1. 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.