Japanese and non-Japanese patient outcomes in the PLATINUM randomized trial comparing the PROMUS Element and XIENCE V everolimus-eluting stents.
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.
Shonan Kamakura General Hospital, Kanagawa, Japan. Electronic address: saito@shonankamakura.or.jp.
Shigeru
S
Saito
Tokyo Women's Medical University Hospital, Tokyo, Japan.
Nobuhisa
N
Hagiwara
Sakakibara Heart Institute, Tokyo, Japan.
Atsushi
A
Seki
Hokkaido Social Insurance Hospital, Hokkaido, Japan.
Keiichi
K
Igarashi
Saiseikai Yokohama-City Eastern Hospital, Kanagawa, Japan.
Toshiya
T
Muramatsu
The Cardiovascular Institute, Tokyo, Japan.
Junji
J
Yajima
Kokura Memorial Hospital, Fukuoka, Japan.
Hiroyoshi
H
Yokoi
Toho University Ohashi Medical Center, Tokyo, Japan.
Masato
M
Nakamura
Sakurabashi Watanabe Hospital, Osaka, Japan.
Kenshi
K
Fujii
Teikyo University Hospital, Tokyo, Japan.
Takaaki
T
Isshiki
Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.
Gregg W
GW
Stone
Scripps Clinic, La Jolla, CA, USA.
Paul S
PS
Teirstein
MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia.
Ian T
IT
Meredith
Boston Scientific Corporation, Natick, MA, USA.
Dominic J
DJ
Allocco
Boston Scientific Corporation, Natick, MA, USA.
Keith D
KD
Dawkins
D000368:Aged; D044466:Asian People; D002858:Chromium Alloys; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D017671:Platinum Compounds; D044469:Racial Groups; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D002858:Chromium Alloys; D010975:Platelet Aggregation Inhibitors; D017671:Platinum Compounds; D000068338:Everolimus; D020123:Sirolimus
Angina pectoris; Clinical trial; Revascularization; Stent