Journal of the American College of Cardiology
© 2005 by the American College of Cardiology Foundation
Published by Elsevier Inc.
Vol. 45, No. 6, 2005
ISSN 0735-1097/05/$30.00
doi:10.1016/j.jacc.2004.11.064
EXPEDITED REVIEWS
What Is the Risk of Stent Thrombosis
Associated With the Use of Paclitaxel-Eluting
Stents for Percutaneous Coronary Intervention?
A Meta-Analysis
Anthony A. Bavry, MD, MPH,* Dharam J. Kumbhani, MD, SM,† Thomas J. Helton, DO,*
Deepak L. Bhatt, MD*
Cleveland, Ohio; and Boston, Massachusetts
This study investigated the risk of stent thrombosis associated with the use of paclitaxeleluting stents (PES) compared to bare-metal stents (BMS).
BACKGROUND Clinical experience with coronary drug-eluting stents (DES) is relatively limited. There is
concern that DES used for percutaneous coronary intervention may result in subsequent
thrombosis.
METHODS
We conducted a meta-analysis on eight trials (total of 13 study arms) in 3,817 patients with
coronary artery disease who were randomized to either PES or BMS.
RESULTS
As compared with BMS, PES do not increase the hazard for thrombosis up to 12 months
(risk ratio [RR] ⫽ 1.06, 95% confidence interval [CI] 0.55 to 2.04, p ⫽ 0.86]). There was no
evidence of heterogeneity among the studies (chi-square value for Q-statistic ⫽ 5.90 [10
degrees of freedom], p ⫽ 0.82). Similar results were obtained when the analysis was restricted
to trials with a polymeric stent platform (Treatment of de novo coronary disease using a single
pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI) (RR ⫽ 1.01, 95% CI 0.40 to 2.53,
p ⫽ 0.99), trials with longer lesions (TAXUS-IV and -VI) (RR ⫽ 0.62, 95% CI 0.2 to 1.91,
p ⫽ 0.41), and trials that used a higher dose of paclitaxel (ASian Paclitaxel-Eluting Stent
Clinical trial [ASPECT], European evaLUaTion of paclitaxel Eluting Stents [ELUTES],
and DELIVER-I) (RR ⫽ 1.87, 95% CI 0.52 to 6.81, p ⫽ 0.34).
CONCLUSIONS Current evidence suggests that standard dose PES do not increase the hazard of stent
thrombosis compared to BMS. (J Am Coll Cardiol 2005;45:941– 6) © 2005 by the
American College of Cardiology Foundation
OBJECTIVES
Percutaneous coronary intervention (PCI) is often limited
by restenosis. The advent of drug-eluting stents (DES)
generated excitement by dramatically reducing restenosis
(1,2). A pooled analysis documented a 74% reduction in the
risk of target-lesion revascularization from the use of
sirolimus-eluting stents (Cypher, Johnson & Johnson, Miami Lakes, Florida) or paclitaxel-eluting stents (PES)
(TAXUS, Boston Scientific Corp., Natick, Massachusetts)
compared to bare-metal stents (BMS) (3).
Based on a number of clinical case reports, concerns have
been raised about an increased risk of stent thrombosis with
DES. This prompted the release of an advisory concerning
a potential risk of subacute thrombosis and hypersensitivity
reactions with the use of sirolimus-eluting stents (4). It is
possible that with increased use and experience with PES,
similar concerns may surface. Accordingly, we conducted a
systematic review of the literature specific to PES to study
From the *Department of Cardiovascular Medicine, Cleveland Clinic Foundation,
Cleveland, Ohio; and the †Department of Cardiac Surgery, Veterans Administration
Boston Healthcare System, Brigham and Women’s Hospital, Harvard Medical
School, Boston, Massachusetts.
Manuscript received August 3, 2004; revised manuscript received November 11,
2004, accepted November 29, 2004.
the association between this stent and the risk of thrombosis
after PCI.
METHODS
Literature review. We searched the MEDLINE, EMBASE, CRISP, metaRegister of Controlled Trials, and
Cochrane databases for randomized clinical trials from 2001
to 2004 using the medical subject heading terms “angioplasty, transluminal, percutaneous coronary,” “stents,” “paclitaxel,” and “thrombosis.” We also hand-searched relevant
journals, obtained recently presented data from national
cardiology and interventional cardiology conferences, corresponded with authors and experts in the field, and used the
Science Citation Index to cross-reference any articles that
met our selection criteria.
Our inclusion criteria were as follows: 1) a randomized
clinical trial that assigned patients to either a PES or BMS;
and 2) angiographically documented thrombosis data were
available for at least 30 days of follow-up. Stent thrombosis
was defined as either an angiographically documented
thrombosis or an event where angiographic data were not
available, although the study investigators clinically pre-
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Bavry et al.
