Author + information
- Piotr Buszman1,
- Przemek Nowakowski2,
- Krzysztof Milewski1,
- Bartlomiej Orlik1,
- Aleksander Zurakowski1,
- Tomasz Ludyga3,
- Marcin Debinski1,
- Mateusz Kachel1,
- Anna Turek4,
- Juan Granada5,
- R. Stefan Kiesz6 and
- Paweł Buszman1
- 1Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland
- 2Center for Cardiovascular Research and Development, Katowice, Poland
- 3IIIrd Clinical Department of Cardiology of Medical University of Silesia, Katowice, Poland
- 4Center for Cardiovascular Research and Development, American, Katowice, Poland
- 5CRF Skirball Center for Innovation, Orangeburg, New York, United States
- 6San Antonio Endovascular and Heart Institute, San Antonio, Texas, United States
Second generation paclitaxel coated balloons (PCB) with improved coating technology and novel carrier molecules have been proposed and have shown improved vascular response in the preclinical setting, however clinical trial data are lacking. The aim of this study was to prove the superiority of a novel, microcrystalline and biodegradable polymer paclitaxel coated balloon (mcPCB, PAK, Balton, Poland) in restenosis inhibition for femoro-popliteal arterial disease when compared to plain balloon angioplasty (PBA).
In this first-in-man, prospective, controlled randomized trial patients with symptomatic (Rutherford Class 2-5) femoro-popliteal, occlusive arterial disease (>50% diameter stenosis) were randomized to either PBA alone or mcPCB dilation after PBA in a 1 :1 fashion. Late lumen loss (LLL) was the primary endpoint of the study, whereas the composite endpoint of Serious Adverse Events (SAE, Death, Amputation, Repeated Revascularizaation) were considered secondary endpoints. Routine angiography was scheduled at 6 months and ambulatory follow-up at 12 months.
In total 66 patients were included in the study, 33 randomized to mcPCB and 33 to POBA. At 6 months The LLL was 0.52±1.3 vs. 1.39±1.1 mm in the mcPCB when compared to POBA, psup<0.01). Binary restenosis occurred in 23% vs. 52% patients subsequently (p=0.02). In doppler evaluation, ankle-brachial index was significantly higher in patients in the mcPCB group (0.97±0.3 vs. 0.83±0.1; p=0.01). At one year, the incidence of SAE was significantly lower in the mcPCB group (25.0 vs. 58.0% ; p<0.01), which was mainly driven by the reduction of repeated revascularizations in the mcPCB group (24.2 vs. 53.3%; p=0.02).
In this pivotal trial, novel, microcrystalline and biodegradable polymer PCB was safe and superior when compared to POBA in restenosis inhibition and reduction of recurrent revascularizations in patients with femoropopliteal PAD.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention