Comparison of short- and mid-term outcomes between CYPHER and TAXUS stents in patients with complex lesions of the coronary arteries.

Abstract

Drug-eluting stent (DES) could obviously reduce in-stent restenosis, which has been proved by international multi-center clinical trials. However, the types of the lesions for stenting were highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in treating complex lesions in real world. Although REALITY trial was just reported during American College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo lesions. This study was conducted to compare the short- and mid-term clinical outcomes between sirolimus-eluting stent (CYPHER stent) and paclitaxel-eluting stent (TAXUS stent) in patients with complex lesion.
This is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were treated with DES in Fu Wai Hospital, of which, 611 patients (642 lesions with 698 CYPHER stents) were in CYPHER group, and 450 patients (534 lesions with 600 TAXUS stents) were in TAXUS group. There was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group.
Success rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent groups respectively. The major adverse cardiac events (MACE) during in-hospital and 6-8-month follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group. There was no significant difference in MACE rate between these two groups. Restenosis rate was a little higher in TAXUS stent group than that in CYPHER stent group (14.0% vs 7.3%), but there was no significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel was 6.9% in CYPHER group and 11.9% in TAXUS group (P < 0.05).
CYPHER and TAXUS DES were safe and effective in patients with complex lesion. Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of CYPHER group.

Full text

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Chinese Medical Journal 2006; 119(1):21-25
21
O
riginal article
Comparison of short- and mid-term outcomes between
CYPHER and TAXUS stents in patients with complex
lesions of the coronary arteries

CHEN Ji-lin, GAO Run-lin, YANG Yue-jin, QIAO Shu-bing, QIN Xue-wen, YAO Min, LIU Hai-bo, XU Bo,
WU Yong-jian, YUAN Jin-qing, CHEN Jue, DAI Jun, YOU Shi-jie and MA Wei-hua

Keywords: coronary disease; drug-eluting stent; major adverse cardiac events; in-stent restenosis

Background Drug-eluting stent (DES) could obviously reduce in-stent restenosis, which has been
proved by international multi-center clinical trials. However, the types of the lesions for stenting were
highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in
treating complex lesions in real world. Although REALITY trial was just reported during American
College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo
lesions. This study was conducted to compare the short- and mid-term clinical outcomes between
sirolimus-eluting stent (CYPHER stent) and paclitaxel-eluting stent (TAXUS stent) in patients with
complex lesion.
Methods This is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were
treated with DES in Fu Wai Hospital, of which, 611 patients (642 lesions with 698 CYPHER stents) were
in CYPHER group，and 450 patients (534 lesions with 600 TAXUS stents) were in TAXUS group. There
was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group.
Results Success rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent
groups respectively. The major adverse cardiac events (MACE) during in-hospital and 6-8-month
follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group.
There was no significant difference in MACE rate between these two groups. Restenosis rate was a little
higher in TAXUS stent group than that in CYPHER stent group (14.0% vs 7.3%), but there was no
significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel
was 6.9% in CYPHER group and 11.9% in TAXUS group（P<0.05）.
Conclusions CYPHER and TAXUS DES were safe and effective in patients with complex lesion.
Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an
increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of
CYPHER group.
Chin Med J 2006; 119(1):21-25

