A Prospective Multicenter Registry of Bioresorbable Vascular Scaffolds in Patients With Coronary Artery BareMetal or DrugEluting InStent Restenosis Fernando Alfonso MD PhD FESC Hospital ID: 535887
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Slide1
RIBS VI:
A Prospective, Multicenter, Registry of Bioresorbable Vascular Scaffolds in Patients With Coronary Artery Bare-Metal or Drug-Eluting In-Stent Restenosis
Fernando Alfonso MD, PhD, FESC
Hospital
Universitario
“La
Princesa
” Madrid
. Spain.
On Behalf of the
RIBS
VI
Investigators
Javier
Cuesta
MD, Fernando Rivero MD, María J. Pérez-
Vizcayno
MD, Bruno García MD, José R. Rumoroso MD, Francisco Bosa MD, Armando Pérez
de
Prado MD, Mónica
Masotti
MD,
Raúl Moreno MD,
Angel
Cequier
MD, Hipólito Gutiérrez MD, Arturo García-
Touchard
MD,
José R López-Mínguez MD, Javier Zueco MD.Slide2
Disclosure Statement of Financial InterestI, [Fernando Alfonso, MD, and the coauthors], DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentationSlide3
RIBS
VI
M
anagement
of
patients
with
in-
stent
restenosis (ISR) still remains a challenge. The role of bioresorbable vascular scaffolds (BVS) in these patients is unknown. However, the potencial benefits of their strong antiproliferative effects without the need of an additional permanent metal layer, make these devices an attractive strategy in this scenario.
Background
:Slide4
Objective:
To a
ssess
the
efficacy
of
BVS
in the treatment of patients with ISR.
To compare BVS results with those obtained with drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in the RIBS IV and RIBS V RCT - Primary Endpoint: MLD at Follow-up - Clinical Endpoint: Combined (Cardiac D, MI,TVR/TLR)RIBS VIClinicalTrials.gov ID: NCT02672878Slide5
1.-
Asturias, HU
Central Asturias.
2.-
Badajoz, HU
Infanta Cristina.
3.-
Barcelona, HU
Bellvitge
.
4.-
Barcelona, HU Clinic.5.- Barcelona, HU Sant Pau.6.- Barcelona, HU Vall D’Hebrón.
7.-
Canarias, HU
de Canarias
8.-
Cantabria, HU
Marques de
Valdecilla
.
9
.- Santiago Compostela, HU Santiago
10.- León, HU CA
de León 11.- Madrid, HU 12 de Octubre.12.- Madrid, HU La Paz. 13.- Madrid, HU La Princesa 14.- Madrid, HU Puerta de Hierro. 15.- Madrid, HU Ramón y Cajal.16.- Málaga, HU Virgen de la Victoria.17.- Toledo, H U Virgen de la Salud Toledo18.- Valladolid, HU Clínico de Valladolid19.- Vizcaya HU Galdakao
19
2
16
1
6
5
4
3
8
9
14
12
15
11
13
17
7
10
18
Research
P
romotor: Spanish Society of Cardiology (SSC)
Auspices: Working Group on Interventional Cardiology of the SSC
Coordinator
Center: H.
Universitario La Princesa Madrid.
Investigators
´
driven
initiative
Unrestricted
research
grants
: Abbott Vascular
(
StJude
y
Terumo
)
Multicenter
,
Prospective
,
Angiographic
FU
RIBS
VISlide6
Coordinating
Center:
Hospital Universitario
La Princesa.
Madrid.
Steering Committee
:
F. Alfonso (Chairman and Principal Investigator), J.
Zueco
, A.
Cequier
, C.
Morís
.
Clinical
Events
Committee
:
R
. Hernández, M.
Sabaté
.
Coronary
Angiography
Core
Laboratory
:
(Hospital Universitario
La Princesa,
Madrid)
J. Cuesta,
M.J. Pérez-
Vizcayno
.
Data Coordination, Safety Monitoring and Statistical Committee
:
J. Cuesta, M.J
.
Pérez-
Vizcayno
, Cristina
Fernández
.
Intravascular Ultrasound and Optical Coherence Tomography Committee
:
F
.
Alfonso J. Cuesta.
