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.