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Chin Med J 2008;121(6):492-497
492
Original article
Sirolimus-eluting cobalt-chromium stents: two-year clinical results
from first-in-man study on the Firebird 2TM stent
XU Bo, ZHANG Qi, YANG Yue-jin, QIAO Shu-bin, ZHANG Rui-yan, ZHANG Jian-sheng, HU Jian,
QIN Xue-wen, HONG Tao, LI Jian-ping, CHEN Ji-lin, HUO Yong, GAO Run-lin and SHEN Wei-feng
Keywords: drug-eluting stents; Firebird 2 stent; coronary artery disease; clinical outcome
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Background Drug-eluting stents (DES) have been shown to significantly reduce clinical events and angiographic
restenosis in the treatment of coronary artery disease (CAD). This study was conducted to assess the long-term efficacy
and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2TM stents in the treatment of patients with
CAD.
Methods This first-in-man study using the Firebird 2TM stent is a prospective, historically-controlled multicenter clinical
study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent (Firebird
2TM, Microport Shanghai, Firebird 2 group), compared to another 49 patients treated with a bare cobalt alloy stent (Driver,
Medtronic, control group). Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic
and 1-year clinical follow-up. The incidence of major adverse cardiac events (MACE) including cardiac death, reinfarction
and target lesion revascularization (TLR) and stent thrombosis were compared between the two groups.
Results All patients in the Firebird 2 group (100.0%) and 48 patients in the control group (98.0%) completed the 2-year
clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94%
decrease of TLR (26.5% in the control group and 1.5% in the Firebird 2 group, P<0.0001). A significant difference in TLR
was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% (P<0.0001). Between 1- and
2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group
(P>0.05). There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5%
and 33.3% in the control group, respectively (all P<0.0001). The cumulative 1- and 2-year MACE free survival rates were
98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group (log rank P<0.0001). No case of stent thrombosis
occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis
in the control group at 19-month post-stenting: this patient presented with unstable angina pectoris and was treated by
balloon angioplasty.
Conclusions Compared with the bare cobalt alloy stent, the Firebird 2TM sirolimus-eluting cobalt-chromium stent is
safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and
significantly lower rate of TLR and MACE up to 2 years post-stenting.
Chin Med J 2008;121(6):492-497
he introduction of drug-eluting stent (DES) has been
shown to significantly reduce clinical events and
angiographic restenosis in the treatment of coronary
artery disease (CAD), as compared to bare metal stents
(BMS).1-3 The first generation of DES using 316L
stainless steel as the stent platform loaded with sirolimus
or paclitaxel has been widely used in clinical practice,4,5
and recently several clinical studies have shown the
safety and efficacy of a new generation of DES with a
stent platform modified by cobalt alloy.6,7
The Firebird 2TM stent system (Microport, Shanghai,
China) combines the cobalt-chromium coronary stent
with the antiproliferative agent sirolimus and a
biologically inertia styrene-butylenes-styrene (SBS)
polymer coating. Results from the first-in-man (FIM)
study demonstrated that the Firebird 2TM stent
significantly reduced the 6-month in-stent late lumen loss,
target lesion revascularization (TLR) rate and one-year
clinical major adverse cardiac event (MACE) when
compared to the bare cobalt alloy stent (Driver,
Medtronic, USA).8 Given the early results, we evaluated
the clinical outcomes up to 2 years post-stenting in order
to assess the long-term efficacy and safety of the Firebird
Department of Cardiology, Cardiovascular Institute and Fuwai
Hospital, Chinese Academy of Medical Sciences and Peking Union
Medical College, Beijing 100037, China (Xu B, Yang YJ, Qiao SB,
Qin XW, Chen JL and Gao RL)
Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong
University School of Medicine, Shanghai 200025, China (Zhang
Q, Zhang RY, Zhang JS, Hu J and Shen WF)
Department of Cardiology, Peking University First Hospital,
Beijing 100034, China (Hong T, Li JP and Huo Y)
The first two authors contributed equally to this study.
Correspondence to: Prof. SHEN Wei-fen, Department of Cardiology,
Ruijin Hospital, Shanghai Jiao Tong University School of
Medicine, Shanghai 200025, China (Tel: 86-21-64370045. Fax:
86-21-64457177. Email: [email protected]); Prof. GAO
Run-lin, Department of Cardiology, Cardiovascular Institute and
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking
Union Medical College, Beijing 100037, China (Email:
[email protected])
文章来源：Chinese Medical Journal
Chinese Medical Journal 2008; 121(6):492-497
493
2TM stent in treating patients with CAD.
