This document summarizes data comparing metallic drug-eluting stents to bioresorbable scaffolds. It notes that bioresorbable scaffolds would be preferred in most cases over having a metal-coated artery after 3 years. However, achieving this without a high risk of technical failure or complications in the first year can be difficult. The document provides data on event rates over time from various studies that show bioresorbable scaffolds have lower long-term event rates compared to metallic stents, though risks may be higher in the first year after implantation until the scaffold is absorbed. Device characteristics like strut thickness and width that may influence outcomes are also discussed.

1. Stents farmacoactivos metálicos vs
Scaffolds bioreabsorbibles
• Scaffolds bioreabsorbible en la mayoria de los
casos

2. Que preferiria a los 3 años de una revascularizacion
percutanea?:
• La sustitucion de su arteria por un vaso
metalizado.
• Su arteria nativa sin lesiones.
Se puede conseguir sin pagar un precio
elevado en terminos de fracaso tecnico o
complicaciones en el primer año?.
✓

3. 3© 2014 Abbott
Higher Event Rates Long Term for Metallic Implants
Long-term Landmarked Event Rates
Brodie et al, J Interven Cardiol 2014:27: 21-28

4. 4© 2014 Abbott
Best in Class DES Demonstrate Year over Year Increase in
Clinical Events
Long-term Landmarked Event Rates
G. Stone, TCT 2011

5. 5© 2014 Abbott
Clinical Events Post PCI
0%
10%
20%
30%
40%
Balloon Angioplasty
Drug Eluting Stenting
22.93%
Absorb (dotted line: projection)
3.87%
1 2 3 4 50 107.5
Years
Average of events from various publications from 1994 to 2015 on patients with de novo native coronary artery lesions, no lesion or patient subgroups.
See appendix for references (Balloon Angioplasty: References 1,4. Bare Metal Stent: References 1,2,3,5. DES: References 3, 6-11. Absorb: Reference 12).
19.40%
11.44%

6. Diferencias entre los stents
farmacoactivos metálicos y el BVS
GROSOR

7. ANCHURA DEL STRUT

8. Do not distribute. Absorb GT1 is pending CE mark as of April 28, 2015 and is not available for sale. Absorb GT1 is authorized for sale in CE Mark and certain independently
regulated countries outside the United States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the regulation in force.
Information contained herein for presentation outside the United States only. ©2015 Abbott. All rights reserved. AP2941102-OUS Rev. A
Absorb Registry Data @ EuroPCR2015
Ghost EU –1 Year Follow-Up
1.9% 2.0%
1.4%
Days 0 90 180 365
Pts at risk 1,477 1,376 1,332 1,012
Thrombosis rate is maintained
between 6 and 12 months,
confirming the importance of
proper implantation technique

9. Registries
9
4Cities
n~1,300, International Registry
Enrollment & Follow-Up 1 Y
2011 2012 2013 2015 20162014
Nitrates
Sizing with ballon (1:1:1) ,
2 angiographic planes
Low threshold for OCT
Implant following IFUs
NC postdilation (+0.5mm)
Do not accept MLD<2.5/2.9mm
MLA<4.9/6.6mm2
Prof. Gori – Lessons from Registries

10. Zona de inexpansión
APTC NC 3 mm 25atm
Predilatacion
2.5 mm
BVS 3x28 m

11. APTC NC 3.5 mm
a 40 atm

12. Do not distribute. Absorb GT1 is pending CE mark as of April 28, 2015 and is not available for sale. Absorb GT1 is authorized for sale in CE Mark and certain independently
regulated countries outside the United States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the regulation in force.
Information contained herein for presentation outside the United States only. ©2015 Abbott. All rights reserved. AP2941102-OUS Rev. A
Absorb Registry Data @ EuroPCR2015
ABSORB EXTEND – 812 Patients at 1 Year
12 Months
(N = 812)
NON-HIERARCHICAL COMPONENTS
Cardiac Death (%) 0.7
Myocardial Infarction (%) * 3.3
Q-wave MI 1.0
Non Q-wave MI 2.3
Ischemia driven TLR (%) 2.3
CABG 0.2
PCI 2.1
Hierarchical MACE (%) 5.0
Hierarchical TVF (%) 5.5
Hierarchical TLF (%) 5.0
Scaffold Thrombosis (ARC Def/Prob) (%) 1.0

13. Do not distribute. Absorb GT1 is pending CE mark as of April 28, 2015 and is not available for sale. Absorb GT1 is authorized for sale in CE Mark and certain independently
regulated countries outside the United States. Please check the regulatory status of the device before distribution in areas where CE Mark is not the regulation in force.
Information contained herein for presentation outside the United States only. ©2015 Abbott. All rights reserved. AP2941102-OUS Rev. A
Absorb Registry Data @ EuroPCR2015
ABSORB First – 958 Patients at 1 Year