he two drug-eluting stents (DES), CYPHER
(Cordis Johnson &
Company, USA) and TAXUS (Boston Scientific
Company, USA), were clinically perfectly effective
in treating de novo lesions. This has been proved
in several international multi-center clinical trials.
Restenosis of patients with DES was found much
lower compared with bare metal stent.1-14
However, there is no large scale study on
comparison of effects between CYPHER and
TAXUS stents on complex lesions such as long
diffuse lesion (>30 mm), bifurcation lesion,
chronic total occlusion lesion, ostial lesion,
in-stent restenosis lesion and so on. This is a
Johnson Medical
single center study, and has no limitation in the
kinds of DESs for treating the types of target
lesions. It aimed to discuss the clinical effect of
DES in complex lesions and to compare the
linical effects between the two DESs in real world.
c
Cardiovascular Institute and Fu Wai Hospital, Chinese
Academy of Medical Sciences and Peking Union Medical
College, Beijing 100037, China (Chen JL, Gao RL, Yang YJ,
Qiao SB, Qin XW, Yao M, Liu HB, Xu B, Wu YJ, Yuan JQ,
Chen J, Dai J, You SJ and Ma WH)
Correspondence to: Dr. CHEN Ji-lin, Cardiovascular Institute
and Fu Wai Hospital, Chinese Academy of Medical Sciences
and Peking Union Medical College, Beijing 100037, China (Tel:
86-10-88398044. Fax: 86-10-68331759. Email: jilin.chen@263.net )
T

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Chin Med J 2006; 119(1):21-25
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METHODS

Patients
A total of 1061 patients with coronary heart
disease were implanted with DES during
percutaneous coronary intervention (PCI) from
April 2002 to June 2004 in Fu Wai Hospital,
Beijing, China. Of which, 611 patients treated with
CYPHER or CYPHER selected stents belonged
to CYPHER group, 450 with TAXUS stents
belonged to TAXUS group. The baseline clinical
features were well matched between the 2 groups
(Table 1).

Stents and lesions
In CYPHER group, 611 patients with 642 lesions
are treated with 698 CYPHER or CYPHER
selected stents. In TAXUS group, 450 patients
with 534 lesions were treated with 600 TAXUS
stents. The distribution of target vessels, types of
lesions and angiographic features of coronary are
showed in Table 2. According to the sorts of target
lesions, diffuse lesion (length>20 mm) was the
most common in morphology, with 227 sites
(35.4%) and 171 sites (32.0%) in CYPHER group
and TAXUS group respectively. Bifurcation lesion
ranked the second, with 173 sites（26.9%）and
109 sites (20.4%), respectively (P<0.05). There
were 96 sites (15.0%) and 78 sites (14.6%) with
chronic total occlusion lesions, 70 sites (10.9%)
and 64 sites (12.0%) with lesions of in-stent
restenosis, 37 sites (5.8%) and 43 sites (8.1%)
with lesions in ostia, 6 sites (1.0%) and 12 sites
(2.7%) with lesions in left main stem, and 33 sites
and 55 sites with lesions of other sorts in
CYPHER group and TAXUS group respectively.
In total, according to the types of target lesions
[American College of Cardiology/American Heart
Association (ACC/AHA)], complex lesions were
74.8% in CYPHER group and 75.3% in TAXUS
group.

Stents and procedures
Stenting results are showed in Table 3. There was
no significant difference in diameter of target
vessel after stenting, length of stent and pressure
needed for opening stent.

Anti-platelet therapies
According to results of international clinical trials,
anti-platelet therapies after DES stenting in this
study were as follows: aspirin and clopidogrel
Table 1. Baseline clinical features of CYPHER group and
TAXUS group

Clinical features
CYPHER
（n＝611）
TAXUS
（n＝450）

P value
Mean age (years) 57.9 57.2 NS
Male（％） 80.4 81.1 NS
Hypertension（％） 53.5 56.9 NS
Diabetes（％） 35.7 37.1 NS
Hyperlipidemia（％）
38.1 38.2 NS
Smoke（％） 50.9 56.4 NS
OMI（％） 43.9 40.4 NS
Previous PCI（％） 20.3 26.2 NS
OMI=old myocardial infarction; PCI=percutaneous coronary
intervention; NS=no significant difference.

