Significant difference in primary patency and freedom from TLR at one year favors PTA plus stent.
 
In patients with superficial femoral artery disease and lesions shorter than 150 mm, treatment with percutaneous transluminal angioplasty plus a primary stent was more effective with fewer adverse events than treatment with PTA alone, according to RESILIENT trial results.

Barry T. Katzen, MD, founder and medical director of the Baptist Cardiac and Vascular Institute and clinical professor of radiology at the University of Miami School of Medicine, said that the longer, more calcified lesions did not respond sufficiently to angioplasty.

“Both arms were extremely safe in terms of procedural major adverse cardiovascular events, death and bleeding. There was no significant difference between these acutely and at 30 days,” Katzen said.

Femoral artery disease

Katzen and colleagues enrolled 206 patients with superficial femoral artery (SFA) disease and proximal popliteal lesions , 150 mm at 24 sites worldwide. They randomized 134 patients to PTA plus a LifeStent (Edwards LifeSciences), and 72 patients to PTA alone.

At one year, there was an 80% primary patency rate in patients treated with PTA plus stenting, compared
with 38% in patients treated with PTA alone. Also at one year, 87% of the PTA-plus-stent group was free of TLR, compared with 46% of the PTA-alone group (Figure).

Investigators found lesion success, meaning residual stenosis , 30%, in 85.6% of lesions in the PTA-plusstent group (n = 153) and in 71.6% of lesions in the PTA-alone group (n=81). They measured procedure success as residual stenosis , 30% and no periprocedural complications.

Based on these criteria, they found 85.1% procedure success in the PTA-plus-stent group and 70.8%
success in the PTA-alone group.

Quality of life

Peri-procedure and at 30 days, there was no incidence of death, stroke, MI, emergent surgical revascularization, thrombosis or renal failure in either group of patients, Katzen said. Two patients in each group required transfusion, and one patient in the PTA-alone group had a significant distal embolization.

Investigators also found significant improvement in quality of life for patients in the PTA-plus-stent group at six months, with sustained and, in some cases, improved quality of life at 1 year, Katzen said.

In the PTA-alone arm of the trial, 29 patients (40.2%) crossed-over to the PTA-plus-stent group, Katzen said. Eleven of these patients crossed-over because of major flowlimiting dissection and 18 because of residual stenosis >30%.

“There was definitely an increase in lesion length that characterized this crossover group, and this reached statistical significance,” Katzen said. These patients also had significantly more lesion calcification.

Investigators identified 9 stent fractures (2.9%), but none of these fractures were associated with restenosis at 1 year.