Long-term results with bare-metal LifeStent in the SFA: Is this bad news for DES technologies?
Co-Principal Investigator Laird et al recently published the 3-year follow-up data from the RESILIENT randomized trial.1 This clinical study evaluated the long-term outcomes of primary nitinol stenting with the LifeStent self-expanding nitinol stent (Bard Peripheral Vascular) for the treatment of femoropopliteal lesions up to 15 cm in length, as these stents were found to have superior short-term patency compared with balloon angioplasty alone.
The RESILIENT trial randomized 206 patients (143 men; mean age: 67) 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. During that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 patients (78.2%) available for a 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<0.0001). At 3 years, there was no difference in survival (90% vs. 91.7%; P=0.71) or freedom from major adverse events (75.2% vs. 75.2%; P=0.98) 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<0.0001), as was clinical success (63.2% vs 17.9%; P<0.0001). At 18 months, there was a 4.1% (12/291) stent fracture rate.
These results are clearly excellent, and make me wonder how one could intellectually or economically justify the use of drug-eluting stents for the same indications?
- Laird JR, Katzen BT, Scheinert D, et al; for the RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19(1):1-9.