Clopidogrel Use and Death/MI After Stent Implantation in a Diabetic Population
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Transcript of Clopidogrel Use and Death/MI After Stent Implantation in a Diabetic Population
Clopidogrel Use and Death/MI After Stent Implantation in a
Diabetic Population
Somjot S. Brar, Simerjeet K. Brar, John Kim,
Ray Zadegan, Michael Ree, In-lu A. Liu, Prakash Mansukhani,
Vicken Aharonian, Ric Hyett, Albert Y-J. Shen
Department of CardiologyKaiser Permanente, Los Angeles
&UCLA School of Medicine Kaiser
Permanente
Results from the SUNSET registry
SCAI ‘07
Disclosures
• Research grant support from Boston Scientific– S. Brar, MD– A. Shen, MD
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Background
Death / MI reportedly increased with DES compared to BMS.
Two prior landmark analysis show increased death / MI in DES compared to BMS. BASKET-LATE Eisenstein et al.
Limited data in patients with diabetes. Duration of clopidogrel after PCI remains
unknown.
Study Questions
Is death / MI influenced by: Clopidogrel duration? Stent type (DES, BMS)?
Among patients taking clopidogrel for ≤ 6 months, is death / MI more frequent with DES compared to BMS?
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Methods
• Study date: January 2002 – December 2005• Study type: observational using the SUNSET
registry• Population:
– consecutive diabetic patients undergoing first PCI– No prior PCI or CABG – Multiple stent types not permitted– Insured members of a prepaid integrated health plan
• Location: high volume tertiary care referral center (Los Angeles, CA)
• Main outcome measure: death or MI at 18 months (545 days) post PCI
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Methods
• Clopidogrel – pharmacy prescription records– Duration of clopidogrel calculated from index PCI– User: >6 months of clopidogrel use from index PCI
date– Non-users: ≤6 months of use from the index PCI date
• “Landmark” analysis– Excluded patients with events within first 6 months– Similar to an observational analysis from BASKET-
LATE.
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Study Flow
749 diabetics underwent first revascularization
671 event free from Death or MI at 6 months
Exclusion: 41 Death/MI/Revascularization 37 Clopidogrel usage unknown
F/U to 18 months post PCI
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DES (n=450)
Four Study Groups: Stratified by Stent Type & Clopidogrel
671 Patients
Clopidogrel / Stent type
Clopidogrel (-)N=74
Clopidogrel (+)N=147
Clopidogrel (-)N=127
Clopidogrel (+)N=323
Death or MI (18 months)
BMS (n=221)
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Baseline CharacteristicsClopidogrel User Clopidogrel Non-user
DES BMS DES BMS
Age 61.5 ± 10.2 64.3 ± 10.2 63.3 ± 12.1 64.0 ± 11.6
Female 30.1% 29.9% 33.9% 36.5%
Insulin 20.7% 20.4% 31.5% 27.0%
HgA1c 7.4 ± 1.7 7.6 ± 1.8 7.3 ± 1.6 7.6 ± 1.9
LDL 114 ± 37 122 ± 39 103 ± 36 111 ± 41
Creatinine 1.2 ± 1.1 1.1 ± 0.7 1.3 ± 1.3 1.3 ± 1.6
Hemoglobin 13.5 ± 1.7 13.3 ± 1.7 13.3 ± 2.0 13.0 ± 1.7
Ejection fraction 0.61 ± 0.15 0.63 ± 0.15 0.62 ± 0.15 0.59 ± 0.16
BMI 30.7 ± 6.2 30.0 ± 5.9 30.1 ± 5.8 29.4 ± 5.9
Clopidogrel
dur. >6 mo 71.8% 66.5%
dur. >9mo 55.3% 48.9%
dur >12mo 22.9% 21.3%
Baseline CharacteristicsClopidogrel User Clopidogrel Non-user
DES BMS DES BMS
Stent No. of Stents 1.4 ± 0.6 1.4 ± 0.6 1.3 ± 0.7 1.5 ± 0.7 Mean diameter (mm) 2.9 ± 0.3 3.2 ± 0.5 3.0 ± 0.3 3.0 ± 0.5 Total cumulative
stent length (mm)26.9 ± 13.4 20.1 ± 10.2 25.1 ± 14.0 21.8 ± 9.9
Stent Location
LAD 50.5% 42.2% 44.9% 41.9%
Diagonal 4.0% 2.7% 1.6% 0%
Circumflex 16.4% 20.4% 19.7% 18.9%
Obtuse marginal 9.9% 10.2% 8.7% 12.2%
RCA 28.8% 35.4% 30.7% 31.1%
PDA / PLV 3.1% 2.7% 3.9% 8.1%
Ramus 0.9% 0% 2.4% 1.4%
Death / MI by Stent type(0d – 18mo)
Cu
mu
lati
ve I
nci
de
nce
(%
)
00
55
1010
1515
2020
No. at Risk
DES
BMS
498 469 459
251 237 225
320
218
p=0.05
Death / MI by Stent Type(6mo – 18mo)
0
5
Cu
mu
lati
ve I
nci
den
ce (
%) p=0.08
10
3.1%
6.2%
Death / MI in BMS group(6mo – 18mo)
0
10
20C
um
ula
tive
In
cid
ence
(%
)
3.5%
12.2%
p=0.01
Death / MI in DES group(6mo – 18mo)
0
10
20C
um
ula
tive
In
cid
ence
(%
)
2.2%
5.5%
p=0.07
Death / MI in Clopidogrel Non-Users (6mo – 18mo)
0
10
20
Cu
mu
lati
ve I
nci
den
ce (
%)
5.5%
12.2%
30
p=0.11
Death / MI by Clopidogrel Duration(6mo – 18mo)
10
20
Cu
mu
lati
ve I
nci
den
ce (
%)
2.0%
1.0%
7.3% (64% DES)
(69% DES)(71% DES)
p= 0.27 0
<9 months (n=314)9-12 months (n=207)>12 months (n=150)
p=0.0005
Discussion
• From index PCI date to 18 months, death / MI less with DES vs. BMS (p=0.05).
• Landmark Analysis– Clopidogrel use was associated with less death / MI
in both DES (p=0.07) and BMS groups (p=0.01). – Among clopidogrel non-users, death / MI less with
DES vs. BMS (p=0.11). – Death / MI less with 9-12 mo and >12 mo. of
clopidogrel use compared to ≤ 9 mo (p < 0.001).
• Clopidogrel compliance by Rx records was 95%
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Conclusion
• Extended clopidogrel use ( >6 mo) from the index PCI was associated with less death / MI in both DES and BMS groups.
• Overall trend towards less death / MI in the DES group compared to the BMS group.
• Among clopidogrel non-users, no difference in death / MI by stent type.
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