Retrospective multicentre analysis of S.M.A.R.T. vs. Luminexx nitinol stent implantation for superficial femoral artery lesions (REAL SL) Registry. 5 years' experience

Circ J. 2011;75(2):421-7. doi: 10.1253/circj.cj-10-0741. Epub 2011 Jan 6.

Abstract

Background: The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions, but a systematic comparison of the patency of 2 different nitinol stents (S.M.A.R.T. and Luminexx) in patients with SFA lesions has not been done.

Methods and results: A multicenter, prospective database that included 511 consecutive patients who had undergone endovascular therapy with nitinol stenting for 638 limbs (S.M.A.R.T.: n=503; Luminexx: n=135) was retrospectively analyzed. Patency was assessed by duplex ultrasound. Outcomes were compared between the groups by the Kaplan-Meier and log-rank methods. To minimize the differences between each group, propensity-matched analysis was also performed. Stent fracture occurred in 11% (57/503) of the S.M.A.R.T. and 23% (31/135) of the Luminexx stents (P=0.0005). Despite a higher prevalence of chronic total occlusion (55% vs. 40%, P=0.002) and longer lesions (154±93mm vs. 135±71mm, P=0.03) in the S.M.A.R.T. group, there was no significant difference in patency for up to 5 years (P=0.50). When 119 lesions per group were assessed after propensity-matched analysis, the 5-year patency rate was 74% for the S.M.A.R.T. and 65% for the Luninexx stent (P=0.10).

Conclusions: Despite a different stent fracture rate, there was no significant difference in terms of patency between the S.M.A.R.T. and Luninexx stents for up to 5 years.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Alloys
  • Angioplasty, Balloon
  • Arterial Occlusive Diseases / diagnostic imaging
  • Arterial Occlusive Diseases / surgery
  • Equipment Failure
  • Femoral Artery / diagnostic imaging
  • Femoral Artery / surgery*
  • Humans
  • Limb Salvage
  • Prevalence
  • Prosthesis Design
  • Radiography
  • Recurrence
  • Registries
  • Retrospective Studies
  • Stents* / adverse effects
  • Ultrasonography, Doppler, Duplex
  • Vascular Patency

Substances

  • Alloys
  • nitinol