Comparison of pre-dilation with a non-compliant balloon versus a dual wire scoring balloon for coronary stenting

doi:10.4236/wjcd.2013.36061

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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

Email: *[email protected]

Received 2 July 2013; revised 2 August 2013; accepted 12 August 2013

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.

OPEN ACCESS

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

OPEN ACCESS

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.

REFERENCES

[1] Okura, H., Hayase, M., Shimodozono, S., Kobayashi, T.,

Sano, K., Matsushita, T., Kondo, T., Kijima, M., Nishi-

kawa, H., Kurogane, H., Aizawa, T., Hosokawa, H., Su-

zuki, T., Yamaguchi, T., Bonneau. H.N., Yock, P.G. and

Fitzgerald, P.J. (2002) Mechanisms of acute lumen gain

following cutting balloon angioplasty in calcified and

noncalcified lesions: An intravascular ultrasound study.

Catheterization & Cardiovascular Interventions, 57, 429-

436. doi:10.1002/ccd.10344

[2] Furuichi, S., Tobaru, T., Asano, R., Watanabe, Y., Taka-

misawa, I., Seki, A., Sumiyoshi, T. and Tomoike, H.

(2012) Rotational atherectomy followed by cutting-ba-

lloon plaque modification for drug-eluting stent implan-

tation in calcified coronary lesions. Journal of Invasive

Cardiology, 24, 191-195.

[3] Ozaki, Y., Yamaguchi, T., Suzuki, T., Nakamura, M., Ki-

tayama, M., Nishikawa, H., Inoue, T., Hara, K., Usuba, F.,

Sakurada, M., Awano, K., Matsuo, H., Ishiwata, S., Ya-

sukawa, T. and Ismail, T.F., Hishida, H. and Kato, O.

(2007) Impact of cutting balloon angioplasty (CBA) prior

K. Sadamatsu et al. / World Journal of Cardiovascular Diseases 3 (2013) 395-400

400

OPEN ACCESS

to bare metal stenting on restenosis. Circulation Journal,

71, 1-8. doi:10.1253/circj.71.1

[4] Tsuchikane, E., Otsuji, S., Awata, N., Azuma, J., Na-

kaoka, Y., Uesugi, H., Kobayashi, T., Sakurai, M. and

Kobayashi, T. (2001) Impact of pre-stent plaque debulk-

ing for chronic coronary total occlusions on restenosis

reduction. Journal of Invasive Cardiology, 13, 584-589.

[5] Karvouni, E., Stankovic, G., Albiero, R., Takagi, T., Cor-

vaja, N., Vaghetti, M., Di Mario, C. and Colombo, A.

(2001) Cutting balloon angioplasty for treatment of calci-

fied coronary lesions. Catheterization & Cardiovascular

Interventions, 54, 473-481. doi:10.1002/ccd.1314

[6] de Ribamar Costa Jr., J., Mintz, G.S., Carlier, S.G.,

Mehran, R., Teirstein, P., Sano, K., Liu, X., Lui, J., Na,

Y., Castellanos, C., Biro, S., Dani, L., Rinker, J., Moussa,

I., Dangas, G., Lansky, A.J., Kreps, E.M., Collins, M.,

Stones, G.W., Moses, J.W. and Leon, M.B. (2007) Non-

randomized comparison of coronary stenting under intra-

vascular ultrasound guidance of direct stenting without

predilation versus conventional predilation with a semi-

compliant balloon versus predilation with a new scoring

balloon. American Journal of Cardiology, 100, 812-817.

doi:10.1016/j.amjcard.2007.03.100

[7] Kawasaki, T., Koga, H., Serikawa, T., Orita, Y., Ikeda, S.,

Mito, T., Gotou, Y., Shintani, Y., Tanaka, A., Tanaka, H.,

Fukuyama, T. and Koga, N. (2009) Impact of a prolonged

delivery inflation time for optimal drug-eluting stent ex-

pansion. Catheterization & Cardiovascular Interventions,

73, 205-211. doi:10.1002/ccd.21813

[8] Asano, T., Kobayashi, Y., Fukushima, K., Iwata, Y., Ki-

tahara, H., Ishio, N., Nakayama, T., Kuroda, N. and Ko-

muro, I. (2009) Effect of balloon inflation time on expan-

sion of sirolimus-eluting stent. Heart and Vessels, 24,

335-339. doi:10.1007/s00380-008-1130-1

[9] Iwamoto, Y., Okamoto, M., Hashimoto, M., Fukuda, Y.,

Iwamoto, A., Iwasaki, T., Kinoshita, H. and Kihara, Y.

(2012) Better stent expansion by two-time inflation of

stent balloon and its responsible mechanism. Journal of

Cardiology, 59, 160-166. doi:10.1016/j.jjcc.2011.12.003

[10] Solar, R.J. and Ischinger, T.A. (2003) Focused force

angioplasty: Theory and application. Cardiovascular Ra-

diation Medicine, 4, 47-50.

doi:10.1016/S1522-1865(03)00119-7

[11] Kato, R., Ashikaga, T., Sakurai, K., Ito, J., Ogawa, T.,

Tahara, T., Yokoyama, Y. and Satoh, Y. (2012) Influ-

ence of additional ballooning with a dual wire balloon

after a rotational atherectomy to expand drug-eluting stent

for calcified lesions. Cardiovascular Interve ntion and Th e-

rapeutics, 27, 155-160.

doi:10.1007/s12928-012-0102-7

[12] Otsuka, Y., Kasahara, Y. and Kawamura, A. (2007) Use

of safecut balloon for treatment of in-stent restenosis of a

previously underexpanded sirolimus-eluting stent with a

heavily calcified plaque. Journal of Invasive Cardiology,

19, E359-E362.

[13] Kanai, T., Hiro, T., Takayama, T., Fukamachi, D., Wata-

nabe, Y., Ichikawa, M., Kawano, T. and Hirayama, A.

(2012) Three-dimensional visualization of scoring me-

chanism of “Angiosculpt” balloon for calcified coronary

lesions using optical coherence tomography. Journal of

Cardiology Cases, 5, e16-e19.

doi:10.1016/j.jccase.2011.10.008

[14] Takano, M., Yamamoto, M., Murakami, D., Takano, H.,

Asai, K., Yasutake, M., Seino, Y. and Mizuno, K. (2010)

Optical coherence tomography after new scoring balloon

angioplasty for in-stent restenosis and de novo coronary

lesions. International Journal of Cardiology, 141, e51-

e53. doi:10.1016/j.ijcard.2008.11.154

[15] Hosokawa, Y., Tanaka, K. and Mizuno, K. (2012) Succe-

ssful treatment for refractory coronary thrombus with

scoring balloon angioplasty. Catheterization & Cardiova-

scular Interventions, 79, 282-287.

doi:10.1002/ccd.23073

[16] Caixeta, A.M., Brito, F.S.Jr., Rati, M., Perin, M.A., da

Luz, P.L., Ramires, J.A., Ambrose, J.A. and Martinez,

E.E. (2000) High versus low-pressure balloon inflation

during MultilinkTM stent implantation: Acute and long-

term angiographic results. Catheterization & Cardiovas-

cular Interventions, 50, 398-401.

doi:10.1002/1522-726X(200008)50:4<398::AID-CCD5>

3.0.CO;2-1

[17] Uretsky, B.F., Rosanio, S., Lerakis, S., Wang, F.W., Smi-

ley, M., Stouffer, G.A., Tocchi, M., and Estella, P. (2000)

A prospective evaluation of angiography-guided coronary

stent implantation with high versus very high balloon in-

flation pressure. American Heart Journal, 140, 804-812.

doi:10.1067/mhj.2000.110572

[18] Hoffmann, R., Guagliumi, G., Musumeci, G., Reimers, B.,

Petronio, A.S., Disco, C., Amoroso, G., Moses, J.W., Fi-

tzgerald, P.J., Schofer, J., Leon, M.B. and Breithardt, G.

(2005) Vascular response to sirolimus-eluting stents de-

livered with a nonaggressive implantation technique: Com-

parison of intravascular ultrasound results from the mul-

ticenter, randomized E-SIRIUS, and SIRIUS trials. Ca-

theterization & Cardiovascular Interventions, 66, 499-

506. doi:10.1002/ccd.20542

[19] Ako, J., Morino, Y., Honda, Y., Hassan, A., Sonoda, S.,

Yock, P.G., Leon, M.B., Moses, J.W., Bonneau, H.N. and

Fitzgerald, P.J. (2005) Late incomplete stent apposition

after sirolimus-eluting stent implantation: A serial intra-

vascular ultrasound analysis. Journal of the American

College of Cardiology, 46, 1002-1005.

doi:10.1016/j.jacc.2005.05.068

[20] Kalinczuk, L., Demkow, M., Mintz, G.S., Cedro, K., De-

bski, A., Ciszewski, M., Ciszewski, A., Kruk, M., Karcz,

M., Warminski, G., Pregowski, J., Chmielak, Z., Witkow-

ski, A., Lubiszewska, B. and Ruzyllo, W. (2009) Impact

of different re-stenting strategies on expansion of a drug-

eluting stent implanted to treat bare-metal stent restenosis.

American Journal of Cardiology, 104, 531-537.

doi:10.1016/j.amjcard.2009.03.067