title: One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]).
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.
authors.affiliation: Interventional Cardiology, Piedmont Hospital, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Cardiac Cath Lab, Texas Heart and Vascular, South Austin Hospital, South Austin, Texas.
authors.forename: Nima
authors.initials: N
authors.lastname: Amjadi
authors.affiliation: Interventional Cardiology, North Florida Regional Medical Center, Gainesville, Florida.
authors.forename: Christopher
authors.initials: C
authors.lastname: Caputo
authors.affiliation: Interventional Cardiology, Cox Medical Centers, Springfield, Missouri.
authors.forename: Steven K
authors.initials: SK
authors.lastname: Rowe
authors.affiliation: Interventional Cardiology, Novant Health Heart and Vascular Institute Presbyterian Medical Center, Charlotte, North Carolina.
authors.forename: Jerome
authors.initials: J
authors.lastname: Williams
authors.affiliation: Cardiology, Brandon Regional Hospital, Brandon, Florida.
authors.forename: Hoshedar P
authors.initials: HP
authors.lastname: Tamboli
authors.affiliation: Boston Scientific Corporation, Marlborough, Massachusetts.
authors.forename: Thomas
authors.initials: T
authors.lastname: Christen
authors.affiliation: Boston Scientific Corporation, Marlborough, Massachusetts.
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.affiliation: Boston Scientific Corporation, Marlborough, Massachusetts.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002857:Chromium; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D018795:Device Approval; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010984:Platinum; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000494:pharmacology*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; D002857:Chromium; D010984:Platinum; D020123:Sirolimus