Anecdotal vs. evidence‐based,off label use of drug eluting stents for infrapopliteal disease: Abusus non tollit usum (Misuse does not nullify proper use)

Objectives: The purpose of this study was to assess the long‐term limb preservation and/or healing of ulcers in patients with critical limb ischemia (CLI) and severe infrapopliteal atherosclerotic disease treated with drug eluting stents (DES). Background: Percutaneous revascularization has become an effective treatment for CLI in patients with infrapopliteal atherosclerotic disease. Recent reports using DES in patients with CLI have documented excellent short‐term infrapopliteal vessel patency. Higher primary patency rates in infrapopliteal vessels treated with DES could translate into better long‐term clinical outcomes and improved limb salvage rates. Methods: Twenty‐four consecutive patients with CLI (defined as rest pain, nonhealing ulcers, or gangrene) because of severe infrapopliteal disease were treated with DES from August 2004 to June 2006. Results: Procedural success was achieved in 96% (27/28) of targeted lesions. There were no procedure‐related deaths, acute vessel thrombosis events, or need for urgent surgical intervention. There was one case of distal embolization. Clinical follow up, ranging 8–34 months, is available for 100% of patients of which 83% (20/24) achieved limb preservation and healing. Angiographic and/or sonographic follow up, ranging 6–34 months, is available in 79% (19/24) of patients of which 95% (18/19) had patent target vessels. Conclusions: DES is a safe and effective long‐term option for CLI due to severe infrapopliteal arterial disease. Long‐term vascular patency led to a high rate of limb preservation and low amputation rate. A multicenter trial should further elucidate the role of DES in the treatment of CLI. © 2008 Wiley‐Liss, Inc.