Presentación "Update de los estudios de ABSORB hasta 2014" del Dr. Flavio Ribichini durante la Mesa Redonda sobre Scaffolds reabsorbibles de la XXV Reunión Anual de la Sección de Hemodinámica y Cardiología Intervencionista (SHCI) de 2014 en Córdoba.

1. 16-EH-4-4488-01 06-2014
ABSORB:
OVERVIEW OF CLINICAL
RESULTS.
Flavio Ribichini
Cardiologia Universitaria
Verona, Italia

2. 26-EH-4-4488-01 06-2014
Total Pts Studied n=~599 n~965 n~5,709 n~7,609 n~8,709 n~9,709
2011 2012 2013 2014 2015 2016
ABSORB Japan
n = ~400, Japan Pivotal RCT
Enrollment & Follow-Up 2 Y1 Y
ABSORB China
n = ~440, China Pivotal RCT
Enrollment & Follow-Up 2 Y1 Y
ABSORB II
n = ~501, International RCT
2 Y 3 Y1 YEnrollment & Follow-Up
ABSORB EXTEND
n = ~800, Registry
1 YEnrollment & Follow-Up
ABSORB Cohort B
n = 101; FIM
1 Y 2 Y 3 Y 4 Y 5 Y
ABSORB Cohort A
n = 30; FIM
5 Y
ABSORB FIRST
n = ~1,800, International Registry
Enrollment & Follow-Up 1 Y
Each trial n reflects total patients. Data effective June 2014
*ABSORB IV trial is in the planning stage and subject to change.
ABSORB III
n = ~2,250, US Pivotal RCT
Enrollment & Follow-Up 1 Y 2 Y
ABSORB IV*
n = ~3,000, US RCT
UK Registry
n = 1000, UK Registry
Enrollment & Follow-Up 1 Y
Absorb
Comprehensive AV-Sponsored Clinical Program: >10,000pts
2 Y

3. 36-EH-4-4488-01 06-2014
Investigator Sponsored Trials - Overview and Status Update
Not Sponsored by Abbott Vascular
Randomized Controlled Trials (> 3,500Pts)
Study Title Design Number of
Patients Enrolled
Primary Endpoint Patient FU
(Years)
AIDA All – comers RCT vs Xience 418/2670 2-Yr TVF 5
TROFI II STEMI RCT vs XIENCE 57/190 6-Mo neo-intimal healing score 3
PROSPECT II
ABSORB
RCT vs OMT in unstable
asymptomatic pts
300* 2-Yr IVUS MLA 3
PROACTIVE RCT vs XIENCE 11/20 Peri-Proc Platelet Reactivity 1
VANISH RCT vs XIENCE 30/60 Evolution of myocardial blood
flow values over time
3
EVERBIO II** Non-inferiority RCT EES, vs BES,
vs BVS
240 Not available 9m
ISAR ABSORB
MI**
Randomized, non-inferiority vs EES 260 Percentage diameter stenosis at
6-8 months
1
Update from May 2014
* Enrolment has not started yet
** ISS w/o Abbott Funding – not all information is available

4. 46-EH-4-4488-01 06-2014
Investigator Sponsored Trials - Overview and Status Update
Not Sponsored by Abbott Vascular
Registries (>10,000 Pts)
Study Title Design Number of
Patients Enrolled
Primary Endpoint Patient FU
(Years)
BVS EXPAND All – comers Registry (excl STEMI) 260/300 1 – Yr MACE 5
ASSURE All – comers Registry 180/180 Safety and Efficacy 3
ABSORB CTO Feasibility in CTO 20/20 Safety and Performance 2
PABLOS Feasibililty in Bifurcations 4/30 Device, Procedural, Main and
Side Branch Success
2
IT-DISSAPEARS MVD and Long Lesion Registry 6/1000 Safety and Efficacy 5
GABI-R All – comers Registry 448/5000 Safety and Efficacy 5
REPARA All – comers Registry 41/1500 1- Yr MACE 1
POLAR ACS ACS Registry 100/100 Safety, clinical device, procedure
success and in-hospital MACE
1
France ABSORB Feasibility in de novo lesions 2000* 1 – Yr MACE 1
GHOST** All – comers Registry consecutive and
continuous
enrolment
Target Vessel Failure (TVF) 1
Prague 19** STEMI (STEMI Killip I/II) 79/300 Clinical Outcomes 1
Update from May 2014
* Enrolment has not started yet
** ISS w/o Abbott Funding – not all information is available

