A three-year follow-up study has shown that an alternate treatment for obstructed arteries in the leg may be warranted. The results are from a clinical trial comparing primary nitinol stent implantation with balloon angioplasty. This examination of the study provides a long-term assessment of the two procedures, which is favorable for the primary stent.
An article in the the Journal of Endovascular Therapy reports on a 36-month follow-up of 161 patients in the RESILIENT randomised, multicenter trial. An accompanying commentary asks if these results are enough to mandate a change in practice that could bring with it a dramatic increase in treatment costs.
Patients in the RESILIENT study were treated for moderate-length lesions in the femoral and popliteal arteries. The superficial femoral artery provides blood flow to the leg, extending behind the knee where it becomes the popliteal artery. Patients with atherosclerosis experience blockage or narrowing of these arteries.
Balloon angioplasty is the more common treatment for this condition. In this study, angioplasty alone was compared to the Lifestent self-expanding stent. After 36 months, no significant difference was found between the stent and angioplasty groups in survival or in occurrence of major adverse events. However, freedom from further intervention – target lesion revascularization (TLR) – was significantly better in the stent group (75.5%) compared to the angioplasty group (41.8%).
The original study showed that after 12 months, 87.3% of patients in the stent group remained free from TLR, while only 45.2% of the angioplasty group did. A post-hoc analysis of the original study compared primary stenting to balloon angioplasty plus provisional stenting. In this analysis, the difference between groups for freedom from TLR was less pronounced, although still favoring the primary stent (81.5% vs. 66.9%).
These results led the authors to conclude that primary implantation of a nitinol stent is associated with better long-term results than balloon angioplasty. However, the author of the commentary points out that no significant difference in freedom from TLR was found between primary stent and angioplasty plus provisional stenting at the 36-month follow-up, and that these procedures, rather than angioplasty alone, are the basis of current practice.
