PLATINUM study of the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent finds little difference in outcomes between patients groups in coronary artery disease- Boston Scientific

Boston Scientific has reported results of the PLATINUM Diversity study to evaluate the clinical outcomes of the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System in women and minorities. In this study, there were no significant outcome differences between white men and women or minorities for the composite primary endpoint of death, myocardial infarction (MI) or target vessel revascularization (TVR) at 12 months. The composite death/MI/TVR rate was 7.6 percent for white men compared to 8.6 percent for women (p=0.33), and 9.6 percent for minorities (p=0.08).

Additionally, secondary endpoint results were as follows (differences with p less than 0.05 were statistically significant). All-cause death was 2.2 percent for white men compared to 3.4 percent for women (p=0.04), and 3.7 percent for minorities (p=0.03). MI reported at 1.1 percent for white men compared to 1.9 percent for women (p=0.06), and 3.1 percent for minorities (p=0.0002). TVR was reported at 5.5 percent for white men compared to 4.6 percent for women (p=0.27), and 5.4 percent for minorities (p=0.97). Definite or probable stent thrombosis was reported in 0.7 percent for white men compared to 0.9 percent for women (p=0.55), and 1.2 percent for minorities (p=0.22). The clinical endpoints were presented at the 28th Transcatheter Cardiovascular Therapeutics (TCT).

Comment: The Promus PREMIER stent system received CE Mark approval in February 2013 and has been available in the U.S. since November 2013. The PROMUS Element Plus stent system received CE Mark approval in 2009 and FDA approval in 2011.