5. 56-EH-4-4488-01 06-2014
Study Objective First In Man, Single Arm – safety/performance
Endpoints Typical PCI clinical and imaging endpoints
Treatment
Up to 2 de novo lesions in different epicardial vessels
Reference vessel diameter of 3.0 mm, lesions ≤ 14 mm in length
Device Sizes 3.0 x 18 mm devices
Imaging Follow-Up (Months)
101 subjects
(Non-randomized) 12 sites in Europe, Australia, New
Zealand
24 mo12 mo6 mo 18 mo 36 mo
Group B1 (n = 45)
Group B2 (n = 56)
QCA, IVUS, OCT, IVUS VH
MSCT
ABSORB Cohort B
48 mo 60 mo

6. 66-EH-4-4488-01 06-2014
No new MACE between 1-year and 4-years
No scaffold thrombosis by ARC or Protocol
Non-Hierarchical
30 Days 1 Year 2 Years 3 Years 4 Years
N = 101 N = 101 N = 100* N = 100* N = 99*
Cardiac Death % 0 0 0 0 0
Myocardial Infarction % (n) 2.0(1) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3)
Q-wave MI 0 0 0 0 0
Non Q-wave MI 2.0(1) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3)
Ischemia driven TLR % (n) 0 4.0 (4) 6.0 (6) 7.0 (7) 7.1 (7)
CABG 0 0 0 0 0
PCI 0 4.0 (4) 6.0 (6) 7.0 (7) 7.1 (7)
Hierarchical MACE % (n) 2.0 (2) 6.9 (7) 9.0 (9) 10.0 (10) 10.1 (10)
Hierarchical TVF % (n) 2.0 (2) 6.9 (7) 11.0 (11) 13.0 (13)** 13.1 (13)**
MACE: Cardiac death, MI, ischemia-driven TLR, TVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR
ABSORB Cohort B Clinical Long-term Results
Intention-to-Treat
ABSORB Cohort B – 4 Yr Clinical Results, E. Christiansen, ACC 2014
*One patient lost to FU at 2-year FUP
*One patient missed the 4-year FUP
**Non-TLR TVR at 957 days

7. 76-EH-4-4488-01 06-2014
Study Objective Continued Access trial. FPI: Jan 11, 2011
Endpoints Typical PCI clinical endpoints
Treatment
Up to 2 de novo lesions in different epicardial vessels
Planned overlapping allowed in lesions >22 and ≤ 28 mm
Device Sizes
Scaffold diameters: 2.5, 3.0, 3.5 mm
Scaffold lengths: 12*, 18, 28 mm
Clinical Follow-up (months)
Clinical Follow-Up
MSCT follow up (n=100)
OCT follow up (n=50)
24 mo12 mo6 mo 18 mo 36 mo
* Available in EU only
814 subjects Registry
Up to 100 global (non US) sites
ABSORB Extend

8. 86-EH-4-4488-01 06-2014
Non-Hierarchical % (n) 12 Months 24 Months*
(N = 450) (N = 448)
Cardiac Death % 0.2 0.7
Myocardial Infarction % ** 2.9 4.0
Q-wave MI 0.9 0.9
Non Q-wave MI 2.0 3.1
Ischemia driven TLR % 1.8 3.8
CABG 0.2 0.4
PCI 1.6 3.6
Hierarchical MACE % 4.2 6.7
Hierarchical TVF % 4.7 7.4
Hierarchical TLF % 4.2 6.5
Scaffold Thrombosis (ARC Def/Prob) % 0.9 1.1
*Reflects an interim snapshot of patients with 24 month follow-up as of the cut-off date of 31 Jan 2014
ABSORB EXTEND - Two Year Clinical Outcomes
ABSORB EXTEND 450 pts 2yr, D. Carrié – ACC 2014
ABSORB EXTEND 450 pts 1yr, B. Chevalier – PCR Rotterdam 2013

