Commentary: does 9 months signal sustained results in the claudicant?

摘要

The current report by ACTIVE trial investigators (Use of the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) in this issue of the JEVT describes the safety profile and the short-term improvements in the anatomical and functional outcomes using the Assurant Cobalt Iliac Balloon-Expandable Stent System in patients with claudication and both primary atherosclerotic and restenotic iliac occlusive disease. This was a successful trial and met its narrow goals. It is important to note that the majority of lesions were in the common iliac artery and that the majority of patients suffered from mild claudication. It is disappointing that the authors did not use the TASC (TransAtlantic Inter-Society Consensus) classification of lesions to provide a perspective to the readers and be consistent with the literature. The need for trials to obtain Food and Drug Administration (FDA) approval is obvious given current trends in federal regulations and the interest of insurance carriers in funding only approved devices at appropriate locations. This study thus adds to the portfolio of stents currently approved for iliac indications (Wallstent, Palmaz, SMART, Zilver, and Intra-Stent) and available to the interventionist community.