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 No

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.