title: Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.
abstract: OBJECTIVE
  The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES.
  
  
  RESULTS
  We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44).
  
  
  CONCLUSIONS
  At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.forename: Sonia
authors.initials: S
authors.lastname: Petronio
authors.forename: Azfar
authors.initials: A
authors.lastname: Zaman
authors.forename: Mark
authors.initials: M
authors.lastname: Spence
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Simon
authors.initials: S
authors.lastname: Elhadad
authors.forename: David
authors.initials: D
authors.lastname: Roberts
authors.forename: Thomas
authors.initials: T
authors.lastname: Hovasse
authors.forename: Mariano
authors.initials: M
authors.lastname: Valdés
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D010984:Platinum / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D010984:Platinum; D000068338:Everolimus