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.
OBJECTIVE
To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty.


METHODS
Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment.


RESULTS
The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or 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, but freedom from TLR at 3 years was significantly better 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, a 4.1% (12/291) stent fracture rate was documented.


CONCLUSIONS
In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.
UC Davis Health System, Sacramento, California 95817, USA. john.laird@ucdmc.ucdavis.edu
John R
JR
Laird
Barry T
BT
Katzen
Dierk
D
Scheinert
Johannes
J
Lammer
Jeffrey
J
Carpenter
Maurice
M
Buchbinder
Rajesh
R
Dave
Gary
G
Ansel
Alexandra
A
Lansky
Ecaterina
E
Cristea
Tyrone J
TJ
Collins
Jeffrey
J
Goldstein
Annie Y
AY
Cao
Michael R
MR
Jaff
D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016009:Chi-Square Distribution; D003251:Constriction, Pathologic; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011859:Radiography; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States; D014654:Vascular Patency
D000497:Alloys; C013616:nitinol