Stent Grafts Found Effective for SFA Patients with Moderate, Long Lesions

SAN FRANCISCO, CALIF.—Three-year follow up data confirm the superiority of self-expanding nitinol stents for moderate-length lesions in the superficial femoral artery and proximal popliteal artery,  results presented at TCT 2011 showed.

RESILIENT trial

John R. Laird Jr., MD, of the University of California, Davis Medical Center, presented follow-up data from the RESILIENT trial.

RESILIENT was a prospective, randomized, multicenter, international study that included 24 sites in the United States and Europe. The nitinol stent (LifeStent, C.R. Bard) was used in patients (n=134) with an occlusive SFA and/or proximal popliteal artery (4-6.5 mm in diameter); balloon angioplasty was used to treat the same lesions in the control group (n=72). Restenosis in balloon angioplasty participants must only have occurred 6 months or more prior to study enrollment.

At 36 months, in patients with SFA and/or popliteal lesions less than 150 mm in length, freedom from target lesion revascularization was 75.5% in the stent group vs. 41.8% in the angioplasty only group (P<.0001). MACE-free rates were comparable in both groups (75.2% vs. 75.2%; P=1.00). The stent group also saw improvements in several quality of life metrics. Laird said, however, that angioplasty “has a role in patients with less complex lesions,” such as those that are not extremely calcified and are shorter than the lesions treated in the study.  Persons with prior stenting were not included. The median age for the stent group was 68.4 years; for the stent group it was 66.1 years.

VIBRANT trial

Gary M. Ansel, MD, of Midwest Cardiology Research Foundation, Columbus, Ohio, presented 3-year results of the prospective, multicenter, randomized VIBRANT trial, which compared a bare nitinol stent (n=76) with a heparin-bonded stent graft (n=72) (Viabahn, Gore) in patients with occlusive SFA disease and lesions of at least 8 cm. The primary endpoint was a 3-year primary patency as measured by a a core lab adjudicated duplex PSV ratio of less than 2.0.

“These were the toughest lesions ever studied in a controlled trial,” Ansel said.

Technical success was 97% for the stent graft and 96% for the bare nitinol stent (P=1.0). Sixteen bare nitinol stent patients crossed over to the endoprosthesis during subsequent reinterventions. There were no amputations in either group over the study period. At 3 years, the overall patency rates were fairly even between the two groups, Dr. Ansel said (see Figure). Of the patients studied, 85% of those who were treated with stent grafting required no more than one reintervention to maintain patency over the 3-year period. “The rates were excellent for these patients,” Ansel said. None of the study participants required amputation.

According to Ansel, data indicated that while the stent grafts restenosed at the edges, bare nitinol stents restenosed diffusely. The bare nitinol stents also had a significantly higher fracture rate than the stent grafts (58% vs. 0.9%; P<.001). Fractures were not always associated with overlap, but seemed to depend on lesion length, he said.