Saito Shigeru, Hagiwara Nobuhisa, Seki Atsushi, Igarashi Keiichi, Muramatsu Toshiya, Yajima Junji, Yokoi Hiroyoshi, Nakamura Masato, Fujii Kenshi, Isshiki Takaaki, Stone Gregg W, Teirstein Paul S, Meredith Ian T, Allocco Dominic J, Dawkins Keith D
Shonan Kamakura General Hospital, Kanagawa, Japan.
Tokyo Women's Medical University Hospital, Tokyo, Japan.
J Cardiol. 2014 Aug;64(2):105-12. doi: 10.1016/j.jjcc.2013.12.003. Epub 2014 Jan 23.
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.
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).
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).
This PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients.
