J Cardiol 2007 Jun; 49（6）: 305 – 312

Use and Long-Term Outcome ofBare Metal Stent Implantation in
the Drug-Eluting Stent Era
Hajime FUJIMOTO, MD
Tomotaka DOHI, MD
Jun MASUDA, MD
Haruo MITANI, MD
Yo FUJIMOTO, MD
Akiko MAEHARA, MD
Shin-ichiro NISHIYAMA, MD, FJCC
Shigemoto NAKANISHI, MD
Tetsu YAMAGUCHI, MD, FJCC
Sugao ISHIWATA, MD, FJCC
Minoru OHNO, MD
Abstract ─────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
Background. Although drug-eluting stents（DES）are widely used today, bare metal stents（BMS）are
still frequently employed. We investigated the utilization and clinical outcomes of BMS implantation since
we first began using DES.
Methods. The clinical course following percutaneous intervention with de novo implantation of BMS
was studied beginning in July 2004, when sirolimus-eluting stents（SES）
were first used in our hospital, toAugust 2006. Outcomes following BMS and SES implantation were compared.
Results. BMS implantation was carried out in 160 lesions and SES implantation in 242 lesions. Followup coronary angiography was performed for 208 lesions（78 lesions in which BMS were implanted and 130
lesions in which SES were implanted）within 1 year. There were no significant differences in patient characteristics between the SES and BMS groups. Regardless of the reason for BMS implantation, the rates ofin-stent restenosis and target lesion revascularization were higher in the BMS group than in the SES group.
However, the rate of in-stent restenosis and target lesion revascularization of BMS in lesions with a diameter of 4.0 mm or greater was 0%.
Conclusions. In order to reduce the risk of in-stent restenosis and target lesion revascularization, we recommend implantation of BMS with a diameter of 4.0 mm or greater or SES unless it is contraindicated.
──────────────────────────────────────────────────────────────────────────────────────────────────────────────────────J Cardiol 2007 Jun; 49（6）: 305−312

Key Words■ Stent（bare metal stent implantation）■ Restenosis■ Revascularization■ Coronary artery disease

INTRODUCTION
Currently, drug-eluting stents（DES）are widelyused for percutaneous coronary intervention（PCI）.
Implantation of DES is reported to significantly

reduce the rates of in-stent restenosis（ISR）and target lesion revascularization（TLR）,1−4）but even in
the current DES era we still use bare metal stent（BMS）
for reasons such as the absence of need to
implant DES for a focal simple lesion in a large──────────────────────────────────────────────
虎の門病院 循環器センター : 〒 105−8470 東京都港区虎ノ門 2−2−2
Department of Cardiovascular Center Medicine, Toranomon Hospital, Tokyo
Address for correspondence : FUJIMOTO H, MD, Department of Cardiovascular Center Medicine, Toranomon Hospital, Toranomon
2−2−2, Minato-ku, Tokyo 105−8470 ; E-mail : hafujimoto-circ@umin.ac.jp
Manuscript received February 19, 2007 ; revised March 10, 2007 ; accepted March 19, 2007

305

306

Fujimoto, Dohi, Masuda et alvessel because restenosis may be unlikely ; inability to carry out DES implantation in stenotic lesions
with severe vessel tortuosity or calcification, i.e.
lesions in which flexible BMS implantation or simple balloon angioplasty may be effective ; and proscription in Japan of DES implantation in acutecoronary syndrome（ACS）patients. Accordingly,
BMS remains important even in the DES era.
In order to clarify the appropriate indications forand results of BMS implantation in the DES era,
we investigated the utilization and the short-and
long-term outcomes of BMS implantation performed in our institution since we first initiated theuse of DES.
SUBJECTS AND METHODS
Subjects
From July 2004 to April 2006, 242 lesions in 214
patients underwent stent implantation in our hospital. Among the 242 lesions, 208 were studied bycoronary angiography 6 to 12 months after stentimplantation. Among these 208 lesions, SES（Cypher stent, Johnson and Johnson）had been
implanted in 130 lesions, and BMS had been
implanted in 78 lesions. We classified the lesions inwhich BMS were implanted by the reason for BMS
implantion rather than SES : Group A−lesions forwhich SES did not seem to be the preferredapproach because of short lesion length and large
vessel diameter, both findings compatible with agood outcome using BMS ; Group B−lesions in
ACS patients, whom SES implantation is not officially permitted in Japan ; Group C−lesions towhich SES could not be delivered or in which SES
seemed difficult to deliver because of severe vessel
tortuosity or calcification ; Group D−lesions inpatients who could not take ticlopidine because
they were allergic to this agent, or who had a highrisk of hemorrhage ; Group E−lesions with a small
vessel diameter（less than 2.5 mm）, making SES
difficult to implant.
Primary endpoints
The primary endpoint was a composite of major
adverse cardiac and cerebrovascular events（deathfrom cardiac causes, myocardial infarction, andischemia-driven TLR）
within the first 12 months offollow-up. TLR was defined as revascularization
for a stenosis within the stent or in the adjacent
5 mm of the distal or proximal edge of the stent.
Successful stenting was defined as a final steno-

