Original title: Elutax paclitaxel-eluting balloon followed by bare-metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis: A randomized trial. Reference: Francesco Liistro et al. Am Heart J 2013;166:920-6.
Recently, drug eluting balloons (DEB) have emerged as a potential alternative to drug-eluting stents (DES). Paclitaxel is an appropriate drug for DEBs given his quick release and prolonged retention shown to be effective in-stent restenosis and de novo lesions in small vessels. This work randomized patients with de novo lesions to pre-dilatation with Elutax, paclitaxel DEB (Aachen Resonance GmbH, Aachen, Germany) followed by systematically conventional cobalt – chrome stent implantation versus Xience V, everolimus DES implantation.
The primary end point was binary restenosis at 9 months. The study was planning to include 366 patients but had to be stopped prematurely, when had enrolled only 125 patients (59 in the DEB group and 66 in the DES group) as an excess of events in the DEB branch. At 9 months follow-up, binary restenosis was significantly higher in the DEB (in-stent 17% versus 3 %, p = 0.01 and in the segment 25 % versus 4%, P = 0.009), as well as revascularization guided by ischemia (4% versus 25 %; p = 0.01) and the composite of death, myocardial infarction and revascularization (6 % versus 29%, p = 0.01). Restenosis in the DEB branch followed by conventional stent is similar to conventional stent branch in the comparing series of such stent to the DES. Neo intimal volume observed by OCT is comparable to historical data in conventional stent. Furthermore, OCT showed no erroneous apposition in conventional stents, leaving solely responsible for the outcome of the study the lack of efficacy of DEB.
Conclusion:
In this study, pre-dilatation strategy of paclitaxel DEB systematically followed by conventional stent implantation, was significantly lower than the implantation of everolimus DES.
Editorial comment
DEBs efficacy was good in the jobs that used them, in the in-stent restenosis and de novo lesions in small vessels context, yet the pre-dilatation using DEB strategy followed by conventional stent implantation, which seems pathophysiology reasonable, failed to show efficacy in this study and in 2 recently published meta-analysis. It is noteworthy that the devices have shown great heterogeneity given the different variables involved (way to drug transportation, drug dose per mm2 of balloon, etc.) so there is definitely no class effect with regard to DEBs .
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