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

Selected in American Heart Journal by R. El Mahmoud

References

Authors

Liistro F, Porto I, Angioli P, Grotti S, Ducci K, Falsini G, Bolognese L.

Reference

Am Heart J 2013;166:920-6

Published

November 2013

Link

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My Comment

Background

The study aims to compare the 9-month restenosis rates of a strategy of predilatation with Paclitaxel-eluting balloons (PEB) followed by bare-metal CoCr stent (PEB + BMS group) versus implantation of everolimus DES (DES group).

Major findings

  • A randomised, single-center study with initially 366 patients with stable angina (183 patients per arm)
  • PCI of a de novo, native coronary artery stenosis 15 mm in length.
  • A noninferiority study design, where primary end-point was 9-month binary angiographic restenosis.
  • A frequency-domain optical coherence tomography (FDOCT) substudy investigated the malapposed/ uncovered struts and the percentage of net volume obstruction at 9-month FU among the first 30 patients enrolled in the PEB + BMS group.
  • The study was prematurely stopped after enrollment of 125 patients (59 in PEB + BMS group and 66 in DES group, because of excess of ischemia-driven TLR in PEB + BMS group.
  • TLR rate was 14% in PEB + BMS versus 2% in DES group (P = 0.001).
  • Binary restenosis, either in-stent or in-segment, was significantly higher in PEB + BMS compared with DES group (17% vs 3% [P =0.01] and 25% vs 4% [P =0.009] respectively).
  • Frequency-domain OCT demonstrated important neointimal regrowth in the PEB + BMS group.
  • Data suggest a lack of efficacy by second-generation Elutax PEB prior to BMS implantation

 My comments

  • Results can be compared with the data of PEPCAD III study comparing the Coroflex BMS with SeQuent Please PEB vs Cypher sirolimus-eluting stent where PEB-treated patients showed 3 times higher in-stent late lumen loss.
  • Nevertheless, the study was prematurely stopped which can reduce the power and the applicability of the results.
  • Biological studies demonstrating the role of pro-restenotic gene activation in the first 3 weeks after stent implantation explain more efficiency of a DES associated with a more delayed drug release, whereas paclitaxel is generally released by PEB in one time.
  • The increase in PEB technologies with drug carriers capable to release drug with more favorable bioavailability in the vessel is needed for future studies.

4 comments

  • Rajev Gupta 17 Dec 2013

    If we uses Sirolimus Eluting balloon then it make sense and can have better outcome. Recently In TCT one DEB namely Magic touch was presented. If I can have comments on this from you will be appreciated.

  • RAMI EL MAHMOUD 23 Dec 2013

    Yes. the Magic touch DEB is a Sirolimus drug coated balloon using nanotechnology where drug coating are encapsulated nano particles of Sirolimus. This mechanism allows larger and more uniform drug delivery in the lesion and increase bio-availability of drug. We have pharmacokinetic and OCT studies measuring instent neointimal obstruction but we need to wait for large randomized studies comparing new generation of DES and Sirolimus eluting balloon with BMS

  • Mantyla Pirjo 01 May 2014

    The results of DEB depend on the DEB, which drug, which carrier and so on.

  • Vladimir Manchurov 22 Jul 2014

    The effect of DEB may depend of DEB inflation technic i.e. balloon inflation time, pressure, lesion preparation etc...We use paclitaxel eluted balloons (DIOR) and have not bad results in our pts. Sometimes we use DEB together with BMS.