Sites
and
Investigators
:
In
order
of
enrollment
:
1
Hospital Universitario La Princesa, Madrid, (F. Alfonso, J. Cuesta, F. Rivero, T. Bastante, A. Benedicto, M. García-
Guimaraes
);
2
Hospital Universitario
Vall
d’Hebron
, Barcelona, (B. García del
Blanco);
3
Hospital Universitario de Canarias (F. Bosa);
4
Hospital
Galdakao
, Vizcaya (J.R. Rumoroso);
5
Complejo Asistencial Universitario de León, León, (A. Pérez del Prado);
6Hospital Universitario Clinic de Barcelona, Barcelona, (M. Masotti); 7Hospital
Universitario Infanta Cristina, Badajoz, (J.R. López-Mínguez); 8Hospital Universitario de Valladolid, Valladolid (H. Gutierrez); 9Hospital Universitario de Bellvitge, Barcelona, (A. Cequier);
10Hospital Universitario Marqués de Valdecilla, Santander, (J. Zueco); 11Hospital Universitario Puerta de Hierro, Majadahonda, (A. García-Touchard); 12Hospital Universitario La Paz, Madrid, (R. Moreno);
13Hospital Universitario 12 de Octubre, Madrid, (T. Velazquez); 14Hospital Universitario Sant Pau, Barcelona, (V. Martí); 15Hospitalario
Universitario Central de Asturias, Oviedo, (C. Morís); 16Hospital Ramón y Cajal, Madrid (R. Hernández); 17Hospital Universitario Virgen de la Salud Toledo, Toledo, (J. Moreu); 18Hospital Universitario Virgen de la Victoria, Málaga, (J.M. Hernández);
19Complejo Hospitalario Universitario de Santiago, Santiago de Compostela (R. Trillo)
Study Organization
RIBS VISlide7
Inclusion
/ Exclusion Criteria
Informed consent
Age 20 - 85 y
ISR
(> 50% stenosis)
Angina or silent ischemia
ISR amenable for
BVS
Inclusion:Exclusion:
Stent Related:
Stent location undefined
ISR <1
Month
Thrombus
Vessel
diameter < 2.25 mm ISR outside the StentGeneral: Life expectancy < 1 y Female in childbearing age Problems FU angiography Intolerance DAT LVEF < 25%
RIBS
VISlide8
Flow
Diagram
Same RIBS Centers
Incl
/
E
xcl
/ Criteria
Informed Consent
RIBS VI
Prospective
,
Angio
FU
(BMS-ISR and DES-ISR)
141 9Mo (100%); 124 (88%) 1Y (17 Pending)
QCA
(
95%
of
Eligible)
Primary End-point
134
Pts
Angio
FU
498 Pts
ISR
309 Pts RIBS IV; 189 Pts RIBS V
Randomization
249 Pts
EES
249 Pts
DEB
219 Pts
Angio
FU
223 Pts
Angio
FU
Mean: 257
days
Mean: 270
days
100%
Angio
Success
SeQuent
Please
(B. Braun)
Xience
Prime
(Abbott Vascular)
498 1Y Clinical FU (100%)
442
Pts:
91% of Eligible
QCA
Primary End-point
January 2010
August 2013
141
Pts
BVS
Absorb
(Abbott Vascular)
100%
Angio
Success
April
2014
December 2015
ClinicalTrials.gov Identifier:
NCT01239953 &
NCT01239940
RIBS
VISlide9
BVS (141)
DEB (249)
EES (249)
Age (years)
65
+
10
67
+
10
65
+
10
Female
16 (11)
40 (16)
37 (15)
- Diabetes
72 (51)
*
105 (42)
85 (34)
-
Hyperlipidemia
113 (80)
179 (72)
183 (74)
- Hypertension
106 (75)
178 (72)
189 (76)
Unstable
Angina
69 (49)
118 (47)
121 (49)
Stable
Angina /
Isch
72 (51)
131 (53)
128 (51)
Time to ISR
(median
days
)
1770
*
496
535
Clinical
Characteristics
RIBS
VISlide10
BVS (141)
DEB (249)
EES (249)
- LAD
66 (47)
112 (45)
108 (43)
- RCA
44 (31)
80 (32)
77 (31)
- LCX
27 (19)
48 (19)
56 (23)
DES-ISR
70 (51)
154 (62)
155 (62)
Length
ST (mm)
20±7
20±7
20±7
>1
Treatment
of ISR
21 (15)
23 (9)
20 (8)
LVEF (%)
56±13
58±12
59±11
Angiographic
Data
RIBS
VISlide11
BVS (141)
DEB (249)
EES (249)
Device Length
19
+
8
20
+
6
21
+
9
Max Pressure (
atm
)
20
+
4
18
+
4
20
+
4
Inflation
Time (
sec
)
60
+
50
108
+
48
62
+
46
B/A Ratio
1.20
+
0.2
1.23
+
0.2
1.19
+
0.2
Cross-
over
0 (0)
13 (5)
1 (0.4)
Success
141 (100)
249 (100)
249 (100)
Procedural
Data
RIBS
VISlide12
QCA: In-
Segment
Analysis
Reference
Diameter
p = 0.
