Paclitaxel coated angioplasty balloons are effective in reducing restenosis in the leg

February 14, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [mailto:vkunadian@perfuse.org]

Germany: Researchers from Germany demonstrate beneficial effects in terms of reduction in restenosis using angioplasty balloons coated with the cytotoxic drug paclitaxel during peripheral interventions.

The occurrence of restenosis is not only a problem faced with coronary artery interventions but also with peripheral interventions. It is known from previous studies that following peripheral interventions, restenosis can occur as high as in 40-60% of the cases after 6-12 months of intervention. A previous study called the SIROCCO (Sirolimus Coated Cordis Self-Expandable Stent) trial using the sirolimus eluting stents did not prove superior to bare metal stents in terms of reduction in restenosis during peripheral interventions Researchers from Germany conducted a study to determine the benefit of using paclitaxel coated balloons in reducing restenosis. This study was published in the latest issue of the New England Journal of Medicine (see link below). This study consisted of 154 patients with occlusion or stenosis of the femoro-popliteal arteries recruited between June 2004 and June 2005. These patients were randomized to undergo percutaneous intervention using the following three protocols: (1) angioplasty using balloons containing paclitaxel 3μg/Sqmm of the balloon surface (n=48); (2) angioplasty using uncoated balloons and contrast media containing paclitaxel (n=52); and (3) angioplasty using uncoated balloons without paclitaxel in contrast media (control group, n=54).

The primary endpoint for this trial was late lumen loss at 6 months. This study consisted of patients aged 18-96 years with a mean age of 68 years. In total 27% of patients had chronic occlusion and 36% of patients had restenosis.

The investigators did not note any significant differences in the baseline characteristics between the three groups. There were no adverse events associated with the use of contrast media containing paclitaxel. At 6 months, there was a significant reduction in the late lumen loss in the paclitaxel coated group (0.4±1.2mm) compared to the paclitaxel contrast media group (2.2±1.6mm) and the control groups (1.7±1.8mm).

During 6 months and 24 months follow-up, the investigators also demonstrated a significant reduction in the occurrence of target lesion revascularization in the paclitaxel coated group (4% and 15%) compared to the paclitaxel contrast media group (29% and 40%) and the control group (37% and 52%). The restenosis rate was also reduced significantly in the paclitaxel coated group (17%) compared to the paclitaxel contrast media group (55%) and the control group (44%).

This study which was conducted subsequent to positive results in animal studies using drug coated balloons demonstrated that angioplasty using paclitaxel coated balloons is associated with a reduction in the incidence of restenosis and target lesion revascularization up to 2 years. This study is limited by its small numbers and hence the authors indicate that larger studies would be required to confirm these findings.

Source
http://content.nejm.org/cgi/reprint/358/7/689.pdf