Tacrolimus-eluting carbon-coated stents versus sirolimus-eluting stents for prevention of symptom-driven clinical end points

Abstract

Coating of stents has been shown to minimize the interactions between platelets, stent surface and vascular response following stent implantation. The aim of our study was to compare the tacrolimus-eluting carbon-coated JANUS(®) stent with sirolimus-eluting CYPHER(®) stent for the prevention of symptom-driven clinical end points in a real world clinical setting. This prospective registry with a follow-up period of 24 months was conducted in 90 consecutive patients undergoing coronary artery stenting receiving CYPHER(®) (n = 48) or JANUS(®) (n = 42) stents. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction and target vessel revascularisation, and the secondary end point was clinically driven in-stent restenosis. The primary combined endpoint occurred in 38% of patients (n = 16) in the JANUS(®) group compared to 10% (n = 5) in the CYPHER(®) group. The relative risk increase of the composite end point was therefore 63% higher in patients receiving JANUS(®) stents compared to the CYPHER(®) stents (crude HR = 1.63, 95% CI = 1.17-2.28, p = 0.004; adjusted HR = 1.79, CI = 1.26-2.55, p = 0.001). Interestingly, 75% of events in the JANUS(®) group occurred during the first 6 months after stent implantation. Similarly, the rate of clinically driven in-stent restenosis was higher in patients receiving JANUS(®) stent (n = 10, 2%) compared to the CYPHER(®) stent (n = 2, 4%). Concordantly, the relative risk for clinically driven in-stent restenosis was 81% higher in the JANUS(®) group compared to the CYPHER(®) group (crude HR = 1.81, 95% CI = 1.08-3.02, p = 0.02; adjusted HR = 2.24, CI = 1.26-3.96, p = 0.006). The use of tacrolimus-eluting carbon coated JANUS(®) stent was associated with worse clinical outcome compared to the sirolimus-eluting CYPHER(®) stent in clinical routine use.