Author(s): Kandzari DE, Amjadi N, Caputo C, Rowe SK, Williams J,
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Abstract The PROMUS Element Plus US Post-Approval Study (PE-Plus PAS) was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice in patients treated with everolimus-eluting, platinum-chromium PROMUS Element Plus stents at 52 centers in the United States. This is the first report of results from this large study. The primary end point of the PE-Plus PAS was 12-month cardiac death or myocardial infarction in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE-PROVE (PROMUS Element European post-approval study), and PLATINUM Workhorse/Small Vessel trials. Additional clinical end points were tested in the overall PE-Plus PAS patient population. Of the 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 the PLATINUM-like patients, 12-month cardiac death or myocardial infarction was 1.8\% (33 of 1,855) with an upper 1-sided 95\% confidence interval of 2.3\%, which was significantly less than the prespecified performance goal of 3.2\% (pnoninferiority <0.001). 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 of 2,554), cardiac death was 1.4\% (37 of 2,554), MI was 1.1\% (28 of 2,554), and ARC-definite/probable stent thrombosis was 0.7\% (19 of 2,554). A prespecified secondary end point of 12-month target vessel failure in diabetic patients demonstrated a rate of 4.2\% (14 of 332) with an upper 1-sided 95\% confidence interval of 6.03\%, which was significantly less than the performance goal of 12.6\% (pnoninferiority <0.001). In conclusion, in this large registry of unselected patients, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent demonstrates favorable results with low 1-year clinical event rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT01589978. Copyright © 2016 Elsevier Inc. All rights reserved.
This article was published in Am J Cardiol
and referenced in Angiology: Open Access