14. BVS Expand
2.2%
GHOST EU
2.1%
AMC
3.0%
EVERBIO II
0.0%
ABSORB First
0.4%
ABSORB II
0.9%
BVS Luscher
2.0%
GABI-R
0.4%
POLAR ACS
1.1%
CTO Feasibility
0.0% ASSURE
0.0%
Polish Registry
0.4%
Colombo CCI
0.0%
Australian Registry
0.0%
-0.5%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
3.5%
Apr-14 Jun-14 Jul-14 Sep-14 Nov-14 Dec-14 Feb-15 Apr-15
Absorb Scaffold Thrombosis Results
30 days
6 months
1 year
Retrospective
Prospective
Since GHOST EU
Absorb Scaffold Thrombosis in Perspective
R. Van Guens: BVS Expand Presentation, PCR 2014; D. Capodanno: PCI with BVS in routine clinical practice: GHOST-EU Registry, EuroIntervention 2014; doi: 10.4244/EIJY14M07_11; Kraak: Initial experience and
clinical evaluation of the Absorb BVS in real world practice: AMC Single Center PCI Registry, EuroIntervention 2014; doi: 10.4244/EIJY14M08_08; Cook: EVERBIO II presentation, TCT2014; Serruys: ABSORB II,
Lancet Sept 2014; T. Luscher: Feasibility of second generation BVS implantation in complex anatomical and clinical scenarios; Clinical Research Cardology 2014; Doi 10.1007/s00392-014-0757-4; Prof Christian
Hamm, Prof Holger Nef, Prof Stephan Achenback, Dr. Christoph Naber. Press conference DGK Herbsttagung Oct 10, 2014, Dusseldorf; D. Dudek: Polar ACS Study, Polish Archives of Internal Medicine Oct 2014;
AOP_14_076; J. Worhrle: Beyond the early stages: insights from the ASSURE registry on BVS. EuroIntervention 2014; doi: 10.4244/EIJY14M12_10; B. Vaquerizo: BVS for the treatment of CTOs: CTO-ABSORB Pilot
study; Eurointervention 2014; doi: 10.4244/EIJY14M12_07 ; D. Dudek: Polish Absorb Experience BVS Registry Update, NFIC Conference December 2014; A. Colombo: Comparison of early clinical outcomes
between Absorb BVS and EES In a Real World Population, CCI June 2014. doi: 10.1002/ccd.25569; E. Eeckhout: Absorb First Interim Report on 1800 pt 30 days, AsiaPCR 2015; N. Jepsen: Everolimous-eluting
bioresorbable vascular scaffold implantation in real world, Heart, Lung, and Circulation (2015).02.011.

15. 15
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside
the United States. Please check the regulatory status of the device before distribution in areas
where CE Mark is not the regulation in force. For presentation only outside the United States.
©2014 Abbott. All rights reserved. AP2940371-OUS Rev. A 09/14
ABSORB Data
TLR
0.9%
0.4%
0.8%
3.3%
2.5%
4.1%
1.4%
2.3%
1.2%
2.8%
0.0%
1.1%
4.5%
0.0%
-1.0%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
(1)
30d 6m 1y 2y 3y 4y 5y
(15)
(1) REPARA: All Comers (@EuroPCR2015)
(2) ABSORB FIRST: All Comers (@EuroPCR2015)
(3) GABI-R: All Comers (@EuroPCR2015)
(4) AMC Registry: AC (in Eurointervention 2014)
(5) Dr. Costopoulos on CCI: All Comers (in CCI2014)
(6) ABSORB EXPAND: All Comers (@EuroPCR2014)
(7) CTO (Dr. Serra): CTO (on Eurointervention2014)
(8) ABSORB EXTEND: mod complexity (@ EuroPCR2015)
(9) GHOST-EU: All Comers (@EuroPCR2015)
(10) ABSORB II: selected (on Lancet 2014)
(11) POLAR ACS: ACS (@ EuroPC2014)
(12) ASSURE: All Comers (on Eurointervention2014)
(13) Polish BVS registry: all comers (@NFIC2014)
(14) ABSORB Cohort B: simple (@ EuroPCR2014)
(15) ABSORB Cohort A: simple (@ EuroPCR2011)
(3)
(2)
(4)
(6)
(7)
(2)
(9)
(8)
(10)
(14)
(12)
EFICACIA

16. <100 µm 157 µm
Proxima generación de ABSORB
• Scaffolds bioreabsorbible en la mayoria de los
casos?
……SI pero implantandolo con mimo.

17. Razón a medias tenian…. más nadie en lo cierto estaba…
Estrategia hibrida
Ojeda et al. Am J Cardiol ahead of print