Table 2. Comparison of target lesions in CYPHER group
and TAXUS group

Target lesions
CYPHER
（n＝611）
TAXUS
（n＝450）

P value
1-vessel（％） 66.9 56.9 <0.01
2-vessel（％） 29.5 36.4 <0.01
3-vessel（％） 3.6 6.7 <0.05
LAD（％） 69.9 57.7 <0.01
LCX（％） 14.8 13.1 NS
RCA（％） 14.0 25.7 <0.01
Grafted vessel（％） 0.3 0.9 NS
Type A（％） 2.5 3.0 NS
Type B1（％） 22.7 21.7 NS
Type B2/C（％） 74.8 75.3 NS
LAD=left anterior descending; LCX=left circumflex; RCA=right
coronary artery; NS=no significant difference.

were given 300 mg as a loading dose respectively
for oral administration the day before PCI. After
stenting, aspirin was administrated at 300 mg/d
for at least 1 month. Then the dose could be
adjusted 100 - 300 mg/d according to situation of
patients. Clopidogrel was administrated at 75
mg/d with aspirin for at least 6 months after
stenting. Aspirin should be administrated as long
as possible.

Statistical analysis
Student’s t test was employed for continuous data,
and Pearson’s chi-square test for discrete
data.Continuous variables are presented as
mean ± ± standard deviation (SD). All probability
values were 2-sided, and statistical significance
was set at the 0.05 level.

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Chinese Medical Journal 2006; 119(1):21-25
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Table 3. Stenting in CYPHER group and TAXUS group

Parameters
CYPHER
（n=698）
TAXUS
（n=600）
P
value
Vessel diameter after
stenting(mm)
2.93 ±0.25 3.02±0.35 NS
Length of stent
（mm）
21.51±5.90 21.14±6.71 NS
Atmosphere for
stenting (kPa)
1412.47±235.07 1401.32±245.21NS
NS=no significant difference. 1 kPa=0.009869 atm.

RESULTS

Stenting success rate
Success rate of stenting was 99.2% in CYPHER
group and 98.8% in TAXUS group. In CYPHER
group, 3 failed because stent could not be carried
into the right place, another failed because stent
could not be opened well against seriously
calcified lesion. In TAXUS group, all the reasons
for failure were that the stent could not be carried
into the right place.

In-hospital complications
In CYPHER group, there was no death during
hospitalization, 4 patients suffered from acute
myocardial infarction (AMI), of which, 2 for acute
thrombosis and 2 for occlusion of side branch. In
TAXUS group, 1 patient died of hemorrhagic
shock, 5 suffered AMI, of which, 1 for acute
thrombosis, 1 for acute closure by dissection and
3 for acute closure of side branch. In-hospital
major adverse cardiac events (MACE) rate is
showed in Table 4. The incidence of acute
occlusion of side branch (diameter ≤2.5 mm)
during PCI of bifurcation lesions in CYPHER
group was significantly lower than that in TAXUS
group [6.9% (12/173) versus 11.9% (13/109),
P<0.05]. Subacute thrombosis rate was 0.3% in
CYPHER group and 0.2% in TAXUS group. There
was no significant difference between the two
groups.

Six to eight-month follow-up
Six to eight-month clinical follow-up was available
in 97.5% (596/611) of patients in CYPHER group
and 96.2% (433/450) in TAXUS group. In
CYPHER group, 2 patients died during follow-up
period, 1 of which died of cancer, 2 suffered from
AMI (not related to CYPHER stent). In TAXUS
group, 2 patients suffered sudden death during
follow-up period, 3 suffered from AMI, and 2
related to TAXUS stent. There was a tendency
that the late thrombosis rate was higher in TAXUS
group than in CYPHER group, although there was
no significant difference (0.7% versus 0.2%,
P=0.18). The revascularization of target lesion
and MACE rate are showed in Table 4.