9. 96-EH-4-4488-01 06-2014
ABSORB EXTEND
Propensity Score Matched Clinical Outcomes: 2 Years
Absorb
(EXTEND, N = 501)
XIENCE V
(N = 628) P Value
NON-HIERARCHICAL COMPONENTS
Cardiac Death % 0.53 1.11 0.30
Myocardial Infarction % 4.50 3.06 0.20
Ischemia Driven TLR % 4.28 3.98 0.80
MACE % 7.57 7.32 0.87
TVF % 8.43 11.34 0.11
TLF % 7.28 6.85 0.78
Scaffold Thrombosis (ARC Def/Prob) % 0.76 1.21 0.45
ABSORB EXTEND 2 yr propensity matched - D. Carrié – PCR 2014

10. 106-EH-4-4488-01 06-2014
Study Objective Randomized against XIENCE PRIME control. FPI 28-Nov-2011
Co-primary
Endpoints
• Vasomotion assessed by change in Mean Lumen Diameter
between pre- and post-nitrate at 3 years (superiority)
• Minimum Lumen Diameter (MLD) at 3 years post nitrate minus
MLD post procedure post nitrate (non-inferiority, reflex to superiority)
Treatment
Up to 2 de novo lesions in different epicardial vessels
Planned overlapping allowed in lesions ≤ 48 mm
501 subjects
(Randomized 2:1 Absorb versus XIENCE PRIME) Up to 40 European sites
Clinical Follow-Up
24 mo6 mo 12 mo 36 mo30 days
QOL follow-up
Angio, OCT, IVUS follow-up
MSCT follow-up (Absorb arm only*)
ABSORB II
Randomized Controlled Trial vs. XIENCE
48 mo 60 mo

11. 116-EH-4-4488-01 06-2014
QOL (PRO)
Angio, IVUS
OCT
~2250 subjects in up to 220 sites (predominantly US)
Lead-in (n≤50); Clinical (n~2000); Imaging (n~200)
PI: Dean Kereiakes, Steve Ellis; Chairman: Gregg Stone
24126 18 36 48 60Follow-Up (Months)
Clinical
Study Objective Randomized against XIENCE control. 2:1. FPI Lead-in 28 Dec 201230
Primary Endpoint Target Lesion Failure at 1 year, non-inferiority to XIENCE (n~2000)
Major Secondary
Endpoints
• Vasomotion assessed by change in angiographic Mean Lumen Diameter
between pre- and post-nitrate at 3 years (superiority)
• Change in Mean Lumen Area by IVUS, from post-procedure to 3 years
(Mean Lumen Area measured post-nitrate, superiority)
Treatment
Up to 2 de novo lesions in different epicardial vessels,
Lesion lengths ≤ 24 mm, RVD ≥ 2.5 mm and ≤ 3.75 mm
Follow-Up (Months) 30 days 6 12 24 48 60Follow-Up (Months) 30 days 6 mo 12 mo 24 mo 36 mo 48 mo 60 mo
ABSORB III – US pivotal Trial
Randomized Controlled Trial vs. XIENCE

12. 126-EH-4-4488-01 06-2014
Study Objective Randomized against XIENCE V 2:1
Primary Endpoint
Clinically indicated target lesion failure at 1-year (composite of cardiac
death, target vessel MI or clinically indicated TLR)
Treatment
Up to two de novo lesions in different epicardial vessels. No planned
overlap allowed
24126 36 48 60Follow-Up (Months)
Clinical follow-up
MSCT
Angiography
IVUS/OCT/Vasomotion
ACh Study
~400 subjects (267 Absorb, 133 XIENCE)
~30 Japan Sites. Follow-up out to 5 years
PI: Takahashi Kimura
30 days 13Follow-Up (Months) 30 days 6 12 13 24 36 48 60
ABSORB JAPAN – Approval Trial
Randomized Controlled Trial vs. XIENCE