sis of less than 50% of the vessel diameter after
implantation of the study stent, and treatment success was defined as a final stenosis of less than 50%of the vessel diameter with the use of any percutaneous intervention.
Quantitative coronary angiography
Coronary angiograms were digitally recorded atbaseline, post procedure, and at follow-up, andwere assessed at an angiographic core laboratory
with an automated edge-detection system（CAAS
Ⅱ, Pie Medical Imaging）
by experienced personnel
unaware of the patients profiles. All measurements
were performed on cineangiograms recorded after
the intracoronary administration of nitroglycerin.
The single projection in which the stenosis
appeared to be most severe was used at all times.
The contrast-filled nontapered catheter tip was used
for calibration, and the reference diameter wasdetermined by interpolation. Quantitative measurements included the diameter of the reference vessel,
the minimal luminal diameter, and the extent of diametric stenosis defined as （reference[
vessel diameter−minimal lumen diameter）/reference vessel
diameter]× 100. We defined ISR as stenosis of atleast 50% of the minimal luminal diameter in thestented area and within the margins 5 mm proximaland distal to each stent edge.
Statistical analysis
Quantitative data are presented as mean ± SD,
and the categorical data as frequencies（percentage）. Continuous variables were comparedusing the unpaired t-test. Binary variables werecompared by the Fisher exact test. Statistical significance was defined as p value less than 0.05. All
statistical analyses were performed using JMP 5
software（SAS Institute）.
RESULTS
Ratio of BMS implantation and SES implantation in our hospital
Since July 2004 to August 2006, BMS implantation was carried out in 160 lesions and SES implantation in 242 lesions. Percentages of BMS and SES
implantation in our hospital are shown in Fig. 1 andthe reasons for BMS implantation are shown in Fig.
2. Since July 2004, BMS has been consistently
used in about 40% of stent implantations in our
hospital. Follow-up coronary angiography was performed for 208 lesions（78 lesions in which BMS
J Cardiol 2007 Jun; 49（6）: 305– 312

Results of Bare Metal Stent Implantation

Fig. 2 Rationale for BMS implantation

Fig. 1 Ratio of SES and BMS implanted in our hospital

Abbreviation as in Fig. 1.

SES ＝ sirolimus-eluting stent ; BMS ＝ bare metal
stent.

Table 1 Baseline patient and lesion characteristics
SES group（n＝130）

BMS group（n＝78）

p value66.6±10.0

67.1±8.7

0.74

Male（%）

82.2

92.0

0.24

Hypertension
（%）

56.2

55.1

0.89

Hyperlipidemia（%）

67.7

71.8

0.54

Diabetes mellitus（%）

45.4

38.5

0.33

Smoking
（%）

62.3

62.8

0.94

Hemodialysis（%）

6.2

5.1

0.76

24.2±3.0

24.1±3.7

0.79

16.2

19.2

0.57

Statin

57.5

60.2

0.82

ACE inhibitor

12.3

16.7

0.63

ARB

10.1

11.5

0.73

Calcium channel blocker

43.8

44.8

0.92

Beta-blocker

15.1

16.7

0.78

Left anterior descending artery
（%）

38.5

34.6

0.58

Left circumflex artery
（%）

16.2

16.7

0.92

Right coronary artery
（%）

36.2

43.6

0.07

Left main trunk
（%）

5.4

5.1

0.94

Saphenous vein graft（%）

3.8

0

0.08

Type A
（%）

2.7

0

0.41

Type B1（%）

20.1

12.0

0.35

Type B2
（%）

27.4

20.0

0.47

Type C
（%）

49.3

68.0

0.11

Bifurcated lesion
（%）

2.3

5.1

0.28

Chronic total occlusion
（%）

10.8

3.8

0.08

Age（yr, mean±SD）

Body mass index（kg/m2, mean±SD）
Family history of coronary artery disease（%）
Medication（%）

Lesion types of A, B1, B2, and C are defined according to the American Heart Association/American College of
Cardiology（AHA/ACC）classification.5）
ACE＝angiotensin converting enzyme ; ARB＝angiotensin receptor blocker. Other abbreviations as in Fig.1.

J Cardiol 2007 Jun; 49（6）: 305– 312

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Fujimoto, Dohi, Masuda et al

Table 2 Procedure characteristics
SES group（n＝130）

BMS group（n＝78）

p value17.1±3.1

20.0±6.2

0.003

Number of stents

1.3

1.6

0.08

Kissing balloon technique（%）

2.1

5.1

0.28

PTCRA
（%）

0

7.7

0.01

Preintervention

2.85±0.45

2.91±0.41

0.30

Postintervention

3.04±0.53

3.18±0.51

0.59

Follow-up

2.93±0.49

2.97±0.48

0.55

Preintervention

0.24±0.21

0.21±0.21

0.27

Postintervention

2.89±0.49

2.92±0.47

0.65

Follow-up

2.59±0.74

1.94±0.97＜0.000191.7±7.1

93.0±7.2

0.21

Lesion length（mm）

Reference diameter（mm）

MLD
（mm）

Diametric stenosis（%）
Preintervention
Postintervention

6.4±2.1

5.6±1.9

0.10

Follow-up

11.7±19.6

35.6±29.5＜0.0001

Stent length（mm）

20.7±4.1

19.5±5.0

0.06

Stent diameter（mm）

2.98 ±0.37

3.37±0.50＜0.0001

Number of stents

1.15±0.40

1.03±0.23

0.015

Final balloon diameter（mm）

3.00±0.38

3.38±0.49＜0.0001

Final inflation pressure（atm）

14.6±3.3

14.3±3.8

0.70

PCI-follow-up CAG period（month）

7.3±1.4

7.9±1.2

0.08

Late loss（mm）

0.30±0.56

0.98±0.85＜0.0001

ISR rate（%）

3.8

19.2

0.0002

Continuous value are mean±SD.
PTCRA＝percutaneous transuluminal coronary rotational ablation ; MLD＝minimal lumen diameter ; PCI＝
percutaneous coronary intervention ; CAG＝coronary angiography ; ISR＝in-stent restenosis. Other abbreviations
as in Fig.1.

were implanted and 130 lesions in which SES were
implanted）
within 1 year.
Baseline and procedural characteristics
The characteristics of the patients and the 208
lesions examined by follow-up coronary angiography are shown in Tables 1 and 2. Baseline patientcharacteristics were not significantly different
between the BMS and the SES groups, and vessel
diameter also did not differ between the groups.
Stent diameter was larger in the BMS group than in
the SES group（ 3.37 ± 0.50 vs 2.98 ± 0.37 mm,
p ＜ 0.0001 ; Table 2）.
Lesion characteristics of each subgroup of the
BMS group classified according to the reason for
BMS implantation are shown in Table 3. In eachsubgroup of the BMS group, reference vessel andstent diameters tended to be larger in Group A（lesions in which SES implantation was not clearly
indicated because of short lesion length and large
vessel diameter, both consistent with a good outcome using BMS）
, and lesion type according to theAmerican Heart Association/American College of
Cardiology（AHA/ACC）classification5）tended tobe simpler than in other groups. That is, there weremore type A and B1 lesions in Group A than inother subgroups（Table 3）.
Types of BMS
Types of BMS used from July 2004 to April
2006 are shown in Fig. 3. Driver stents（MedtronicCo.）were most frequently used（59.8%）.
Clinical outcome: SES vs BMS
Clinical outcomes are shown in Table 4. Major
adverse cerebral and cardiac events did not occur in
J Cardiol 2007 Jun; 49（6）: 305– 312

Results of Bare Metal Stent Implantation

309

Table 3 Lesion characteristics of each subgroup of the BMS group classified according to the reason
for BMS implantation
Group A
（n＝40）

Group B
（n＝21）

Group C
（n＝9）

Group D
（n＝4）

Group E
（n＝4）

Lesion length（mm）

14.4±5.2

16.3±4.3

14.6±4.0

14.0±5.7

15.5±4.8

Vessel diameter（mm）

3.27±0.44

3.04±0.33

2.76±0.38

2.97±0.36

2.44±0.64

Stent length（mm）

18.4±4.522.3±5.5

18.6±4.3

18.3±4.7

19.8±3.9

Stent diameter（mm）

3.62±0.38

3.42±0.35

2.78±0.34

3.13±0.25

2.31±0.13

1.05

1.00

1.00

1.00

1.00

0.40 / 0.60

0.29 / 0.71

0.30 / 0.70

0.75 / 0.25

0.25 / 0.75

Number of stents
Type of lesion（A＋B1/B2＋C）
Continuous value are mean±SD.
Abbreviation as in Fig. 1.

