Transcript Late Thrombosis in DES: Meta-Analysis of All

Late Thrombosis in Drug Eluting Stents (DES).
Meta-Analysis of All Published Case Reports
Artang R, Khadim G, Dieter RS
Medical College of Wisconsin
Milwaukee, WI
Authors have no relationships to disclose
Background
Number of Reported Late Stent Thrombosis (LST) in
clinical trials with DES
Patient
number
Follow up
months
Paclitaxel
Sirolimus
All DES
Mauri et al.
NEJM 2007
2278
48
11
7
18
Iakovou et al.
JAMA 2005
4495
9
10
5
15
Kuchulakanti et al.
Circ 2006
2972
12
-
-
8
2
Background
• Systematic review of Case reports of Late stent thrombosis
• Sources:
– Medline search using key word “drug eluting stent” (all languages
since 2000-present).
– ACC, AHA and TCT Abstracts 2003-present
3
Methods:
845 positive matches for “drug eluting stents”, were found, including
the randomized and the real world trials. Cases were included only if the
following information were available:
•
•
•
•
•
•
The stent thrombosis occurred after 30 days. (Late and Very Late)
Thrombosis was angiographically verified. (Definite)
Time from stent deployment to clinical event.
Stent type, diameter and length.
Stented vessel.
Antiplatelet regimen at the time of event.
Reports from collaborating groups were cross-referenced to avoid counting
the same case more than once.
Data presented as medians and total range
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Results:
Over all
Sirolimus
Paclitaxel
p value
36
16
20
ns
57
(33-85)
63
(42-85)
54
(33-76)
ns
Male Gender
97%
93%
100%
ns
MI at
presentation
92%
87%
95%
ns
Death
8%
12%
5%
Event Related
to Surgical
Procedure
42%
44%
40%
ns
LAD
RCA
Circ
74%
17%
9%
73%
13%
13%
75%
20%
5%
ns
Number of
patients
Age
ns
small sample size
Artang ACC 2007
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Results:
Over all
n=36
Sirolimus
n=16
Paclitaxel
n=20
p value
55%
55%
55%
ns
discontinued
42%
40%
45%
ns
Stent length
23
23
(8-46)
20
(12-68)
ns
3.0
(2.5-3.5)
3.0
(2.25-3.5)
ns
240
(49-570)
289
(39-927)
ns
Clopidogrel &
Aspirin
discontinued
Clopidogrel
mm
(8-68)
Stent diameter
3.0
mm
(2.25-3.5)
Time to event
242
days
(39-927)
Time from disc.
dual antiplatelet
agents to event
days
Time from disc.
clopidogrel to
event (days)
7
(3-150)
30
(14-690)
10
(4-45)
127
(14-690)
7
(3-150)
30
(15-84)
ns
ns
small sample size
Artang ACC 2007
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Results:
p < 0.001
Time from disc. antiplatelet agent to event
days
1000
Continued on ASA
ASA and clopigogrel
stopped
100
10
1
Artang ACC 2007
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Results:
Time from disc. antiplatelet agent to event
days
1000
Continued on ASA
ASA and clopigogrel
stopped
Surgical procedure
100
10
1
Artang ACC 2007
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Observation
•
•
•
•
1 out of 36 cases was a female
This may represent selection or publication bias.
30% of the patients included in the RCT were females.
Review of the published data from randomized and real
world trials:
• Gender was not specified in patients with LST.
Artang ACC 2007
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Limitations:
• This study is limited due to small number of reported
cases. We did however gather 36 cases of definite late and
very late stent thrombosis.
• Risk factors such as diabetes, lesion type, race, procedure
time, off label use of DES, and circumstances prior to
discontinuation of antiplatelet agents were not available in
all references.
Artang ACC 2007
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Conclusion
• Discontinuation of dual antiplatelet agents appeared to be
associated with earlier onset of stent thrombosis as
compared to discontinuation of clopidogrel alone.
• Efforts should be made to maintain patients with DES on
aspirin for routine surgical procedures.
• In this data set we observed no statistical difference
between sirolimus and paclitaxel eluting stents.
• Gender differences in LST may require further
investigation.
Artang ACC 2007
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Thank you