JACC: CARDIOVASCULAR INTERVENTIONS

VOL. 2, NO. 4, 2009

2009 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

PUBLISHED BY ELSEVIER INC.

ISSN 1936-8798/09/$36.00
DOI: 10.1016/j.jcin.2008.12.013

Safety and Efficacy of Biodegradable Polymer-Coated

Sirolimus-Eluting Stents in Real-World Practice
18-Month Clinical and 9-Month Angiographic Outcomes
Yaling Han, MD,* Quanmin Jing, MD,* Bo Xu, MBBS, Lixia Yang, MD,
Huiliang Liu, MD, Xiaoming Shang, MD, Tieming Jiang, MD, Zhanquan Li, MD,#
Hua Zhang, MD,** Hui Li, MD, Jian Qiu, MD, Yingfeng Liu, MD, Yi Li, MD,*
Xuezhi Chen, MD,* Runlin Gao, MD, for the CREATE (Multi-Center Registry of Excel
Biodegradable Polymer Drug-Eluting Stents) Investigators
Shenyang, Beijing, Kunming, Tangshan, Tianjin, Xian, Daqing, and Guangzhou, China
Objectives This study sought to evaluate the safety and efcacy of a biodegradable polymer-coated
sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet
therapy in daily practice.
Background It has been hypothesized that persistent presence of polymer may compromise the
safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late
adverse events.
Methods Between June and November 2006, 2,077 patients, exclusively treated with Excel
stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry.
Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by
chronic aspirin therapy.
Results The average duration of clopidogrel treatment was 199.8 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent
thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974
(31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 0.39
mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.
Conclusions This multicenter registry documents satisfactory safety and efcacy proles, as evidenced
by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in
a real-world setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent
[CREATE]; NCT00331578) (J Am Coll Cardiol Intv 2009;2:3039) 2009 by the American College of
Cardiology Foundation

From the *Shenyang Northern Hospital, Shenyang, China; Cardiovascular Institute and Fuwai Hospital, Beijing, China;
Kunming General Hospital of Chengdu Military Region, Kunming, China; General Hospital of Armed Police Forces, Beijing,
China; Tangshan Gongren Hospital, Tangshan, China; Affiliated Hospital of Chinese Peoples Armed Police Forces Medical
College, Tianjin, China; #The Peoples Hospital of Liaoning Province, Shenyang, China; **Shanxi Provincial Corps Hospital of
Chinese Peoples Armed Police Forces, Xian, China; Daqing Oilfields General Hospital, Daqing, China; Guangzhou Army
General Hospital, Guangzhou, China; and the Zhujiang Hospital of Southern Medical University, Guangzhou, China.
Supported by a grant from JW Medical System, Weihai, China.
Manuscript received October 14, 2008; revised manuscript received December 9, 2008, accepted December 21, 2008.

304

Han et al.
Biodegradable Polymer-Coated DES

Although first-generation drug-eluting stents (DES) were

touted as a major breakthrough in interventional cardiology
because of their efficacy in reducing in-stent restenosis and
target lesion revascularization (TLR) rates compared with
bare-metal stents (13), the initial enthusiasm has been
tempered by concerns about their long-term safety, particularly numerically higher rates of late and very late stent
thrombosis, which have been associated with catastrophic
consequences (4 7).
See page 310

The mechanisms of late or very late stent thrombosis after

DES implantation have not yet been clarified, but the stent
platform design, the toxicity of active drug and the durable
polymer coatings are considered potentially relevant to this
problem. Several histopathological studies indicated that the
durable polymer coatings of DES, which were associated
with hypersensitivity reactions directed against the polymer,
localized vascular inflammation, apoptosis of smooth muscle
cells, and thrombogenic reacAbbreviations
tions, may play important roles
and Acronyms
in late or very late stent thromDES drug-eluting stent(s)
bosis (8 11). Based on this consideration, biodegradable polyMACE major adverse
cardiac event(s)
mer coatings have been used in
some new generation DES, inMI myocardial infarction
cluding the Excel stent (JW MedPLA polylactic acid
ical System, Weihai, China). In
SES sirolimus-eluting
the present study, we sought to
stent(s)
evaluate the long-term safety
TLR target lesion
revascularization
and efficacy of the Excel stent in
the context of 6-month dual antiplatelet therapy for the treatment of coronary lesions in
real-world practice.

Methods
Patient enrollment. The CREATE (Multi-Center Registry
of Excel Biodegradable Polymer Drug Eluting Stents)
registry is a post-marketing surveillance multicenter, prospective study. Between June and November 2006, multiple
demographic, clinical, angiographic, and follow-up variables
were collected for patients receiving successful Excel stent
implantation at 59 medical centers from 4 countries (China,
Indonesia, Malaysia, and Thailand). The indications for
stenting were left to the operators discretion. Patients with
device or procedural failure, who received 1 stent other
than the protocol stent, or had contraindications for dual
antiplatelet therapy, heart function worse than New York
Heart Association functional class III, or a planned upcoming surgery were excluded. Ethics committees in all partic-

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ipating centers approved the study protocol, and a signed,

informed consent was obtained from every enrolled patient.
Stent features. The Excel stent is a sirolimus-eluting stent
(SES) that is coated with a biodegradable polylactic acid
(PLA) polymer. The stent platform is a laser-cut, 316L
stainless steel, open cell design stent with strut thickness of
0.0047 inches. The PLA coating used in the Excel stent is
mixed with sirolimus (C51H79NO13, molecular weight
914.2) (North China Pharmaceutical Group Corporation,
Shijiazhuang, China) and coated onto the abluminal surfaces of the stent to a thickness of 10 to 15 m. The coating
has been shown in animal studies to have a complete
degradation cycle of 6 to 9 months (based on communications with JW Medical System, October, 2007). There is no
adhesive surface between the polymer and the stent struts.
Total sirolimus dosage varies from 195 to 376 g per stent
according to the stent length.
Antithrombotic therapy. Loading doses of aspirin (300 mg)
and clopidogrel (300 mg) were given at least 24 h before
elective procedures, followed by maintenance dosages of
aspirin of 100 mg per day indefinitely and clopidogrel of 75
mg per day for 6 months. Use of low-molecular weight
heparin and glycoprotein IIb/IIIa inhibitors during the
periprocedure period was left to operators discretion.
Outcomes, denitions, and follow-up. The predefined primary outcome was rate of major adverse cardiac events
(MACE) at 12 months after Excel stent implantation in
real-world practice. Secondary outcomes were in-stent late
lumen loss and binary restenosis at 9 months, and cumulative thrombotic event rates up to 18 months after the index
procedure. We defined MACE as a composite of cardiac
death, nonfatal myocardial infarction (MI), and TLR. All
deaths were considered to be cardiac unless a noncardiac
origin could be clearly established by clinical and/or pathological study. The diagnosis of MI was based on either the
development of new pathological Q waves in 2 contiguous
electrocardiogram leads and/or elevation of creatine kinasemyocardial band isoenzyme level 3 times the upper
normal limit after the procedure during index hospitalization, or cardiac enzyme level elevation 2 times the upper
normal limit thereafter. We defined TLR as any repeat
intervention inside the stent implanted during the index
procedure or within 5 mm proximal or distal to the stent.
Stent thrombosis was classified as definite, probable, and
possible according to definitions proposed by the Academic
Research Consortium (12); it was stratified as acute (24
h), subacute (24 h to 30 days), late (30 days to 1 year), and
very late (1 year). Off-label indications included lesions
that did not meet the manufacturers instructions for use for
the Cypher SES (Cordis Corporation, Miami Lakes, Florida), as well as patients with acute MI or who had lesions in
the left main coronary artery or ostial, bifurcated, or totally
occluded lesions.

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Clinical follow-ups, by office appointment or phone call,

