Update de los estudios de ABSORB hasta 2014 - Dr. Flavio Ribichini

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ABSORB:

OVERVIEW OF CLINICAL

RESULTS.

Flavio Ribichini

Cardiologia Universitaria

Verona, Italia

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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 Japann = ~400, Japan Pivotal RCT

Enrollment & Follow-Up 2 Y1 Y

ABSORB Chinan = ~440, China Pivotal RCT

Enrollment & Follow-Up 2 Y1 Y

ABSORB IIn = ~501, International RCT

2 Y 3 Y1 YEnrollment & Follow-Up

ABSORB EXTENDn = ~800, Registry

1 YEnrollment & Follow-Up

ABSORB Cohort Bn = 101; FIM

1 Y 2 Y 3 Y 4 Y 5 Y

ABSORB Cohort An = 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 IIIn = ~2,250, US Pivotal RCT

Enrollment & Follow-Up 1 Y 2 Y

ABSORB IV*n = ~3,000, US RCT

UK Registryn = 1000, UK Registry

Enrollment & Follow-Up 1 Y

AbsorbComprehensive AV-Sponsored Clinical Program: >10,000pts

2 Y

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Investigator Sponsored Trials - Overview and Status UpdateNot 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

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Investigator Sponsored Trials - Overview and Status UpdateNot 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

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Study Objective First In Man, Single Arm – safety/performance

Endpoints Typical PCI clinical and imaging endpoints

TreatmentUp to 2 de novo lesions in different epicardial vesselsReference 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

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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 ResultsIntention-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

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Study Objective Continued Access trial. FPI: Jan 11, 2011

Endpoints Typical PCI clinical endpoints

TreatmentUp to 2 de novo lesions in different epicardial vesselsPlanned overlapping allowed in lesions >22 and ≤ 28 mm

Device SizesScaffold diameters: 2.5, 3.0, 3.5 mmScaffold 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 RegistryUp to 100 global (non US) sites

ABSORB Extend

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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

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ABSORB EXTENDPropensity 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

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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)

TreatmentUp to 2 de novo lesions in different epicardial vesselsPlanned 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

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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)

TreatmentUp 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

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Study Objective Randomized against XIENCE V 2:1

Primary EndpointClinically indicated target lesion failure at 1-year (composite of cardiac death, target vessel MI or clinically indicated TLR)

TreatmentUp 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

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All-Comers

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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

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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

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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

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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 RegistryPCI Complications

Polish BVS Registry Patient Profile and Device Performance, D. Dudek NFIC 2013

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Ghost Registry (C. Tamburino)

Single Center registry in Italy

Investigating performance of Absorb in all-comers


&

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

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Ghost Registry (C. Tamburino)Preliminary 6 Months Results

4

12

5

0

1

2

3

4

5

6

7

8

< 1 month 1 - 3 months 3 - 6 months 6 - 12 months

Absolu

te n

um

be

ro

f events

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

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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

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ABSORB First

Preliminary 30 Day Safety Results on First 800 Patients


&

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 OutcomesData 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%

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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

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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

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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


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

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France ABSORB


Design: Prospective, Multi Center, Observational Registry in 2000 Pts, 40-50 sites





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

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UK Registry


Design: Prospective, Multi Center, Observational Registry, in 1000 pts, in 15-30 sites





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

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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)

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ACS, STEMI and NSTEMI

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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

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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

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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.

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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, TVROutcomes to date70 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

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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

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CTO

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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

Que nos interesa saber de la VRT?

1. Que no sea peor!

2. Si es igual…

3. Si puede ser mejor!

• ANTOPOLOGICO/SOCIAL: Expectativa de vida de 50 anios con un stent en el corazòn.

• MEDICO PRACTICO: Regresion de una infiltraciònarterioesclerotica difusa a un buen vaso funcionante.

• MEDICO FUTURO: Prevenciòn de la progresionarterioesclerotica 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:

• ANTOPOLOGICO/SOCIAL: Expectativa de vida de 50 anios con un stent en el corazòn.

• Pacientes biologicamente jòvenes:


Racional:

• 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

Fig 5.

Thromboaspirationwith Export.Immediate symptomsand ST resolution

Direct implantationof a BVS3.5x18 mm

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.

• MEDICO PRACTICO: Regresion de una infiltraciònarterioesclerotica difusa a un buen vaso funcionante.

• La enfermedad coronaria difusa:


Racional:

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

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

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

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.

2 years

3 years

4 years

HE staining

Alcian Blue

Movat

Alcian Blue

3.9mm2

1-3YVA =PA ↓LA ↑

ABSORB B

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 EndpointAngiogram

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


Racional:

• MEDICO FUTURO: Prevenciòn de la progresiònarterioesclerotica en eventos agudos (ACS) y

evolucion a enfermedad cronica compleja (MVD)


Racional:

• 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

Occluded proximal RCA – diagnostic angio

LAD– diagnostic angio

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

PB/MLA= 74%

MLA= 4.1mm2

VH SECTIONS

LAD- From distality

distal

pro

xim

al

Pre-discharge assessment of the LAD lesion

LAD - PCI

Final LAD result after 1BVS 3.5x18mm

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?

• 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?


Racional:

El helicoptero de Leonardo

Genial o insano?

o simplemente

“momentaneamente

fuera del contexto”

GRACIAS

Health & Medicine

Update de los estudios de ABSORB hasta 2014 - Dr. Flavio Ribichini