Paclitaxel-Eluting Stent Thrombosis
Abbreviations and Acronyms
BMS ⫽ bare-metal stents
CI ⫽ confidence interval
DES ⫽ drug-eluting stents
PCI ⫽ percutaneous coronary intervention
PES ⫽ paclitaxel-eluting stents
RR ⫽ risk ratio
sumed that a stent thrombosis occurred. Studies were
excluded from analysis if both groups received DES, if
sirolimus (rapamycin) was used, if paclitaxel was given
orally, if other analogues of paclitaxel such as QP-2 were
employed, or if reliable data could not be obtained.
We identified eight studies that compared PES to BMS
(Treatment of de novo coronary disease using a single
pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI,
ASian Paclitaxel-Eluting Stent Clinical trial [ASPECT],
European evaLUaTion of paclitaxel Eluting Stents
[ELUTES], DELIVER-I, and PAclitaxel-Coated logics
TENt for the CYtostatic prevention of restenosis [PATENCY]) (5–16). This represents 13 study arms as
TAXUS-II had two DES arms, ASPECT had two arms,
and ELUTES had four arms.
Data abstraction. Two independent reviewers abstracted
the following outcomes by intention-to-treat analysis: 1)
angiographically documented or presumed coronary thrombosis; and 2) length of follow-up from deployment of the
index stent procedure. We also abstracted baseline information such as patient demographics as well as angiographic
and procedural characteristics of the coronary artery revascularization. Discrepancies were resolved through a third
reviewer. Because all eight studies were double-blind randomized clinical trials, a formal quality assessment was not
used.
End points. In order to utilize data from all available
studies, and thereby increase the statistical power of our
meta-analysis, we considered stent-associated thrombosis at
any point in time (up to one year) after the index procedure
as the primary end point. In trials that examined various
doses or release kinetics of paclitaxel, each DES arm was
treated as a separate study for analysis. We also conducted a
number of subanalyses by analyzing groups that shared
various similarities. The four TAXUS trials were analyzed
together because they used clopidogrel for six months in
addition to aspirin, while the other four trials used a shorter
duration of dual antiplatelet therapy. Similarly TAXUS-IV
and -VI trials studied patients with longer lesions (mean
length ⬎12 mm), while ASPECT, ELUTES, and
DELIVER-I trials examined higher doses of paclitaxel (2.7
to 3.1 ␮g/mm2) and were analyzed together.
Statistical methods. We tabulated the number of thromboses and persons at risk for thrombosis in each arm of a
study and calculated the risk ratio (RR) (PES vs. BMS). In
order to determine if the studies were similar enough to be
comparable for analysis, the Cochran’s Q statistic for
JACC Vol. 45, No. 6, 2005
March 15, 2005:941–6
heterogeneity was employed. To evaluate if the studies were
published with a certain bias (i.e., only studies with positive
results were published), the Egger’s funnel plot for publication bias was constructed. We utilized the automatic “zero
cell” correction so that studies with no events in a single arm
would still be included for analysis. We obtained a summary
estimate of the RR and 95% confidence interval (CI) for
PES compared to BMS. A fixed effects model was used to
calculate the summary statistic. All p values were two-tailed,
with statistical significance set at 0.05. All CIs were calculated at the 95% level. All analyses were performed using
STATA software v8.0. (STATA Corp., College Station,
Texas).
RESULTS
Baseline characteristics. The eight studies that met our
inclusion criteria were TAXUS-I, -II, -V, and -VI, ASPECT, ELUTES, DELIVER-I, and PATENCY (5–16).
The characteristics of these studies are listed in Table 1. A
total of 3,817 patients were enrolled; 1,995 were randomized to PES and 1,822 to BMS. All trials were multicentered studies. The baseline characteristics of patients randomized to PES and to BMS were similar within each
study. The median ages of participants ranged from 58 to 66
years. The percentage of enrolled females ranged from 6%
to 38%. Approximately one-quarter to one-third of the
patients had a history of previous myocardial infarction.
Heterogeneity/publication bias. There was no evidence
for heterogeneity among the studies (chi-square value for
Q-statistic ⫽ 5.90 [10 degrees of freedom], p ⫽ 0.82).
Similarly the p value for publication bias was nonsignificant
(p ⫽ 0.86).