were scheduled at 1, 3, and 6 months, and every 6 months
thereafter up to 3 years. Angiographic follow-up was performed 6 to 12 months after the index procedure or earlier
if clinically indicated. The anticipated angiographic
follow-up rate was 35%.
Data collection and management. Clinical data were prospectively collected on case-report forms and submitted to a
data coordination center (located at Shenyang Northern
Hospital). The consistency and accuracy of the data, including baseline, in-hospital, and follow-up outcomes, were
audited by independent study monitors. At least 15% of
patients in each center were randomly selected for audit
check. If a discrepancy between the case-report form versus
source documentation was found, all data from the center
was audited. A total of 332 patients from 56 centers were
selected for audit check, accounting for 16.0% of all enrolled
patients. All adverse clinical events were reviewed and
adjudicated by an independent clinical events committee.
The overall data accuracy rate was 99.4% (330 of 332),
because 2 patients underwent non-TLR that was reported
as MACE.
Visual estimation of lesion characteristics in relation to
those in the index procedure was performed by the operator
and recorded. If a patient underwent angiographic followup, coronary angiograms obtained at baseline, procedure
completion, and follow-up were submitted to the independent angiographic core laboratory (Catheterization Lab,
Cardiovascular Institute and Fu Wai Hospital, Beijing,
China). Quantitative coronary angiography was performed
with Quantcor QCA (CAAS II) version 5.0 (Pie Medical
Imaging, Maastricht, the Netherlands). Binary restenosis
was defined as 50% diameter stenosis at follow-up and
was classified as in-stent if inside of the stent or in-segment
if located at the stented segment or up to 5 mm proximal or
distal to the stents. Late lumen loss was defined as the
difference between the minimal lumen diameter immediately after the procedure and at follow-up.
Statistical analysis. Comparisons between continuous variable data, expressed as mean SD, were performed with
the t test, while the chi-square or the Fisher exact tests were
used for categorical data, expressed as percentages. The
MACE-free survival curve was calculated by the KaplanMeier method. Statistical analyses were performed with the
SPSS 12.0 software (SPSS, Inc., Chicago, Illinois). A p
value of 0.05 was considered statistically significant.
Results
Patient sample and baseline characteristics. Data for 2,077

patients in the registry were analyzed, representing 95.1% of

2,183 consecutive patients. We excluded 90 patients (4.1%)
because of hybrid stenting with other DES types and 16
(0.7%) patients because of failure to deliver the stent. The

305

Table 1. Baseline Characteristics

Parameters

n 2,077

Age (yrs)

60.6 11.1

Male

1,528 (73.6)

Risk factors
Smoker
Prior MI
Hypertension

1,041 (50.1)
234 (11.3)
1,157 (55.7)

Diabetes

440 (21.2)

Hyperlipidemia

624 (30.0)

Peripheral or cerebral vascular disease

356 (17.1)

Family history of coronary heart disease

158 (7.6)

Indications for index procedure

Silent ischemia

81 (3.9)

Stable angina

131 (6.3)

Unstable angina

1,105 (53.2)

AMI within 24 h

386 (18.6)

Recent MI (24 h to 30 days)

374 (18.0)

Cardiogenic shock

22 (1.1)

Data are expressed as mean SD or n (%).

AMI acute myocardial infarction; MI myocardial infarction.

mean age of the cohort was 60.6 11.1 years, 73.6% were
men, and 21.2% were diabetics. Baseline characteristics are
further detailed in Table 1.
Angiographic and procedural characteristics. A total of
3,080 target lesions were treated, including 26 (0.8%)
unprotected left main, 667 (21.7%) bifurcation, 76 (2.5%)
chronic total occlusion, 69 (2.2%) restenotic, and 1,309
(42.5%) diffusely diseased lesions. Multivessel stenting was
performed in 26.9% of patients and 84.5% of enrolled
patients had at least 1 off-label indication for DES implantation. A total of 3,748 Excel stents were implanted at index
procedure (1.8 stents per patients) with an average diameter
and total stent length of 3.05 0.44 mm and a 26.7 13.0
mm, respectively. A total of 52.4% of all stents were
implanted without pre-dilation. Major angiographic and
procedural characteristics are shown in Table 2.
Antiplatelet therapy. At time of discharge, all surviving
patients were being treated with aspirin and clopidogrel
except for 1 patient in whom all antiplatelet therapy was
discontinued because of thrombocytopenia. Data on dual
antiplatelet treatment status from 2,053 discharged patients
were obtained. The mean duration of dual antiplatelet
therapy was 199.8 52.7 days. Out of 2,053 patients, 1,652
(80.5%) discontinued clopidogrel treatment at 6 months
after their index procedures. The other 401 patients (19.5%)
had their clopidogrel treatment extended to 7 to 12 months.
Clinical outcomes. Clinical follow-up was completed in
2,077 (100%) patients at 30 days, 2,063 (99.3%) at 1 year,
and 2,062 (99.3%) at 18 months, respectively. Primary
events developed in 56 patients (2.7%) at 1 year, consisting
of 22 (1.1%) cardiac deaths, 8 (0.4%) nonfatal MIs, and 32

