Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery

Twelve-month results from the RESILIENT randomized trial

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, Michael R. Jaff

Research output: Contribution to journalArticle

452 Citations (Scopus)

Abstract

Background-Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results-A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions-In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.

Original languageEnglish (US)
Pages (from-to)267-276
Number of pages10
JournalCirculation: Cardiovascular Interventions
Volume3
Issue number3
DOIs
StatePublished - Jun 2010

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Popliteal Artery
Balloon Angioplasty
Femoral Artery
Stents
Angioplasty
nitinol
Intermittent Claudication
Multicenter Studies
Dissection
Pathologic Constriction

Keywords

  • Angioplasty
  • Peripheral vascular disease
  • Stents

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery : Twelve-month results 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; Jaff, Michael R.

In: Circulation: Cardiovascular Interventions, Vol. 3, No. 3, 06.2010, p. 267-276.

Research output: Contribution to journalArticle

Laird, JR, Katzen, BT, Scheinert, D, Lammer, J, Carpenter, J, Buchbinder, M, Dave, R, Ansel, G, Lansky, A, Cristea, E, Collins, TJ, Goldstein, J & Jaff, MR 2010, 'Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: Twelve-month results from the RESILIENT randomized trial', Circulation: Cardiovascular Interventions, vol. 3, no. 3, pp. 267-276. https://doi.org/10.1161/CIRCINTERVENTIONS.109.903468
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 ; Jaff, Michael R. / Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery : Twelve-month results from the RESILIENT randomized trial. In: Circulation: Cardiovascular Interventions. 2010 ; Vol. 3, No. 3. pp. 267-276.
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abstract = "Background-Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results-A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30{\%} residual stenosis) was superior for the stent group compared with the angioplasty group (95.8{\%} versus 83.9{\%}; P<0.01). Twenty-nine (40.3{\%}) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3{\%} for the stent group compared with 45.1{\%} for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3{\%} versus 36.7{\%}; P<0.0001). Through 12 months, fractures occurred in 3.1{\%} of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions-In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.",
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T1 - Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery

T2 - Twelve-month results from the RESILIENT randomized trial

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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 - Jaff, Michael R.

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N2 - Background-Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results-A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions-In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.

AB - Background-Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. Methods and Results-A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. Conclusions-In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone.

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