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

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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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 languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalJournal of Endovascular Therapy
Volume19
Issue number1
DOIs
StatePublished - 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

Laird, J. R., Katzen, B. T., Scheinert, D., Lammer, J., Carpenter, J., Buchbinder, M., Dave, R., Ansel, G., Lansky, A., Cristea, E., Collins, T. J., Goldstein, J., Cao, A. Y., & Jaff, M. R. (2012). 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. Journal of Endovascular Therapy, 19(1), 1-9. https://doi.org/10.1583/11-3627.1