METHODS
Statistical analysis
Site monitoring, data management and results analysis
were undertaken by an independent organization (Clinical
New Drug Base of Ministry of Health, Beijing, China).
All analyses were based on the intention-to-treat principle.
For continuous variables, a 2-tailed unpaired t test was
used. Categorical data were compared by means of the
chi-square test or Fisher’s exact test. The rate of
endpoints of MACE up to 2 years was estimated with the
Kaplan-Meier method, and the difference between groups
was estimated with a log-rank test. A P value <0.05 was
considered statistically significant. All statistical analyses
were performed using SPSS 11.0 statistical software
(SPSS Inc., USA).
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Study design and patient selection
The design and detailed methods of the Firbird 2 FIM
study have been reported previously.8 In brief, 67 patients
with de novo or non-stented restenostic coronary lesions
with reference diameters between 2.25 mm and 4.0 mm
and length <30 mm per lesion were included in the
Firebird 2 group. Another 49 patients received Driver
stents and were served as controls. Major exclusion
criteria included acute myocardial infarction within 1
week, left main or ostial lesions, angiographically visible
thrombus containing lesions, a calcified lesion that could
not be successfully predilated, bifurcation lesions needing
two stents, chronic total occluded lesions, a left
ventricular ejection fraction less than 30% and expected
life span <12 months. The study was approved by each
participating institution’s ethical review committee and
all patients provided written informed consents before
enrollment.
stent thrombosis was defined as unexplained sudden
cardiac death or Q-wave MI in the distribution of the
stented artery. Possible stent thrombosis was considered
in any unexplained death from 30 days after stent
implantation.
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All patients received aspirin (100 mg/d) and clopidogrel
(75 mg/d) at least 2 days before the procedure.
Postprocedural dual antiplatelet therapy consisted of 100
mg aspirin daily for all patients indefinitely and
clopidogrel 75 mg daily for 6 months in the Firebird 2
group and for 3 months in the control group.
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Follow-up and study endpoints
Patients were contacted in the out-patient department
(OPD) for an interview or by telephone every month in
the first year post-stenting, thereafter every three months.
Results of six-month angiographic and one-year clinical
follow-up have been reported.8 In brief, all patients
finished one-year clinical follow-up and 86.6% of
patients in the Firebird 2 group and 100.0% of the control
group received six-month angiographic follow-up.
Forty-seven patients (70.1%) in the Firebird 2 group
received intravascular ultrasound (IVUS) examination at
the time of angiographic follow-up to evaluate the
volume obstruction percentage.
The primary endpoint of the Firebird FIM study was
in-stent late lumen loss at six-month angiographic
follow-up with a major secondary endpoint of in-stent
percentage of volume obstruction at six-month by IVUS.
Other secondary endpoints included angiographic binary
restenosis at six months, MACE including cardiac death,
recurrent myocardial infarction (MI) or reinfarction and
TLR at 1-, 6- and 12-month clinical follow-up and stent
thrombosis. At the 2-year clinical follow-up, the
prevalence of MACE and stent thrombosis was compared
between the two groups. The Academic Research
Consortium (ARC) definitions of stent thrombosis were
compared between the two groups up to a 2-year
follow-up.9 Briefly, definite stent thrombosis was defined
as the presence of an angiographic thrombus in a stent
that previously had been successfully deployed. Probable
RESULTS
Baseline clinical characteristics
The baseline and procedure characteristics of the Firebird
2 FIM study have been described in detail previously.8 In
brief, the baseline clinical characteristics of the two
groups were comparable, though more patients in the
Firebird 2 group were previously treated by percutaneous
coronary intervention (PCI, 22.4% vs 8.2%, P=0.0418)
and had diabetes mellitus (29.9% vs 12.2%, P=0.0253).
Eighty-eight and sixty-three lesions were treated in the
Firebird 2 group and the control group, respectively. The
acute lesion, device and procedure success rates were all
100.0% in both groups (Table 1).