13. 6-EH-4-4488-01 06-2014
All-Comers

14. 146-EH-4-4488-01 06-2014
BVS EXPAND (Rotterdam)
Preliminary Results
Dr. van Geuns concluded: “Stent like results with a scaffold”
BVS EXPAND 6 months preliminary results , R.J. van Geuns , EuroPCR 2014
 Single center registry out of Erasmus in the Netherlands
 Measuring MACE after Absorb implantation in routine clinical practice in
patients with NSTEMI, stable or unstable angina, or silent ischemia
6 Months Results N=180
MACE 3.3% (6/180)
Cardiac death 1.5% (3/200)
Any reMI 1.7% (3/180)
TLR 2.2% (4/180)
(Non-TLR)-TVR 0% (0/180)
Non-TVR 0.6% (1/180)
Def/prob ST 2.2% (4/180)
All
(N=200, L=275))
MVD 77(38,5%)
Bif 80/275 (29.1%)
CTO 16/275 (5.8%)
STEMI 0 (0%)
Overlap 88/275 (32.0%)
Scaffolds per
procedure
1.95

15. 156-EH-4-4488-01 06-2014
ASSURE (Germany)
Twelve Months Clinical Results
• Multi-center registry in Germany
• Investigating performance of Absorb in all-comers
Twelve Months ASSURE, T. Schmitz, PCR 2014
Baseline Charactaristics N=183
Hypertension 82.0%
Diabetes 25.7%
Dyslipidemia 76.0%
Angina (not stable) 27%
ACC/AHA B2 or C lesions 64.6%
Moderately to heavy Ca-lesions 15.7%
Diameter stenosis 64.4%
12 Months Results N=183
Death 0.5%*
Target lesion revascularization** 2.8%
Myocardial infarction*** 1.6%
MACE 5%
*Patient died due to major gastrointestinal bleeding
** Restenosis in complex lesions
*** MI’s were caused by non-TVF
Dr. Schmitz„ conclusion: One-year ASSURE results suggest that BVS for de novo
coronary artery disease are associated with favorable clinical and functional
outcomes in all day clinical practice without mandatory IVUS or OCT guidance

16. 166-EH-4-4488-01 06-2014
Polish BVS Registry
• 592 patients in 30 Polish hospitals (enrolment between Sep 2012 and Nov 2013)
• Preliminary analysis on 407 patients
48%
23%
16%
13%
0
10
20
30
40
50
60
stable angina unstable angina NSTEMI STEMI
Acute Coronary Syndrome
Clinical Presentation
Polish BVS Registry Patient Profile and Device Performance, D. Dudek NFIC 2013

17. 176-EH-4-4488-01 06-2014
3,7%
0,25% 0,25%
0,0%
1,0%
2,0%
3,0%
4,0%
5,0%
6,0%
dissection no-reflow SB occlusion
Polish BVS Registry
PCI Complications
Polish BVS Registry Patient Profile and Device Performance, D. Dudek NFIC 2013

18. 186-EH-4-4488-01 06-2014
Ghost Registry (C. Tamburino)
 Single Center registry in Italy
 Investigating performance of Absorb in all-comers
Clinical Presentation
&
Lesion Characteristics
BVS
289 Pts
367 Lesions
ACS 50.2%
ACC/AHA B2/C Lesions 49.6%
Bifurcations 15.8%
In-stent restenosis 5.7%
CTO 9.0%
Left Main 2.2%
Ostial 3.3%
Procedural Information BVS
289 Pts
367 Lesions
Predilation 95.9%
Postdilation 61.6%
Ghost Registry, C. Tamburino, PCR 2014

19. 196-EH-4-4488-01 06-2014
Ghost Registry (C. Tamburino)
Preliminary 6 Months Results
4
1
2
5
0
1
2
3
4
5
6
7
8
< 1 month 1 - 3 months 3 - 6 months 6 - 12 months
Absolutenumberofevents
1 TLR *
1 Acute ST **
2 Death (1 CV***)
1 TLR
1 non-TVR
4 TLR
1 non-TVR
* Definite ARC ST at 25 days due to DAPT discontinuation
** Definite ARC Acute ST due to a BVS proximal dissection
*** Sub-acute probable ST at d26
1 non-TVR
Ghost Registry, C. Tamburino, PCR 2014

20. 206-EH-4-4488-01 06-2014
ABSORB First
Objective: Evaluate the safety of Absorb in all-day clinical practice by measuring MACE
Design: Prospective, Single Arm Registry, in 1800 pts, in about 90 sites in EMEA, APAC, LA
Primary Endpoint:
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac
death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven:
and emergent bypass surgery
Secondary Endpoints: Device and procedure success
Ischemia Driven TVF, TLR, ST, Patient and Physician Questionnaire at 12 months
Clinical follow-up
1yr
Primary
Endpoint
Absorb

