Initial Findings Published From United States Postapproval Study for Boston Scientific's Promus Element Plus

December 11, 2015—David E. Kandzari, MD, et al published the first report of results from the PE-Plus Postapproval Study (PE-Plus PAS) online ahead of print in the American Journal of Cardiology. PE-Plus PAS was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice among patients treated with Boston Scientific’s everolimus-eluting platinum chromium Promus Element stents at 52 centers in the United States.

In November 2011, Boston Scientific announced US Food and Drug Administration approval of the Promus Element Plus stent system. 

As summarized in the American Journal of Cardiology, the primary endpoint of the PE-Plus PAS was 12-month cardiac death or myocardial infarction (MI) in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE PROVE, and PLATINUM Workhorse/Small Vessel trials. Additional clinical endpoints were tested in the overall PE-Plus PAS patient population. 

Among 2,683 patients enrolled in PE-Plus PAS, 70% were men, mean age was 64 years, 33% had diabetes, and 29% were “PLATINUM-like.” Among PLATINUM-like patients, 12-month cardiac death or MI was 1.8% (33/1,855) with an upper one-sided 95% confidence interval of 2.3%, which was significantly below the prespecifed performance goal of 3.2% (P_{noninferiority} < .001). 

In the overall PE-Plus population, 12-month target vessel failure (defined as death, MI, or revascularization related to the target vessel) was 6.7% (170/2,554), cardiac death was 1.4% (37/2,554), MI was 1.1% (28/2554), and Academic Research Consortium definite/probable stent thrombosis was 0.7% (19/2,554). A prespecifed secondary endpoint of 12-month target vessel failure among diabetics demonstrated a rate of 4.2% (14/332) with an upper one-sided 95% confidence interval of 6.03%, which was significantly below the performance goal of 12.6% (P_{noninferiority} < .001). 

The investigators concluded that in this large registry of unselected patients, coronary artery revascularization with the Promus Element Plus everolimus-eluting stent demonstrated favorable results with low 1-year clinical event rates.