Early results with LifeStent implantation in RESILIENT and non-RESILIENT inclusion criteria patients.

The purpose of our study was to determine outcomes of patients receiving the LifeStent (Bard Peripheral Vascular, Tempe, AZ) for femoropopliteal peripheral arterial disease in real-world academic practice outside the limitations of an industry supported trial. All patients from 2009 to 2012 at our institution who received a LifeStent during endovascular interventions and had follow-up were included. Outcomes evaluated included patency and freedom from limb loss. A total of 166 limbs in 151 patients had the LifeStent implanted in de novo vessels (54% male; 68 ± 12 years). Eighty-percent of limbs did not meet RESILIENT criteria due to Rutherford category >3 (51%), TransAtlantic Inter-Society Consensus II classifications C/ D (51%), zero runoff vessels (6%), or stent location (17%). Primary patency rates were 81% at 6 months and 58% at 12 months with predictors for primary patency loss at 1 year including Rutherford category >3 (HR: 1.8 (95% CI: 1.0-3.1), p = 0.04), tobacco use (HR: 1.8 (95% CI: 1.0-3.3), p = 0.04), and no clopidogrel at discharge (HR: 3.2 (95% CI: 1.6-6.7), p < 0.01). A preintervention Rutherford category >3 predicted 24-month limb loss (HR, 16.0 (95% CI: 2.0-122.0), p < 0.01). The LifeStent is a viable option regardless of the TransAtlantic Inter-Society Consensus II classification; however, critical limb ischemia, current tobacco use, and absence of clopidogrel on discharge predict decreased patency on follow-up.