Table 1. Baseline characteristics and procedural results
in Firebird 2 FIM study
Characteristics
Female (n (%))
Age (years)
Previous MI (n (%))
Previous PCI (n (%))
Previous CABG (n (%))
Diabetes mellitus (n (%))
Hypertension (n (%))
Hyperlipidemia (n (%))
Pre-procedure
Lesion length (mm)
RVD (mm)
DS (%)
Pre-dilatation (n (%))
Post-procedure (In-stent)
DS (%)
MLD (mm)
Device success (number of lesion (%))
Firebird 2
(n=67)
16 (23.9)
59.1±9.6
32 (47.8)
15 (22.4)
1 (1.5)
20 (29.9)
43 (64.2)
25 (37.3)
Control
(n=49)
5 (10.2)
59.9±11.3
21 (42.9)
4 (8.2)
2 (4.1)
6 (12.2)
25 (51.0)
12 (24.5)
19.7±10.7
2.79±0.46
66.9±12.3
52 (59.1)
17.6±6.4
2.98±0.49
66.8±10.8
38 (60.3)
0.1387
0.0175
0.9739
0.8800
14.8±5.1
2.69±0.43
88 (100)
13.5±4.9
2.82±0.49
63 (100)
0.1419
0.0936
P value
0.0599
0.6845
0.6020
0.0418
0.3876
0.0253
0.1570
0.1450
MACE
Clinical follow-up was available in all patients in the
Firebird 2 group (100.0%) and 48 patients in the control
group (98.0%) at 2 years after stent implantation. The
incidence of recurrent angina pectoris was similar between
文章来源：Chinese Medical Journal
Chin Med J 2008;121(6):492-497
494
Table 2. MACE rate at 2-year follow-up (n (%))
Outcomes
Death
Myocardial infarction
Q wave
Non-Q wave
Target lesion revascularization
CABG
PCI
MACE
6-month
Firebird 2 group
Control group
(n=67)
(n=49)
0 (0)
0 (0)
1-year
Firebird 2 group
Control group
(n=67)
(n=49)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1 (1.5)
1 (1.5)
0 (0)
0 (0)
6 (12.2)*
1 (1.5)
6 (12.2)*
1 (1.5)
*
P<0.05, **P<0.0001 vs Firebird 2 group.
0 (0)
0 (0)
0 (0)
0 (0)
1 (2.0)
0 (0)
1 (2.0)
12 (24.5)**
13 (26.5)**
0 (0)
1 (1.5)
1 (1.5)
2 (4.2)
13 (27.1)**
16 (33.3)**
(CABG) surgery, respectively. Specifically, the 6-month,
1- and 2-year survival rates free from TLR were 98.5%,
98.5% and 98.5% in the Firebird 2 group vs 87.8%
(P<0.05), 73.5% (P<0.0001) and 68.7% (P<0.0001) in
the control group (Figure 2). The superiority of the
Firebird 2 stentTM treatment appeared at six-month
post-stenting and persisted up to 2 years.
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the two groups (9.0% in the Firebird 2 group and 14.3%
in the control group, P=0.38). The cumulative MACE and
TLR rates at the 2-year follow-up were significantly
reduced in the Firebird 2 group, which was consistent
with the 1-year follow-up results. The cumulative 1- and
2-year MACE free survival rates were, respectively,
98.5% and 98.5% in the Firebird 2 group, 73.5% and
66.7% in the control group (Figure 1), mostly attributable
to a lower number of TLR in the Firebird 2 group.
2-year
Firebird 2 group
Control group
(n=67)
(n=48)
0 (0)
0 (0)
Figure 1. Cumulative MACE-free survival rate at 2-year clinical
follow-up.
Death and MI
No one died at 2-year clinical follow-up in either group.
In the control group, one patient experienced non-fatal
Q-wave MI at 19-month after the index procedure. The
2-year actuarial survival rate free from death and MI
between the two groups was similar (100% vs 98.0%,
P>0.05).
Target lesion revascularization
There were a total of 16 patients who experienced
revascularization up to 2 years after the initial procedure.
Only one patient in the Firebird 2 group had TLR at the
time of the six-month angiographic follow-up, no more
TLR was observed from six-month to the 2-year
follow-up. Two patients in the control group had TLR
between the 1- and 2-year follow-up and they were
treated by PCI and coronary artery bypass grafting
Figure 2. Cumulative TLR-free survival rate at 2-year clinical
follow-up.
