Current Status of Drug-Eluting Stents and Drug-Eluting Balloons for the Superficial Femoral Artery.

The endovascular management of symptomatic atherosclerotic superficial femoral artery disease is challenging and requires consideration of unique anatomic, hemodynamic, and biomechanical factors. For innovative local drug delivery technologies to have a cost-effective and clinically meaningful benefit, they must provide patency rates in more complex lesions equivalent or superior to those currently approved devices are able to provide. Several proof-of-concept trials have either been published or been recently presented and many more are in the pipeline suggesting biologic effectiveness of these hybrid devices in reducing restenosis. Local drug delivery technology has already been commercially introduced in some countries for a variety of clinical settings. However, although these technologies offer promise in improving outcomes following lower extremity intervention, caution and safety are paramount. Adequately powered, multicenter, well-designed, randomized controlled trials with long-term follow-up (3-5 years) are still needed to accurately assess safety and efficacy.