29
Lesion
Length
p =
0.89
(mm)
(mm)
CAAS II System
RIBS
VI
2.7
±
0.5
2.6
±
0.5
2.7
±
0.5
12
±
6
12
±
7
12
±
6
DEB
BVS
EESSlide13
QCA: MLD at FU
MLD-FU
p
<
0.001
(mm)
In-
Segment
(
Primary
Endpoint
)
Lesion
Seg
RIBS
VI
DEB
BVS
EES
p
<
0.001
In-
Lesion
1.87
±
0.5
1.88
±
0.6
2.16
±
0.7
1.94
±
0.5
1.94
±
0.6
2.30
±
0.7Slide14
Late
Loss
p
<
0.05
(mm)
QCA: In-
Segment
RIBS
VI
DEB
BVS
EES
0.23
0.24
0.12
Acute
Gain
p
<
0.001
(mm)
1.16
1
.24
1.47Slide15
RIBS
VI
MLD (mm)
PRE
POST
p <0.001
p = 0.03
FU
p <0.001
__
BVS
__DEB
__
EES
(%)Slide16
RIBS
VI
(%) Stenosis
(%)
POST
p < 0.001
p < 0.001
FU
PRE
p = 0.008
RE
35 (16%)19 (9%)15 (11%)p = 0.07
__
BVS
__
DEB
__
EESSlide17
RIBS
VI
On
multivariate
analysis
,
after
adjusting
for all potential confounders: - MLD at FU was significantly smaller - % DS at FU was significantly largerafter BVS compared with EES treatment Slide18
RIBS
VI
Events
at Final FU (1
Year
)
141
Pts
(100%) 10 Mo FU; 1Y
FU
124
Pts
(88%) (17
Pts
pending
1Y)
Death
Def
/Pr ST
AMI
TLR
TVR
0 (0)
1
(0.7)
4
(2.8)
16 (11.3)
19 (13.5)
(%)
5
10
15
20
AMI: 1
p
eriprocedural
; 1
definitive
BVS
thrombosis
1 late SB
closure
; 1
d
efinitive
ST of a
stent
in
another
vessel
segmentSlide19
RIBS
VI
0
1
2
3
4
5
6
7
8
9
10
11
12
0
2
0
4
0
6
0
8
0
1
0
0
%
Time (
months
)
Freedom from Cardiac Death, MI, TVR
Breslow, p = 0.12
Log Rank, p = 0.14
91%
85%
86%
__
BVS
__
DEB
__
EESSlide20
RIBS
VI
0
1
2
3
4
5
6
7
8
9
10
11
12
0
2
0
4
0
6
0
8
0
1
0
0
%
Breslow, p = 0.02
Log Rank, p = 0.03
94%
87%
87%
__
BVS
__
DEB
__
EES
Time (
months
)
Freedom
from
Cardiac
Death
, MI, TLRSlide21
RIBS
VI
0
1
2
3
4
5
6
7
8
9
10
11
12
0
2
0
4
0
6
0
8
0
1
0
0
%
Breslow, p = 0.002
Log Rank, p = 0.002
97%
89%
__
BVS
__
DEB
__
EES
89%
Time (
months
)
Freedom
from
TLRSlide22
RIBS
VI
BVS are
safe
and
effective
in
the
treatment
of
selected patients with ISR BVS provide favorable late angiographic (restenosis rate 11%) and clinical results (TLR 11%) in these patients The acute and late angiographic findings of BVS appear to be similar to those obtained with DEB (“leave nothing behind strategy”) but poorer than those seen after EES implantation (caution required as historical
controls
from
RCT
were
used
)
Further studies with long-term follow-up will be required to elucidate the relative value of BVS vs other well-established therapeutic strategies in this challenging settingConclusions: