World Journal of Cardiovascular Diseases, 2013, 3, 395-400 WJCD
http://dx.doi.org/10.4236/wjcd.2013.36061 Published Online September 2013 (http://www.scirp.org/journal/wjcd/)
Comparison of pre-dilation with a non-compliant balloon
versus a dual wire scoring balloon for coronary stenting
Kenji Sadamatsu*, Keiki Yoshida, Yuya Yoshidomi, Yasuaki Koga, Kaori Amari, Tomotake Tokunou
Department of Cardiology, Saga-ken Medical Centre Koseikan, Saga, Japan
Received 2 July 2013; revised 2 August 2013; accepted 12 August 2013
Copyright © 2013 Kenji Sadamatsu et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Purpose: The aim of this study was to determine the
influence of lesion preparation using the dual wire
scoring balloon on stent expansion and long-term
outcomes. Methods: Forty-six consecutive de novo
lesions treated with a single >2.5 mm drug-eluting
stent under intravascular ultrasound guidance, using
two implantation strategies, were randomly assigned
to: 1) pre-dilation with a non-compliant balloon (NC
group; n = 23) or 2) pre-dilation with a dual wire
scoring balloon (DS group; n = 23). Results: Although
the balloon size and the maximal dilation pressure for
pre-dilatation was larger (3.33 ± 0.28 vs 3.09 ± 0.33
mm, p = 0.01) and higher (11.6 ± 3.2 vs 8.6 ± 2.7 atm,
p < 0.01) in the NC group than the DS group, there
were no significant differences in the stent expansion.
Quantitative coronary angiography at the follow-up
demonstrated a smaller in-stent late loss (0.71 ± 0.63
mm vs 0.23 ± 0.52 mm, p = 0.03) in the DS group.
During the long-term follow-up, there were no signi-
ficant differences in the major adverse cardiac event
rates. Conclusions: Lesion preparation with a dual
wire scoring balloon prior to drug-eluting stent im-
plantation might therefore be a more feasible strategy
than that u si ng a non-c om pliant balloon.
Keywords: Intravascular Ultrasound; Stent; Coronary
Artery Disease; Restenosis; Angioplasty
1. INTRODUCTION
Stent expansion remains an important predictor of re-
stenosis and subacute thrombosis, even in the drug-elu-
ting stent (DES) era. Plaque modification with rotational
atherectomy or pre-dilation with a cutting balloon has
been demonstrated to improve stent expansion [1-5]. Re-
cently, pretreatment with the AngioSculpt balloon cathe-
ter (AngioScore, CA) has also been reported to enhance
stent expansion [6]. However, the delivery of these de-
vices to stenotic lesions is occasionally difficult, and thus,
the use of these devices has not become widespread. The
Scoreflex balloon (Orbus Neich, Hong Kong), which is a
novel semi-compliant balloon with a dual wire system, is
designed for use in focused force angioplasty, and is ex-
pected to allow the enhancement of luminal gain with
modification of the plaque. Although the concept of both
the scoring balloon catheters seems to be similar, the
number of scoring elements is higher, with three in the
AngioSculpt and two in the Scoreflex. Therefore, the
Scoreflex balloon has the potential advantage in its de-
liverability through severely stenotic lesions. This study
was conducted to determine the influence of lesion pre-
paration using the dual wire scoring balloon on stent ex-
pansion and to examine the long-term outcomes.
2. METHODS
2.1. Study Population
The institutional review board approved this study. Writ-
ten informed consent was obtained from all patients. Be-
tween December 2008 and September 2009, 46 consecu-
tive patients who underwent elective DES implantation
under intravascular ultrasound guidance were prospec-
tively enrolled and randomly assigned to two implanta-
tion strategies: 1) pre-dilation with a non-compliant bal-
loon (Hiryu, Terumo, Tokyo) (NC group; n = 23), and 2)
pre-dilation with a dual wire scoring balloon (Scoreflex)
(DS group; n = 23). Eligible patients were ≥18 years old
with de novo lesions in native coronary arteries ≥ 2.5
mm in angiographic diameter (by visual assessment) and
who were to receive a single DES. We excluded patients
with acute coronary syndrome, total occlusion, bifurca-
tion lesions with a significant side branch, and severely
calcified lesions that an intravascular ultrasound (IVUS)
catheter could not cross, or in which rotational atherec-
tomy was needed.
*Corresponding author.

K. Sadamatsu et al. / World Journal of Cardiovascular Diseases 3 (2013) 395-400 396
2.2. Te ch niques
All procedures were performed using the standard tech-
nique. Unfractionated heparin at 10,000 units was ad-
ministered at the start of the procedure. Dual antiplatelet
therapy with aspirin at 100 mg/day and clopidgrel at 75
mg/day was recommended to be continued for at least 12
months.
Three different commercially available DESs were used:
sirolimus-eluting stents (Cypher, Cordis, FL), paclitaxel-
eluting stents (Taxus, Boston Scientific, MA) and zo-
tarolimus-eluting stents (Endeavor, Medtronic Vascular,
CL). The selection of the DES type, size and length were
left to the discretion of the operators. The stents were
deployed at the same pressure of 14 atmosphere and in-
flated several times over 60 seconds in total to obtain an
optimal stent expansion [7-9]. The non-compliant pre-
dilation balloon was used in a diameter of 2.5 to 3.75
mm and a length of 15 mm. The dual wire scoring bal-
loon catheter is a semi-compliant balloon with 2 wires
that exert focused inflation forces. It can facilitate con-
trolled plaque fractures, because the built-in integral wire
and the coronary guide wire on the outside of the balloon
create a focused force in a localized region of the plaque.
The sizes used were 2.5 to 3.5 mm in a diameter, and 10
or 15 mm in a length. The pressure used for the pre-
dilatation was left to the operators’ discretion.
All the patients underwent baseline and post-stent de-
ployment intravascular ultrasound using a commercially
available catheter (Atlantis Pro, Boston Scientific, MA or
Revolution, Volcano, CA) with motorized transducer
pullback (0.5 mm/s). Quantitative coronary ultrasound
was performed in all the lesions. Stent expansion was
defined as the ratio of the intravascular ultrasound-mea-
sured stent area in the lesion to the manufacturer’s pre-
dicted stent area. After the post-stent deployment intra-
vascular ultrasound, the addition of post-dilation was
also left to the discretion of the operators.
2.3. Patient Follow-Up
Patients were followed up at six months after the proce-
dure and once a year routinely, unless symptoms or
events required earlier consultation. Angiographic fol-
low-up at eight months was encouraged for all the pa-
tients. The follow-up data were collected until February
2013. Major adverse cardiac events were defined as car-
diac death, non-fatal myocardial infarction, target lesion
revascularization and stent thrombosis.
2.4. Statistical Analysis
Quantitative data are presented as the mean values ± SD
or the medians [the interquartile range], and qualitative
data as frequencies. Continuous variables between two
groups were compared using a Mann-Whitney test. Cate-
gorical variables were compared with the chi-square test.
The Kaplan-Meier method and log-rank test were used to
assess the time to major adverse cardiac events. All
probability values were 2-tailed and a value of p < 0.05
was considered to be statistically significant. All statisti-
cal analyses were performed with the SPSS software
program (SPSS, Inc, Chicago, Ill).
3. RESULTS
All the procedures were successful, while an additional
stent was needed in a patient in the NC group due to
coronary dissection. The clinical and procedural charac-
teristics are shown in Ta b l e 1 . All the patients were di-
agnosed to have angina pectoris or silent myocardial is-
chemia. Although the clinical background of the patients
was similar, the balloon size (3.33 ± 0.28 vs 3.09 ± 0.33
mm, p = 0.01) and maximal dilation pressure (11.6 ± 3.2
vs 8.6 ± 2.7 atm, p < 0.01) for the pre-dilation were sig-
nificantly different between the NC group and the DS
group. The pre-interventional quantitative coronary an-
giography and intravascular ultrasound, and the post-
stent deployment and post-interventional quantitative
data are shown in Ta bl e 2. There were no differences in
the angiographic or ultrasound data. The percentage of
stents that had minimum stent areas > 5.0 mm2 (a com-
monly accepted criterion for adequate DES expansion)
was 87% in both groups. Post-dilation was added for
four lesions (17.4%) in the NC group and seven lesions
(30.4%) in the DS group (p = 0.30). Clinical follow-up
data at 1-year were obtained for all patients in the NC
group and 20 patients in the DS group, and the durations
to the final clinical follow-up were 1197 [813 - 1271] and
1206 [642 - 1301] days, respectively. During the follow-
up period, 43 patients (93.5%) were assessed using some
imaging modality, such as myocardial scintigraphy, com-
puted tomography or coronary angiography. Follow-up
coronary angiography was performed in 33 patients (71.7
%), and the periods from the index coronary intervention
until angiography consisted of 258 [215 - 297] days in
the NC group (n = 16) and 273 [252 - 383] days in the
DS group (n = 17). Quantitative coronary angiography
demonstrated a significantly lower in-stent late loss in
the DS group (0.71 ± 0.63 mm vs 0.23 ± 0.52 mm, p =
0.03; Figure 1), and the other parameters including the
in-stent % diameter stenosis, in-segment % diameter
stenosis, and binary restenosis rate all tended to be lower
in the DS group (Ta ble 3). The incidence of major ad-
verse cardiovascular events was also lower in the DS
group, although the difference was insignificant (Table 3,
Figure 2). Non-cardiac death occurred in one patient in
the NC group and four in the DS group.
4. DISCUSSION
Focused-force angioplasty is a technique in which the

K. Sadamatsu et al. / World Journal of Cardiovascular Diseases 3 (2013) 395-400 397
Table 1. Clinical and procedural characteristics.
Non-compliant balloon (n = 23) Dual wire scoring balloon (n = 23) p value
Age (years) 70.7 ± 9.4 66.2 ± 10.1 0.10
Male 12 (52.2%) 17 (73.9%) 0.13
Diabetes mellitus 10 (43.5%) 12 (52.2%) 0.56
Hypertension 22 (95.7%) 19 (82.6%) 0.35
Dyslipidemia 13 (56.5%) 17 (73.9%) 0.22
Coronary artery treated 0.91
LAD/LCx/RCA 12/5/6 12/6/5
Lesion complexity 0.13
Type A/B1 6 (26.1%) 11 (47.8%)
Type B2/C 17 (73.9%) 12 (52.2%)
Procedure
Balloon size (mm) 3.33 ± 0.28 3.09 ± 0.33 0.01
Maximal inflation pressure (atm) 11.6 ± 3.2 8.6 ± 2.7 <0.01
Stent type (SES/PES/ZES) 10/11/2 11/11/1 0.83
Stent size (mm) 3.33 ± 0.24 3.25 ± 0.31 0.43
Stent length (mm) 22.6 ± 7.0 21.5 ± 7.5 0.51
LAD = left anterior descending artery; LCx = circumflex artery; RCA = right coronary artery; SES = sirolimus-eluting stent; PES = paclitaxel-eluting stent;
ZES = zotarolimus-eluting stent.
Table 2. Angiographic and intravascular ultrasound data.
Non-compliant balloon (n = 23) Dual wire scoring balloon (n = 23) p value
Pre-interventional coronary angiography
Reference vessel diameter (mm) 2.75 ± 0.55 2.60 ± 0.58 0.18
Minimal lumen diameter (mm) 1.16 ± 0.39 1.07 ± 0.36 0.31
% diameter stenosis 56.5 ± 16.5 54.9 ± 18.4 0.90
Lesion length (mm) 11.50 ± 5.81 9.54 ± 3.95 0.20
Pre-interventional intravascular ultrasound
Plaque morphology
Soft/Fibrous/Calcified/Mixed 5/2/3/13 2/8/4/9 0.12
Superficial lesion calcium 17 14 0.35
Arc of lesion calcium 0.55
No 6 9
<90 9 7
90 - 180 4 4
180 - 270 2 0
>270 2 3
External elastic membrane area (mm2) 11.17 ± 3.59 11.35 ± 5.03 0.77
Luminal area (mm2) 2.23 ± 0.77 2.21 ± 0.78 0.85
Plaque and media area (mm2) 8.89 ± 3.67 9.14 ± 4.73 0.91
Plaque burden (%) 78.2 ± 9.4 78.1 ± 10.0 0.88
Post-stent deployment intravascular ultrasound
Minimal stent diameter (mm) 2.70 ± 0.34 2.58 ± 0.38 0.21
Minimal stent cross sectional area (mm2) 6.98 ± 1.48 6.54 ± 1.68 0.18
Stent expansion (%) 70.7 ± 11.2 69.1 ± 11.1 0.52
Post-interventional coronary angiography
Minimal lumen diameter in stent (mm) 2.81 ± 0.43 2.65 ± 0.47 0.17
Minimal lumen diameter in segment (mm) 2.21 ± 0.49 2.33 ± 0.57 0.73

K. Sadamatsu et al. / World Journal of Cardiovascular Diseases 3 (2013) 395-400 398
Table 3. Clinical and Angiographic outcome.
Non-compliant balloon (n = 23) Dual wire scoring balloon (n = 23) p value
Major adverse cardiac event 0.30
Cardiac death 0 0
Non-fatal myocardial infarction 1 1
Target lesion revascularization 2 0
Stent thrombosis 0 0
Coronary angiography at follow-up n=16 n = 17
In-stent
Minimal lumen diameter (mm) 2.03 ± 0.77 2.38 ± 0.59 0.31
% diameter stenosis 29.7 ± 22.7 17.5 ± 11.0 0.16
In-segment
Minimal lumen diameter (mm) 1.80 ± 0.66 2.00 ± 0.56 0.42
% diameter stenosis 37.9 ± 18.9 26.9 ± 11.4 0.09
Binary restenosis 3 0 0.07
Figure 1. In-stent (left panel) and in-segment (right panel) late
loss of the NC group (pre-dilation with the non-compliant bal-
loon) and DS group (pre-dilation with the dual wire scoring
balloon) observed at the follow-up coronary angiographic ex-
aminations.
Figure 2. The major adverse cardiac event rate during
the follow-up period of the NC group (pre-dilation
with the non-compliant balloon) and the DS group
(pre-dilation with the dual wire scoring balloon).
forces resulting from inflating an angioplasty balloon in
a stenotic lesion are concentrated and focused at one or
more locations within the stenosis [10]. This technique,
including the conventional buddy wire technique and
cutting balloon, have been shown to be useful for re-
solving resistant stenosis. Recently, several scoring bal-
loon catheters developed based on the concept of fo-
cused-force angioplasty have been in use, however, the
clinical data on the scoring balloon have been limited
[11]. The similar type of the dual wire scoring balloon
catheter used in the present study has previously been
demonstrated to be superior to the buddy wire technique
for resistant calcified lesions [12]. Thus, scoring balloon
catheters could potentially be used to treat fibrocalcific
or undilatable lesions that have failed treatment with
conventional balloon catheters.
The AngioSculpt Scoring balloon catheter, the other
type of scoring balloon, consists of a minimally compli-
ant balloon encircled by three nitinol spiral elements, and
several case reports have demonstrated the scoring effect
on intravascular ultrasound or optical coherence tomo-
graphy [13-15]. An observational, nonrandomized study
using intravascular ultrasound has demonstrated that
pre-dilation with the AngioSculpt balloon increased the
final stent diameter and the area of the expansion of drug
eluting stents [6], although no randomized investigations
have so far confirmed this result. The cutting balloon
consists of a balloon catheter with three or four blades
that create longitudinal incisions in the atherosclerotic
lesion during balloon inflation. The microtome sharp
metal blades mounted on the cutting balloon are ex-
pected to provide better stent expansion than the scoring
elements attached to the other scoring balloons. In fact, a

K. Sadamatsu et al. / World Journal of Cardiovascular Diseases 3 (2013) 395-400 399
randomized study showed that the cutting balloon yiel-
ded greater luminal diameters with less inflation pressure
compared with conventional balloon angioplasty for the
treatment of calcified coronary lesions [1]. However, this
advantage was not demonstrated for the treatment of non-
calcified lesions. The present study also did not demon-
strate significant superiority of the pre-dilation with a
dual wire scoring balloon in terms of the stent area or
expansion, although the smaller balloon size and the
lower inflation pressure used in the DS group might have
affected the acute gain. Therefore, it remains unclear
whether pre-dilation by a scoring balloon with the same
balloon size would lead to a larger stent expansion than
the pre-dilation using a conventional balloon.
