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

Shigeru Saito, Nobuhisa Hagiwara, Atsushi Seki, Keiichi Igarashi, Toshiya Muramatsu, Junji Yajima, Hiroyoshi Yokoi, Masato Nakamura, Kenshi Fujii, Takaaki Isshiki, Gregg W Stone, Paul S Teirstein, Ian T Meredith, Dominic J Allocco, Keith D Dawkins

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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 =2.50. mm to =4.25. mm and length =24. mm) 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.
Original languageEnglish
Pages (from-to)105 - 112
Number of pages8
JournalJournal of Cardiology
Volume64
Issue number2
DOIs
Publication statusPublished - 2014

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