Bifurcated coronary stents for infrapopliteal angioplasty in critical limb ischemia.

OBJECTIVE: The goal of this article is to report the preliminary results of infrapopliteal percutaneous transluminal angioplasty stenting with the Nile Croco coronary bifurcated stent (Minvasys, Gennevilliers, France) for selected patients with critical limb ischemia (CLI).

METHODS: From October 2006 to December 2010, 31 patients with CLI with below-the-knee TransAtlantic Inter-Society Consensus C and D lesions at the popliteal (n = 17, 54.8%) and distal tibioperoneal trunk (n = 14, 45.2%) bifurcations, with suboptimal primary percutaneous transluminal angioplasty results (residual stenosis >30%, elastic recoiling, or dissection), with at least two-vessel runoff to the foot (present or after percutaneous transluminal angioplasty), free of aortoiliac arterial disease, and at high surgical risk (more than three risk factors) were treated with the Nile Croco coronary bifurcated stent. Study end points included technical success, immediate and midterm primary and secondary patency rates, clinical improvement, and limb salvage.

RESULTS: Technical success was achieved in all patients (100%) without any intraoperative complications. Early complications included an acute stent occlusion and an acute compartment syndrome for a collateral arterial branch perforation. Median follow-up was 12.1 months (range, 1-32). Primary and secondary patency rates were 96.7% and 86.2% (95% confidence interval [CI], 67.2%-94.6%) at 30 days and and 100% and 96.6% (95% CI, 78.0%-99.5%) at 1 year, respectively. Clinical improvement (an upward shift of at least two Rutherford categories) was achieved in 28 patients (90.3%). A major amputation was required in one patient (3.2%). The overall limb salvage rate at 1 year was 96.7% (95% CI, 78.6%-99.5%).

CONCLUSIONS: Preliminary data suggest that the Nile Croco bifurcated stent for below-the-knee angioplasty in selected patients with CLI is associated with high rates of technical success, early and midterm patency, and clinical improvement. Limb salvage rates are acceptable for this technically highly challenging anatomy, yet further studies with larger patient populations are necessary to validate these results.