Drug-eluting stents enter periphery in U.S.

November 4, 2004



While drug-eluting stents have proved successful in repairing coronary arteries, the periphery has been more challenging. The first FDA-approved clinical trial of a drug-coated stent for a peripheral artery began in October.

The DESTINY Trial will examine the effectiveness of the Zilver PTX drug-eluting stent in the above-the-knee femoropopliteal artery. The stent, made by Cook, is self-expanding and coated with the antitumor agent paclitaxel.

The trial will initially be conducted at 10 facilities and will enroll 60 patients. The Zilver PTX stent is 8 cm long, allowing for treatment of lesions up to 7 cm. A maximum of one drug-eluting stent will be implanted per patient. The trial will allow for another Zilver bare metal stent to be used in conjunction with the Zilver PTX if there is a dissection.

Results reported earlier this year from the first phase of the SIROCCO Trial conducted in Europe showed promise for the Cordis Smart sirolimus-eluting stent in the periphery. The stent was 8 cm long and 1 to 2 mm larger than the vessel diameter (6 to 7 mm). A maximum of three stents per patient were implanted. Investigators also determined that a slow-eluting rate is better than a faster one.