Title: Stent Thrombosis:
1Stent Thrombosis Patient, Procedural, and Stent
Factors
Eugene Mc Fadden Cork, Ireland
2Definitions
- Early lt30 day
- Late 30d 1yr
- V late
- gt1 yr TAXUS
- gt6months CYPHER
3Incidence and Timing BMS
- Registry data BMS angiographic ST
- most early, in hospital or lt10 days
- LST and VLST rare
ST 20/1191 patients (1.6)
Wang CCI 2002
days
lt1
1-30
60
120
180
240
ST 97/6,058 patients (1.6)
Wenaweser EHJ 2005
days
4Outcome
- Nonfatal MI
- approx 80
- Mortality depends on definition, duration FU
- Studies including all sudden deaths
- 20-50 Iakovou, Cutlip
- Patients Rx for angiographic stent thrombosis
- 10-30 6 months Wenaweser, Cutlip, Waksman
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6 Improved technology
Patient selection
- Stent
- Material
- Polymer
- Drug
- Patient/lesion
- Diameter
- Length
- ACS
- LV function
- Procedure
- Under-expansion
- Dissection
- Thrombus
- Antiplatelet RX
Technique
7Procedural Factors in Stent Thrombosis Bare
Metal Stents
8- 54F
- CRF on CAPD DM
- Rx
- RCA prox direct stented 3.0x32mm
- LAD/diag crush with kiss 2.75x32 / 2.25x24mm
- LAD dist edge 2.25x12
- LAD prox edge 3.0x8
- Abciximab intraproc
- Day 6 Ant ST elevation
- Died before reaching cath lab
- Not taking ASA, only clopidogrel
- Dx NO ASA, RESIDUAL DISSECTION
9Stent Thrombosis BMS vs.DES
10Evidence From Randomized Trials
- Relatively Simple Patient and Lesion Subsets
11Taxus vs Endeavor Definition For ST
QWMI Q-wave myocardial infarction NQWMI
nonQ-wave myocardial infarction MI myocardial
infarction STEMI ST-segment elevation
myocardial infarction. 1. Stone et al. N Engl
Med. 2004350221.. 2. Fajadet et al.
Circulation. 2006 11498-806 Endeavor is a
trademark of Medtronic Vascular, Inc.
12Taxus vs Endeavor Definition For ST
Stone et al. N Engl Med. 2004350221..
Fajadet et al. Circulation. 2006 11498-806
13CYPHER - Stent Thrombosis to 9 Months
Meta-analysis of 6 studies (N2074)
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17Conclusions
- No significant difference, between SES and BMS,
in either early or late ST events. - However, there are soft signals of increased ST
with Cypher, including 4 vs. 0 ST events between
1-3 years (0.5). - Larger studies in more complex lesions are
definitely required to determine differences vs.
BMS or other DES. - Extended antiplatelet RX recommendations (? 6
months, 1 yr, gt1 yr) remain problematic until
more data are available!
18TAXUS - Stent Thrombosis to 9 Months
Meta-analysis of 4 studies (N3445)
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23Conclusions
- Early Stent Thrombosis
- Accounts for 57 of total stent thrombosis
- Distribution similar in Taxus and Control
suggesting peri-procedural causes - Late Stent Thrombosis
- Taxus gt Control at 6 months
- Overall rate of very late ST is 0.4
- No stent thrombosis in Taxus after 2 years
24How often does it occur in the Real World ?
25Late Stent Thrombosis
- 2229 pts (SES 1062, PES 1167)
- Definition of stent thrombosis
- Acute clinical event angiographic proof
- OR
- Sudden cardiac death not attributable to another
lesion. - Follow-up 9 months
Iakovou J, Colombo A, JAMA 2005
262229 Patients Successful DES Implantation
27Predictors of stent thrombosis
At a mean follow-up of 9.3 ? 5.6 months
28Thrombosis rates according to selected patient
characteristics
Aspirin And Clopidogrel Stopped
Prior Brachytherapy
DM
UA
LMS
BIFURC
RENAL FAILURE
Iakovou et al JAMA 2005
29Recent Data ESC 2006
- RAVEL five year follow-up
- Meta-analysis DES Trials- Basel
- Meta-analysis DES Trials- Geneva
- BASKET
- Rotterdam/Zurich Registry
30RAVEL Five Year Follow-Up
Fischers exact test
31Recent Data ESC 2006
- RAVEL five year follow-up
- Meta-analysis DES Trials- Basel
- Meta-analysis DES Trials- Geneva
- BASKET
- Rotterdam/Zurich Registry
32Safety of Drug-Eluting StentsInsights from a
Meta-AnalysisAlain J Nordmann, Matthias Briel,
Heiner C BucherBasel Institute for Clinical
EpidemiologySwitzerland
33Purpose
Meta-analysis of randomised controlled trials
comparing sirolimus-or paclitaxel-eluting stents
to bare metal stents to evaluate their effect on
total, cardiac, and non-cardiac mortality.