Risk of stent-associated thrombosis. Length of followup, event data, and RRs (with 95% CI) for the development
of stent-associated thrombosis are listed in Table 2. Six
study arms revealed a nonsignificant decrease in the risk of
stent-associated thrombosis (TAXUS-IV, TAXUS-VI,
ELUTES: 0.2, 0.7, and 1.4 ␮g paclitaxel/mm2 of stent
arms; and DELIVER-I), five study arms revealed a nonsignificant increase in risk (TAXUS-II SR and MR arms and
ASPECT: 1.3 and 3.1 ␮g paclitaxel/mm2 of stent arms, and
ELUTES 2.7 ␮g paclitaxel/mm2 of stent arm), and in two
studies there were no events (TAXUS-I and PATENCY).
In the ASPECT trial, all cases of thrombosis occurred in
individuals randomized to PES who received nontraditional
antiplatelet therapy (i.e., aspirin without the use of a
thienopyridine). Aspirin and cilostazol was used in these
individuals for one month (n ⫽ 29) or six months (n ⫽ 8)
as this was considered standard antiplatelet therapy at the
participating centers. The remaining individuals in this trial
received aspirin with ticlopidine (n ⫽ 120) or clopidogrel (n
⫽ 18) for one or six months. The duration of therapy for
those that received clopidogrel was one month, while the
duration of therapy for 78% of the individuals given ticlo-
Characteristic
TAXUS-II*
TAXUS-IV
TAXUS-VI
ASPECT†
ELUTES‡
DELIVER-I
PATENCY
Germany
Europe
U.S.
Europe
Asia
Europe
U.S.
U.S.
31
30
266
270
662
652
219
227
118
59
153
39
522
519
66
64
60
60
63
62
62
63
59
58
60
61
62
63
94
83
73
78
72
72
76
76
76
76
82
82
71
71
67
62
23
13
14
15
23
25
18
22
21
17
17
10
31
29
25
23
54
47
23
27
23
20
NA
44
46
36
33
25
25
NA
26
30
38
43
31
30
43
42
23
29
33
41
26
27
NA
16
18
58
57
21
19
NA
31 (overall)
64
64
NA
NA
24
26
66 (overall)
55/23/23
27/37/37
41/35/24
48/37/16
40/31/29
41/32/27
53/29/18
47/34/19
51/24/23
51/29/20
38/27/21
38/28/23
42/34/23
47/23/30
40/28/32
(overall)
32/39/29/0
13/43/43/0
NA
NA
1/35/63/1
0/35/64/1
54/40/4/1
51/41/8/0
NA
17/42/33/8
20/42/35/4
NA
2.99
2.94
2.75
2.75
2.75
2.75
2.82
2.77
2.93
2.88
2.95
2.99
2.85
2.77
2.77
3.01
10.7
11.9
1.0
10.4
10.6
1.0
13.4
13.4
1.0
21.0
20.3
1.0
11.0
10.5
1.3 and 3.1
10.8
10.8
0.2, 0.7, 1.4, and 2.7
11.7
11.1
3.0
⬍25 (overall)
TAXUS-SR
NIRx
TAXUS-SR/MR
NIRx
TAXUS-SR
EXPRESS
TAXUS-MR
EXPRESS
Supra-G non-polymeric
Supra-G
V-flex Plus non-polymeric
V-flex Plus
ACHIEVE
ML PENTA
LOGIC PTX
LOGIC
2.0
943
*TAXUS-II had two stent arms with different release kinetics. Participants received either a slow release stent (TAXUS-SR) or a moderate release stent (TAXUS-MR). Each group had its own control. Data presented here are pooled
from both SR and MR arms. †ASPECT had two stent arms with different dose densities. Participants received either 1.3 or 3.1 ␮g paclitaxel/mm2 of stent. There was one control arm. Data presented here are weighted averages from
both dose density arms. Data from the 3.1 ␮g paclitaxel/mm2 of stent arm was used for subanalysis. ‡ELUTES had four stent arms with different dose densities. Participants received either 0.2, 0.7, 1.4 or 2.7 ␮g paclitaxel/mm2 of stent.
There was one control arm. Data presented here are weighted averages from all dose density arms. Data from the 2.7 ␮g paclitaxel/mm2 was used for subanalysis. §Manufacturers of paclitaxel eluting stents: TAXUS/NIRx/EXPRESSBoston Scientific, Supra-G/V-Flex/LOGIC PTX-Cook Inc., RX ACHIEVE/ML PENTA-Cook Inc./Guidant Corp. Only the TAXUS stents are polymeric, the others are non-polymeric stents.
BMS ⫽ bare-metal stent; DES ⫽ drug-eluting stent; GP ⫽ glycoprotein; LAD/RCA/CX ⫽ left anterior descending artery, right coronary artery, and circumflex artery, respectively; MI ⫽ myocardial infarction; MR ⫽ moderate-release;
NA ⫽ data not available; SR ⫽ slow-release.
