Long-term results of the S.M.A.R.T. Control(TM) stent for superficial femoral artery lesions, J-SMART registry.

BACKGROUND The use of a stent in the treatment of lesions of the superficial femoral artery (SFA) remains controversial. Although some reports have suggested that use of a nitinol stent in conjunction with aggressive medical management is effective for long SFA lesions, few long-term, large-scale studies have been done. METHODS AND RESULTS A retrospective analysis was conducted of data from a multicenter study in which the S.M.A.R.T. Control(TM) stent was used for treatment of de novo SFA lesions. A total of 528 lesions in 432 patients were included. Mean patient age was 72.5±9.1 years; mean stent length was 15.7±8.1cm; 259 lesions (49%) were classified as C/D according to the TransAtlantic Inter-Society Consensus (TASC) II classification. Primary and secondary patency at 4 years was 66% and 87%, respectively. No cilostazol administration (41% re-stenosis group vs. 29% no-restenosis group, P<0.01), female gender (42% vs. 26%, P<0.01), younger age (70.7±9.3 years vs. 72.9±9.0 years, P<0.05), and chronic total occlusion (CTO; 72% vs. 52%, P<0.01) were independent predictors of re-stenosis. CONCLUSIONS The S.M.A.R.T. Control(TM) stent provided good long-term durability in the treatment of SFA lesions, and no cilostazol administration, female gender, younger age and CTO were associated with re-stenosis.