Bare stents for iliac chronic total occlusions (“TELIS”): a prospective cohort study with a mid-term follow-up.

Abstract Objectives This study aims to assess primary bare stenting for iliac Chronic Total Occlusions (CTO) with mid-term follow-up. Methods From April 2013 to May 2016, all patients presenting with symptomatic iliac CTO were treated endovascularly and included in a prospective single-center cohort. Common iliac CTO were treated with balloon-expandable bare metal stents. External iliac lesions were treated with bare self-expandable nitinol stents. Primary endpoint was primary sustained clinical improvement. 49 iliac CTO were treated in 46 patients. Results 22 lesions were located at the level of the common iliac artery (45%), 20 at the external iliac artery (41%), 7 extending to both (14%). Mean stenting length was 114.4±49.8mm. Technical success was 98%. Primary sustained clinical improvement was achieved for 93.4±3.7% of patients at 12 months and 87.7±5.2% at 24 months. 3 in-stent thrombosis were observed with no restenosis in the remaining patients at 24 months. Freedom from target lesion revascularization was 93.3%±3.7% at 24 months. 3 stent fractures were noted, none were symptomatic. Mean quality of life (EQ5D-3L) was significantly improved at 24 months (71.2 ±20.3 vs. 52.4 ±22.6, p=0.001). Conclusions Our results showed that primary bare metal stenting for iliac CTO is safe and efficient at 24 months and could be considered as a first-line strategy.