Japanese and non-Japanese patient outcomes in the PLATINUM randomized trial comparing the PROMUS Element and XIENCE V everolimus-eluting stents

J Cardiol. 2014 Aug;64(2):105-12. doi: 10.1016/j.jjcc.2013.12.003. Epub 2014 Jan 23.

Abstract

Background: The PLATINUM randomized trial enrolled 1530 patients treated with either the platinum chromium PROMUS Element everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, MA, USA) or the predicate cobalt chromium PROMUS/XIENCE V EES (CoCr-EES; manufactured as XIENCE V by Abbott Vascular, Santa Clara, CA, USA also distributed as PROMUS by Boston Scientific), including 124 patients from Japanese sites. This substudy examines 2-year outcomes in the Japanese and non-Japanese cohorts.

Methods: Patients with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter ≥2.50mm to ≤4.25mm and length ≤24mm) were randomized 1:1 to PtCr-EES (N=63 patients in Japan) versus CoCr-EES (N=61 patients in Japan).

Results: Several significant differences were noted in baseline demographics, lesion characteristics, and procedural technique between Japanese and non-Japanese patients, including longer fluoroscopy time, less use of contrast, and greater post-dilatation usage and maximum pressure in Japan. Dual antiplatelet usage at 2 years was also higher in Japan. Despite these differences, the 2-year rates of target lesion failure were comparable in patients treated with PtCr-EES and CoCr-EES both in Japan (3.2% vs 5.0% respectively, p=0.68) and outside Japan (4.7% vs 5.9% respectively, p=0.33; p for interaction=0.82).

Conclusions: This PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients.

Keywords: Angina pectoris; Clinical trial; Revascularization; Stent.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Asian People
  • Chromium Alloys*
  • Cohort Studies
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Everolimus
  • Female
  • Fluoroscopy
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platinum Compounds*
  • Racial Groups
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Treatment Outcome

Substances

  • Chromium Alloys
  • Platelet Aggregation Inhibitors
  • Platinum Compounds
  • Everolimus
  • Sirolimus