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) |
|---|---|
| Pages (from-to) | 1-9 |
| Number of pages | 9 |
| Journal | Journal of Endovascular Therapy |
| Volume | 19 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2012 |
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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
Cite this
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. / Laird, John R.; Katzen, Barry T.; Scheinert, Dierk; Lammer, Johannes; Carpenter, Jeffrey; Buchbinder, Maurice; Dave, Rajesh; Ansel, Gary; Lansky, Alexandra; Cristea, Ecaterina; Collins, Tyrone J.; Goldstein, Jeffrey; Cao, Annie Y.; Jaff, Michael R.
In: Journal of Endovascular Therapy, Vol. 19, No. 1, 2012, p. 1-9.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication
T2 - Three-year follow-up from the resilient randomized trial
AU - Laird, John R.
AU - Katzen, Barry T.
AU - Scheinert, Dierk
AU - Lammer, Johannes
AU - Carpenter, Jeffrey
AU - Buchbinder, Maurice
AU - Dave, Rajesh
AU - Ansel, Gary
AU - Lansky, Alexandra
AU - Cristea, Ecaterina
AU - Collins, Tyrone J.
AU - Goldstein, Jeffrey
AU - Cao, Annie Y.
AU - Jaff, Michael R.
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
KW - Balloon angioplasty
KW - Claudication
KW - Femoropopliteal segment
KW - Outcome analysis
KW - Peripheral vascular disease
KW - Popliteal artery
KW - Quality of life outcome
KW - Stenosis
KW - Stents
KW - Superficial femoral artery
UR - http://www.scopus.com/inward/record.url?scp=84857133568&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84857133568&partnerID=8YFLogxK
U2 - 10.1583/11-3627.1
DO - 10.1583/11-3627.1
M3 - Article
C2 - 22313193
AN - SCOPUS:84857133568
VL - 19
SP - 1
EP - 9
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
SN - 1526-6028
IS - 1
ER -