Bavry et al.
Paclitaxel-Eluting Stent Thrombosis
Demographic characteristics
Primary site
Total no. of patients
DES
BMS
Age (median yrs)
DES
BMS
Men (%)
DES
BMS
Diabetes (%)
DES
BMS
Current smokers (%)
DES
BMS
Previous MI (%)
DES
BMS
Angiographic and procedural characteristics
Use of GP IIb/IIIa inhibitors (%)
DES
BMS
Target coronary artery—LAD/RCA/CX (%)
DES
BMS
AHA/ACC lesion class, A/B1/B2/C (%)
DES
BMS
Diameter of reference vessel (mm)
DES
BMS
Length of lesion (mm)
DES
BMS
Dose of paclitaxel used (␮g/mm2 of stent)
Stent used§
DES
BMS
TAXUS-I
JACC Vol. 45, No. 6, 2005
March 15, 2005:941–6
Table 1. Baseline Characteristics of Eight Paclitaxel-Eluting Stent Studies
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Bavry et al.
Paclitaxel-Eluting Stent Thrombosis
JACC Vol. 45, No. 6, 2005
March 15, 2005:941–6
Table 2. Event Data and Outcome Measures
Trial Name
TAXUS-I
TAXUS-II (SR)
TAXUS-II (MR)
TAXUS-IV
TAXUS-VI
ASPECT (1.3)
ASPECT (3.1)
ELUTES (0.2)
ELUTES (0.7)
ELUTES (1.4)
ELUTES (2.7)
DELIVER-I
PATENCY
Follow-Up
12
12
12
12
9
6
6
12
12
12
12
12
9
months
months
months
months
months
months
months
months
months
months
months
months
months
DES
Thrombosis
BMS
Thrombosis
0/31
2/131
1/135
4/662
1/219
1/58
3/60
0/37
0/40
0/39
1/37
2/522
0/24
0/30
0/136
0/134
5/652
3/227
0/59
0/59
1/39
1/39
1/39
1/39
2/519
0/26
Risk Ratio
(95% CI)
5.11
2.96
0.79
0.35
3.00
6.56
0.36
0.33
0.34
1.05
0.99
—
(0.25, 105.49)
(0.12, 71.93)
(0.21, 2.93)
(0.04, 3.32)
(0.12, 72.18)
(0.35, 124.41)
(0.02, 8.56)
(0.01, 7.95)
(0.01, 8.14)
(0.07, 16.24)
(0.14, 7.03)
—
Numbers within parentheses in trial name column represent dose of paclitaxel in ␮g/mm2 of stent.
CI ⫽ confidence interval.
pidine was six months (one month of therapy for the
remaining individuals on ticlopidine).
The plot of stent-associated thrombosis and the pooled
RR estimate is shown in Figure 1. The hazard of stent
thrombosis for PES versus BMS was not increased up to 12
months after the index stent deployment (RR ⫽ 1.06, 95%
CI 0.55 to 2.04, p ⫽ 0.86).
Subanalyses. When the four TAXUS trials that used
aspirin and clopidogrel for six months were analyzed together, the summary RR obtained was similar to the overall
effect estimate (RR ⫽ 1.01, 95% CI 0.40 to 2.53, p ⫽ 0.99).
Analyzing TAXUS-IV and -VI, which enrolled patients
with longer lesions (mean length ⬎12 mm) resulted in a
similar association (RR ⫽ 0.62, 95% CI 0.20 to 1.91, p ⫽
0.41). Analyzing ASPECT, ELUTES, and DELIVER-1,
which used a higher dose of paclitaxel (approximately 3.0
␮g/mm2) revealed the same overall association (RR ⫽ 1.87,
95% CI 0.52 to 6.81, p ⫽ 0.34).
Figure 1. In trials with varying doses of paclitaxel, a ⫽ 1.3, b ⫽ 3.1, A ⫽
0.2, B ⫽ 0.7, C ⫽ 1.4, and D ⫽ 2.7 ␮g paclitaxel/mm2 of stent. BMS ⫽
bare-metal stent; CI ⫽ confidence interval; DES ⫽ drug-eluting stent;
MR ⫽ moderate-release; SR ⫽ slow-release.
DISCUSSION
Our meta-analysis suggests that stent-associated thrombosis
is not increased by standard-dose PES compared to BMS.
In fact, the risk of stent-associated thrombosis up to 12
months after the index procedure was equivalent with PES
compared to BMS. This information is derived from systematically analyzing eight worldwide clinical trials that
have been published or presented at prominent cardiology
conferences to date.
