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Effects of cobalt-chromium everolimus eluting or bare

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Effects of cobalt-chromium everolimus eluting or bare
Potential conflicts of interest
Speaker's name: Marco Valgimigli
I have the following potential conflicts of interest to report:
Consultant:
Abbott, CID (Carbostent & Implantable
Devices), Daiichi Sankyo, Eli Lilly,
Medtronic, The Medicines Company
Speaker’s bureaus:
Abbott, Accumetrics, AstraZeneca,
Daiichi Sankyo, Eli Lilly, Iroko
Pharmaceuticals, Terumo
Institutional grant/ Iroko Pharmaceuticals, Medtronic,
research support: Terumo, The Medicines Company
Effects of cobalt-chromium everolimus
eluting or bare metal stent on fatal and
non-fatal cardiovascular events.
A collaborative patient-level meta-analysis,
including 4,896 individuals with a median 2-year
follow-up duration
Manel Sabaté, Christoph Kaiser, Salvatore Brugaletta,
Jose Maria de la Torre Hernandez, Soeren Galatius, Angel Cequier,
Franz Eberli, Adam de Belder, Patrick W. Serruys, Giuseppe Ferrante,
Presenter: Marco Valgimigli, MD PhD, FESC
Erasmus MC, Thoraxcenter
Rotterdam
The Netherlands
Background
• Some second-generation DES, including
cobalt-chromium everolimus eluting (Co-Cr
EES), have been shown to improve safety
while maintaining efficacy when contrasted
with first generation DES.
• However, the comparative safety and efficacy
of second-generation DES as compared to
BMS on fatal and non-fatal cardiovascular
outcomes remains largely unknown.
This reflects the common practice in the last years to compare
2 gen DES to 1 gen DES but only rarely to BMS
Methods
• Of the 346 citations screened, 5 randomized trials were selected:
1: J Am Coll Cardiol 2013; Nov 21-XIMA:
2: Circulation. 2012;125(16):2015-26-PRODIGY
3: N Engl J Med 2010; 363(24): 2310-9-BASKET PROVE;
4: EuroIntervention 2007; 3(2): 206-12-SPIRIT First:
5: Lancet 2012; 380(9852): 1482-90-EXAMINATION
Independent adjudication of events
by CEC members in all 5 studies
• The principal investigators were invited provide the following data
for individual patients:
Clinical data
Age
sex
body mass index
diabetes
smoking
hypertension
hypercholesterolemia
Presenting syndrome:
Stable CAD
Unstable Angina
NSTEACS
STEMI
Angiographic data
Diseased vessels
Treated lesions
No of implanted stents
Overlapping stents
Total stent length
Average stent diameter
Use of anti-thrombotics
Duration of clopidogrel therapy,
use of glycoprotein IIb/IIIa inhibitors
Outcome data
Death
Cardiac death
Myocardial infarction
Stent thrombosis
Repeat revascularization
Last follow-up contact
Methods ii
Endpoints
The primary outcome was cardiac mortality at the longest
available follow-up. Cardiac mortality and not all-cause mortality was
selected as primary outcome measure to minimize the confounding effect of noncardiac events on stent performance in the context of a relatively old and unselected
patient population followed-up through 2-years. Importantly, cardiac mortality was
homogenously classified across the five included studies according to the ARC criteria.
Statistical Analyses
The impact of stent type (Co-Cr EES vs BMS) on outcomes
was assessed by Cox regression model stratified by trial,
with random-effects.
A multivariable Cox regression model was also performed
after entering the following prespecified covariates: i.e.
female sex, duration of DAPT > 1 year, clinical syndrome
(acute coronary syndrome vs stable syndrome), use of
glycoprotein IIb/IIIa inhibitors and history of diabetes
mellitus.