21. 216-EH-4-4488-01 06-2014
ABSORB First
Preliminary 30 Day Safety Results on First 800 Patients
Clinical Presentation
&
Lesion Characteristics
800 Patients
MVD (≥ 2) 46.1%
Lesion Length ≥ 20 mm 37.7%
Acute MI 25.8%
Mod/Sev Calcification 20.4%
Total Occlusion 10.5%
Bifurcation 11.9%
Ostial 6.0%
Absorb First, Acute Perromance Interim Update on 800 Patients, E. Eeckhout, PCR 2014
Interim Clinical Outcomes
Data snapshot as of May 6th, 2014
ABSORB
FIRST
N=800
All Death 0.0%
Cardiac Death 0.0%
Scaffold Thrombosis
(Definite/Probable)
Early (0-30 days) 0.3%
Acute (< 1 day) 0.0%
Sub-acute (1-30 days) 0.3%

22. 226-EH-4-4488-01 06-2014
Objective: Compare the efficacy and performance of ABSORB vs.
XIENCE Prime/Xpedition
Design: Prospective, randomized (1:1), active control, single blinded,
multiple centers, all-comers, non-inferiority trial, in about 2200 pts in 4 Dutch
sites
Primary Endpoint: Composite endpoint Target Vessel Failure (TVF) at 2 years:
 Cardiac death
 Myocardial infarction (MI) according to Third Universal Myocardial Infarction
definitions (unless clearly attributable to a non-target vessel)
 Target Vessel revascularization
Secondary Endpoints:
• Device success
• Procedural success
• Scaffold/Stent Thrombosis
• Target lesion failure
• All coronary revascularizations
• MACE & QoL
ABSORB
N= 1,345
Prime/Xpedition
N= 1,345
Clinical follow-up
30dy 6mo 1yr 2yr 3yr 4yr 5yr
Primary Endpoint
AIDA (Netherlands)
AIDA trial: A clinical evaluation comparing the efficacy and performance of ABSORB everolimus eluting
bioresorbable vascular scaffold strategy versus the XIENCE-family everolimus eluting coronary stent strategy
in the treatment of coronary lesions in consecutive all-comers: Rationale and study design. P. Woudstra, Am
Heart J. 2014 Feb;167(2):133-40

23. 236-EH-4-4488-01 06-2014
GABI-R (Germany-Austria)
Objective: Evaluate the Short and Long-term Safety and Therapy Outcomes of EE-BVS Absorb
in patients with CAD.
Design: Prospective, multi-center, Observational German/Austrian registry, in 5000 pts, in
about 100 sites
Primary Endpoint: Clinical endpoints at 9 months
Secondary Endpoints: MACE, TVF, Death, MI, ST, Stroke, Angina, QoL, direct and indirect costs at 9,
months, 2 and 5 years.
30 day 6 mo 24 mo 60 mo
Primary Endpoint
Absorb
Clinical follow-up

24. 246-EH-4-4488-01 06-2014
REPARA (Spain)
Objective: Evaluate the safety and efficacy of BVS usage in real world patients under
well-controlled implementation criteria.
Design: Prospective, Open-Label, Multi Center, Iberian registry in 1500 Pts, 60 Spanish sites
Primary Endpoint: MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac
death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven:
Cardiac Death/All MI/ID-TLR
Secondary Endpoints: Components: Death (Cardiovascular, Non-Cardiovascular), Myocardial Infarction
(MI: QMI and NQMI, TV,…), Angina, DAPT rates and relationship to events
Clinical follow-up
30 day 6 mo 12 mo
Primary Endpoint
Absorb

25. 256-EH-4-4488-01 06-2014
France ABSORB
Objective: Evaluate the safety of Absorb in all-day clinical practice by measuring MACE
Design: Prospective, Multi Center, Observational Registry in 2000 Pts, 40-50 sites
Primary Endpoint:
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac
death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven:
and emergent bypass surgery
Secondary Endpoints: Device and procedure success
Death, MI, Target Vessel and non-Target Vessel MI, TLR, TVR, ST, Stroke, and
angina at 12 months
Clinical follow-up
12 mo
Primary
Endpoint
Absorb

