Author + information
- Piotr P. Buszman,
- Krzysztof Milewski,
- Michal Jelonek,
- Jacek Pająk,
- Paweł Gąsior,
- Agata Krauze,
- Beata Gwiazdowska–Nowotka,
- Armando Tellez,
- Juan Granada and
- Pawel Buszman
Since the advent of first paclitaxel coated balloons (PCB), new developments have been proposed to maintain therapeutic tissue levels while decreasing particle release. In these series of studies, we evaluated the pharmacokinetic profile and biological effects after paclitaxel delivery via novel microcrystalline PCB coating (mcPCB) in porcine iliofemoral arteries.
In total 21 iliofemoral segments of 10 domestic swine were enrolled. In the first pharmacokinetic study, 9 mcPCB's (Pax®, Balton) were dilated for 60s and animals sacrificed after 1 hour, 3 and 7 days. Studied segments were harvested and tissue paclitaxel concentration was analyzed utilizing HPLC. In the tissue effects study, following self–expandable stent implantation post dilation either with mcPCB (n=10) or POBA (n=5) was performed. After 28 days angiography was performed, animals sacrificed and stented segments harvested for histopathological evaluation.
The 1–hour, 3 and 7 days vessel paclitaxel concentrations were 152.9±154.5, 36.5±49.5, and 0.9±0.7 ng/mg respectively. In the tissue effects study, at 28 days stents in the mcPCB group when compared to POBA presented lower angiographic measures of neointimal hyperplasia as expressed by late loss (−0.43±0.9 vs. 0.23±1.2; p=0.24). In the histopathological evaluation, the degree of percent area of stenosis (%AS) was reduced by 42% in the mcPCB group (mcPCB:19.8±8.7% vs. POBA:34.2±15.7%; p<0.05). The healing process in mcPCB group was comparable to POBA with regard to fibrin deposition (0.7 vs. 0.7; p=ns), neointima maturity (1.97 vs. 1.93; p=ns), inflammation score (0.92 vs. 1;p=ns) and endothelialization score (1.77 vs. 1.73;p=ns). The media cell loss and mineralization tended to occur more often in the mcPCB group (60% vs. 0;p=0.08).
Delivery of paclitaxel via a novel mcPCB resulted in lower long–term tissue levels compared to first generation crystalline coatings. However, this technological approach displayed an important reduction of neointimal proliferation with favorable healing profile.
Poster Sessions, Expo North
Saturday, March 09, 2013, 10:00 a.m.–10:45 a.m.
Session Title: Coronary Stents
Abstract Category: 47. TCT@ACC–i2: Coronary Intervention, Devices
Presentation Number: 2101–246
- 2013 American College of Cardiology Foundation