosis than in patients with DES restenosis (0.05 mm vs. 0.18 mm; P = 0.03). 

Dr. Habara and colleagues cite the main findings of the study as: 

• Use of paclitaxel-eluting balloons for treatment of in-stent restenosis was effective and resulted in a low incidence of TVF 
• Paclitaxel-eluting balloons reduced neointimal hyperplasia more effectively in BMS-restenosis than in DES-restenosis   

Biological Responses for BMS, DES Restenosis May Differ  

Though the mechanisms are poorly understood, the authors observe that BMS and DES restenosis “had different biological responses after [paclitaxel-eluting balloons].”   

One possible explanation, they add, is that in DES restenosis, there is already a failure of local antiproliferative drug therapy, whereas BMS restenosis is still naïve regarding such treatment.   

“The effect of [paclitaxel-eluting balloons] on DES-[restenosis] was relatively less than that on BMS-[restenosis],” the authors conclude, “but the absolute effect size after treatment with [paclitaxel-eluting balloons] was still remarkably favorable even in DES-[restenosis] lesions.”   

In an e-mail communication with TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), noted that “The present study is the seventh randomized clinical trial showing the efficacy and safety of paclitaxel-iopromide coated balloons in the treatment of BMS- or DES-[restenosis]. Clinical evidence from randomized clinical trials is only available for paclitaxel-iopromide coated balloons, e.g. SeQuent Please.”   

In addition, Dr. Scheller noted, the study shows the importance of lesion preparation prior to drug-eluting balloon use. “Careful predilatation was mandatory in this trial according to the recommendations of the Drug Coated Balloon Consensus group,” he said, adding that “future guidelines should give a class I recommendation for the treatment of BMS- and DES-[restenosis] with [drug-coated balloons].”   

  

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Source: 
Habara S, Iwabuchi M, Inoue N, et al. A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis. Am Heart J. 2013;166:527-533. 

  

Disclosures: 

• The study was supported by Nipro Corp (Osaka, Japan), which has exclusive rights to sell the SeQuent Please balloon catheter in Japan. 
• Dr. Habara reports no relevant conflicts of interest. 
• Dr. Scheller reports being named as a co-inventor of patent applications for various methods of restenosis inhibition, including drug-coated balloons. He also is a shareholder of InnoRa GmbH, and reports receiving lecture fees from B.Braun and Medtronic. 

  

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