Baseline Features
Pat ient s
Charact erist ics
Overall
N= 4 ,8 9 6
PRODI GY
N= 1 ,0 0 3
Age
mean±SD
Female (%)
Diabetes (%)
Prior MI (%)
Target
population
STEMI (%)
NSTEACS (%)
Stent control
arm
Recommended
DAPT duration
Experimental
arm
Control arm
Follow-up
(years)
67±13
25
19
15
…
44
44
Mixture of
BMS
…
…
EXAMI NA
TI ON
N= 1 ,4 9 8
BASKET
PROVE
N= 1 ,5 3 9
SPI RI T
First
N= 5 6
XI MA
N= 8 0 0
69±11
25
22
26
All comer
PCI
61±12
17
17
5
All comer
STEMI
64±11
24
15
12
All comer
PCI
63±9
27
11
83±3
40
25
0
Low risk
population
26
All comer
octogenarians
34
20
Mixture
of BMS
100
0
15
80
0
0
7*
68*
Vision
Vision
Vision
Vision
6 or 24
months
up to 6 or
24
months
12
months
12
months
≥3
months
12 months
12
months
12
months
≥3
months
3 months
2
2
2
5
1
All baseline clinical and angiographic characteristics were well matched between groups with the only
exception for hypertension and hyperlipidemia being slightly more prevalent in the BMS group whereas
Clopidogrel use beyond one year was slightly higher in the CoCr-EES group 15.3 vs 13.6, p=0.09
0.08
Cardiac death
0.04
HR, 0.67; 95% CI, 0.49-0.92; P=0.013;
NNTB, 74.8;
BMS
EES
P=0.01
0.00
NNTB, 74.8; 95% CI, 48.3 to 312
Adjusted HR, 0.69; 95% CI, 0.50-0.95; P=0.02
0
200
400
600
800
Days
Number of patients
BMS
EES
4.0%
2.7%
0.02
Cumulative Hazard
0.06
At 2 years, the risk of cardiac death was significantly reduced in the Co-Cr EES group at
2.7% as compared to 4.0% in the BMS arm. At multivariable regression, cardiac
mortality remained significantly lower in the in the Co-Cr EES group
2444
2452
2349
2376
1939
1975
1927
1958
0
0
Myocardial infarction
5.6%
P=0.01
0.04
4.0%
BMS
EES
0.02
Cumulative Hazard
0.06
0.08
The risk of fatal and non-fatal MI was significantly lower in the in the Co-Cr EES group
[4.0% vs 5.6% in the BMS group]
NNTB, 62.0; 95% CI, 40 to 256.4
0.00
unadjusted HR, 0.71; 95% CI, 0.55-0.93; P=0.011
adjusted HR, 0.71; 95% CI, 0.55-0.93; P=0.011]
0
200
600
800
Days
Number of patients
BMS
EES
400
2444
2452
2262
2311
1986
1918
1849
1894
0
0
0.05
Fatal myocardial infarction
0.03
0.02
BMS
EES
P=0.003
0.00
0.01
Cumulative Hazard
0.04
Fatal MI was more than 80% lower in the Co-Cr EES group [0.08% vs. 0.8% in the BMS
group; unadjusted HR, 0.11; 95% CI, 0.03-0.48, P=0.003; NNTB 142.2; 95% CI, 129.8 to
243.9; adjusted HR, 0.11; 95% CI, 0.03-0.49, P=0.004].
0
200
600
800
Days
Number of patients
BMS
EES
400
2444
2452
2349
2377
1940
1975
1928
1958
0
0
0.04
Definite stent thrombosis
0.02
BMS
EES
1.4%
P=0.006
0.01
Cumulative Hazard
0.03
Adjusted HR, 0.41; 95% CI, 0.22-0.76; P=0.005; NNTB, 127.7; 95% CI, 95.2 to 333.3].
0.00
0.6%
0
200
600
800
Days
Number of patients
BMS
EES
400
2444
2452
2328
2369
1914
1968
1901
1946
0
0
0.20
Target vessel revascularization
0.10
10.2%
P<0.001
0.05
Cumulative Hazard
0.15
the need for reintervention in the previously instrumented vessel [4.3% vs. 10.2%;
adjusted HR, 0.39; 95% CI 0.29-0.51; P<0.001; NNTB, 16.1; 95% CI, 14.0 to 20.1]
was reduced by 61% in the Co-Cr EES
4.3%
0.00
BMS
EES
0
200
600
800
1727
1869
0
0
Days
Number of patients
BMS
EES
400
2444
2452
2196
2328
1761
1899
Results
As shown in the Figure, the benefit of treatment with Co-Cr EES re cardiac death was consistent across all
analysed subgroups with a qualitative positive interaction testing for stable coronary artery disease:
Conclusions
• Our collaborative individual patient-data metaanalysis of 5 studies, including 4,896 largely ACS
patients shows a consistent reduction of several
fatal and non-fatal ischemic endpoints in favor of
Co-Cr EES as compared to BMS, including, cardiac
mortality, ST (both definite and definite or
probable), MI throughout 2-year follow-up.
• Our observation supports a major paradigm shift
in current understanding about the safety and
efficacy of coronary devices.
• This is the first observation that a specific DES
implantation leads to a cardiac mortality benefit
as compared to BMS
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