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.- 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

19

2

16

1

6

5 4

3

8 9

14

12 15

11 13

17

7

10

18

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)

Multicenter, Prospective, Angiographic FU

RIBS VI

Flow Diagram

Same RIBS Centers

Inclusion / 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 VI

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 VI

QCA: MLD at FU

0

0,5

1

1,5

2

2,5

MLD-FU p < 0.001

(mm)

In-Segment (Primary Endpoint)

Lesion

Seg

RIBS VI

DEB BVS EES

0

0,5

1

1,5

2

2,5p < 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±0.7

0

0,1

0,2

0,3

0,4

0,5

0,6

0,7

Late Loss p < 0.05

(mm)

QCA: In-Segment

RIBS VI

DEB BVS EES

0.23 0.24

0.12

0

0,5

1

1,5

2

Acute Gain p < 0.001

(mm)

1.16 1.24

1.47

RIBS VI

0

20

40

60

80

100

-20 -10 0 10 20 30 40 50 60 70 80 90 100

(%) Stenosis

(%)

__ BVS

__ DEB

__ EES

RIBS VI

0

20

40

60

80

100

-20 -10 0 10 20 30 40 50 60 70 80 90 100

(%) Stenosis

(%)

PRE p = 0.008

__ BVS

__ DEB

__ EES

RIBS VI

0

20

40

60

80

100

-20 -10 0 10 20 30 40 50 60 70 80 90 100

(%) Stenosis

(%)

POST

p < 0.001

PRE p = 0.008

__ BVS

__ DEB

__ EES

0

20

40

60

80

100

-20 -10 0 10 20 30 40 50 60 70 80 90 100

(%)

POST

p < 0.001

p < 0.001

FU

PRE p = 0.008

RE

35 (16%)

19 (9%)

15 (11%)

p = 0.07

__ BVS

__ DEB

__ EES

RIBS VI

(%) Stenosis

RIBS VI

Events at Final FU (1 Year) 141 Pts (100%) 10 Mo FU; 1Y FU 124 Pts (88%) (17 Pts pending 1Y)

0

5

10

15

20

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

RIBS VI

0 1 2 3 4 5 6 7 8 9 10 11 12

0

20

40

60

80

100

%

Breslow, p = 0.002

Log Rank, p = 0.002

97%

89%

__ BVS

__ DEB

__ EES

89%

Time (months)

Freedom from TLR

RIBS VI

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

Conclusions: