title: A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.
abstract: OBJECTIVE
  We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance.
  
  
  METHODS
  A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority.
  
  
  RESULTS
  The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00).
  
  
  CONCLUSIONS
  In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI.
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, 111 East 59th Street, New York, NY 10022, USA. gs2184@columbia.edu
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Bruno
authors.initials: B
authors.lastname: Farah
authors.forename: Christophe L
authors.initials: CL
authors.lastname: Dubois
authors.forename: Robert L
authors.initials: RL
authors.lastname: Feldman
authors.forename: Joseph
authors.initials: J
authors.lastname: Dens
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Hagiwara
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D054855:Drug-Eluting Stents / Q000592:standards / Q000639:trends*; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D020123:Sirolimus