title: 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 disease: the SPIRIT II trial.
abstract: OBJECTIVE
  To assess the safety and performance of the XIENCE V everolimus-eluting stent (EES) versus the TAXUS paclitaxel-eluting stent (PES) in the treatment of patients with de novo coronary artery lesions after a five-year follow-up period. Second-generation drug-eluting stents (DES) were developed with the aim of improving the safety profile of DES, after reports of stent thrombosis (ST) with first-generation devices. However, long-term follow-up data are scarce.
  
  
  RESULTS
  SPIRIT II was a multicentre, prospective, single-blind, clinical trial, randomising 300 patients with up to two de novo coronary artery lesions in a ratio of 3:1 to either a EES or a PES. The five-year clinical follow-up was completed in 244 patients (81%). At five-year follow-up, 19.5% of patients were on thienopyridine in the EES arm, while 30.5% were on the same therapy in the PES arm. Cardiac mortality was significantly lower in EES than in PES (1.5% vs. 7.3%, p=0.015). There was a trend towards lower cardiac death and MI (4.8% vs. 11.4%) and lower ID-TLR (4.7% vs. 9.4%) in EES than in PES. As a result, there was a consistent reduction in ID-MACE for EES vs. PES (ID-MACE 8.0% vs. 18.1%, p=0.018). In addition, the ARC-defined stent thrombosis rate was numerically lower in EES compared to PES (0.9% vs. 2.8%). No definite stent thrombosis events were observed after two years in the EES arm.
  
  
  CONCLUSIONS
  Five-year clinical follow-up of the SPIRIT II trial demonstrated the continuing long-term safety and efficacy of EES.
authors: Thoraxcenter, Erasmus Medical Center, Dr. Molewaterplein 40 , Rotterdam, The Netherlands.
authors: Yoshinobu
authors: Y
authors: Onuma
authors: Karine
authors: K
authors: Miquel-Hebert
authors: Patrick W
authors: PW
authors: Serruys
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D017202:Myocardial Ischemia; D017239:Paclitaxel; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus