0. 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.

1. Disclosure Statement of Financial Interest
I, [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 presentation

2. RIBS VI
Background:
Management 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.

3. RIBS VI
Objective:
To assess 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)
ClinicalTrials.gov ID: NCT

4. RIBS VI Multicenter, Prospective, Angiographic FU19 2 16 1 6 5 4 3 8 9 14 12 15 11 13 17 7 10 18
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 Madrid, HU La Paz Madrid, HU La Princesa Madrid, HU Puerta de Hierro.  15.- Madrid, HU Ramón y Cajal Málaga, HU Virgen de la Victoria Toledo, H U Virgen de la Salud Toledo 18.- Valladolid, HU Clínico de Valladolid 19.- Vizcaya HU Galdakao
Research Promotor: 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)

5. RIBS VI Study Organization
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:
1Hospital Universitario La Princesa, Madrid, (F. Alfonso, J. Cuesta, F. Rivero, T. Bastante, A. Benedicto, M. García-Guimaraes); 2Hospital Universitario Vall d’Hebron, Barcelona, (B. García del Blanco); 3Hospital Universitario de Canarias (F. Bosa); 4Hospital Galdakao, Vizcaya (J.R. Rumoroso); 5Complejo 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)

6. Inclusion / Exclusion Criteria
RIBS VI
Inclusion / Exclusion Criteria
Inclusion:
Exclusion:
Stent Related:
Stent location undefined
ISR <1 Month
Thrombus
Vessel diameter < 2.25 mm
ISR outside the Stent
General:
Life expectancy < 1 y
Female in childbearing age
Problems FU angiography
Intolerance DAT
LVEF < 25%
Informed consent
Age y
ISR (> 50% stenosis)
Angina or silent ischemia
ISR amenable for BVS

7. Flow Diagram RIBS VI EES DEB BVS RIBS VI 249 Pts 219 Pts 223 Pts
Same RIBS Centers
Incl/Excl / Criteria
Informed Consent
RIBS VI
Prospective, Angio FU
(BMS-ISR and DES-ISR)
498 Pts ISR
309 Pts RIBS IV; 189 Pts RIBS V
Randomization
249 Pts
EES
DEB
219 Pts
Angio FU
223 Pts
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
QCA
(95% of Eligible)
Primary End-point
134 Pts
Angio FU
141 9Mo (100%); 124 (88%) 1Y (17 Pending)
ClinicalTrials.gov Identifier: NCT & NCT

8. Clinical Characteristics
RIBS VI
Clinical Characteristics
BVS (141)
DEB (249)
EES (249)
Age (years)
65+10
67+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

9. Angiographic Data RIBS VI DEB (249) EES (249) BVS (141) - 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
>1 Treatment of ISR
21 (15)
23 (9)
20 (8)
LVEF (%)
56±13
58±12
59±11

10. Procedural Data RIBS VI DEB (249) EES (249) BVS (141) Device Length
19+8
20+6
21+9
Max Pressure (atm)
20+4
18+4
Inflation Time (sec)
60+50
108+48
62+46
B/A Ratio
Cross-over
0 (0)
13 (5)
1 (0.4)
Success
141 (100)
249 (100)

11. QCA: In-Segment Analysis
RIBS VI
QCA: In-Segment Analysis
Reference Diameter
Lesion Length
(mm)
(mm)
2.7±0.5
2.6±0.5
2.7±0.5
12±6
12±7
12±6
p = 0. 29
p = 0.89
CAAS II System
DEB
BVS
EES

12. QCA: MLD at FU In-Segment In-Lesion RIBS VI MLD-FU (Primary Endpoint)
(mm)
p < 0.001
In-Segment
(Primary Endpoint)
1.87±0.5
1.88±0.6
2.16±0.7
Seg
Lesion
p < 0.001
1.94±0.5
1.94±0.6
2.30±0.7
In-Lesion
DEB
BVS
EES

13. QCA: In-Segment RIBS VI Acute Gain Late Loss 1.47 1.24 1.16 0.24 0.23
p < 0.001
p < 0.05
(mm)
(mm)
1.47
1.24
1.16
0.23
0.24
0.12
DEB
BVS
EES

14. __ RIBS VI MLD (mm) (%) DEB EES BVS PRE FU POST p = 0.03 p <0.001

15. __ RIBS VI (%) Stenosis (%) DEB EES BVS POST PRE FU p < 0.001
35 (16%)
19 (9%)
15 (11%)
p = 0.07
PRE
p = 0.008
p < 0.001 FU
p < 0.001 __
BVS
DEB
EES
(%) Stenosis

16. RIBS VI
On multivariate analysis, after adjusting for all potential confounders:
- MLD at FU was significantly smaller
- % DS at FU was significantly larger
after BVS compared with EES treatment

17. Events at Final FU (1 Year)
RIBS VI
Events at Final FU (1 Year)
141 Pts (100%) 10 Mo FU; 1Y FU 124 Pts (88%) (17 Pts pending 1Y) 20
(%)
19 (13.5) 15
16 (11.3) 10 5
4 (2.8)
1 (0.7)
0 (0)
Death
Def/Pr ST
AMI
TLR
TVR
AMI: 1 periprocedural; 1 definitive BVS thrombosis
1 late SB closure; 1 definitive ST of a stent in another vessel segment

18. 91% 86% 85% __ RIBS VI Freedom from Cardiac Death, MI, TVR
100
86% 80
Breslow, p = 0.12
Log Rank, p = 0.14
85% 60 __
BVS
DEB
EES 40 20
Freedom from Cardiac Death, MI, TVR 1 2 3 4 5 6 7 8 9 10 11 12
Time (months)

19. 94% 87% 87% __ RIBS VI Freedom from Cardiac Death, MI, TLR
100
87% 80
Breslow, p = 0.02
Log Rank, p = 0.03
87% 60 __
BVS
DEB
EES 40 20
Freedom from Cardiac Death, MI, TLR 1 2 3 4 5 6 7 8 9 10 11 12
Time (months)

20. 97% 89% 89% __ RIBS VI Freedom from TLR Time (months) % DEB EES BVS
100
89% 80
89%
Breslow, p = 0.002
Log Rank, p = 0.002 60 __
BVS
DEB
EES 40 20
Freedom from TLR 1 2 3 4 5 6 7 8 9 10 11 12
Time (months)

21. RIBS VI
Conclusions:
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 setting