Download PLATINUM WH Final 5Yr Outcomes_Stone

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
CoCr-EES
(n=762)
PtCr-EES
(n=768)
P value
71.1%
71.6%
0.83
• Patients implanted with the PtCr-EES had significantly less bail-out stenting
(9.8% CoCr-EES vs 5.9% PtCr-EES; P=0.004)
Age, years
Diabetes
25.1%
22.0%
0.16
• 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)
Hypertension
73.2%
70.9%
0.32
RVD, mm
2.63 ± 0.49
2.67 ± 0.49
0.09
• The present analysis reports the final 5-year, long-term follow-up from this trial
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
63.5%
65.4%
0.42
Patient Flow at 5 Years
Hypercholesterolemia
Unstable angina
ACC/AHA lesion type B2 or C
1530 Patients Randomized
Not Treated* (n=13)
CoCr-EES Analysis Set
N=749
No 5-Yr Follow-up (n=49)
Withdrew Consent: 15
Lost to Follow-up: 19
Other: 0
Missed 5-Yr Visit: 15
5-Year Clinical Follow-Up or Death:
93.5% (700/749)
63.1 ± 10.3
76.2%
24.7%
64.0 ± 10.3
78.2%
24.1%
0.36
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
PtCr-EES Analysis Set
N=758
No 5-Yr Follow-up (n=41)
Withdrew Consent: 10
Lost to Follow-up: 11
Other: 2
Missed 5-Yr Visit: 18
5-Year Clinical Follow-Up or Death:
94.6% (717/758)
15
HR:0.97
[0.69, 1.37]
P=0.87
12
9
6
3
TLF Subgroups
CoCr-EES Group
All
PtCr-EES
Age <65
21
CoCr-EES
PtCr-EES
18
0.80
Antiplatelet Medications at 5 Years
TLR
21
0.09
Core lab data. Values are percent or mean ± SD.
Not Treated* (n=10)
TLF
Patients, %
Male
Target Lesion Failure, Revascularization, and Subgroups at 5 Years
18
Patients, %
Baseline and Procedural Characteristics
9.3%
9.1%
15
HR: 0.84
[0.54, 1.29]
P=0.42
12
9
6.2%
6
3
5.3%
0
0
0
1
2
3
Year
4
0
5
1
2
3
Year
4
5
HR P
interaction
0.97
0.80
1.11
1.05
0.84
1.08
0.95
0.96
1.04
0.92
1.05
Age >=65
Male
Female
Diabetes
No diabetes
RVD ≤2.62mm
RVD >2.62mm
Lesion ≤13mm
Lesion >13mm
0.34
0.53
0.72
0.83
0.70
0
1
2
PtCr better CoCr better
Other Clinical Outcomes at 5 Years
CoCr-EES
PtCr-EES
20
P=0.60
Patients, %
• 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
Results
P=0.32
P=0.94
P=0.35
P=0.79
15
10
7.8
7.2
3.5
5
0
All Death
2.6
3.4
3.2
Cardiac Death
Time to event rates
1.0
MI
0.6
Q-wave MI
0.7
0.8
ARC ST
(Def/Prob)
Summary & Conclusions
 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 64 th Annual Scientific Session and Expo; March 14-16, 2015; San Diego, CA, USA.