Stents farmacoactivos metálicos vs Scaffolds bioreabsorbibles

• Scaffolds bioreabsorbible en la mayoria de los casos

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© 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© 2014 Abbott

Best in Class DES Demonstrate Year over Year Increase in Clinical Events

Long-term Landmarked Event Rates

G. Stone, TCT 2011

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%

Diferencias entre los stents farmacoactivos metálicos y el BVS

GROSOR

ANCHURA DEL STRUT

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

Registries

9

4Cities n~1,300, International Registry

Enrollment & Follow-Up 1 Y

2011 2012 2013 2015 2016 2014

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<2.5/2.9mmMLA<4.9/6.6mm2

Prof. Gori – Lessons from Registries

Zona de inexpansión

APTC NC 3 mm 25atm

Predilatacion

2.5 mm BVS 3x28 m

APTC NC 3.5 mm a 40 atm

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

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

Apr-14 Jun-14 Jul-14 Sep-14 Nov-14 Dec-14 Feb-15 Apr-15-0.5%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

BVS Expand2.2%

GHOST EU 2.1%

AMC3.0%

EVERBIO II 0.0%

ABSORB First 0.4%

ABSORB II 0.9%

BVS Luscher2.0%

GABI-R0.4%

POLAR ACS1.1%

CTO Feasibility0.0% ASSURE

0.0%

Polish Registry 0.4%

Colombo CCI0.0%

Australian Registry 0.0%

Absorb Scaffold Thrombosis Results

30 days 6 months 1 yearRetrospectiveProspective

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.

15Absorb 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 DataTLR

-1.0%

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

83000.0%

180100.0%

162700.0%

9000.0%

18000.0%

147700.0%

95800.0%

81200.0%

33500.0%

18000.0%

3500.0%

9000.0%

2900.0%

4500.0%

(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

<100 µm 157 µm

Proxima generación de ABSORB

• Scaffolds bioreabsorbible en la mayoria de los casos?……SI pero implantandolo con mimo.

Razón a medias tenian…. más nadie en lo cierto estaba… Estrategia hibrida

Ojeda et al. Am J Cardiol ahead of print