1. Real world usage of BVS in Europe
Corrado Tamburino, MD, PhD
Chief of Cardiovascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy

2. Corrado Tamburino, MD I have the following financial relationships:
I have the following financial relationships:
Speaker honoraria Abbott Vascular, Medtronic,
Advisory Board: Abbott Vascular, Medtronic
Stockholder: Edwards

3. Coronary stent approval pathways in Europe and in the US
Byrne RA et al. Eur Heart J 2015;36:2608–2620.

4. Bioresorbable scaffolds
Commercially Available
Reva
ReZolve
Biotronik
DREAMS-2
Abbott Vascular
Absorb
ART
Amaranth
Fortitude
Elixir
DESolve
Template Thickness
Tyrosine-derived Polycarbonate
PLLA
PLA-based
PDLA
PLLA
Magnesium
Template Thickness
~150 m
~150 m
~122 m X 2
~160 m
~150 m
~125 m
Support Time
6 months
3 – < 6 months
~6 months
 3 months
3 – 6 months
 3 months
I2DAT, I2DT,
PCL, Tyrosine
Degradation Products
Soft Hydroxyapatite
H2O & CO2
H2O & CO2
H2O & CO2
H2O & CO2
Resorption Time
< 36 months
18 – 24 months
~ 36 months
~18 months
> 48 months
9 – 12 months
(slow)
(fast)
(slow)
(very fast)
(very slow)
(very fast)

5. Absorb Studies Real World and complex patient populations
Randomized Controlled Clinical Trial
Absorb Studies Real World and complex patient populations
ALL-COMERS
COMPLEX POPULATIONS
GABI-R
Design: All-comers registry
N=5000
1˚: Safety & efficacy
AIDA
Design: RCT vs XIENCE
N=2690
1˚: 2-year TVF
POLAR-ACS
Design: ACS registry N=100
1˚: Safety, clinical device, procedure, success & in-hospital MACE
ABSORB CTO
Feasibility: CTO
N=35
1˚: Safety & performance
FEAST Russia Registry
Design: All-comers registry
N=2500
1˚: 1-year MACE, TVF, Revascularization, ST, Peri-procedural MI, Angina
FRANCE ABSORB
Feasibility: De novo lesions
N=2000
1˚: 1-year MACE
PABLOS
Feasibility: Bifurcations
N=30
1˚: Device, procedural, main & side branches
ISAR ABSORB MI
Design: Non-inferiority vs EES
N=260
1˚: % diameter stenosis at 6-8 months
ABSORB FIRST
Design: Prospective, multi-center, global registry N= ~1800
1˚: ST, CD, MI, revascularization, MACE, TLF, & TVF
REPARA
Design: All-comers registry
N=1500
1˚: 1-year MACE
IT-DISAPPEARS
Design: MVD and Long Lesion Registry N=1000
1˚: Safety & efficacy
PRAGUE 19
Design: STEMI (STEMI Killip I/II)
N=100
1˚: Clinical outcomes
BVS EXPAND*
Design: All-comers registry
N=300
1˚: 1-year MACE
GHOST EU
Design: All-comers registry
N=continuous enrollment
1˚: TVF
COMPARE ABSORB
Design: High risk for ISR N=2100
1˚:TLF
TROFI II
Design: STEMI vs XIENCE
N=190
1˚: 6-month, neo-intimal healing score
Kuwait Registry
Design: All-comers registry
N=200
1˚: Safety & efficacy
EVERBIO II
Design: Non-inferiority
RCT EES vs BES vs BVS
N=240
1˚: Late lumen loss at 9 months
PROSPECT
Design: RCT BVS vs OMT in unstable asymptomatic pts N=900
1˚: 2-Yr IVUS MLA
ASSURE
Design: All-comers registry
N=180
1˚: Safety & efficacy
UK REGISTRY
Design: Prospective, single-arm, multi center, observational registry
N= 1000
1˚: RDS < 50% at procedure conclusion, MACE
SIMPLE TO MODERATELY COMPLEX POPULATIONS
ABSORB II
Design: Randomized 2:1 Absorb BVS:XIENCE
N=501
1˚: Vasomotion & lumen diameter after the index procedure & at 3 years
ABSORB EXTEND
Design: Prospective, single-arm, open-label clinical study
N=800
1˚: ID-MACE
ABSORB COHORT B
Design: Allocated
(non-randomized)
N=101
1˚: Safety & performance
ADDITIONAL LARGE RCTs
ABSORB III
Design: RCT
N= ~2250
1˚: TLF at 1 year
ABSORB JAPAN
Design: RCT
N= ~400
1˚: TLF at 1 year
ABSORB CHINA
Design: RCT
N= ~440
1˚: In-segment late loss at 1 year
ABSORB IV
Design: RCT
N= ~3000
1˚: Angina within 1 year
*Excludes STEMI patients. ACS, acute coronary syndrome; MVD, multi-vessel disease; CTO, chronic total occlusion; MI, myocardial infarction RCT, randomized controlled trial; OMT, optimal medical therapy; EES, everolimus-eluting stents; BVS, bioresorbable vascular scaffold; STEMI, ST-segment–elevation myocardial infarction; MACE, major adverse cardiac events; ID-MACE, ischemia-driven major adverse cardiac events; TLF, target lesion failure; IVUS MLA, intravascular ultrasound minimal lumen area; TVF, target vessel failure; LAD, left anterior descending; FIM, first-in-man.
Information contained herein for presentation outside the US only. Not for distribution. Absorb BVS is currently CE marked. Please check the regulatory status of the device prior to use in countries where CE mark is not the regulation in force. ©2015 Abbott. All rights reserved. AP OUS Rev. A

6. Participating centers (n=11)
Elisabeth Krankenhaus, Essen
C. Naber
S. Pyxaras
University of Giessen, Giessen
H. Nef
Medizinische Klinik, Mainz
T. Gori
Royal Brompton Hospital, London
C. Di Mario
A. Mattesini
Uniwersytet Medyczny, Poznan
M. Lesiak
A. Araszkiewicz
San Raffaele Hospital and Emocolumbus Clinic, Milan
A. Colombo
A. Latib
Klinikum Großhadern, Munich
J. Mehilli
Biomedical Investigation Institute, IDIBAPS, University of Barcelona
M. Sabatè
S. Brugaletta
Ferrarotto Hospital, Catania
C. Tamburino
D. Capodanno
P. Capranzano
S. G. Di Dio Hospital, Agrigento
G. Caramanno
S. Geraci
Tamburino C, et al. on behalf of GHOST-EU investigators

7. Patient Population (n=1,477)
Age, years±SD
62±11 (1,477)
Male
1180/1,477 (80%)
Diabetes mellitus
381/1,477 (26%)
On insulin
134/1,450 (9%)
Hyperlipidemia
778/1,477 (53%)
Hypertension
1070/ 1,477 (72%)
Smoker
448/1,477 (30%)
Previous PCI
497/1,477 (34%)
Prior CABG
71/1,477 (5%)
Stroke/TIA
53/1,477 (4%)
ACS
697/1,477 (47%)
NSTEMI
259/1,477 (18%)
STEMI
248/1,477 (17%)
LV ejection fraction <30%
38/1219 (3.1%)
eGFR<60 mL/min
135/934 (14%)
Overall Patients
N=1,477; 1,736 lesions
30-day FU*
N= 1,444/1,477 (97.8%)
6-month FU*
N=1397/1,477 (94.6%)
12-month FU*
N=1276/1,477 (86.4%)
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

