Transcript Document 7200010

Bern-Rotterdam Registry
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
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
Clinical Trial Results . org
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
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
PES
n=3823
n=4323
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 (>30 days) stent thrombosis and between SES and PES.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
Bern-Rotterdam Registry: Baseline Characteristics
Characteristic
Overall
(n= 8146)
SES
(n=3823)
PES
(n=4323)
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%)
<.0001
Family History
2279 (28%)
1112 (29%)
1167 (27%)
0.04
Current
smoker
2993 (37%)
1721 (45%)
1272 (29%)
<.0001
Dyslipidemia
4079 (50%)
2087 (55%)
1992 (46%)
<.0001
Diabetes
1315 (16%)
697 (18%)
618 (14%)
<.0001
55 (12)
54 (12)
55 (11)
0.01
LVEF*
*Left Ventricular Ejection Fraction
Data are recorded as mean (SD) or n (%)
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
Bern-Rotterdam Registry: Baseline Characteristics
Overall
(n= 8146)
SES
(n=3823)
ACS** at
presentation
2853/4859 (59%)
795/1481(54%)
2058/3378 (61%) <.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)
<.0001
Total stent
length per
patient (mm)
35.9 (25.3)
33.6 (22.6)
37.9 (27.4)
<.0001
Duration of
clopidogrel
(mos.)
5.94 (3.1)
4.72 (4.0)
6.36 (2.6)
<.0001
Characteristic
PES
(n=4323)
p
value
**Acute Coronary Syndrome
Data are recorded as mean (SD) or n/total (%)
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
Bern-Rotterdam Registry: Results (cont.)
Percentage of Patients (%)
Early Stent Thrombosis
Late Stent Thrombosis
2%
2%
1.8%
p = 0.49
p = 0.031
1.4%
1.3%
1.1%
1%
1%
0%
0%
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
Bern-Rotterdam Registry: Results (cont.)
Days after
PCI
Cumulative
Incidence of
ST (%)
Cumulative
Events (n)
Patients at
Risk (n)
9
30
365
730
1095
1.1
1.2
1.7
2.3
2.9
79
90
116
141
152
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
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 < 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).
Clinical Trial Results . org
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.
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.
Clinical Trial Results . org
Daemen et al. Lancet. 2007 Feb 24; 369: 667 – 78.