Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial.
BACKGROUND
Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation.


RESULTS
A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization.


CONCLUSIONS
In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.
Laird
John R
JR
Department of Medicine, Division of Cardiovascular Disease, University of California Davis Health System, Sacramento, Calif., USA. john.laird@ucdmc.ucdavis.edu
Katzen
Barry T
BT
Scheinert
Dierk
D
Lammer
Johannes
J
Carpenter
Jeffrey
J
Buchbinder
Maurice
M
Dave
Rajesh
R
Ansel
Gary
G
Lansky
Alexandra
A
Cristea
Ecaterina
E
Collins
Tyrone J
TJ
Goldstein
Jeffrey
J
Jaff
Michael R
MR
D000368:Aged; D000497:Alloys / Q000008:administration & dosage / Q000009:adverse effects; D000792:Angiography; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology / Q000601:surgery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology / Q000601:surgery; D019919:Prosthesis Implantation; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States
D000497:Alloys; C013616:nitinol