Five-year long-term clinical follow-up of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT FIRST trial
Background: Drug-eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long-term follow-up data are scarce and only available for sirolimus-and paclitaxel-eluting stents. Aim: To assess the feasibility and performance of the XIENCE V everolimus-eluting stent (EES) versus an identical bare metal stent after a 5-year follow-up period. Methods: SPIRIT FIRST was a First in Man, multicentre, prospective, single-blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent. Results: At 5-year clinical follow-up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1- and 5-year follow-up. The 5-year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2- and 5-year follow-up. No additional clinically driven TVR events were observed between 3- and 5-year follow-up. The 5-year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years. Conclusion: The favorable 5-year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow-up.