Published 3-Year RESILIENT Data Support Bard's LifeStent in the SFA

February 8, 2012—Co-Principal Investigator John R. Laird, MD, et al published 3-year follow-up data from the RESILIENT randomized trial in the Journal of Endovascular Therapy (2012;19:1–9). Co-Principal Investigator Barry T. Katzen, MD, first presented the data in October at the VIVA 2011: Vascular Interventional Advances meeting, which was previously reported in Endovascular Today.

According to the investigators, the purpose of RESILIENT is to evaluate longer-term outcomes of primary nitinol stenting with the LifeStent self-expanding nitinol stent (Bard Peripheral Vascular, Tempe, AZ) for the treatment of femoropopliteal lesions up to 15 cm long, as these stents were found to have superior short-term patency compared with balloon angioplasty.

As detailed in the Journal of Endovascular Therapy, the RESILIENT trial randomized 206 patients (143 men; mean age, 67 years) with intermittent claudication due to superficial femoral artery and proximal popliteal artery lesions in a 2:1 ratio to treatment with nitinol stents or balloon angioplasty at 24 centers in the United States and Europe. The patients were followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 patients (78.2%) available for 36-month assessment.

The RESILIENT investigators reported that the 12-month freedom from target lesion revascularization rate was 87.3% for the stent group versus 45.2% for the angioplasty group (P < .0001). At 3 years, there was no difference in survival (90% vs 91.7%; P  = .71) or freedom from major adverse events (75.2% vs 75.2%; P  = .98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year; however, freedom from target lesion revascularization at 3 years was significantly higher in the stent group (75.5% vs 41.8%; P < .0001), as was clinical success (63.2% vs 17.9%; P < .0001). At 18 months, there was a 4.1% (12/291) stent fracture rate.

In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results versus balloon angioplasty alone, concluded the RESILIENT investigators.