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Angiographic outcomes. Angiographic follow-up was com-

Table 2. Angiographic and Procedural Characteristics

Multivessel stenting
Off-label use
No. of target vessels
No. of target lesions
Average reference vessel diameter, mm

558 (26.9)
1,756 (84.5)
2,717
3,080
3.0 0.46

Average lesion length, mm

22.3 13.1

Average diameter stenosis, %

87.0 11.3

Lesion features
Unprotected left main disease
Saphenous vein graft
Chronic total occlusions
Bifurcations
Restenotic lesions
Reference diameter 2.5 mm

26 (0.8)
1 (0.04)
76 (2.5)
667 (21.7)
69 (2.2)
180 (5.8)

Lesion length 20 mm

1,309 (42.5)

B2/C type

2,049 (66.5)

Procedural features
Total stent no.
No. of stents per patient

3,748
1.8 1.1

Average stent diameter, mm

3.05 0.44

Average stent length, mm

26.7 13.0

Direct stenting

1,965 (52.4)

Overlapping stents

658 (17.5)

Post-dilation

496 (13.2)

Intravascular ultrasound guidance

47 (1.3)

Data are expressed as mean SD or n (%).

pleted in 974 (31.6%) lesions from 653 (31.7%) patients.

Quantitative coronary angiography results at baseline, after
the procedure, and at follow-up are shown in Table 5.
In-stent and -segment late lumen loss were 0.21 0.39 mm
and 0.21 0.35 mm, respectively. Binary restenosis rates
were 3.8% in-stent and 6.7% in-segment.
Discussion
The present study, to our knowledge, is the first postmarketing, multicenter registry of a biodegradable polymerbased SES. The results indicate that, although 80.5% of
discharged patients received only 6 months or even shorter
periods of dual antiplatelet treatment, the safety profile of
this novel DES when used in real-world practice is satisfactory with low rates of MACE, overall stent thrombosis,
and late stent thrombosis.
It has been widely accepted that DES can effectively
reduce the need for TLR. However, several recent studies
have suggested that first-generation DES could delay local
Table 3. Clinical Outcomes
n (%)
30-day outcomes (n 2,077)
Death
Cardiac

(1.6%) TLRs. At 18-month clinical follow-up, 39 patients

(1.8%) had died, including 23 patients (1.1%) who died of
cardiac reasons. The rates of MACE, MI, and TLR at
18-month follow-up were 3.1% (64 of 2,062), 0.4% (9 of
2,062), and 1.9% (39 of 2,062), respectively. The 30-day,
1-year, and 18-month adverse clinical events are shown in
Table 3. The 18-month MACE-free survival curve is
illustrated in Figure 1.
At the 18-month follow-up, stent thromboses had developed in 18 patients (0.87%), including 2 (0.1%) acute, 8
(0.38%) subacute, 7 (0.34%) late, and 1 (0.05%) very late
stent thromboses. Another 4 (0.19%) out of 8 late or very
late stent thromboses developed at 4, 31, 130, and 198 days
after clopidogrel discontinuation, respectively, while the
other 4 stent thromboses occurred during treatment with
clopidogrel. The occurrence of Academic Research Consortium definite or probable stent thromboses was 0.58% (12 of
2,063). Further details are shown in Table 4.
Univariate analyses showed that male sex (odds ratio
[OR]: 2.508, 95% confidence interval [CI]: 1.173 to 5.359;
p 0.007), acute MI within 24 h (OR: 1.895, 95% CI:
1.113 to 3.226; p 0.017), 2 stents implanted (OR:
2.191, 95% CI: 1.252 to 3.836; p 0.005), and multivessel
stenting (OR: 2.426, 95% CI: 1.421 to 4.139; p 0.001)
were predictors of MACE.

Noncardiac
Nonfatal MI
Urgent TLR
MACE

16 (0.77)
13 (0.63)
3 (0.14)
6 (0.29)
4 (0.19)
19 (0.91)

1-year outcomes (n 2,063)

Death

35 (1.7)

Cardiac

22 (1.1)

Noncardiac

13 (0.6)

Nonfatal MI
TLR
Percutaneous
Surgical
MACE
Non-TLR target vessel revascularization

8 (0.4)
32 (1.6)
31 (1.5)
1 (0.05)
56 (2.7)
2 (0.1)

18-month outcomes (n 2,062)

Death

39(1.9)

Cardiac

23 (1.1)

Noncardiac

16 (0.6)

Nonfatal MI
TLR
Percutaneous
Surgical
MACE
Non-TLR target vessel revascularization

9 (0.4)
39 (1.9)
38 (1.8)
1 (0.05)
64 (3.1)
4 (0.2)

Data are depicted as n (%).

