Two-year results of a durable polymer everolimus-eluting stent in de novo coronary artery stenosis (The SPIRIT FIRST Trial).

AIMS: The successful use of everolimus on a durable polymer was earlier reported with 6 and 12 months data from this first-in-man study. This reports the long-term follow-up of the XIENCE V everolimus-eluting stent.

METHODS AND RESULTS: This prospective, single-blinded, randomised, multicentre clinical trial evaluated the safety and efficacy of the XIENCE V everolimus-eluting coronary stent system versus an identical bare metal stent in the treatment of patients with a single de novo coronary artery stenosis of >/=50% and <100% and a vessel diameter of 3.0 mm as assessed by on-line quantitative coronary angiography that could be covered by a single 18 mm stent.Sixty patients were randomised and at two-year follow-up, clinical data was available in 96% and 97% of patients in the everolimus and control arm, respectively. Four patients were excluded due to protocol violations and two patients withdrew consent.In the everolimus arm no additional death, myocardial infarction, clinically driven TLR, or TVR events were observed between one and two-year follow-up. The 2-year hierarchical MACE rate for the everolimus arm remained 15.4% (4/26). In the control group, two patients had a clinically driven target lesion revascularisation. MACE rate increased from 21.4% (6/28) to 25.0% (7/28) in the control group.

CONCLUSIONS: This report confirms and extends the safety and efficacy results of the durable polymer XIENCE V everolimus-eluting stent up to two years as compared to identical bare metal stents.