Short and long term comparison (24 months) of an alternative sirolimus-coated stent with bioabsorbable polymer and a bare metal stent of similar design in chronic coronary occlusions: the CORACTO trial

Abstract

We studied a novel sirolimus eluting stent with a bioabsorbable coating (SES) in >3 months old chronic total coronary occlusions (CTO). Ninety-five patients were randomised to either BMS (n=47) or SES (n=48). The primary endpoints were late lumen loss (LLL) and in-segment restenosis (ISR) after six months. Secondary endpoints were target vessel revascularisation after six and 24 months. Occlusion length (37.6 mm), reference diameter (2.8 mm) as well as the stented segment (45.5 mm) were similar in both groups. Up until six months no death, myocardial infarction or stent thrombosis occurred in either group. Angiographic follow-up (45BMS/46SES): LLL 1.8 mm/0.77 mm (p<0.0001), ISR 60%/17.4% (p<0.0001). In-segment re-occlusion 15.5%/0% and TVR 53.3%/10.8% (p<0.0001). After 24 months: 1 BMS, 2 SES patients died; 0 BMS, 0 SES infarction; 0 BMS, 0 SES stent thrombosis and 3 BMS, 0 SES TVR between six and 24 months. Thus total TVR after 24 months was 60% for BMS and 10.8% for SES (p<0.0001). The alternative sirolimus-coated stent was shown to reduce the relative risk of restenosis after six months by 71%, and of TVR after 24 months by 82%. Between six and 24 months, neither stent thrombosis occurred, nor repeat revascularisation was required in patients who received a SES.