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Title: Stent Thrombosis:


1
Stent Thrombosis Patient, Procedural, and Stent
Factors
Eugene Mc Fadden Cork, Ireland
2
Definitions
  • Early lt30 day
  • Late 30d 1yr
  • V late
  • gt1 yr TAXUS
  • gt6months CYPHER

3
Incidence 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
4
Outcome
  • 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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Improved technology
Patient selection
  • Stent
  • Material
  • Polymer
  • Drug
  • Patient/lesion
  • Diameter
  • Length
  • ACS
  • LV function
  • Procedure
  • Under-expansion
  • Dissection
  • Thrombus
  • Antiplatelet RX

Technique
7
Procedural 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

9
Stent Thrombosis BMS vs.DES
10
Evidence From Randomized Trials
  • Relatively Simple Patient and Lesion Subsets

11
Taxus 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.
12
Taxus vs Endeavor Definition For ST
Stone et al. N Engl Med. 2004350221..
Fajadet et al. Circulation. 2006 11498-806
13
CYPHER - Stent Thrombosis to 9 Months
Meta-analysis of 6 studies (N2074)
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Conclusions
  • 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!

18
TAXUS - Stent Thrombosis to 9 Months
Meta-analysis of 4 studies (N3445)
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Conclusions
  • 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

24
How often does it occur in the Real World ?
25
Late 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
26
2229 Patients Successful DES Implantation
27
Predictors of stent thrombosis
At a mean follow-up of 9.3 ? 5.6 months
28
Thrombosis rates according to selected patient
characteristics

Aspirin And Clopidogrel Stopped
Prior Brachytherapy
DM
UA
LMS
BIFURC
RENAL FAILURE
Iakovou et al JAMA 2005
29
Recent Data ESC 2006
  • RAVEL five year follow-up
  • Meta-analysis DES Trials- Basel
  • Meta-analysis DES Trials- Geneva
  • BASKET
  • Rotterdam/Zurich Registry

30
RAVEL Five Year Follow-Up
Fischers exact test
31
Recent Data ESC 2006
  • RAVEL five year follow-up
  • Meta-analysis DES Trials- Basel
  • Meta-analysis DES Trials- Geneva
  • BASKET
  • Rotterdam/Zurich Registry

32
Safety of Drug-Eluting StentsInsights from a
Meta-AnalysisAlain J Nordmann, Matthias Briel,
Heiner C BucherBasel Institute for Clinical
EpidemiologySwitzerland
33
Purpose
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.
34
Overall Mortality
35
Non-Cardiac Mortality
36
Non-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

37
Conclusions
  • 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

38
Recent Data ESC 2006
  • RAVEL five year follow-up
  • Meta-analysis DES Trials- Basel
  • Meta-analysis DES Trials- Geneva
  • BASKET
  • Rotterdam/Zurich Registry

39
Safety of Drug-Eluting Stents Insights From
Meta-AnalysisE. CamenzindGeneva
40
Goal 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

41
BMS vs. SES
42
BMS vs. PES
43
Conclusions
  • 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

44
Recent Data ESC 2006
  • RAVEL five year follow-up
  • Meta-analysis DES Trials- Basel
  • Meta-analysis DES Trials- Basel
  • BASKET
  • Rotterdam/Zurich Registry

45
BASKET 18 Month Results (n826)
46
Recent Data ESC 2006
  • RAVEL five year follow-up
  • Meta-analysis DES Trials- Basel
  • Meta-analysis DES Trials- Geneva
  • BASKET
  • Rotterdam/Zurich Registry

47
Late 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
48
Ong et al, JACC 2005
49
Angiographically Proven Stent Thrombosis
50
Stent 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

51
Differences 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)

52
Angiographically 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
53
Late Stent Thrombosis Mechanisms?
  • Delayed healing?
  • Abnormal endothelium?
  • Hypersensitivity to polymer?
  • Neointimal regression?
  • Acquired aneurysm formation?

54
All Plausible Mechanisms- but
  • LST fortunately relatively rare
  • Overlapping stents common
  • Endothelial dysfunction ubiquitous
  • Denominator unknown
  • Analogous to the VP conundrum

55
Late 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

56
Pre Post Six Months Three Years
57
IVUS Crosssections-Bare Cypher
58
LAD Three Overlapping Covered Stents
59
Take 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?

60
Take 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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