26. 266-EH-4-4488-01 06-2014
UK Registry
Objective: Evaluate the safety of Absorb in all-day clinical practice by measuring MACE
Design: Prospective, Multi Center, Observational Registry, in 1000 pts, in 15-30 sites
Primary Endpoint:
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac
death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven:
and emergent bypass surgery
Secondary Endpoints: Device and procedure success
Death, MI, Target Vessel and non-Target Vessel MI, TLR, TVR, ST, Stroke, and
angina at 12 months
Clinical follow-up
12 mo
Primary
Endpoint
Absorb

27. 276-EH-4-4488-01 06-2014
Objective: Investigate short-and long-term clinical performance of Absorb in MVD (at
least 2≠ epicardial vessels) or long single vessel disease (>24mm)
Design: Prospective, multi-centre, Italian registry, in 1000 pts, in 50-80 sites
Primary Endpoint: Major Adverse Cardiac Event (MACE): Composite of ischemia driven target lesion
revascularization (TLR), non-fatal myocardial infarction and cardiac death
Secondary Endpoints: Scaffold thrombosis
All cause and Cardiac death
Myocardial infarction
Ischemia driven target lesion revascularization (TLR).
Major Adverse Cardiac Event (MACE):
Ischemia driven target vessel revascularization (TVR)
Any type of angina post-procedure
Clinical follow-up
30dy 6mo 1yr 2yr 3yr 4yr 5yr
Primary Endpoint
Absorb
IT-DISSAPEARS (Italy)

28. 6-EH-4-4488-01 06-2014
ACS, STEMI and NSTEMI

29. 296-EH-4-4488-01 06-2014
Clinical Outcomes in ACS (T. Gori)
 Single center in Germany
 Study Objective: Performance of Absorb in ACS
Clinical
Presentation
BVS
150 Pts
194 BVS
DES
103 Pts
129 Stents
Unstable Angina 16% 19%
NSTEMI 40% 45%
STEMI 44% 36%
Single vessel
disease
43% 36%
2 – or 3-vessel
disease
57% 64%
In Hospital outcome BVS
150 Pts
194 BVS
DES
103 Pts
129 Stents
Death 0.7% 1.0%
Non-fatal MI 2.1% 1.0%
Non-TLR 0.0% 0.0%
Def ST 1.4% 1.0%
One month outcome
Death 1.4% 2.9%
Non-fatal MI 4.0% 3.9%
Non-TLR 6.6% 6.9%
Def ST 2.0% 1.9%
Prob ST 0.7% 1.0%
Early Outcome after BVS in ACS;T. Gori, EuroIntervention 2013

30. 306-EH-4-4488-01 06-2014
Polar ACS (D. Dudek)
Polish multicenter registry in 100 ACS patients
To evaluate safety, clinical device and procedure success in ACS
patients.
Clinical Presentation 100 Patients
STEMI 16%
NSTEMI 38%
Unstable Angina 46%
Procedure
Characteristics
Lesions
Aspiration thrombectomy 13%
Pre-dilation 93%
Direct Scaffolding 7%
Post-dilation 38%
POLAR ACS The MultiCenter Registry in Poland, D. Dudek, PCR 2014

31. 316-EH-4-4488-01 06-2014
Polar ACS (D. Dudek)
12 Months Results
12 Months Results 94 Patients
Death 0% (0/94)
Myocardial Infarction* 3.2% (3/94)
TVR 1.1% (1/94)
Non-TVR 1.1% (1/94)
Hospitalization for HF 1.1% (1/94)
Definite ST** 1.1% (1/94)
Probable ST 0.0% (0/94)
Possible ST 0.0% (0/94)
POLAR ACS The MultiCenter Registry in Poland, D. Dudek, PCR 2014
* 2 Peri-Procedural at index PCI and 1 during 30 day FU
** Patient did not take any medications after discharge. Definite stent thrombosis in BVS confirmed by angiography
several days (within 30-days) after index hospital discharge.