34Overall Mortality
35Non-Cardiac Mortality
36Non-Cardiac Deaths (n35) in 7 SES Trials Ravel,
Sirius, C E-Sirius, SES Smart, Diabetes, Basket
- Cancer 15 43
- Stroke 6 17
- Sepsis 6 17
- Respiratory failure 4 11
- Pulmonary embolism 2 6
- Alzheimers 1 3
- Road traffic accident 1 3
37Conclusions
- DES for the treatment of coronary artery disease
do not reduce total mortality when compared to
BMS - Preliminary evidence suggests that sirolimus-,
but not paclitaxel-eluting stents, may lead to
increased non-cardiac mortality - Long term follow-up and assessment of
cause-specific deaths in patients receiving DES
are mandatory to determine long-term safety of
these devices
38Recent Data ESC 2006
- RAVEL five year follow-up
- Meta-analysis DES Trials- Basel
- Meta-analysis DES Trials- Geneva
- BASKET
- Rotterdam/Zurich Registry
39Safety of Drug-Eluting Stents Insights From
Meta-AnalysisE. CamenzindGeneva
40Goal of the Study
- To evaluate, in a metaanalysis, the effect of the
use of BMS compared to DES (SES or PES) on the
long-term rate of death or Q-wave MI - Data from RAVEL, SIRIUS, E- and C-SIRIUS , TAXUS
I, II, IV, V, VI
41BMS vs. SES
42BMS vs. PES
43Conclusions
- Treatment with SES was associated with a
significant increase in death/QMI at 3 years
compared with BMS - Death or QMI did not differ between PES and BMS
- The present meta-analysis shows a significant
increase in death/QMI with SES compared to BMS
and mandates further long term follow-up of
patients receiving DES
44Recent Data ESC 2006
- RAVEL five year follow-up
- Meta-analysis DES Trials- Basel
- Meta-analysis DES Trials- Basel
- BASKET
- Rotterdam/Zurich Registry
45BASKET 18 Month Results (n826)
46Recent Data ESC 2006
- RAVEL five year follow-up
- Meta-analysis DES Trials- Basel
- Meta-analysis DES Trials- Geneva
- BASKET
- Rotterdam/Zurich Registry
47Late Stent thrombosis Following Drug-Eluting
Stent Implantation Data From a Large,
Two-institutional Cohort Study P. Wenaweser,
K. Tsuchida, S. Vaina, L. Abrecht, J. Daemen, C.
Morger, S. Windecker, PW SerruysBern and
Rotterdam
48Ong et al, JACC 2005
49Angiographically Proven Stent Thrombosis
50Stent Thrombosis Rate, Time, SES vs. PES
- April 2002 - December 2005
- 8668 pts PCI with DES only
- SES n3817
- PES n4851
- Angiographically documented ST
- 1.8 (N157/8668), SESPES
- Early (median 4, range 0-28) 59 cases
- Late (median 453, range 31-1074) 41 cases
51Differences Between Early and Late ST Cohorts
- Not on dual antiplatelet therapy
- 11 early ST patients
- 75 late ST pts (plt0.001)
- Premature discontinuation of either aspirin or
plavix - 6 early ST patients
- 22 late ST patients (p0.004)
- CAD risk factors more often encountered in late
ST patients - Continued smoking (plt0.0001)
- Hypertension (0.003)
- Hyperlipidaemia (0.004)
- Early ST Patients had (vs. Late ST patients)
- Smaller final MLD 2.39 vs. 2.57 mm ( p0.03)
- Greater residual diameter stenosis 18 vs. 13
(p0.04)
52Angiographically Proven ST RotterdamZurich
Incremental rate of 0.6 per year
ST
SESPES
Days
Pts at risk
6349 6173 6042 4556 3083 865 0
1.3 1.5 2.0 2.6 3.3
53Late Stent Thrombosis Mechanisms?
- Delayed healing?
- Abnormal endothelium?
- Hypersensitivity to polymer?
- Neointimal regression?
- Acquired aneurysm formation?
54All Plausible Mechanisms- but
- LST fortunately relatively rare
- Overlapping stents common
- Endothelial dysfunction ubiquitous
- Denominator unknown
- Analogous to the VP conundrum
55Late Acquired Aneurysm Formation
- 50 years, woman, Anterior MI 2/2002
- Staged intervention
- LAD 3/2002, RCA 4/2002
- LAD CYPHER, RCA CYPHER BARE
- RESEARCH Control angio 6 months
- Elective surgery 3/2005
- Aspirin stopped
- Anterior MI 3 days later, cardiogenic shock
- LAD stent occlusion
56Pre Post Six Months Three Years
57IVUS Crosssections-Bare Cypher
58LAD Three Overlapping Covered Stents
59Take Home Messages
- Early ST accounts for 60 of ST with DES
- Ensure intervention justified and that the
patient informed of risks - Keep interventions simple especially in patients
with high-risk features - Optimise the result-postdilate, kiss
- Compliance with antiplatelet therapy
- Disseminate information on antiplatelet RX to
non-cardiologists - More liberal BMS use?
60Take Home Messages
- LST is a reality
- Longer dual antiplatelet therapy?
- More long-term studies (IVUS)?
- Trends for increased mortality need to be
elucidated
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