Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study - PowerPoint PPT Presentation

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Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study

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Title: Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study


1
Early and late coronary stent thrombosis of
sirolimus-eluting and paclitaxel-eluting stents
in routine clinical practice data from a large
two-institutional cohort study
Bern-Rotterdam Registry
Joost Daemen, MD Peter Wenaweser, MD Keiichi
Tsuchida, MD Linda Abrecht, MD Sophia Vaina,
MD Cyrill Morger, MD Neville Kukreja, MBBS
Peter Jüni, MD Georgios Sianos, MD Gerrit
Hellige, MD Ron T van Domburg, PhD Otto M Hess,
MD Eric Boersma, PhD Bernhard Meier, MD
Stephan Windecker, MD and Patrick W Serruys, MD
Published in the Lancet February 24, 2007
2
Bern-Rotterdam Registry Background
  • Drug-eluting stents (DES) significantly reduce
    rates of restenosis and target lesion
    revascularization compared with bare metal stents
    (BMS).
  • Since the publication of randomized trials on the
    two FDA approved DES, sirolimus-eluting stents
    (SES) and paclitaxel-eluting stents (PES), these
    devices have been widely used.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
3
Bern-Rotterdam Registry Background (cont.)
  • However, several safety concerns have since been
    expressed, including concern about stent
    thrombosis.
  • Little is known about occurrence of stent
    thrombosis more than one year after implantation
    of DES.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
4
Bern-Rotterdam Registry Study Design
Registry of 8146 patients undergoing percutaneous
coronary intervention (PCI) with PES or SES at
two academic hospitals Mean follow-up 3 years
Exclusion Criteria Patients treated with both
types of stents (SES and PES) in one lesion, and
lesion previously treated with brachytherapy
SES n3823
  • PES
  • n4323

3 yrs. follow-up
  • Data assessed to ascertain the incidence, time
    course, and correlates of stent thrombosis, and
    the differences between early (0-30 days) and
    late (gt30 days) stent thrombosis and between SES
    and PES.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
5
Bern-Rotterdam Registry Baseline Characteristics
Characteristic Overall (n 8146) SES (n3823) PES (n4323) p value
Age (yrs) 62.6 (11.6) 62.5 (11.5) 62.7 (11.6) 0.31
Male 6065 (75) 2859 (75) 3206 (74) 0.53
Hypertension 3745 (46) 1965 (51) 1780 (41) lt.0001
Family History 2279 (28) 1112 (29) 1167 (27) 0.04
Current smoker 2993 (37) 1721 (45) 1272 (29) lt.0001
Dyslipidemia 4079 (50) 2087 (55) 1992 (46) lt.0001
Diabetes 1315 (16) 697 (18) 618 (14) lt.0001
LVEF 55 (12) 54 (12) 55 (11) 0.01
Left Ventricular Ejection Fraction Data are
recorded as mean (SD) or n ()
Daemen et al. Lancet. 2007 Feb 24 369 667 78.
6
Bern-Rotterdam Registry Baseline Characteristics
Characteristic Overall (n 8146) SES (n3823) PES (n4323) p value
ACS at presentation 2853/4859 (59) 795/1481(54) 2058/3378 (61) lt.0001
Bifurcation treatment 781/4889 (16) 267/1488 (18) 514/3401 (15) 0.01
No. of stents per patient 1.96 (1.23) 1.87 (1.13) 2.03 (1.31) lt.0001
Total stent length per patient (mm) 35.9 (25.3) 33.6 (22.6) 37.9 (27.4) lt.0001
Duration of clopidogrel (mos.) 5.94 (3.1) 4.72 (4.0) 6.36 (2.6) lt.0001
Acute Coronary Syndrome Data are recorded as
mean (SD) or n/total ()
Daemen et al. Lancet. 2007 Feb 24 369 667 78.
7
Bern-Rotterdam Registry Results
  • Angiographically documented ST occurred in 152
    patients.
  • Incidence density was 1.3 per 100 person-years,
    with a cumulative incidence of 2.9 at three
    years.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
8
Bern-Rotterdam Registry Results (cont.)
Early Stent Thrombosis
Late Stent Thrombosis
p 0.031
p 0.49
Percentage of Patients ()
PES
DES
PES
DES
  • Incidence of early ST was similar for SES and
    PES, but late ST was more frequent with PES than
    with SES.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
9
Bern-Rotterdam Registry Results (cont.)
Days after PCI 9 30 365 730 1095
Cumulative Incidence of ST () 1.1 1.2 1.7 2.3 2.9
Cumulative Events (n) 79 90 116 141 152
Patients at Risk (n) 7173 7041 5549 2852 989
  • Late stent thrombosis occurred steadily at a
    constant rate of 0.6 per year up to three years
    after stent implantation.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
10
Bern-Rotterdam Analysis Results (cont.)
  • At the time of ST, dual antiplatelet therapy was
    being taken by 87 (early) and 23 (late) of
    patients, p lt 0.0001.
  • Independent predictors of overall ST were acute
    coronary syndrome at presentation (hazard ratio
    2.28, 95 CI 1.29-4.03) and diabetes (HR 2.03,
    95 CI 1.07-3.83).

11
Bern-Rotterdam Analysis Limitations
  • This was a non-randomized cohort study that was
    observational in nature, thus possibly
    disadvantaged by confounding by indication.
  • PES were available for commercial use 1 year
    later than were SES, and the difference in follow
    up may have biased results.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
12
Bern-Rotterdam Analysis Limitations (cont.)
  • The data estimate the incidence of stent
    thrombosis after DES implantation during routine
    clinical practice at two tertiary care centers,
    so findings may not apply to institutions with
    more restricted use of DES.
  • Only angiographically documented cases of stent
    thrombosis were counted, which might have
    underrepresented the actual incidence of stent
    thrombosis.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
13
Bern-Rotterdam Analysis Summary
  • The data suggest that late stent thrombosis
    occurs at a steady rate during follow-up up to
    three years, tends to be more frequent with PES
    than with SES, and can unpredictably occur at any
    time point despite antiplatelet therapy.
  • Late stent thrombosis complicating the use of DES
    seems to be a distinct entity with
    pathophysiological factors that differ from those
    of early stent thrombosis.

Daemen et al. Lancet. 2007 Feb 24 369 667 78.
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