Paclitaxel has been a much studied and discussed drug in the US vascular field of late. For years, devices containing paclitaxel have had the European CE mark for peripheral vascular therapies, but only recently have devices that use the drug earned FDA approval. In November, the FDA approved the first drug-eluting stent to treat peripheral artery disease, the Zilver PTX paclitaxel-eluting stent.
Evidence continues to mount in support of the efficacy of paclitaxel for peripheral applications. Two studies published this month in JACC: Cardiovascular Interventions described success for paclitaxel-coated devices in the tortuous femoropopliteal arteries.
US trials are also being undertaken to study the drug’s effectiveness. In March, Vascular Disease Management interviewed VDM editorial board member Peter Schneider, MD, about the IN.PACT SFA II trial, the US arm of a clinical study for the IN.PACT Admiral drug-eluting balloon (DEB) as a treatment for peripheral artery disease in the superficial femoral and proximal popliteal arteries. Dr. Schneider is a co-principal investigator. The IN.PACT Admiral DEB has a coating formulated with paclitaxel. The trial completed enrollment in January.
“Data on multiple DEBs is coming out, especially following the recent LINC 2013 meeting in Leipzig, Germany,” said Dr. Schneider. “It is important for physicians to carefully review the data on DEBs coming on the market since there are differences in outcomes. There is not a ‘class’ effect and in other words, all DEBs do not perform with the same level of efficacy. More patients have been treated with IN.PACT products than any other DEB, and the safety and efficacy performance has been well documented by the 9 studies presented and 6 published.”