Document Detail

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.
MedLine Citation:
PMID:  22313193     Owner:  NLM     Status:  In-Data-Review    
Abstract 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.
John R Laird; Barry T Katzen; Dierk Scheinert; Johannes Lammer; Jeffrey Carpenter; Maurice Buchbinder; Rajesh Dave; Gary Ansel; Alexandra Lansky; Ecaterina Cristea; Tyrone J Collins; Jeffrey Goldstein; Annie Y Cao; Michael R Jaff
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists     Volume:  19     ISSN:  1545-1550     ISO Abbreviation:  J. Endovasc. Ther.     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-02-08     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1-9     Citation Subset:  IM    
1 UC Davis Health System, Sacramento.
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