The less traumatic ballooning with the smaller balloon
size and the lower inflation pressure associated with the
DS group might therefore have led to the significantly
less in-stent late loss observed in this study. A high infla-
tion pressure is important with regard to the risk of ves-
sel stretching and edge injuries [16]. Several animal and
human studies have suggested that aggressive stent infla-
tion with high pressures caused deeper injury of the ves-
sel wall, with rupture of the intima or media, and might
result in a long-term inflammatory response with a greater
neointimal proliferative response and an increased re-
stenosis rate [17,18]. Moreover, a SIRIUS substudy sug-
gested that more injury to the contiguous vasoelastic nor-
mal wall, coupled with a drug that delays the healing
process, could contribute to late stent malapposition ow-
ing to focal positive vessel remodeling [19]. Therefore,
the less traumatic ballooning using the dual wire scoring
balloon might be a more feasible strategy for pre-dilation
prior to stent implantation than conventional ballooning
in order to obtain an equivalent acute gain, while also re-
sulting in less late loss. Further investigations are needed
to confirm the effectiveness of this less traumatic bal-
looning strategy.
A large-scale randomized study investigating the use-
fulness of the lesion preparation prior to coronary stent
implantation is lacking, while rotational atherectomy or a
cutting balloon have been demonstrated to yield a greater
acute gain in selected cases [1-4]. A high-pressure pre-
dilation stenting strategy was also shown to lead to supe-
rior stent expansion compared to a direct or non-agres-
sive pre-dilation strategy in patients with bare-metal stent
restenosis in a non-randomized study [20]. These results
suggest that the lesion preparation prior to coronary sten-
ting may modify the vessel compliance and conesquen-
tly improve the stent expansion. In fact, in some cases,
lesion preparation is absolutely necessary to avoid stent
thrombosis and restenosis due to stent underexpansion.
In daily practice, it is difficult to differentiate the cases
needing lesion preparation prior to the procedure, and
stent underexpansion is often undetectable angiographi-
cally. Therefore, high-pressure pre-dilation seems to be
one of the most practical strategies to gain appropriate
stent expansion, and the present study supports pre-dila-
tion with a dual wire scoring balloon because it is an
easy and feasible option.
There are some important limitations asociated with
our study: 1) our study involved a small number of sub-
jects at a single institution; 2) the drug-eluting stents
used in the present study were first-generation stents and
are no longer being used as contemporary coronary stents.
The improved characteristics of the stent platform might
minimize the validity of the plaque modification prior to
stent implantation; 3) follow-up coronary angiography
was not performed in all of the patients, and thus, the
follow-up results might be biased to some degree.
5. CONCLUSION
In this study, pretreatment using a dual wire scoring bal-
loon was found to be associated with less in-stent late
loss at follow-up coronary angiography compared to that
using a non-compliant balloon, although the lesion pre-
paration did not demonstrate any significant superiority
in acute stent expansion.
6. ACKNOWLEDGEMENTS
The authors appreciate the support and collaboration of our catheteriza-
tion laboratory staff, and also acknowledge Dr. Takafumi Koga and Dr.
Shujiro Inoue for collecting the clinical follow-up data. The authors
recevied a funding for the preparation of this article from Saga Prefec-
tural Hospital Koseikan, which is the previous name of Saga-ken
Medical Centre Koseikan. The authors have no conflicts of interest that
are directly relevant to the content of this study.
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