Final Five-Year Outcomes Following Implantation of the Promus Element® Platinum Chromium Everolimus-Eluting Stent in De Novo Coronary Artery Lesions in.

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Final Five-Year Outcomes Following Implantation of the Promus Element® Platinum Chromium Everolimus-Eluting Stent in De Novo Coronary Artery Lesions in Small Vessels (SV) and Long Lesions (LL): Results of the PLATINUM Small Vessel and Long Lesion Trials Paul S. Teirstein1; Gregg W. Stone2; Ian T. Meredith3; Abram Rabinowitz MD4; Vincent J. Pompili MD5; Tommy C. Lee MD6; Louis A. Cannon MD7; Dean J. Kereiakes MD8; Michael R. Mooney MD9; Didier Carrié MD PhD10, Shigeru Saito, MD11; Dominic J. Allocco, MD12; Keith D. Dawkins, MD12 1 Scripps Clinic, La Jolla, CA, USA; 2 Columbia University Medical Center, Cardiovascular Research Foundation, New York, NY, USA; 3 Monash Medical Centre, MonashHEART, Clayton, VIC, Australia; 4TexSan Heart Hospital, San Antonio, TX; 5Ohio State University Medical Center, Columbus, OH, United States; 6Bakersfield Memorial Hospital, Bakersfield, CA; 7Cardiac & Vascular Research Center of Northern Michigan, Petoskey, MI, United States; 8The Christ Hospital Heart and Vascular Center/The Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH; 9Minneapolis Heart Institute, Minneapolis, MN, United States; 10Centre Hôpital Universitaire Rangueil, Toulouse, France; 11Shonan Kamakura General Hospital, Kanagawa, Japan; 12Boston Scientific Corporation, Marlborough, MA, USA Background Results At 5 Years The thin-strut, everolimus-eluting, platinum chromium PROMUS™ Element stent (Boston Scientific, Marlborough, MA, USA) has shown favorable outcomes at up to 4 years post-implantation for the treatment of long lesions (LL) & small vessels (SV). The primary endpoint, 1-year target lesion failure (defined as cardiac death or MI related to the target vessel, or ischemia-driven TLR), was 2.4% for SV and 3.2% for LL, which was significantly less than the prespecified performance goals of 21.1% for SV and 19.4% for LL (P<0.001 for each). However, 5-year follow-up in SV or LL patients has not been previously reported. Patient Disposition 5-Year Clinical Results in the Small Vessel Study Small Vessel Study Long Lesion Study N=94 Enrolled at 23 clinical sites N=102 Enrolled at 30 clinical sites Not Treated* (n=5) Not Treated* (n=2) Patients, % Study Stent Analysis Set N=89 Study Stent Analysis Set N=100 N/A N/A Study Design & Patients No 5-Yr Follow-up (n=6) Withdrew Consent: 1 Lost to Follow-up or Missed 5-Yr Visit: 5 PLATINUM SV and LL are prospective, single-arm, multinational studies that enrolled patients with angina pectoris or documented silent ischemia and one de novo native coronary artery target lesion. Long lesions (LL) were defined as >24 to ≤34mm in length with reference vessel diameter (RVD) ≥2.50 to ≤4.25mm). Small vessels (SV) were defined as RVD ≥2.25mm to <2.5mm in baseline diameter with lesion length ≤28 mm. Death (n=7) No 5-Yr Follow-up (n=12) Withdrew Consent: 2 Lost to Follow-up or Missed 5-Yr Visit: 10 Binary rates Death (n=10) 5-year Clinical Results in the Long Lesion Study 5-Year Clinical Follow-Up or Death: 93.3% (83/89) 5-Year Clinical Follow-Up or Death: 88.0% (88/100) Baseline Patient and Lesion Characteristics *Per protocol, patients not treated with a study stent were not followed beyond 1 year Small Vessels (N=94) Male 72.3% Age, years 64.3 ± 11.0 Diabetes 42.6% Hypertension 79.8% Hyperlipidemia 81.9% Unstable angina 24.5% RVD, mm 2.0 ± 0.3 Lesion length, mm 14.2 ± 7.0 Diameter stenosis, % 75.1 ± 9.5 Long Lesions (N=102) Male 62.7% Age, years 66.0 ± 9.8 Diabetes 30.0% Hypertension 82.4% Hyperlipidemia Unstable angina 23.8% RVD, mm 2.6 ± 0.4 Lesion length, mm 24.4 ± 8.2 Diameter stenosis, % 71.7 ± 11.0 Antiplatelet Medications at 5 Years Patients, % Small Vessels Aspirin 92.1% (70/76) Thienopyridine 39.5% (30/76) DAPT 36.8% (28/76) Long Lesions Aspirin 93.6% (73/78) Thienopyridine 38.5% (30/78) DAPT 35.9% (28/78) N/A N/A Binary rates Summary & Conclusions At the final 5 year follow-up, the PROMUS Element stent had low target lesion failure and revascularization rates, and very good safety outcomes in patients with small vessels and long lesions. This is the longest-term follow-up available with the everolimus-eluting, platinum-chromium PROMUS stent in these higher-risk subsets. FOR INTERNAL USE ONLY Core lab data. Values are percent or mean ± SD. Conflict of Interest Disclosures PT: Consultant Fees/Honoraria/Speaker’s Bureau: Boston Scientific (BSC; modest), Medtronic (modest), Abbott (modest); IM: Consultant Fees/Honoraria/Speaker’s Bureau: BSC (significant), Medtronic (modest); VJP: Consultant Fees/Honoraria/Speaker’s Bureau: BSC (modest); DJK: Grant Support/Research Contract and Consultant Fees/Honoraria/Speaker’s Bureau: Abbott (significant); Grant Support/Research Contract and Consultant Fees/Honoraria/Speaker’s Bureau: BSC (significant); MRM: Consultant Fees/Honoraria/Speaker’s Bureau: Zoll (modest), Medtronic (modest); SS: Grant Support/Research Contract and Consultant Fees/Honoraria/Speaker’s Bureau: Terumo (significant); DA & KD: Salary/Salary Support/Employee: BSC (significant), Equity: Boston Scientific (Significant); GS, AR, TCL, DC, LAC : none. Study supported by BSC; Statistical support from Songtao Jiang (BSC); poster support from Kristine Roy (BSC). Presented at: TCT 2015; Oct, 2015; San Francisco, CA, USA.