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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
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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
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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
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Journal Article
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
2012
Overview
Purpose
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.
Conclusion
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.
Publisher
SAGE Publications,Allen Press Inc
Subject
/ Alloys
/ Angioplasty, Balloon - adverse effects
/ Angioplasty, Balloon - instrumentation
/ Angioplasty, Balloon - mortality
/ Arterial Occlusive Diseases - complications
/ Arterial Occlusive Diseases - diagnosis
/ Arterial Occlusive Diseases - mortality
/ Arterial Occlusive Diseases - physiopathology
/ Arterial Occlusive Diseases - therapy
/ Europe
/ Female
/ Femoral Artery - diagnostic imaging
/ Femoral Artery - physiopathology
/ Humans
/ Intermittent Claudication - diagnosis
/ Intermittent Claudication - etiology
/ Intermittent Claudication - mortality
/ Intermittent Claudication - physiopathology
/ Intermittent Claudication - therapy
/ Male
/ Popliteal Artery - diagnostic imaging
/ Popliteal Artery - physiopathology
/ Stents
/ Studies
