title: PLATINUM China: a prospective, randomized investigation of the platinum chromium everolimus-eluting stent in de novo coronary artery lesions.
abstract: OBJECTIVE
  The PLATINUM China clinical trial evaluated the safety and effectiveness of the thin-strut, everolimus-eluting, platinum-chromium PROMUS™ Element™ stent (PtCr-EES) (Boston Scientific, Marlborough, MA) for the treatment of patients in China.
  
  
  BACKGROUND
  Clinical outcomes from the PtCr-EES have not been evaluated in patients from China, nor has it been directly compared with the second-generation stainless steel paclitaxel-eluting TAXUS Liberté stent (PES) in a randomized head-to-head trial. Methods In this prospective, multicenter, single-blind, superiority trial, patients with a single de novo atherosclerotic coronary artery lesion were randomized 1:3 to receive either the PES or PtCr-EES. The primary endpoint was in-stent late loss at 9 months.
  
  
  RESULTS
  Among 127 PES and 373 PtCr-EES patients (71.2% male; mean age 57.3 years), the primary endpoint of 9-month in-stent late loss was 0.40 ± 0.45 mm for PES versus 0.11 ± 0.36 mm for PtCr-EES (P < 0.001). In-stent % diameter stenosis was 22.20 ± 16.00% for PES versus 11.06 ± 13.86% for PtCr-EES (P < 0.001) at 9 months. The 1-year rate of death/MI was 1.6% (2/127) for PES versus 0% (0/371) for PtCr-EES (P = 0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr-EES (P = 0.26). No stent thromboses occurred at 12 months in either group.
  
  
  CONCLUSIONS
  In the largest prospective angiographic evaluation conducted to date with this stent, the PROMUS Element PtCr-EES was superior to the TAXUS Liberté PES for the primary endpoint of late loss at 9 months, with low rates of clinical events at 1 year. Clinical follow-up will continue to 2 years.
authors: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors: Runlin
authors: R
authors: Gao
authors: Yaling
authors: Y
authors: Han
authors: Yuejin
authors: Y
authors: Yang
authors: Jian
authors: J
authors: Zhang
authors: Yuqing
authors: Y
authors: Hou
authors: Haichang
authors: H
authors: Wang
authors: Hui
authors: H
authors: Li
authors: Quan
authors: Q
authors: Fang
authors: Bo
authors: B
authors: Yu
authors: Bo
authors: B
authors: Xu
authors: Dominic J
authors: DJ
authors: Allocco
authors: Keith D
authors: KD
authors: Dawkins
mesh_terms: D000328:Adult; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D002857:Chromium; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D010984:Platinum; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D002857:Chromium; D010984:Platinum; D000068338:Everolimus
keywords: coronary artery disease; drug-eluting stents; everolimus; paclitaxel; platinum chromium; randomized controlled trial