MACE major adverse cardiac events; MI myocardial infarction; TLR target lesion revascularization.

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Figure 1. Survival Free From Primary Outcomes at 18-Month Follow-Up

Kaplan-Meier estimates of survival free from major adverse cardiac events
(MACE) in studied populations.

vessel healing and increase the risk of potentially fatal late

stent thrombosis (5,1315), an adverse event that may be
attributed to the durable polymer coatings of DES
(8 11,1520). Although prolonged dual antiplatelet therapy for at least 1 year after DES implantation was recommended to address the increased risk of late stent thrombosis (21), long-term dual antiplatelet therapy is associated
with increased hemorrhagic events, financial burden, variable patient compliance and responsiveness, and other side
effects. Therefore, new generation DES with bioabsorbable
polymer coatings or even bioabsorbable stent struts have
been recently developed. It is anticipated that those stents
will result in comparable neointimal hyperplasia prohibition
and fewer late complications compared with first-generation
DES.
In accordance with the experience with other SES, in this
study the Excel stent has efficiently reduced neointima
hyperplasia and in-stent restenosis with an average 0.21 mm

307

in-stent late lumen loss and an in-segment binary restenosis

rate of 6.7%. The higher mean late lumen loss in the present
study as compared with the 0.12 mm in-stent late lumen
loss that we had reported for the Excel stent in a single
center pilot registry study (22) was likely due to the fact that
angiographic follow-up was not mandatory in the present
study, which might have led to an increased proportion of
clinically driven angiographic follow-up and thus an overestimated late loss. In the recently published LEADERS
(Limus Eluted from A Durable Versus ERodable Stent
Coating) trial, a biolimus-eluting stent with abluminal
biodegradable PLA polymer coatings has shown a similar
late loss when compared with SES with durable polymer
(0.13 mm vs. 0.19 mm) (23). Notably, both the present
study and the LEADERS trial had enrolled real-world
all-comers including more than 80% off-label indications.
Those results suggest that a limus-eluting stent with abluminal coated biodegradable PLA polymer is as effective as
SES with durable polymer in reducing restenosis. Thus, the
potential differences in pharmacokinetic release of the drug
between the 2 kinds of DES have not lead to different effects
on restenosis prevention.
It is anticipated that the biodegradable PLA polymer
coatings in the Excel stent can be fully absorbed within 6 to
9 months and exert few adverse effects on vascular response
and endothelialization. We hypothesized that 6-month dual
antiplatelet therapy is enough after Excel stent implantation
regardless of baseline characteristics. In the present study,
80.5% of discharged patients discontinued clopidogrel treatment within 6 months and the overall occurrence of stent
thrombosis was 0.87%; the rate of Academic Research
Consortium definite or probable stent thrombosis, in line
with the definition of stent thrombosis in previous studies,
was 0.58%, which is similar to that in SES randomized trials
(range: between 0% and 2.0%) (1,24 27) as well as that
in real-world registries (range: between 0.4% and 1.5%)
(28 30). After the discontinuation of clopidogrel, the rate
of documented stent thrombosis was 0.19% for the present
study, which was substantially lower than that reported in
the BASKET-LATE (Late Clinical Events Related to Late
Stent Thrombosis After Stopping Clopidogrel) study
(2.6%) (5). These encouraging results indicate that the

Table 4. Stent Thrombotic Events at 18-Month Follow-Up

Thrombotic Events

ARC Definite

ARC Probable

ARC Possible

Total

Acute (24 h)

2 (0.10)

Subacute (24 h to 30 days)

8 (0.38)

Late (30 days to 1 year)

7 (0.34)

Very late (1 year)

1 (0.05)

7 (0.34)

5 (0.24)

6 (0.29)

18 (0.87)

Total
Data are depicted as n (%).
ARC Academic Research Consortium.