8. Lesion characteristics (n=1,736)
Vessel treated
LMCA
20/1,715 (1.2%)
LAD
821/1,704 (48%)
LCX
415/1,703 (24%)
RCA
447/1,705 (26%)
Vessel diameter (n=1,224)
RVD (mm)
3.0±0.53
RVD ≤ 2.5 mm
275 (22.5%)
RVD ≥ 3.5 mm
278 (22.7%)
Mean lesion length (n=1,215)
19.5±14.0
Length > 34 mm
139 (11.4%)
Lesion ACC/AHA B2/C
857/1614 (53.1%)
Bifurcation
366 (21.1%)
CTO
113/1736 (6.5%)
ISR
54/1736 (3.1%)
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

9. CV death, target-vessel MI, clinically-driven TLR
Target Lesion Failure
CV death, target-vessel MI, clinically-driven TLR
5.2%
1.8%
3.4%
Days
Pts at risk , , ,
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

10. Clinically-driven target vessel revascularization
2.3%
4.1%
1.1%
3.8%
6.2%
1.5%
Days
Pts at risk , ,
Pts at risk , ,
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

11. Cardiovascular mortality
and target-vessel MI
0.8%
0.9%
0.6%
2.0%
2.4%
1.2%
Days
Pts at risk , ,
Days
Pts at risk , ,
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

12. Scaffold Thrombosis Definite/probable
1.9%
2.0%
1.4%
Days
Pts at risk , , , ,012
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

13. Procedural characteristics
Pre-Dilatation
1670/1736 (96.2%)
Cutting balloon
21/1723 (1.2%)
Scoring balloon
47/1722 (2.7%)
Residual DS ≥ 40% after pre-dilatation
254/911 (28%)
Post-Dilatation
908/1736 (52.3%)
Mean Scaffold Diameter/Les
3.1±0.80
Mean scaffold Length/Les (n=1722)
27.6±16.7
N. of scaffold/Les
1.28±0.64
Overlapping/Les
364/1736 (21%)
OCT*
206/1498 (14%)
IVUS*
240/1498 (16%)
*per patient; DS: diameter stenosis
* Residual in-scaffold diameter stenosis < 30%
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

14. The Four ‘Ps’ For Optimal BVS Implantation
Prepare the Lesion
Possibly with a NC balloon (balloon/RVD 1:1)
2. Properly Size the Vessel
Use IC nitro, imaging if necessary, balloon sizing, plan to upsize the scaffold for any RVD by visual estimation.
3. Pay Attention to Expansion Limits
Stay within the nominal size (+0.5mm), 2 atm increments every 5 seconds. Mantain target pressure for 30 seconds.
4. Post-Dilate with a Non-Compliant Balloon at high pressure
Aim at <10% residual stenosis after scaffold implantation.

15. Predictors of TLF Diabetes mellitus 2.09 (1.28-3.41) 0.003
Hyperlipidemia
0.65 ( )
0.08
ACS at presentation
1.84 ( )
0.02
Bifurcation
1.50 ( )
0.13
In-stent restenosis
2.13 ( )
0.15
Ostial lesion
2.61 ( )
0.007
Total Scaffold length per patient
1.01 ( )
Prasugrel or Ticagrelor use*
1.27 ( )
0.34
Tamburino C, et al. on behalf of GHOST-EU investigators; PCR 2015

16. 1:1 case-control propensity score matching
Study Design
GHOST-EU1
N=1,189 from 10 EU sites
XIENCE V USA2
N=5,034 from 162 US sites
1:1 case-control propensity score matching
Non-parsimonious logistic regression model encompassing 26 variables
GHOST-EU
N=905
XIENCE V USA
Matching ratio 0.76
Matching ratio 0.18
1 Capodanno D, et al. EuroIntervention. 2015;10:
2 Krucoff MW, et al. J Am Coll Cardiol Intv 2011;4:1298–309

