ORIGINAL ARTICLE   

Italian Journal of Vascular and Endovascular Surgery 2018 December;25(4):302-8

DOI: 10.23736/S1824-4777.18.01369-4

Copyright © 2018 EDIZIONI MINERVA MEDICA

language: English

Early results for the Chocolate Touch paclitaxel-coated PTA balloon catheter for the treatment of femoropopliteal lesions

Gary BINYAMIN ¹, Kristine OROSZ ², Eitan KONSTANTINO ¹, Andrew HOLDEN ² ✉

¹ TriReme Medical LLC, Pleasanton, CA, USA; ² Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand

BACKGROUND: Plain old balloon angioplasty for peripheral artery occlusive disease is limited by residual stenosis and flow-limiting dissection in the short term and re-stenosis in the mid-term. A number of strategies have been developed to deal with these issues, including stents and drug-eluting technologies.
METHODS: The early clinical experience with the Chocolate Touch paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter is reported in the prospective, single arm, multi-center ENDURE Trial. This technology combines a different method of angioplasty using the nitinol constrained Chocolate balloon with paclitaxel elution. Seventy lesions in femoro-popliteal arteries in 67 patients were treated, with a mean lesion length of 7.3 cm and moderate or severe calcification in 54.3% of cases. The vast majority of patients were Rutherford 3 claudicants.
RESULTS: Acute outcomes were excellent with no flow-limiting dissections after Chocolate Touch treatment and a residual stenosis (>50% diameter loss) in only one case. Most cases (88.6%) had a residual stenosis <30%, often with “stent-like” appearances. The primary endpoint, angiographically measured late lumen loss at 6 months, was only 0.16 mm. Primary patency, as assessed by the core laboratory adjudicated duplex ultrasound was 89.3% at 6-months and 82% at 12 months. Sustained clinical benefit was also seen with 76.3% of patients having an increase in ABI of at least 0.1 from baseline and a decrease in Rutherford score of 1 or more from baseline at 12 months.
CONCLUSIONS: The ENDURE study demonstrates that the addition of a paclitaxel coating to the Chocolate Touch paclitaxel-coated PTA balloon catheter combines the procedural advantages of the device (including very low incidence of significant dissection) with the long-term benefits of a drug-coated balloon.

KEY WORDS: Balloon angioplasty - Endovascular procedures - Peripheral vascular diseases - Peripheral arterial disease - Femoral artery