Table 4

Clinical outcomes
SES group

BMS group（n＝130） （n＝78）
Primary success rate（%）

p value

100.0

100.0

−

Acute or late thrombosis（%）

0

0

−

Cardiac death
（%）

0

0

−

Myocardial infarction
（%）

0

0

−

Cerebrovascular events（%）

0

0

−

TLR rate（%）

3.8

11.5

0.032

TLR＝target lesion revascularization. Other abbreviations as inFig. 1.

Fig. 3 Types of BMS implanted
Abbreviation as in Fig. 1.

any patient in either the SES group or the BMS
group. TLR rates of the two groups were 3.8%
（SES group）, and 11.5%（BMS group）（p ＝ 0.032 ;Table 4）.
Angiographic analysis and clinical outcome :Subgroups in BMS group
The ISR rates in each subgroup of the BMS
group are shown in Fig. 4−left. The ISR rate wasstatistically significantly higher for BMS than SES
implantation in Group A as well as in Groups C
and D, in which BMS were used due to vessel calcification or tortuosity（Group C）and to ticlopidine
allergy or high risk of hemorrhage（ Group D）.
There were similar findings for TLR in Groups C
and D（Fig. 4−right）. In contrast, ISR and TLR
rates did not differ in Groups B and E, in which
ACS and small vessel diameter, respectively, were
present. ISR occurred in 4 patients in Group E, but
J Cardiol 2007 Jun; 49（6）: 305– 312

none of them underwent TLR because these lesions
were in distal segments of the coronary arteries（three in the distal segment of the right coronary
artery and one in the distal segment of the left anterior descending coronary artery）. The restenosis
was not clinically significant in any of thesepatients.
We also investigated ISR and TLR rates according to BMS diameter（Fig. 5）. For lesions with astent diameter of 4.0 mm or greater（n ＝ 19 totallesions, with 17 in Group A and 2 in Group B）the
ISR rate was 10.5%（Fig. 5−left）and the TLR rate
was 0%（Fig. 5−right）. In addition, we compared
the ISR and TLR rates of BMS and SES implantation in 24 BMS vs 92 SES lesions in Group A vessels having a diameter of 3.0 to 3.5 mm（Fig. 6）.
Both ISR and TLR rates for BMS were significantly higher than for SES, even when BMS was
implanted because SES utilization was not clearly
indicated.
DISCUSSION
In this study, we showed that the ISR of BMS
with a diameter up to 3.5 mm was higher than that

310

Fujimoto, Dohi, Masuda et al

Fig. 4 ISR（left）and TLR（right）rates in BMS＊
p ＜ 0.05 compared with Cypher.
Abbreviations as in Fig. 1, Tables 2, 4.

Fig. 5 ISR（left）and TLR（right）rates in BMS classified according to stent diameter＊

Group A : 17 lesions, Group B : 2 lesions.
Abbreviations as in Fig. 1, Tables 2, 4.

Fig. 6 ISR（left）
and TLR（right）
rates in Group A in vessels with a diameter of 3.0−3.5 mm
Abbreviations as in Fig. 1, Tables 2, 4.

of SES even when BMS was implanted because
SES was not clearly indicated based upon vessel
size and lesion characteristics. It is well recognizedthat use of SES has significantly reduced the rates
of both ISR and TLR. However, we still implant

BMS in a considerable number of PCI cases forvarious reasons. Although from our data it is difficult to predict the long-term outcome of BMS
implantation based solely upon vessel size andlesion length, we recommend that BMS implantaJ Cardiol 2007 Jun; 49（6）: 305– 312