32. 326-EH-4-4488-01 06-2014
PRAGUE 19 (P. Widimsky)
Clinical Outcomes to Date
Number of patients available for follow-up in BVS/Control group
is 40/57 at discharge, 36/48 at 1 month and 17/25 at 6 months.
BVS vs. other stent: cardiac death, myocardial
infarction, TVR
Outcomes to date
70 pts > 1 mo, 52 pts > 6 mo, 21 pts > 12 mo
N = 76
Overall mortality 1/76*
Re-infrarction 1/76**
Scaffold thrombosis 1/76
Stroke 3/76
Clinical restenosis 0/76
*1 patient with anterior STEMI treated 18 hours after symptom
onset died due to septal rupture occurring 4 hours after P-PCI
** 1 BVS thrombosis 3 days after stopping ticagrelor, 10 days
after hospital discharge
 Single center registry from Czech Republic
 Analyze feasibility and safety of Absorb in STEMI patients (Killip class I and II)
Bioresorbable vascular scaffolds in acute STEM (PRAGUE-19 study), P. Widimsky, PCR 2014

33. 336-EH-4-4488-01 06-2014
Thrombectomy +/- pre-dilatation
(based on angiographic guidance)
190 pts with STEMI <24hrs
R
Clinical FU: 30 d, 6 mo, 1 yr, 2 yr, 3 yr
6 months: Angio + OCT
DAPT: 12 months
1:1
ABSORB_STEMI: the TROFI II study
Absorb EES XIENCE EES
Sizing Dmax
Saffolding (BVS) Stenting (DES)
Primary Endpoint: Healing Score at months
M. Sabaté, BVS Summit – Berlin 2013

34. 6-EH-4-4488-01 06-2014
CTO

35. 356-EH-4-4488-01 06-2014
CTO Feasibility Registry (A. Serra)
 Single center feasibility in Spain
 Safety and efficacy in 35 CTO unselected patients
Clinical Results 1 Mo FU
(n=35)
6 Mo FU
(n=33)
Overall Death 0 0
Cardiac Death 0 0
MI 0 0
TLR 0 0
MACE 0 0
Scaffold
Thrombosis
0 0
Lesion and Procedural
Characteristics
N=35
J-CTO score 0 25.6% (9)
J-CTO score 1 48.6% (17)
J-CTO score 2 8.6% (3)
J-CTO score ≥ 3 17.2% (6)
Occlusion length 18.6 mm
Target lesion length 35.9 mm
Total scaffold length/lesion 52.5 mm
Number of scaffolds/lesion 2.2
Cutting balloon predilatation 71.4%
Post-dilatation 62.9%
BVS - Coronary CTO – 6 months results, A. Serra, PCR 2014
12 Months OCT

36. Que nos interesa saber de la VRT?
1.Que no sea peor!
2.Si es igual…
3.Si puede ser mejor!

37. • ANTOPOLOGICO/SOCIAL: Expectativa de vida de 50
anios con un stent en el corazòn.
• MEDICO PRACTICO: Regresion de una infiltraciòn
arterioesclerotica difusa a un buen vaso funcionante.
• MEDICO FUTURO: Prevenciòn de la progresion
arterioesclerotica hacia eventos agudos (ACS) y
evoluciòn a enfermedad cronica compleja (MVD).
• CULTURAL: Inevitable tendencia de la ciencia hacia la
modernidad….
Como y porque puede ser mejor?
Racional:

38. • ANTOPOLOGICO/SOCIAL: Expectativa de vida de 50
anios con un stent en el corazòn.
• Pacientes biologicamente jòvenes:
Como y porque puede ser mejor?
Racional:

39. • 43 years old male
• No cardivascular precedents
• Chest pain while cycling
• Anterior STEMI, referred to the ER by 118
• Pre-hospital delay 45 minutes
• In hospital delay 15 minutes
• Total ischemic time 55 minutes
A young patient with STEMI

41. Thromboaspiration
with Export.
Immediate symptoms
and ST resolution

43. Direct
implantation
of a BVS
3.5x18 mm

45. Con la completa normalizaciòn de la funciòn ventricular,
y la reabsorciòn completa del scaffold en la DA,
este hombre de 43 anios no tendrà rastros ni de su infarto,
ni de su tratamiento a los 47…
Y se espera que viva otros 50 anios, sin llevar una
protesis permanente en el corazòn.
El paciente jòven con STEMI.