We performed various subanalyses. These examined the
effect of longer duration of dual antiplatelet therapy (in
contrast to shorter duration of therapy), longer versus
shorter lesion lengths, and higher versus lower doses of
paclitaxel (around 3 ␮g/mm2). The subanalyses confirmed
the same overall association of no increased (or decreased)
risk of stent-associated thrombosis. It should be noted that
although there was a nonsignificant increased risk of stentassociated thrombosis with higher doses of paclitaxel, this
association was driven by a high rate of stent thrombosis in
the ASPECT trial.
It is interesting that all thrombotic events in the ASPECT trial occurred in participants randomized to PES
who were on aspirin and cilostazol. No events occurred in
either stent group when standard antiplatelet therapy (aspirin with a thienopyridine) was employed. The TAXUS
studies used clopidogrel for six months after the index stent
deployment, while ELUTES, DELIVER-I, and PATENCY used clopidogrel for three months. This suggests
that a nonthienopyridine-based antiplatelet regimen is not
sufficient in preventing thrombosis, and this issue may be
especially important for DES (17).
We did not formally analyze the Stent Comparative
REstenosis (SCORE) trial because this study used a paclitaxel analogue (7-hexanoyltaxol) that could not be directly
compared to PES (18). This trial was terminated early
secondary to a high rate of stent thrombosis (9.4%) and
myocardial infarction (14.5%). This event rate occurred
Bavry et al.
Paclitaxel-Eluting Stent Thrombosis
JACC Vol. 45, No. 6, 2005
March 15, 2005:941–6
despite the use of aspirin plus a thienopyridine for 1 month
in the BMS arm and for 12 months in the DES arm.
The current study is limited in that some of the analyzed
trials had small sample size, with relatively short duration of
follow-up. We also included data that have only been
reported in conference presentations or in abstract form and
so have not undergone peer review. This was necessary,
however, to maximize the utilization of all available data on
this rapidly evolving topic. Experience with coronary stents
has elucidated several predictors of stent thrombosis including residual dissection, underexpansion of the stent, combining/overlapping different stents, and longer total stent
length (19 –22). Based on the randomized nature of the
studies included in the present meta-analysis, any known
and unknown confounders of stent thrombosis should be
divided equivalently between both arms of the study.
A large percentage of enrolled participants eventually
underwent angiographic follow-up. In six of the studies,
repeat angiography was performed in approximately 80% to
nearly 100% of participants. Angiographic follow-up was
lower in the DELIVER-I and TAXUS-IV trials, where
only 42% and 56% of participants, respectively, underwent
follow-up angiography. It remains possible that these angiographic subsets are not representative of the entire group
of participants, although there was no indication of increased mortality or myocardial infarction in either group
during longer periods of clinical follow-up. This is supported by a recent meta-analysis that analyzed sirolimuseluting stents and PES compared to BMS. This analysis
found that all-cause mortality and myocardial infarction
were not increased by the use of DES, (odds ratiomortality ⫽
1.11, 95% CI 0.61 to 2.06; odds ratiomyocardial infarction ⫽
0.92, 95% CI 0.65 to 1.25) (23). Additionally, none of the
analyzed trials commented upon discovering a clinically
silent occluded target vessel at the time of protocol-driven
angiography. Because it is unclear if these events occurred
(and if they did, whether or not they were tabulated as a
thrombotic event), then another source of potential bias
exists.
We also included any occurrence of thrombosis during
follow-up including periprocedural thrombotic events.
Periprocedural myocardial infarctions were not included for
analysis unless the investigators felt that the event was
secondary to stent thrombosis. It is possible that periprocedural thrombi are more influenced by technical aspects of
the stent-based PCI (such as coronary dissection or underdeployment of the stent), rather than effects of the drug
itself. While this might be true, there were only three
occurrences of periprocedural stent-associated thrombi (one
in the PES arm and two in the BMS arms), thus minimizing the importance of this potential effect.
So although there is some anecdotal concern that DES
may increase the hazard of stent thrombosis, the current
study supplements available experimental and clinical evidence to suggest that thrombosis does not occur more (or
less) frequently than with BMS. Additionally, it remains
945
possible that in real word practice, if adequate oral antiplatelet therapy is not used or prematurely discontinued
after revascularization, the hazard of stent thrombosis with
DES may be greater than with BMS.
Reprint requests and correspondence: Dr. Deepak L. Bhatt,
Interventional Cardiology and Cardiovascular Fellowships, Cleveland Clinic Foundation, Department of Cardiovascular Medicine,
9500 Euclid Avenue, Desk F25, Cleveland, Ohio 44195. E-mail:
[email protected].
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