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Table 5. Lesion Data Determined by Quantitative Coronary Angiography at Pre-and Post-Procedure and Follow-Up (n 974)
In-Segment

In-Stent

Proximal Edge

Distal Edge

Reference vessel diameter, mm

2.77 0.47

Lesion length, mm

22.4 13.1

Diameter stenosis, %

73.5 15.1

Minimal lumen diameter, mm

0.74 0.45

Pre-procedure

Post-procedure
Reference vessel diameter, mm

3.19 0.45

Diameter stenosis, %

25.0 9.5

14.3 4.7

12.1 7.8

16.5 9.1

Minimal lumen diameter, mm

2.34 0.52

2.74 0.44

3.0 0.59

2.39 0.58

Acute gain, mm

1.60 0.55

2.0 0.50

Follow-up
Reference vessel diameter, mm

3.13 0.45

Diameter stenosis, %

30.0 14.6

19.4 13.7

15.1 9.9

19.1 10.0

Minimal lumen diameter, mm

2.13 0.59

2.53 0.59

2.81 0.59

2.25 0.56

Late lumen loss, mm

0.21 0.35

0.21 0.39

0.19 0.28

0.14 0.27

Binary restenosis, %

6.7

3.8

1.2

2.0

refinement of DES in coating biocompatibility by use of

biodegradable PLA coating, such as that present in the
Excel stent, might potentially serve as an appealing alternative to minimize the risk of late stent thrombosis, which
requires confirmation with randomized trials.
Several pilot studies had demonstrated the feasibility,
safety, and efficacy of biodegradable polymer-based DES in
selected patients (3134). However, the validity of extrapolating those results to daily practice had remained uncertain because the follow-up period of most studies were not
long enough to elucidate the consequences after completed
degradation of a biodegradable polymer. In the present
study, the Excel stent has shown sustained excellent clinical
outcomes up to 18 months, which suggests the long-term
clinical benefits of biodegradable polymer-based SES.
However, issues must be addressed about the very low
incidence of MACE and stent thrombosis in the present
study. First, patients with device failure, which may influence the long-term prognosis, were excluded in the present
study. Second, there are now several reports that suggest
that the incidence of stent thrombosis is relatively low in
Asian populations (30,35,36). The mechanisms of such
phenomenon are unclear, but might be associated with
genetic specificity. Third, compared with the multicenter
e-Cypher registry, the baseline clinical and angiographic
characteristics of the present study were less complex,
represented as lower incidences of diabetes, history of MI,
prior percutaneous coronary intervention, and fewer B2/C
type lesions (29). These distinctions between the 2 studies,
although both enrolled all-comers, may reflect the different
patient cohort and percutaneous coronary intervention indications between China and other countries, which may
result in some differences in clinical outcomes. Finally, in
comparison with randomized trials, the rate of TLR was

lower in the present study, similar to most of the real-world

registries, because the angiographic follow-up was not
mandatory and there must be some patients with recurrent
ischemia who do not undergo repeat intervention for
different reasons.
Study limitations. The present study is limited by the fact
that it is a single arm, nonrandomized study. A head-tohead comparison with other DES are demanded to confirm
the efficacy and safety of biodegradable polymer-based SES.
Moreover, post-procedure changes in cardiac biochemical
marker levels were not subjected to routine surveillance in
some participating centers; therefore, nonQ-wave MI
might have been underreported. However, most of the
underreported MACEs were asymptomatic events that are
usually associated with less clinical significance than symptomatic events, suggesting that underreporting of MACEs
in the present study exerts limited impact on the
conclusions.

Conclusions
The outcomes of the present study demonstrate satisfactory
efficacy and safety profiles for the Excel biodegradable
polymer-based SES in treating patients in real-world settings, with low rates of MACE and stent thrombosis up to
18 months. The outcomes also suggest that 6 months of
dual antiplatelet therapy with clopidogrel and aspirin after
Excel stent implantation is safe and feasible.
Reprint requests and correspondence: Dr. Yaling Han, Department of Cardiology, Shenyang Northern Hospital, Shenyang
110016, China. E-mail: hanyaling.nh@gmail.com.

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Biodegradable Polymer-Coated DES

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APRIL 2009:3039

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Key Words: drug-eluting stents sirolimus biodegradable polymer coronary heart disease.
APPENDIX
For the list of CREATE investigators and participating institutions, please
see the online version of this article.