17. Patients Characteristics (matched)
ABSORB
(n=905)
XIENCE V (n=905)
P value
Demographics
Age - mean ± SD, yrs
63 ± 11
0.57
Male sex - % 78
1.00
Risk factors
Diabetes - % 28 27
0.82
Renal disease - % 16 19
0.10
Clinical presentation
Acute coronary syndrome - % 42 43
0.92
Multivessel disease - % 58 60
0.41
Lesion characteristics
ACC/AHA B2/C lesions - % 55
0.96
De novo - % 95
Chronic total occlusion - % 8
0.86
Ostial - % 11
0.06
Bifurcation - % 22 23
0.79
Lesion length – mean ± SD, mm
20 ± 15
20 ± 13
0.65
RVD – mean ± SD, mm
3.0 ± 0.5
0.49
Diam. stenosis– mean ± SD, %
85 ± 13
85 ± 11
Procedure details
Post-dilatation - % 52 51
0.64
Tamburino C, et al. JACC Cardiovasc Interv 2016

18. 12-Month Clinical Outcomes
P=0.12
P=0.025
P=0.07
P=0.22
P=0.23
Tamburino C, et al. JACC Cardiovasc Interv 2016

19. GHOST-EU and the ABSORB trials
GHOST-EU (n=905)
ABSORB III
(n=1,322)
ABSORB II
(N=335)
A-JAPAN
(N=266)
A-CHINA
(N=241)
Age - mean ± SD, yrs
62 ± 11
64 ± 11
62 ± 10
67 ± 9
57 ± 11
Male sex - % 79 71 76 72
Diabetes - % 25 32 24 36
Acute coronary syndrome - % 47
27 (UA)
20 (UA)
10 (UA)
65 (UA)
ACC/AHA B2/C lesions - % 54 69 46 NA
In-stent restenosis - % 4
Excluded
Chronic total occlusion - % 8
Ostial - % 9
Bifurcation - % 27
Lesion length – mean ± SD, mm
20 ± 15
13 ± 5
14 ± 7
14 ± 5
14 ± 0
RVD - mean ± SD, mm
3.0 ± 0.5
2.7 ± 0.5
2.6 ± 0.4
2.7 ± 0.4
2.8 ± 0.4
Post-dilatation - % 51 66 61 82 63
Target lesion failure - %
5.8
7.8
4.8
4.2
3.4
Definite or probable ST - %
1.8
1.5
0.6
0.4

20. Lipinski MJ et al. J Am Coll Cardiol Intv 2016;9:12–24.

21. Outcome rates of patients with BVS
Meta-Analysis of ABSORB studies 10,510 patients (8,351 with a BVS and 2,159 with DES) Follow-up: 6.4±5.1 months
Outcome rates of patients with BVS
Lipinski MJ et al. J Am Coll Cardiol Intv 2016;9:12–24.

22. Characteristics of main real-world BVS registries
GHOST EU
GABI-R
REPARA
ABSORB FIRST
Diabetics
27%
21%
24.4%
24%
Ostial Lesions
5.2%
1.2% -
5.7%
ACS
47%
50%
78%
41%
AMI
34%
38%
59%
26%
Bifurcations
3.8%
13%
CTO
6.5%
10%
Mean Lesion Length (mm)
19.5±14.0
18.5 ± 9.3
Lesion Length >34 mm
11.4%
5.9%
Mean Scaffold length (mm)
27.6±16.7
27.6±17.0
23.0±13.3
Post-dilatation
52.3%
66.8%
40%
46.5%
OCT use
14% 4%
9.1%
IVUS use
16% 5%
2.8%

23. Outcomes of main real-world BVS registries
GHOST EU
GABI-R
REPARA
ABSORB FIRST
Patients
1,477
1536
1479
958
Follow-up
1 year
30 days
Cardiac Mortality
0.9%
0.1%
0.34%
0.5%
Myocardial infarction
2.4%
1.4%
1.56%
1.7%
Target lesion failure
5.2% -
2.2%
MACE
1.8%
2.6%
Definite/Probable scaffold thrombosis
2.0
1.0%
0.88%
0.8%

24. Conclusions
The all-comers usage of BVS in Europe has been associated with overall favorable outcomes at mid-term.
European registries results have suggested the procedure optimization and accurate lesion selection are key for improving outcomes with BVS. Further research focusing on this is needed.
Long-term follow-up data on BVS in complex settings are needed