46. • MEDICO PRACTICO: Regresion de una infiltraciòn
arterioesclerotica difusa a un buen vaso funcionante.
• La enfermedad coronaria difusa:
Como y porque puede ser mejor?
Racional:

47. PG, 45 years old
Hypertensive, and smoker.
Strong family history for CAD-MI
Persistent chest pain with diffuse ST-segment depression in
the anterior leads
Pre-treated with ASA 100mg and Clopidogrel 600mg

51. LAD after multiple balloon dilatations from the proximal to the distal segment

52. LAD after implantation of 5 BVS with occlusion of the diagonal branch

56. La DA es el vaso mas importante por pronostico a largo
plazo.
La enfermedad difusa de la DA es un limite de los DES
actuales, y tambièn de la cirugia cardiaca.
Se trata de un real unmet clinical need
La reconstrucciòn de la pared vascular despuès del
absorbiemiento de los scaffolds podrìa tener un enorme impacto
clinico.

57. 2 years
3 years
4 years
HE staining
Alcian Blue
Movat
Alcian Blue
3.9mm2
1-3Y
VA =
PA ↓
LA ↑
ABSORB B

58. Primary Endpoint: Minimal Lumen Area (MLA) at 2 years and TLF at 2 years
Secondary Endpoints: MACE up to 2 years, IVUS and NIRS parameters
Clinical follow-up
30 day 6 month 1 year 2 year 3 year
Primary Endpoint
Angiogram
Absorb + GMDT
N=150
GMDT
N=150
PROSPECT ABSORB is an investigator initiated multicenter, randomized trial, which for the
first time will evaluate the ability of a bioresorbable scaffold to safely increase luminal
dimensions of vulnerable plaque
“PROSPECT ABSORB will test the feasibility of an interventional approach in preventing future
major adverse events arising from plaques which appear angiographically innocuous but are in fact
the source of future acute coronary syndromes" - Dr. Stone
Patients with plaque at high risk of causing future coronary events (plaque burden ≥70%)
GMDT: Guideline Directed Medical Therapy
PROSPECT II Absorb (J. Erlange & G. Stone)
Demonstration Clinical Superiority with BVS - ABSORB III and IV Clinical Trial Program G. Stone, TCT 2013

59. Como y porque puede ser mejor?
Racional:

60. • MEDICO FUTURO: Prevenciòn de la progresiòn
arterioesclerotica en eventos agudos (ACS) y
evolucion a enfermedad cronica compleja (MVD)
Como y porque puede ser mejor?
Racional:

61. • Patient: 54 years-old, Male
• Risk Factors: Grade II arterial hypertension, moderate smoker
• No relevant comorbidities or heart problems in the past
• Clinical presentation: Access to the ER due to chest pain
• Parameters: BP: 110/60mmHg; HR: 80bpm.
• ECG: inferior STEMI without q waves

62. Occluded proximal RCA – diagnostic angio

63. LAD– diagnostic angio

64. RCA – Final Angio after 1BVS 3.5x28mm post expanded with 4.0mm balloon

65. PB/MLA= 74%
MLA= 4.1mm2
VH SECTIONS
LAD- From distality
distal
proximal
Pre-discharge assessment of the LAD lesion

66. LAD - PCI
Final LAD result after 1BVS 3.5x18mm

67. Bioresorbable Scaffolds –
A Template for Capping Plaque
Plaque
core
Cap The neomedia post
implantation of Absorb
resembles a thick, fibrous cap
known for contribution to
plaque stability1
1Brugaletta, S, et al. Atherosclerosis. 2012; volume 221, issue 1
Would a thinner cap be less stable long term?

68. • CULTURAL: Inevitable tendencia de la ciencia hacia la
modernidad….
• Una protesis de femur en titanio o platino…. o
absorbible…?
• Un corazòn artificial en acero inoxidable…. o
celulas mesenquimales…?
• Subirse a un helicoptero en el 1500dc?
Como y porque puede ser mejor?
Racional:

69. El helicoptero de Leonardo

70. Genial o insano?
o simplemente
“momentaneamente
fuera del contexto”
GRACIAS