Results of Bare Metal Stent Implantation

tion be restricted to lesions with a diameter of 4.0
mm or greater, or in which use of SES is contraindicated, to reduce the risk of ISR and TLR.
In our institution about 11% of BMS were
implanted because SES could not be delivered or
because SES seemed difficult to deliver due tosevere tortuosity or calcification of the vessel. It issometimes pointed that the Bx Velocity stent,
which is the platform stent of SES, is less flexible
than several new BMS models, and SES may bedifficult to deliver to lesions in markedly tortuous
or calcified vessels. Accordingly, it will be important to develop DES that have greater flexibility andwhich can be safely used in ACS patients.
Several studies have reported upon the safety andefficacy of SES implantation in patients with
ACS.6−8）However, SES implantation is not officially permitted in this group in Japan. In our study, therates of ISR and TLR following BMS implantationin ACS patients were similar to those of SES
implantation for stable stenotic lesions. Recently
results of randomized trials comparing DES and
BMS for the treatment of acute myocardial infarction have been reported.6,9）One study reported thatSES significantly reduces the rate of restenosis and
TLR,6）and another study reported that paclitaxeleluting stent implantation did not significantly
reduce restenosis.9）The difference between the twostudies may be partly due to the rates of restenosis
要and TLR following BMS implantation. Whatever
the explanation, the rates of restenosis and TLR following BMS implantation for acute myocardial
infarction reported in both of these two randomized
trials were lower than the rates following BMS
implantation for stable atherosclerotic lesions
reported in other randomized trials comparing DES
and BMS.1−4,10）In our study, ISR and TLR rates
following BMS implantation in ACS patients wereboth 4.8%, which were also lower than the rate following BMS implantation for stable atherosclerotic
lesions. These findings may relate to the fact thatthe pathophysiology of ACS in many respects differs from that responsible for progression of stableatherosclerotic lesions.11）Several other studies havealso indicated that the mechanism of restenosis
after stent implantation in ACS lesions differs fromthat observed in stable atherosclerotic lesions.12,13）
Further investigation will be required to clarify theusefulness of SES vs. BMS in ACS patients.
CONCLUSIONSWe recommend that BMS implantations be carried out in lesions having a diameter of 4 mm or
greater, or in situations in which SES implantationis contraindicated to reduce the risk of ISR and
TLR. It is also important to develop DES withimproved flexibility, and which can be safely usedin ACS patients.
約

薬剤溶出性ステント時代における通常型金属ステント留置術の現況と成績
藤 本

背

肇

土肥

智貴

増 田

純

三谷

治夫

藤 本

陽

前原

西山信一郎

中西

成元

山 口

徹

石綿

清雄

大 野

実

晶子

景 : 今日，薬剤溶出性ステントが広く用いられるようになったが，なお通常型金属ステントも多く用いられている．我々は薬剤溶出性ステント使用開始後における通常型金属ステント使用の現況と臨床成績を検討した．
方

法 : 当院でシロリムス溶出性ステントを使用開始した 2004 年 7 月−2006 年 8 月にかけて，新規病変に対して施行された通常型金属ステント留置術後の臨床経過を，シロリムス溶出性ステント留置術と比較検討した．
結果 : 通常型金属ステントは 160 病変，シロリムス溶出性ステントは 242 病変に留置され，そのうち 208 病変（通常型金属ステント留置病変 78, シロリムス溶出性ステント留置病変 130）は 1 年以
内に追跡冠動脈造影が施行された．通常型金属ステントが留置された理由は，1）対照血管径が大きく，病変長が短いため通常型金属ステントを留置しても再狭窄が起こらないと予測されたため，
2）急性冠症候群症例であったため，3）血管の屈曲・石灰化が強くシロリムス溶出性ステントを留置できなかったため，4）患者がチクロピジンを内服できなかったため，5）血管径が小さくシ

J Cardiol 2007 Jun; 49（6）: 305– 312

311

312

Fujimoto, Dohi, Masuda et al

ロリムス溶出性ステントを留置できなかったため，に分類された．シロリムス溶出性ステント留置群と通常型金属ステント留置群で患者・病変背景に大きな差はなかった．通常型金属ステントを留置した理由のいかんにかかわらず，通常型金属ステント留置群の再狭窄率・血行再建率はシ
ロリムス溶出性ステント群よりも高率であった．ただし，径が 4.0 mm 以上のステントを留置した
場合の通常型金属ステントの再狭窄率・再血行再建率は 0% であった．
結論 : 再狭窄率・再血行再建率を低減させるには禁忌でない限り，シロリムス溶出性ステントか径 4.0 mm 以上の通常型金属ステントを留置することが望ましい．

J Cardiol 2007 Jun; 49（6）: 305−312

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