1. Background & Study Design
Final Five-Year Results of the PLATINUM Randomized Trial Comparing Platinum Chromium PROMUS Element and Cobalt Chromium PROMUS/XIENCE V Everolimus-Eluting Stents in Workhorse Lesions
Gregg W. Stone, MD1; Paul S. Teirstein, MD2; Ian T. Meredith, AM, MBBS, PHD3; Bruno Farah, MD4; Christophe L. Dubois, MD, PHD5; Robert L. Feldman, MD6; Joseph Dens, MD, PHD7; Nobuhisa Hagiwara, MD8; Dominic J. Allocco, MD9; Keith D. Dawkins, MD9
1Columbia University Medical Center / New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA; 2Scripps Clinic, Division of Cardiovascular Diseases, La Jolla, CA, USA; 3MonashHEART, Monash Medical Centre, Clayton, Victoria , Australia; 4Clinique Pasteur, Toulouse, France; 5UZ Gasthuisberg, Leuven, Belgium; 6Munroe Regional Medical Center, Ocala, Florida, USA; 7Ziekenhuis Oost Limburg, Genk, Belgium; 8Tokyo Women’s Medical University Hospital, Shinjuku, Tokyo, Japan; 9Boston Scientific Corporation, Marlborough, MA, USA
Background & Study Design
Results
In the PLATINUM randomized controlled trial, a total of 1,530 patients with 1 or 2 de novo native coronary artery lesions (length ≤24mm in a baseline vessel diameter ≥2.50mm to ≤4.25mm) were randomized single-blind 1:1 to the PROMUS Element Everolimus-Eluting Stent (PtCr-EES) or the cobalt chromium PROMUS/XIENCE V EES (CoCr-EES) at 132 sites worldwide
Patients implanted with the PtCr-EES had significantly less bail-out stenting (9.8% CoCr-EES vs 5.9% PtCr-EES; P=0.004)
For the primary endpoint of 12-month target lesion failure (TLF, defined as the composite rate of target vessel-related cardiac death, target vessel-related myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), the PtCr-EES was non-inferior to the CoCr-EES (2.9% CoCr-EES vs 3.4% PtCr-EES; Pnoninferiority=0.001)
The present analysis reports the final 5-year, long-term follow-up from this trial
Baseline and Procedural Characteristics
Target Lesion Failure, Revascularization, and Subgroups at 5 Years
CoCr-EES (n=762)
PtCr-EES (n=768)
P value
Male
71.1%
71.6%
0.83
Age, years
63.1 ± 10.3
64.0 ± 10.3
0.09
Diabetes
25.1%
22.0%
0.16
Hypertension
73.2%
70.9%
0.32
Hypercholesterolemia
76.2%
78.2%
0.36
Unstable angina
24.7%
24.1%
0.80
RVD, mm
2.63 ± 0.49
2.67 ± 0.49
Lesion length, mm
12.5 ± 5.5
13.0 ± 5.7
0.10
Diameter stenosis, %
71.9 ± 11.5
71.8 ± 11.5
0.87
Mean number of stents
1.20 ± 0.48
1.16 ± 0.44
016
ACC/AHA lesion type B2 or C
63.5%
65.4%
0.42
TLF
TLR
TLF Subgroups 3 6 9 12 15 21 18
PtCr-EES
CoCr-EES 3 6 9 12 15 21 18
PtCr-EES
CoCr-EES
Group
All
0.97
Age <65
0.80
0.34
Age >=65
1.11
Male
1.05
0.53
Female
0.84
Diabetes
1.08
0.72
No diabetes
0.95
RVD ≤2.62mm
0.96
0.83
RVD >2.62mm
1.04
Lesion ≤13mm
0.92
0.70
Lesion >13mm HR
Pinteraction
HR:0.97 [0.69, 1.37]
P=0.87
HR: [0.54, 1.29]
P=0.42
9.3%
Patients, %
Patients, %
6.2%
9.1%
5.3% 1 2 3 4 5 1 2 3 4 5
Year
Year 1 2
PtCr better
CoCr better
Other Clinical Outcomes at 5 Years
Patient Flow at 5 Years
1530 Patients Randomized
P=0.60
P=0.32
P=0.94
P=0.35
P=0.79
Core lab data. Values are percent or mean ± SD.
Not Treated* (n=13)
Not Treated* (n=10)
Antiplatelet Medications at 5 Years
Patients, %
CoCr-EES Analysis Set N=749
PtCr-EES Analysis Set N=758
CoCr-EES (n=749)
PtCr-EES (n=758)
P value
Aspirin
93.5%
93.4%
0.94
Thienopyridine
37.9%
35.9%
0.47
Dual Antiplatelet Therapy
34.0%
32.3%
0.52
No 5-Yr Follow-up (n=49)
Withdrew Consent: 15 Lost to Follow-up: 19 Other: 0
Missed 5-Yr Visit: 15
No 5-Yr Follow-up (n=41)
Withdrew Consent: 10 Lost to Follow-up: 11 Other: 2
Missed 5-Yr Visit: 18
Time to event rates
Summary & Conclusions
5-Year Clinical Follow-Up or Death: 93.5% (700/749)
5-Year Clinical Follow-Up or Death: 94.6% (717/758)
At the final 5-year follow-up, both the PROMUS Element and the PROMUS/Xience V stent continued to demonstrate very low rates of revascularization and excellent safety rates, with no significant differences between devices in long-term clinical outcomes.
*Per protocol, patients not treated with a study stent were not followed beyond 1 year
internal use only
Conflict of Interest Disclosures PT: Grant Support/Research Contract: Abbott (significant), Medtronic (significant), Boston Scientific (significant), Consultant Fees/Honoraria/Speaker’s Bureau: Abbott (modest), Medtronic (modest), Boston Scientific (modest); IM: Consultant Fees/Honoraria/Speaker’s Bureau: Boston Scientific (significant); CD: Advisory Board: Boston Scientific (modest); RF: Advisory Board: Boston Scientific (modest); JD: Consultant Fees/Honoraria/Speaker’s Bureau: Boston Scientific (modest), Research/Grant Support : Boston Scientific (significant); DA & KD: Salary/Salary Support/Employee: Boston Scientific (significant), Equity: Boston Scientific (Significant); GS, BF, NH: none. Presented at: The American College of Cardiology 64th Annual Scientific Session and Expo; March 14-16, 2015; San Diego, CA, USA.