Six-year multicenter experience of standard endovascular treatment of critical limb ischemia in the era of drug-eluting devices.

Background: There has been increasing evidence to support the endovascular-first approach in the treatment of below-the-knee (BTK) lesions. Plain old balloon angioplasty (POBA), with bailout bare-metal stent scaffolding in case of flow limiting dissection or recoil, have been considered the standard treatment of choice but industries are continually developing innovative equipment and dedicated technologies, such as drug-eluting platforms whose use is increasingly extended, despite significant costs and lack of high-quality evidence to support a well-established strategy. This study's objective was to analyze the 6-year results of "standard" endovascular treatment of BTK lesions in the era of drug-eluting devices.

Methods: From August 2008 to February 2010, 21 French speaking European centers consecutively enrolled critical limb ischemia (CLI) patients with BTK lesions treated endovascularly into the Angioplastie Jambière (ANJE) registry. Primary endpoint was 1-year limb salvage, a subgroup analysis was performed to compare POBA, bare nitinol stents and balloon-expandable stents (BESs).

Results: Of the 282 patients included (61.7%, men, mean age 75.8±10.0 years), 53.5% were diabetic and 29.4% presented with chronic kidney disease. At 1 year, complete wound healing was described in 187 patients (82.7%), the overall limb salvage rate was 94.0% with a survival rates of 89.2%. The primary and secondary patency rates were 84.5% and 91.7% respectively with significantly lower primary patency rates after stenting (80.6% vs. 87.6% after POBA; P=0.043). The rate of freedom from target lesion revascularization (TLR) was 86.3% with significantly lower rates after stenting (81.8% vs. 89.9% after POBA; P=0.01). The subgroup analysis showed no significant difference between nitinol stents, BESs and POBA in terms of limb salvage and survival rates, however, primary and secondary patency rates were significantly lower after BESs (primary and secondary patency rates of 84.0% after nitinol stents vs. 77.4% after BES vs. 87.6% after POBA; P=0.012 and 93.0% vs. 77.4% vs. 87.6%; P=0.003, respectively), as well as freedom from TLR rates (82.3% vs. 81.2% vs. 89.9%; P=0.04).

Conclusions: In the drug eluting era, the endovascular first approach of BTK lesions based on POBA with bailout spot stenting is feasible, affordable but most importantly remains effective and should be the first line strategy until the place of drug eluting stents is precisely defined.