Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter
- 423 Downloads
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.
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.
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).
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).
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.
KeywordsDrug-coated balloon catheter Peripheral artery occlusive disease Femoro-popliteal lesions
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).
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.
- 9.Rosenfield K, Jaff MR, White CJ, et al. LEVANT 2 investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145-53. Cardiol. 2015;66(21):2329-38.Google Scholar
- 10.Katsanos K, Kitrou P, Spiliopoulos S, Diamantopoulos A, Karnabatidis D. Comparative effectiveness of plain balloon angioplasty, bare metal stents, drug-coated balloons, and drug-eluting stents for the treatment of infrapopliteal artery disease: systematic review and Bayesian network meta-analysis of randomized controlled trials. J Endovasc Ther. 2016;23(6):851–63.CrossRefPubMedGoogle Scholar
- 11.Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-coated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and meta-analysis of randomized clinical trials. JACC Cardiovasc Interv. 2016;9(16):1731–42.CrossRefPubMedGoogle Scholar
- 12.Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther. 2016;23(2):356–70.CrossRefPubMedGoogle Scholar
- 14.Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7(1):10–9.CrossRefPubMedGoogle Scholar