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%, p50.71) 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 moderatelength lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.
Original language | English (US) |
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Pages (from-to) | 1-9 |
Number of pages | 9 |
Journal | Journal of Endovascular Therapy |
Volume | 19 |
Issue number | 1 |
DOIs | |
State | Published - 2012 |
Keywords
- Balloon angioplasty
- Claudication
- Femoropopliteal segment
- Outcome analysis
- Peripheral vascular disease
- Popliteal artery
- Quality of life outcome
- Stenosis
- Stents
- Superficial femoral artery
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Radiology Nuclear Medicine and imaging