Antiplatelet therapy and stent thrombosis
Duration of post-stenting dual antiplatelet therapy was
similar between the two groups ((11.3±4.5) months in the
Firebird 2 group and (11.6±8.6) months in the control
group, P=0.77, Figure 3). A subgroup analysis indicated
that significantly longer dual antiplatelet therapy was
administered in 5 cases of stent malapposition and in 1
case receiving TLR at the 6-month angiographic
follow-up compared with the remaining 61 patients in the
Firebird 2 group ((20.2±3.4) months and (10.4±3.7)
months, P<0.0001), and with the patients in the control
group ((20.2±3.4) months and (11.6±8.6) months in the
control group, P=0.02, Figure 4).
According to the ARC definition one case of very late
definite stent thrombosis occurred at 19 months after the
index procedure in the control group (2.1%). The patient
had clinically defined unstable angina pectoris and
repeated angiography showed stent thrombosis and
in-segment restenosis who was treated by DES implanta-
文章来源：Chinese Medical Journal
Chinese Medical Journal 2008; 121(6):492-497
495
thrombosis; however dual antiplatelet therapy was
continued for a median of 12 months ((11.3±4.5)
months).
The first generation of DES using 316L stainless steel as
the stent platform, including Cypher (Cordis, USA),
Taxus (Boston, USA) and Firebird (Microport) stent etc,
has demonstrated remarkable efficacy in reducing TLR
when compared to BMS in de novo coronary lesions,10-12
although the long-term efficacy and safety of these stents
in treating complex lesions remains controversial.13,14 The
update of current DES includes stent platform or polymer
coating modifications.6,15 Several clinical studies using
thin-strut bare cobalt alloy stents have shown the
advantages of enhanced visibility, deliverability and
radial strength and in reducing restenosis when compared
with bare stainless steel stents.6,16-18 When compared to
the first generation DES, similar clinical results at
9-month follow-up19 and favorable cost-effectiveness20
were found in patients treated by cobalt alloy stents.
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Figure 3. Duration of dual anti-platelet therapy after stent
implantation.
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Figure 4. Subgroup analysis for the duration of dual anti-platelet
therapy after stent implantation.
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tion. No significance was found between the two groups
regarding the occurrence of stent thrombosis; either
definite, probable or possible stent thrombosis.
DISCUSSION
The current study demonstrates the efficacy and safety of
the Firebird 2TM stent up to 2 years in the treatment of
symptomatic patients with de novo or non-stented
coronary lesions. At 2 years, no death occurred in either
the Firebird 2 or control groups. One patient in the
Firebird 2 group experienced TLR at six months after the
initial procedure but no more TLR or MACE occurred
between six-month and the 2-year follow-up. A
significant difference was found when comparing the
results from the control group where 15 cases of TLR
(31.3%) and 16 cases of MACE (33.3%) were recorded in
2 years. The 2-year MACE free survival rates were 98.5%
and 66.7% in the Firebird 2 and the control group,
respectively (P<0.0001). Combining the results from the
Firebird 2 FIM study8 we concluded here that the Firebird
2TM stent continued to provide event-free clinical efficacy
in treating patients with CAD at 2 years after index
procedure. The safety of the Firebird 2TM stent treatment
was also proved at 2-year clinical follow-up without stent
Recently, results from clinical studies using second
generation of DES with modified stent platforms of
cobalt alloy have been reported. Four-year clinical
follow-up results from the ENDEAVOR I FIM study,
reported by Meredith et al,15 showed that the incidence of
MACE was 2% at 1-year, 3% at 2-year, 6.1% at 3-year
and 7.2% at 4-year follow-up; and there was only one
additional case of TLR from 2–4 years. The results from
the ENDEAVOR II trial demonstrated the efficacy of the
Endeavor stent in reducing target vessel failure (7.9% and
15.1%, P=0.0001) and TLR (4.6% and 11.8%, P=0.0001)
at 9-month angiographic follow-up as compared to the
bare cobalt alloy stent. The difference in clinical outcome
was maintained at 12 and 24 months (P<0.0001).21
Three-year clinical results from the SPIRIT First study
showed a significantly reduced MACE rate in the Xience
V stent treated group (15.4% and 26.0%, P=0.04) and
clinically driven TLR (7.7% and 25.0%, P<0.001).6
Pooled meta-analysis for SPIRIT II and III studies
showed that ischemic TLR and MACE were significantly
reduced in the Xience V stent treated group as comparing
to the Taxus stent treated group at 9 months post-stenting
(2.4% and 5.1%, P=0.01; 4.1% and 8.0%, P=0.004).6
The Firebird 2TM stent combines an improved stent
platform with cobalt-chromium alloy and the
anti-proliferate drug sirolimus. The initial results from the
FIM study have shown significantly reduced late lumen
loss ((0.05±0.09) mm vs (0.98±0.61) mm, P<0.0001), and
a mild neointimal volumetric obstruction percentage of
(1.26±1.05)% at 6-month angiographic and intra-vascular
ultrasound follow-up and an improved one-year clinical
outcome compared with a bare cobalt alloy stent.8
Two-year clinical follow-up demonstrated the persisting
efficacy of this stent with MACE or TLR free survival of
98.5%, which was more favorable than the Endeavor or
Xience V stents. The more potent anti-proliferation effect
of sirolumus than zotarolimus, which is loaded on the
文章来源：Chinese Medical Journal
Chin Med J 2008;121(6):492-497
496
Endeavor stent, or everolimus, loaded on the Xience V
stent, may be the reason.22-24 A recent IVUS study by
Miyazawa et al25 showed that the zatarolimus-eluting
stent was associated with a significantly greater incidence
of neointimal hyperplasia when compared with the
sirolimus-eluting stent.
