1. Why I Don’t Believe in BRS as the Future Scaffold Technology
Keith Dawkins MD FRCP FACC FSCAI
Global Chief Medical Officer
Executive Vice President
Boston Scientific Corporation

2. Conflict of Interest
Boston Scientific Corporation
Employee
Stockholder

3. The BRS Story
Now that you have that new very expensive disappearing stent that you can’t see, I assume that you have no more chest pain Mr. Jones…?

4. Is BRS a stairway to Heaven…
…or will it remain a niche product?

5. The BRS Story….
…nothing left behind, a laudable goal

6. BRS Share Determines Investment Thesis
Niche  Pass
Workhorse  Invest $1.5B OR
10%
40%
Source: Eucomed (FY 2014 – Estimate)
FRS Share (%)

8. The BRS Story so far… Thrombosis Rigid Fracture Malapposition Recoil
Low Radial Strength
Poor Visualization
Thrombosis
Malapposition
Infarction
Fracture
Displacement
Death
Restenosis
Recoil
Thick
GHOST
Migration
Cost
Rigid
Pain?
Chest
Lesion Preparation
Limited Matrix
Particulates
Where there's hope, there's life…
Anne Frank: The Diary of a Young Girl

9. BVS: Novel Concept, First Generation Technology
CYPHER® CE-Mark
April 15, 2002
BVS CE-Mark
January 1, 2011
Strut Thickness
152.6µm2 (inc. polymer)
Strut Thickness
157µm x 200µm PLLA
SYNERGY

10. Malapposition, dislodgement, fracture, thrombosis
Are First generation Fully Bioerodable
Stents Fit For Purpose…?
Malapposition, dislodgement, fracture, thrombosis

11. BVS: Stent Thrombosis (GHOST Registry)
1189 patient single arm, ‘Real World’ registry of the ABSORB BVS at 10 European Centers
Low Complexity (SYNTAX Score = 11.3 ±7.9; A/B1 = 48.8%)
Annualized TLF = 10.1%
Annualized Definite/Probable ST = 3.4%
Capoddano D: EuroInterv 2014:10-online publish-ahead-of-print

12. Real-World BVS ST Rates
STUDY
PATIENTS
ST RATE
Jaguszewski***
106
2.1%
Mainz
150
2.7%
RAI Registry* 74
AMC Registry***
135
3.0%
GHOST Registry
1189
3.4%**
*STEMI Population, **Annualized Rate, ***Def ST Only
GHOST: Capodanno, et al. EuroIntervention 2014; Mainz: Gori, et al. EuroIntervention 2013; RAI: lelasi, A. EuroPCR 2014; AMC Registry: Kraak, et al. Eurointervention2014; Jaguszewski, et al. Clin Res Cardiol Results from different studies are not directly comparable. Information provided for educational purposes only.

13. All-Comers Populations
ST Rates: EES & BVS
BVS All-Comers
Populations
XIENCE CoCr EES
PROMUS PtCr EES
ABSORB BVS
ABSORB BVS (6-months)
3.4
BVS Selected
Populations
Ghost
AMC
RAI
Mainz
Expand
Jaguszewski
EXTEND
ABSORB II
Cohort B
HOST ASSURE
PE-PROVE
DUTCH PEERS
PLATINUM +
TWENTE
COMPARE
EXAMINATION
2.1
All-Comers Populations N=

14. Proposed Algorithm for the Treatment of Early Scaffold Thrombosis
Tamburino C: EuroIntervention 2015;10-online publish-ahead-of-print January 2015

15. Possible Causes of High ST Rates with BVS
Poor lesion Preparation
Thick Struts
Non-laminar Flow
Geographic Miss
Edge Dissection
Inadequate Post-Dilatation
Malapposition
Delayed Healing
Fracture

16. Not All Fractures are Visible on OCT
BVS Fracture is Common
Not All Fractures are Visible on OCT

17. Premature low-pressure BVS Fracture compared with Elixir DESolve & Xience Xpedition
Ormiston JA: EuroIntervention 2015;10-online publish-ahead-of-print February 2015

18. Post-dilatation balloon diameter & percentage of 3
Post-dilatation balloon diameter & percentage of 3.0 mm diameter devices with strut fracture
Ormiston JA: EuroIntervention 2015;10-online publish-ahead-of-print February 2015

19. Bioresorbable Drug-Eluting Stents
An Immature Technology in Need of Mature Application
1.5 -
1.0 -
0.5 -
0.0 -
Stent Thrombosis (%)*
*Rates refer to pooled data analysis on adjudicated definite stent thrombosis from published registries with more than 100 treated patients, the ABSORB-II randomized trial, the BVS EXAMINATION study, and EVOLVE II
Byrne RA: JACC Interv 2015;8:
Kereiakes DJ: Circ Cardiovasc Interv 2015 (submitted)

20. ABSORB-II: Interim 1-year Analysis
Co-Primary End-points:
Vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years)
Difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years
Serruys PW: Lancet 2015;385:43-54

21. ABSORB-II: Interim 1-year Analysis
Seattle Angina Questionnaire (SAQ)
No significant difference in angina
between ABSORB BVS and XIENCE
Unvalidated post hoc analysis.
Time to first occurrence and duration. 8.7% difference in favor of BVS, p=0.04
Serruys PW: Lancet 2015;385:43-54

22. BSC is Interested in the Space
FAST Program
Expanded (3.0x16 mm) FRS
Distribution Agreement
Equity Position

23. Conclusions
‘Nothing left behind’ is conceptually appealing both to patients and their physicians
BVS acute performance is suboptimal
BVS has been advocated to a broad patient population, with a paucity of robust clinical supportive data
Complications associated with BVS preclude its use as a workhorse product
The ultimate role of Bioresorbable Scaffolds in everyday clinical practice remains uncertain