1. No category

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.
RIBS VI
Multicenter, Prospective, Angiographic FU
1
9
8
19
10
4
3
6
18
11
12
14
5
13
15
17
2
16
7
Research Promotor: Spanish Society of Cardiology (SSC)
Auspices: Working Group on Interventional Cardiology of the SSC
Coordinator Center: H. Universitario La Princesa Madrid.
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 Toledo
18.- Valladolid, HU Clínico de Valladolid
19.- Vizcaya HU Galdakao
Investigators´ driven initiative
Unrestricted research grants: Abbott Vascular
(StJude y Terumo)
RIBS VI
Flow Diagram
RIBS VI
Prospective, Angio FU
(BMS-ISR and DES-ISR)
141 Pts
BVS
498 Pts ISR
Randomization
Same RIBS Centers
Inclusion / Criteria
Informed Consent
April 2014
December 2015
January 2010
August 2013
309 Pts RIBS IV; 189 Pts RIBS V
249 Pts
249 Pts
DEB
EES
Absorb
SeQuent Please
Xience Prime
(Abbott Vascular)
(B. Braun)
(Abbott Vascular)
100% Angio Success
100% Angio Success
134 Pts
223 Pts
219 Pts
Angio FU
Angio FU
Angio FU
Mean: 257 days
Mean: 270 days
QCA
QCA
Primary End-point
Primary End-point
(95% of Eligible)
442 Pts: 91% of Eligible
498 1Y Clinical FU (100%)
141 9Mo (100%); 124 (88%) 1Y (17 Pending)
ClinicalTrials.gov Identifier: NCT01239953 & NCT01239940
RIBS VI
Procedural Data
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
1.20+0.2
1.23+0.2
1.19+0.2
0 (0)
13 (5)
1 (0.4)
141 (100)
249 (100)
249 (100)
B/A Ratio
Cross-over
Success
RIBS VI
QCA: MLD at FU
MLD-FU
(mm)
p < 0.001
2,5
2
1,5
1
Seg
0,5
1.87±0.5
1.88±0.6
2.16±0.7
In-Segment
(Primary Endpoint)
Lesion
0
p < 0.001
2,5
2
1,5
1.94±0.5
1.94±0.6
1
0,5
In-Lesion
0
BVS
DEB
EES
2.30±0.7
RIBS VI
QCA: In-Segment
Acute Gain
p < 0.001
2
Late Loss
p < 0.05
0,7
(mm)
(mm)
0,6
1,5
1.47
1
1.16
0,5
0,4
1.24
0,3
0,2
0,5
0.23
0,1
0.12
0
0
BVS
DEB
0.24
EES
RIBS VI
(%)
100
80
60
40
__
__
__
20
DEB
EES
BVS
0
-20 -10
0
10
20
30
40
50
60
(%) Stenosis
70
80
90 100
RIBS VI
(%)
100
PRE
80
p = 0.008
60
40
__
__
__
20
DEB
EES
BVS
0
-20 -10
0
10
20
30
40
50
60
(%) Stenosis
70
80
90 100
RIBS VI
(%)
100
POST
80
PRE
p = 0.008
p < 0.001
60
40
__
__
__
20
DEB
EES
BVS
0
-20 -10
0
10
20
30
40
50
60
(%) Stenosis
70
80
90 100
RIBS VI
(%)
100
RE
35 (16%)
19 (9%)
15 (11%)
p = 0.07
POST
80
p < 0.001
60
PRE
p = 0.008
FU
p < 0.001
40
__
__
__
20
DEB
EES
BVS
0
-20 -10
0
10
20
30
40
50
60
(%) Stenosis
70
80
90 100
RIBS VI
Events at Final FU (1 Year)
141 Pts (100%) 10 Mo FU; 1Y FU 124 Pts (88%) (17 Pts pending 1Y)
20
15
10
5
20
(%)
19 (13.5)
15
16 (11.3)
10
4 (2.8)
5
0 (0)
1 (0.7)
Death
Def/Pr ST
0
AMI
TLR
TVR
RIBS VI
%
97%
100
89%
89%
80
Breslow, p = 0.002
Log Rank, p = 0.002
60
__
__
__
40
DEB
EES
BVS
20
Freedom from TLR
0
0
1
2
3
4
5
6
7
Time (months)
8
9
10
11
12
RIBS VI
Conclusions:
BVS are safe and effective in the treatment of selected
patients with ISR
Favorable late angiographic (restenosis rate 11%) and
clinical results are obtained (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 that those seen after EES implantation
(caution required as historical controls from RCT were used)
Further studies with longer-term follow-up will be required
to elucidate the relative value of BVS vs other well-established
therapeutic strategies in this challenging setting