1. on behalf of the ABSORB II Investigators
The 2-year Clinical Outcomes of the ABSORB II Trial: First Randomized Comparison between the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE Everolimus Eluting Stent
Bernard Chevalier
Institut Jacques Cartier, Massy, France
Patrick W. Serruys
Imperial College, London, UK
Erasmus University MC, Netherlands
on behalf of the ABSORB II Investigators
12 October 2015 - San Francisco, CA - U.S.A
Plenary Session VII. First Report Investigations 1. 12:00pm

2. Presentor Disclosures
Bernard Chevalier is a consultant for Abbott Vascular Patrick Serruys is a member of the international advisory board of Abbott Vascular

3. Randomized 2:1 Absorb BVS:XIENCE / 46 sites (Europe and New Zealand)
ABSORB II Study Design
501 subjects
Randomized 2:1 Absorb BVS:XIENCE / 46 sites (Europe and New Zealand)
Clinical Follow-Up
30d 6m
12m
24m
36m
48m
60m
QoL follow-up
Angio, IVUS follow-up
MSCT follow-up (Absorb arm only)*
Study Objective
Randomized against XIENCE control. First Patient In: 28-Nov-2011
Co-primary Endpoints
36 months
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
Device Sizes
Device diameters: 2.5, 3.0, 3.5 mm Device lengths: 12 (3.5 mm diameter only), 18, 28 mm
The ABSORB II study is sponsored by Abbott Vascular

4. 2-Year Patient Flowchart
Intent To Treat
N=501
Absorb BVS
N=335
XIENCE
N=166
Baseline
1 subject consent withdrawn
N=334
30-day
N=166
3 subjects consent withdrawn
1 subject died
N=331
180-day
N=165
2 subjects consent withdrawn
1 subject consent withdrawn
N=329
1-year
N=164
3 subjects consent withdrawn. 2 subjects died
1 subject consent withdrawn
N=324
(96.7%)
N=163
(98.2%)
2-year

5. 1-year Summary Hierarchical PoCE*, % 7.3 9.1 0.47 0.0 0.6 0.33 4.5 1.2
Absorb BVS
N=335
XIENCE
N=166
p value
Hierarchical PoCE*, %
7.3
9.1
0.47
All death (Non-hierarchical)
0.0
0.6
0.33
All MI (Non-hierarchical)
4.5
1.2
0.06
All revascularization (Non-hierarchical)
3.6
0.07 
Per Protocol Myocardial Infarction (MI):
Q wave MI Development of new, pathological Q wave on the ECG.
Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
PoCE (Patient oriented Composite Endpoint)*: All death, all myocardial infarction, and all revascularisation.
*Per ARC. Cutlip et al., Circulation. 2007;115:

6. 1-year Summary Hierarchical PoCE*, % 7.3 9.1 0.47 0.0 0.6 0.33 4.5 1.2
Absorb BVS
N=335
XIENCE
N=166
p value
Hierarchical PoCE*, %
7.3
9.1
0.47
All death (Non-hierarchical)
0.0
0.6
0.33
All MI (Non-hierarchical)
4.5
1.2
0.06
All revascularization (Non-hierarchical)
3.6
0.07 
Hierarchical DoCE* or TLF, %
4.8
3.0
0.35
Cardiac death (Non-hierarchical)
1.00
TV-MI (Non-hierarchical)
4.2
0.07
CI-TLR (Non-hierarchical)
1.8
0.69
Per Protocol Myocardial Infarction (MI):
Q wave MI Development of new, pathological Q wave on the ECG.
Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
PoCE (Patient oriented Composite Endpoint)*: All death, all myocardial infarction, and all revascularisation.
DoCE (Device oriented Composite Endpoint)*/ TLF (Target Lesion Failure): Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR).
*Per ARC. Cutlip et al., Circulation. 2007;115:

7. 2-year Clinical Outcomes Composite Endpoints
Absorb BVS
N=335
XIENCE
N=166
p value
PoCE (%)
11.6
12.8
0.70
PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation

8. 2-year Clinical Outcomes Composite Endpoints
Absorb BVS
N=335
XIENCE
N=166
p value
PoCE (%)
11.6
12.8
0.70
MACE (%)
7.6
4.3
0.16
PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

9. 2-year Clinical Outcomes Composite Endpoints
Absorb BVS
N=335
XIENCE
N=166
p value
PoCE (%)
11.6
12.8
0.70
MACE (%)
7.6
4.3
0.16
DoCE, TLF (%)
7.0
3.0
0.07
PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR) DoCE (Device oriented Composite Endpoint)/ TLF (Target Lesion Failure): Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

10. 2-year Clinical Outcomes Composite Endpoints
Absorb BVS
N=335
XIENCE
N=166
p value
PoCE (%)
11.6
12.8
0.70
MACE (%)
7.6
4.3
0.16
DoCE, TLF (%)
7.0
3.0
0.07
TVF (%)
8.5
6.7
0.48
PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR) DoCE (Device oriented Composite Endpoint)/ TLF (Target Lesion Failure): Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)
TVF (Target Vessel Failure): Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation (TVR)

11. 2-year Clinical Outcomes Composite Endpoints
Absorb BVS
N=335
XIENCE
N=166
p value
PoCE (%)
11.6
12.8
0.70
MACE (%)
7.6
4.3
0.16
DoCE, TLF (%)
7.0
3.0
0.07
TVF (%)
8.5
6.7
0.48
PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR) DoCE (Device oriented Composite Endpoint)/ TLF (Target Lesion Failure): Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)
TVF (Target Vessel Failure): Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation (TVR)

12. Patient oriented Composite Endpoint (PoCE)25
Absorb BVS
XIENCE 20
HR [95% CI]= 0.90 [0.53,1.53]
p=0.69 (Log rank test) 15
12.7%
PoCE (%)
∆=-1.2% 10
11.5% 5 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
PoCE: All death, all myocardial infarction, and all revascularisation

13. Patient oriented Composite Endpoint (PoCE)25
Absorb BVS
XIENCE 20
37-day HR
day HR
1.75 [0.58,5.31]
0.69 [0.37,1.28]
p=0.3151
p=0.2317 15
PoCE (%)
10.3% 10
4.2%
∆=-3.0%
7.3%
∆=1.8%
2.4% 5 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
PoCE: All death, all myocardial infarction, and all revascularisation

14. Major Adverse Cardiac Events (MACE)25
Absorb BVS
XIENCE 20
HR [95% CI]= 1.80 [0.78,4.17]
p=0.16 (Log rank test) 15
MACE (%) 10
7.5%
∆=3.2% 5
4.3% 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
MACE: Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation

15. Major Adverse Cardiac Events (MACE)25
Absorb BVS
XIENCE 20
37-day HR
day HR
3.49 [0.79,15.34]
1.13 [0.39,3.24]
p=0.0760
p=0.8242 15
MACE (%) 10 5
4.2%
3.5%
∆=3.0%
∆=0.4%
1.2%
3.1% 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
MACE: Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation

16. Device oriented Composite Endpoint (DoCE)/ Target Lesion Failure (TLF)25
Absorb BVS
XIENCE 20
HR [95% CI]= 2.32 [0.88,6.10]
p=0.078 (Log rank test) 15
DoCE/TLF (%) 10
6.9%
∆=3.9% 5
3.0% 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

17. Device oriented Composite Endpoint (DOCE)/ Target Lesion Failure (TLF)
DoCE/TLF (%) 5 10 15 20 25
Absorb BVS
XIENCE
Time Post Index Procedure (Months) 90
180
270
360
450
540
630
720
1.2%
3.9%
1.8%
3.2%
∆=2.7%
37-day HR
3.24 [0.73,14.33]
p=0.0996
day HR
1.71 [0.47,6.20]
p=0.4109
∆=1.4%
DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

18. Target Vessel Failure (TVF)25
Absorb BVS
XIENCE 20
HR [95% CI]= 1.28 [0.64,2.57]
p=0.49 (Log rank test) 15
TVF (%) 10
8.5%
∆=1.8% 5
6.7% 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
TVF : Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation

19. Target Vessel Failure (TVF)25
Absorb BVS
XIENCE 20
37-day HR
day HR
2.33 [0.67,8.10]
0.89 [0.37,2.12]
p=0.1683
p=0.7914 15
TVF (%) 10
4.2%
4.9% 5
∆=2.4%
∆=-0.4%
1.8%
4.5% 90
180
270
360
450
540
630
720
Time Post Index Procedure (Months)
TVF : Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation

20. Clinical Outcomes Non Hierarchical Events
2 years
Absorb BVS
N=335
XIENCE
N=166
p value
Death* (%)
1.2
0.6
0.67
Cardiac
0.0
0.55
Non cardiovascular
1.00
*Per ARC. Cutlip et al., Circulation. 2007;115:

21. Clinical Outcomes Non Hierarchical Events
2 years
Absorb BVS
N=335
XIENCE
N=166
p value
Death* (%)
1.2
0.6
0.67
Cardiac
0.0
0.55
Non cardiovascular
1.00
Myocardial Infarction (%)
5.8
2.4
0.10
Q-wave
1.5
Non Q-wave
4.3
1.8
0.16
*Per ARC. Cutlip et al., Circulation. 2007;115:

22. Clinical Outcomes Non Hierarchical Events
2 years
Absorb BVS
N=335
XIENCE
N=166
p value
Death* (%)
1.2
0.6
0.67
Cardiac
0.0
0.55
Non cardiovascular
1.00
Myocardial Infarction (%)
5.8
2.4
0.10
Q-wave
1.5
Non Q-wave
4.3
1.8
0.16
Definite/Probable ST* (%)
0.17
Acute/sub-acute (0-30 days)
Late ( days)
0.3
Very late (365 – 758 days)
*Per ARC. Cutlip et al., Circulation. 2007;115:

23. Post-Procedure Usage of Antiplatelet Medication through 2 years
Absorb BVS
N=335
XIENCE
N=166
p value
On Aspirin (%)
at 1 year
95.8
95.2
0.75
at 2 years
92.2
0.99
On DAPT (%)
81.7
81.3
0.91
36.2
34.3
0.68

24. Very Late Scaffold Thrombosis Cases

25. IVUS Post procedure Proximal MSA frame
Proximal D-max 3.00 mm, Distal D-Max mm
Absorb 3.0x18 mm, 10 atm
MLD 1.84 mm
Pre-dilatation
Hiryu 2.75x10 mm
MLD 3.44 mm
%DS 39.0
Post-dilate Hiryu 3.25x10, 10 atm
%DS 20.5
acute gain 1.6 mm
Malapposed struts
IVUS Post procedure
Possible cause :
1.Proximal stent malapposition
2.Suboptimal expansion
definite very late ST 447 days
Proximal
MSA frame
SA 7.23 mm2 VD 3.03 mm
LA mm2 LD 2.73 mm
LA mm2 LD 3.48 mm
Residual stenosis 21.5%
Malapposition at proximal edge
Suboptimal expansion
DAPT: Aspirin only at time of the event

26. definite very late ST 602 days
Proximal D-max mm, Distal D-Max 2.84 mm
Pre-dilatation Apex 3.0x12 mm
Absorb 3.0x18 mm
10 atm = 3.20 mm
No post-dilatation
Proximal edge
MLA frame
VA mm2 VD mm
LA 6.26 mm2 LD 2.82 mm
VA mm2 VD 4.84 mm
SA mm2 SD mm
Plaque burden 69.8%
Incomplete coverage at distal edge
Suboptimal expansion
RAS 31.8%, Expansion index 0.59,
definite very late ST 602 days
Possible cause :
1. Suboptimal expansion
2. Incomplete coverage at edges
DAPT: Aspirin only at time of the event

27. Revascularizations* Non Hierarchical Events
2 years
Absorb BVS
N=335
XIENCE
N=166
p value
TLR (%)
2.7
1.8
0.76
NTL-TVR (%)
1.5
2.4
0.49
NTVR (%)
5.5
0.13
All revascularization
5.8
9.1
0.17
*Clinically indicated revascularizations per ARC. Cutlip et al., Circulation. 2007;115:

28. Clinically Indicated Target Lesion Revascularization (CI-TLR)5 10 15 20 25
Absorb BVS
XIENCE
Time Post Index Procedure (Months) 90
180
270
360
450
540
630
720
HR [95% CI]= 1.49 [0.40,5.52]
p=0.54 (Log rank test)
2.7%
1.8%
∆=0.9%

29. Limitations The ABSORB II study was not powered for clinical endpoints
The 2-year endpoint represents a non pre-specified interim analysis
Investigators long experience with XIENCE as compared to Absorb BVS might have impacted the results

30. Conclusions
At 2 years there were no significant differences in the clinical outcomes between the two arms:
PoCE (all death, all MI and all revascularization) Absorb BVS: 11.6% vs XIENCE: 12.8%, p=0.70
DoCE/TLF (cardiac death, TV-MI and TLR) Absorb BVS: 7.0% vs XIENCE: 3.0%, p=0.07
The exploratory observations presented in this report are hypothesis generating and need to be confirmed in larger randomized trials such as ABSORB III