Table 4. Short- and mid-term outcomes of different
drug-eluting stents in treating complex lesion

Outcomes
CYPHER
（n＝611）
TAXUS
（n＝450）
P
value
Success rate（％） 99.2 (606/611) 98.8 (445/450)NS
In-hospital
Death (n) 0 1 NS
AMI (n) 4 5 NS
TLR (n) 0 0
Thrombosis [n (%)] 2 (0.3%) 1 (0.2%) NS
MACE (%) 0.7(4/611) 1.3(6/450) NS
6-8-month follow-up（％）
97.5(596/611) 96.2(433/450) NS
Death (n) 2 2 NS
AMI (n) 2 3 NS
TLR [n (%)] 10(1.7%) 9(2.18%) NS
Late thrombosis
[n (%)]
1 (0.2%) 3 (0.7%) NS
MACE (%) 2.3(14/596) 3.2(14/433) NS
Restenosis（％） 7.3(9/123) 14(14/100) NS
AMI=acute myocardial infarction; TLR=target lesion revascularization;
MACE=major adverse cardiac events; NS=no significant difference.

DISCUSSION

Rapamycin and paclitaxel are both immune
inhibitors. The former mainly acts in late G1 of
mitotic phase of smooth muscle cell and makes
cells return to resting phase. The latter mainly
acts in G2-M of mitotic phase of smooth muscle
cell, and has toxic effects on cells which can
induce apoptosis. In recent years, CYPHER and
TAXUS have shown a good clinical effect on de
novo lesion and their restenosis rates were found
significantly lower than that of bare metal stent，
which has been demonstrated by SIRIUS clinical
trials 1-6 and TAXUS clinical trials. 7-14

However, more clinical data are needed for
demonstrating their clinical effects on complex
lesions. Two clinical studies, REALITY and
SIRTAX, 15,16 about comparing clinical outcomes
between CYPHER stent and TAXUS stent just
reported at ACC congress in 2005. The entry
criteria for REALITY trial was limited to one or two

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Chin Med J 2006; 119(1):21-25
24
de novo lesions. Although some kinds of complex
lesions were included in SIRTAX study, the
percentages of bifurcation lesion, chronic total
occlusion lesion, in-stent restenosis lesion and
ostial lesion were much higher in our study than
those in SIRTAX study.

Our study was a retrospective study, which
compared clinical effects of the 2 DES in treating
various complex lesions. Although lesions in left
anterior descending artery in CYPHER group was
more than that in TAXUS group, multi-vessel
lesion was more in TAXUS group, there was no
significant difference between the 2 groups with
regard to complex lesions (type B2/C). So the 2
groups were comparable. In addition, this study
was performed in a single center, and it had no
any limitation in the sorts and types of target
lesions, from this point of view, our study was real
world study.

This study showed that the incidence of acute
occlusion of side branch (diameter ≤2.5 mm)
after stenting in main branch for bifurcation
lesions in TAXUS group was significantly higher
than that in CYPHER group (11.9% versus 6.9%,
P<0.05). This result has not been reported before.
The higher acute occlusion rate of side branch
may be related to the construction of express
bare metal stent or related to the polymer of
paclitaxel-eluting stent
thrombosis rate was higher in TAXUS group than
in CYPHER group (P=0.17), which was similar to
the result of recent studies.15-20 There is an
increase tendency in restenosis rate in TAXUS
group compared with CYPHER group, which is
similar as other clinical trials.21-23 However, there
was no significant difference in MACE and
restenosis rate between the 2 DES groups.

The major limitations of this study are that it is a
single centre registry and is non-randomized. In
addition, angiographic follow-up rate at 6-8
months was less than 30%. However, clinical
follow-up data were available for more than 96%
of cases providing an accurate rate of clinical
important adverse events following therapy of
complex lesions with drug-eluting stents in a
consecutive series of patients without exclusion.
In conclusion, this study demonstrates that these
2 DESs have perfect short- and mid-term clinical
or both. The late
outcomes in treating complex lesions of patients
with coronary heart disease. Their restenosis
rates are also significantly lower than that of bare
metal stent reported before. But as comparison
with TAXUS stent, the clinical results of CYPHER
stent are better in treating bifurcation lesion,
incidence of late thrombosis and restenosis
rate.17-23

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(Received May 19, 2005)
Edited by WANG Mou-yue and SUN Jing
coronary lesions: a
for coronary