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CardioVascular and Interventional Radiology

, Volume 40, Issue 10, pp 1535–1544 | Cite as

Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter

  • Gunnar Tepe
  • Özlem Gögebakan
  • Ulf Redlich
  • Jörg Tautenhahn
  • Jens Ricke
  • Zuhir Halloul
  • Dirk-Roelfs Meyer
  • Matthias Waliszewski
  • Beatrix Schnorr
  • Thomas Zeller
  • Stefan Müller-Hülsbeck
  • Ilka Ott
  • Thomas Albrecht
Clinical Investigation

Abstract

Objectives

Based on a novel paclitaxel–resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions.

Background

The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions.

Methods

In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA).

Results

The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012).

Conclusion

The use of paclitaxel–resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates.

ClinicalTrials.gov identifier NCT01970579.

Keywords

Drug-coated balloon catheter Peripheral artery occlusive disease Femoro-popliteal lesions 

Notes

Acknowledgements

The authors wish to thank Dr. Bettina Kelsch, Dr. Maren Kutschera and Dr. Ines Gemeinhardt at InnoRa Berlin, Germany, for their respective efforts in conducting and monitoring this trial. We also wish to acknowledge Dr. Ralf Degenhardt at the Herzkreislaufzentrum Rotenburg, Germany, for his statistical support and Denny Herberger at Medical Scientific Affairs B.Braun, Berlin, for his logistic contributions. Finally, our thanks are extended to the members of our critical event committee consisting of Prof. Vorwerk (Klinikum Ingolstadt), Prof. Gebauer (Charité Berlin) and Dr. Fiedler (Harzklinikum Wernigerode).

Funding

All study participants received funding from B.Braun per included patient within a milestone-based system.

Compliance with Ethical Standards

Conflict of interest

GT and TA have lectured and received research grants from B.Braun. MW is a full-time employee of Medical Scientific Affairs department of B.Braun Melsungen AG.

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Copyright information

© Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2017

Authors and Affiliations

  • Gunnar Tepe
    • 1
  • Özlem Gögebakan
    • 2
  • Ulf Redlich
    • 3
  • Jörg Tautenhahn
    • 3
  • Jens Ricke
    • 4
  • Zuhir Halloul
    • 4
  • Dirk-Roelfs Meyer
    • 5
  • Matthias Waliszewski
    • 6
  • Beatrix Schnorr
    • 7
  • Thomas Zeller
    • 8
  • Stefan Müller-Hülsbeck
    • 9
  • Ilka Ott
    • 10
  • Thomas Albrecht
    • 2
  1. 1.Department of RadiologyRoMed Klinikum RosenheimRosenheimGermany
  2. 2.Department of Radiology and Interventional RadiologyVivantes Hospital Berlin NeuköllnBerlinGermany
  3. 3.Departments of Radiology and Vascular SurgeryKlinikum MagdeburgMagdeburgGermany
  4. 4.Departments of Radiology and Vascular SurgeryUniversity Hospital MagdeburgMagdeburgGermany
  5. 5.Department of Diagnostic and Interventional RadiologyHubertus HospitalBerlinGermany
  6. 6.Medical Scientific AffairsBerlinGermany
  7. 7.Charité UniversitätsmedizinBerlinGermany
  8. 8.University Heart Center Bad KrozingenBad KrozingenGermany
  9. 9.Diakonissenanstalt zu FlensburgFlensburgGermany
  10. 10.Heart Center MunichMunichGermany

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