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 –

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. (Circ J 2011; 75: 421-427)