Dr. Yoshinobu Murasato. Congreso euroPCR 2013, Paris, Francia. Encuentre más presentaciones en la web oficial de SOLACI: www.solaci.org/

1. Mid-term Results of
Japanese Registry Study in Comparison
between Everolimus-eluting Stent and
Sirolimus-eluting Stent for the Bifurcation
Lesion (J – REVERSE)
Yoshinobu Murasato1, Yoshihisa Kinoshita2, Toshiro Shinke3,
Masahiro Yamawaki4, Yoshihiro Takeda5, Kenichi Fujii6,
Shin-ichiro Yamada7, Yoshihisa Shimada8,
Takehiro Yamashita9, Kazuhiko Yumoto10, Masaya Arikawa11,
Yoritaka Otsuka12 and Masaki Tanabe13
On behalf of J-REVERSE investigators
1. New Yukuhashi Hospital, 2. Toyohashi Heart Center, 3. Kobe University, 4. Saiseikai Yokohama Eastern
Hospital, 5. Rinku General Medical Center, 6. Hyogo Medical University, 7. Himeji Cardiovascular Center,
8. Shiroyama Hospital, 9. Hokkaido Ono Hospital, 10. Yokohama Rosai Hospital, 11. Oita medical Center,
12. Fukuoka Wajiro Hospital, 13. Second Okamoto Hospital
May 23, 2013, Paris

2. Disclosure
• Financial study support
Abbott Vascular, Cordis, Orbus Neich, Kaneka
• Registered in Clinical Trials Government
(NCT01266239)

3. Proximal stent deformation induced by
kissing balloon (KB) inflation
a
b
c
d
e
a
b
c
d
e
Murasato Y, European Bifurcation Club 2010
KB inflation caused oval-shape dilation with the
eccentricity value of 0.75 and 30% enlargement was
obtained compared to the distal site.
Guérin P. Circ Cardiovasc Interv, 2010, 3, 120

4. Impact of symmetricity
Otake H, JACC Intrv, 2009, 2,459
KBT
Asymmetrical stent expansion leads to uneven intimal
growth and frequent thrombus attachment with
uncovered struts after SES deployment.
SEI: stent eccentricity index
NUS: neointima unevenness score
KBT induces more asymmetrical stent expansion.
What are its effects on neointimalialization after
2nd generation DES deployment?

5. Purpose of the studyStudy-1
To compare acute phase and mid-term outcome of
provisional stenting between EES and SES deployment
under the IVUS guidance.
Study-2
To investigate whether asymmetrical expansion in the
bifurcation lesion leads to more disturbance of
neointimalization.
Endpoints
Study-1
Major adverse cardiac events (MACE) during 9-mo F/U period
Death, Myocardial infarction, Target lesion revascularization
(TLR), Target vessel revascularization (TVR), Stent thrombosis
Study-2
OCT abnormal findings (unevenness of intimal growth,
uncovered struts, thrombus attachment)

6. Study design
Bifurcation lesion
Provisional stenting
≧75% stenosis in MV with /wo
SB stenosis (≧75% )
Size: MV ≧ 2.5mm
SB ≧ 2mm
Lesion length < 46mm
EES
(Xience V / Promus)
SES
(Cypher select plus)
KBT (+) KBT (-) KBT (+) KBT (-)
299pts, 302 lesions
CAG
IVUS
ECG, blood sample
Clinical event
+ + +
+ +
+ + + +
+
+ + + +
EES
SES
OCT +
+
+
Before
PCI
Post
PCI
９Mo ３Y１Mo
(n=100)
Multicenter
Prospective registry
study
Exclusion
3pts,
3lns
239 lns 60 lns
129 lns 110 lns 34 lns 26 lns

7. Complications: Acute phase
0
5
10
Total MI SB
dissection
SB
occlusion
SB stenting MV or SV
TIMI≤1
EES
SES
0
5
10
15
Total MI SB
dissection
SB
occlusion
SB stenting MV or SV
TIMI≤1
KBT
Non-KBT
(%)
(%)
*
*
*
* P<0.05 vs. non-KBT

8. 9mo F/U: Major Adverse Cardiac Events (MACE)
0
5
10
15
Prox MV Dist MV
EES
SES
0
5
10
15
Prox MV Dist MV
KBT
Non-KBT
0
10
20
30
40
50
SB
0
10
20
30
40
50
SB
P<0.05
Restenosis in the Bifurcation
(%) (%)
One case of stent thrombosis (ST)
occurred in the non-target lesion.
0
5
10
15
20
MI Death ST Non-TVR
0
5
10
15
20
MI Death ST Non-TVR

9. MACE: TLR
0
2
4
6
8
10
ns
(%)
EES NKBT EES KBT
SES KBTSES NKBT
Focal 13 cases
Diffuse 2 cases
Location of TLR
Type of restenosis
MV edge restenosis
KBT 5/6, NKBT 0/7
(P<0.05)

10. 0
10
20
30
40
50
60
pre post F/U
0
10
20
30
40
50
60
pre post F/U
MB prox
MB dist
SB
-0.1
-0.05
0
0.05
0.1
0.15
0.2
0.25
MV prox MV dist SB
KBT
non-
KBT
(2) Late loss
QCA: KBT vs. Non-KBT
KBT Non-KBT
(1) % Diameter stenosis
(%)
(%) (mm)
※
†
:p<0.05 vs. pre PCI
:p<0.05 vs. post PCI
‡:p<0.05 vs. non-KBT
※
※
※
※
※
※†
†
†
‡
‡
‡
※
※
※
※
※※
†
†

11. QCU: KBT vs. Non-KBT
1
1.5
2
2.5
3
pre final
1
1.5
2
2.5
3
pre final
1
2
3
4
5
6
7
8
pre final
1
2
3
4
5
6
7
8
pre final
40
60
80
pre final
40
60
80
pre final
Prox MV
Dist MV
MLD MLA %AS
KBT
Non-KBT
(mm) (mm2) (%)
※
†
:p<0.05 vs. pre PCI
:p<0.05 vs. non-KBT
※※ ※
※
※
※
※
※
※
※
※※
†
†

12. 0.7
0.8
0.9
P10 P8 P6 P4 P2 P0 D1 D3 D5
KBT
non-
KBT
0
5
10
0
5
10
0
0.5
1
1.5
0
0.5
1
1.5
0
1
2
3
4
5
0
1
2
3
4
5
Average lumen area (mm²)
%Uncovered strut (%)
Average NIT (neointimal thickness)
area (mm²)
KBT NKBT KBT NKBT
Stent Eccentric Index (IVUS)
Prox MV Dist MV
OCT 9mo F/U study:
Interim Report
※
※
※ P<0.1 vs. NKBT
(n=14) (n=17)

13. Impact of asymmetricity on neointimalization
0.7 0.8 0.9 1.0
1.2
1.4
1.6
1.8
2.0
2.2
2.4
2.6
AvgSEI
0.7 0.8 0.9 1.0
0
5
10
15
20
25
AvgSEI
0.7 0.8 0.9 1.0
0
2
4
6
8
10
AvgSEI
noofuncoveredstruts
0.7 0.8 0.9 1.0
0.0
0.1
0.2
0.3
0.4
AvgSEI
AverageNIT
AverageNUS
Frequencyof
uncoveredstrut
numberof
uncoveredstrutAverageNIT
Avg SEI Avg SEI
Avg SEI Avg SEI
No significant relations were found between
SEI and disturbance in neointimalization in this
interim report.

14. Conclusion
• The EES deployment under the IVUS-guidance in the
coronary bifurcation lesion brought a favorable TLR rate
compared to the SES.
• Although the KBT induced more SB dissection requiring
stenting and asymmetrical stent expansion in the
proximal MV, it maintained lower levels of SB stenosis
and larger proximal MV lumen during the 9-month F/U
period without any increase in MACE.
• Asymmetrical stent expansion induced by KBT did not
result in more disturbance in neointimalization, which
might be influenced by the improvement in
malapposition or overstretch in the proximal MV.