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9.
10.
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Stent thrombosis, particularly very late stent thrombosis
(>1 year following PCI), remains a concern for DES.
Although controversies still exist whether or not DES
implantation will increase the rate of stent thrombosis as
compared to BMS, especially for on-label uses of DES,
there is a clear consensus that stent thrombosis is a
clinically relevant adverse outcome.26 Multiple studies
have documented a high rate of death or non-fatal MI
secondary to stent thrombosis.27 In the current study, the
inclusion of all patients was strictly controlled and met
the criteria of on-label use of either the Firebird 2 or the
Driver stent. At 2-year follow-up, according to the ARC
definition, no stent thrombosis was reported in the
Firebird 2 group but one case in the control group had
definite stent thrombosis at 19 months post-stenting
(2.1%). Although the relationship between stent
malapposition and stent thrombosis is still unclear,28,29
patients who were found with stent malapposition by
IVUS and experienced TLR at 6 months post-stenting in
the Firebird 2 group were treated with a longer dual
antiplatelet regimen of clopidogrel and aspirin compared
to those without stent malapposition or TLR. The
extended duration of dual antiplatelet therapy beyond the
protocol defined in Firebird 2 group was mainly due to
these patients.
Nilsson KR, Gharacholou SM, Sketch MH Jr, Krucoff MW.
Simultaneous restenosis of Taxus and Cypher drug-eluting
stents. J Invasive Cardiol 2006; 18: 557-560.
Beijk MA, Piek JJ. XIENCE V everolimus-eluting coronary
stent system: a novel second generation drug-eluting stent.
Expert Rev Med Devices 2007; 4: 11-21.
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Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, et al.
Sirolimus-eluting cobalt alloyed stents in treating patients
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Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van
Es GA, et al. Clinical end points in coronary stent trials: a
case for standardized definitions. Circulation 2007; 115:
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Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR,
O’Shaughnessy C, et al. Sirolimus-eluting stents versus
standard stents in patients with stenosis in a native coronary
artery. N Engl J Med 2003; 349: 1315-1323.
Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C,
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Liu HB, Xu B, Gao RL, Yang YJ, Yao M, Qin XW, et al.
Outcomes of using Firebird rapamycin eluting stents in
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Nikolsky E, Stone GW. Utility of drug-eluting stents in
complex lesions and high-risk patients. Curr Treat Options
Cardiovasc Med 2007; 9: 11-28.
Elezi S, Dibra A, Schomig A, Kastrati A. Current
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Meredith IT, Ormiston J, Whitbourn R, Kay IP, Muller D,
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Moliterno DJ. Restenosis following thin-strut bare-metal
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严
In conclusion, the current 2-year clinical follow-up results
from the Firebird 2 FIM study proved the efficacy and
safety of the Firebird 2TM stent in treating patients with
CAD. The device is highly deliverable and has a
favorable safety profile with significant anti-restenostic
properties and can be strongly recommended as a
valuable therapeutic option for patients with CAD in
clinical practice. The ongoing results of this FIM study
and future trials in high-risk patients will provide further
information on clinical outcome, anti-proliferative effects
and of this novel stent patient safety.
11.
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Chinese Medical Journal 2008; 121(6):492-497
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Edited by WANG Mou-yue and LIU Huan
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文章来源：Chinese Medical Journal