1. on behalf of the ABSORB II Investigators
The 4-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

2. Presentor Disclosures
Bernard Chevalier was a Consultant for Abbott Vascular and is currently consultant for Biotronik, Colibri, Cordis, Medtronic, Terumo. 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.
[NCT ]

4. Characteristics of Patients at Baseline
Absorb
335 pts
Xience
166 pts
95% CI 
Age (year) mean ±SD
61.5 ± 10.0
60.9 ± 10.0
N.S.
Male %
75.5
79.5
Current Tobacco Use %
23.6
21.7
Hypertension %
69.0
71.7
Dyslipidemia %
75.2
80.1
All Diabetes Mellitus %
23.9
24.1
Diabetes Mellitus Insulin Dependent %
6.6
8.4
Family History of Premature CAD %
36.6
41.3
Prior Intervention in Target Vessel %
11.7
8.9
Prior MI %
28.0
28.9
Stable Angina %
63.9
64.5
Unstable Angina %
20.3
22.3
Silent Ischemia %
12.5
11.4
Recent MI with normalized cardiac enzyme %
3.3
1.8

5. Procedural Assessment Pre and Post Procedure
Absorb
364 Lesions
Xience
182 Lesions
p value
Procedural Details Per Lesion
Balloon dilatation prior to device implantation %
100
98.9
0.11
Planned overlap with the same type of device %
15.4
11.0
0.16
Unplanned/bailout implantation “same” %
3.8
6.0
0.25
Nominal size of study device mm
3.01
3.05
0.10
Balloon dilatation after device implantation %
60.7
58.8
0.67
Nominal diameter of last balloon used mm
3.08
3.16
0.02
Maximum last balloon pressure used atm
14.23
15.03
0.01
Acute recoil post device implantation mm
0.19
0.85
Acute Clinical Device Success %
99.2
0.55
Acute Clinical Procedural Success %
96.1
98.8
<
<

6. 20 patients did not sign protocol amendment for 4 & 5 year follow-up
4-Year Patient Flowchart
311* and 154**
patients still in
the study but 5
missed 3 yr FUP
Intent To Treat
N=501
Absorb BVS
N=335
XIENCE
N=166
Baseline
7 withdrawal
1 death
2 withdrawal
N=328
1-year
N=163
4 death
3 withdrawal
1 LFU
3 withdrawal
N=320
2-year
N=160
4 death
3 withdrawal
2 LFU, 3 MV,
5 death, 1 LFU
2 MV
N=308*
3-year
N=152**
2 death,
8 MV, 3 withdrawal
9 no consent, -3 still in study but missed 3yr FUP
1 death,
2 MV, 1 withdrawal
11 no consent ,-2 still in study but missed 3yr FUP
N=289
(86%)
4-year
N=139
(84%)
At 4 years patients with missing visits (MV) were confirmed as alive and well by site PI.
20 patients did not sign protocol amendment for 4 & 5 year follow-up

7. Clinical Endpoints at 3 Years
Hierarchical
Absorb
325 patients
Xience
161 patients
Relative Risk
p value
Device-oriented composite endpoint [DOCE]
10.5%
5.0%
2·11 [1·00, 4·44]
0·04
Cardiac death
0.9%
1.9%
0·50 [0·10, 2·43]
0·4
  Target vessel MI
6.5% (21)
1.2% (2)
5·20 [1·23, 21·91]
0·01
Periprocedural MI*
4.0%(13)
3.22 [0.74, 14.10]
0.16
Spontaneous MI*
2.5% (8)
0% (0)
NC [NC]
0.06
Clinically indicated TLR
3.1% (10)
1.9% (3)
1·65 [0·46, 5·92]
0·56
Patient-oriented composite endpoint [POCE]
20.9%
24.2%
0·86 [0·61, 1·22]
All-cause death
2.5%
3.7%
0·66 [0·23, 1·87]
0·57
Any MI
7.7%
3.1%
2.48 [0.97, 6.35]
0.048
Any revascularization
10.8%
17.4%
0·62 [0·39, 0·98]
0.04
* Per extend historical MI definition

8. Device oriented Composite Endpoint (DOCE)/ Target Lesion Failure (TLF)
TLF per WHO (%) 5 10 15 20 25
Time Post Index Procedure (Days)
180
360
540
720
900
1080
1260
1440
1620
HR [95% CI]= 2.17 [1.01,4.69]
p=0.043 (Log rank test)
10.4%
4.9%
BVS
XIENCE
Source doc:
Data package: Abs2_4Y_KM_Karine_
DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

9. Device oriented Composite Endpoint (DOCE)/ Target Lesion Failure (TLF)
TLF per WHO (%) 5 10 15 20 25
Time Post Index Procedure (Days)
180
360
540
720
900
1080
1260
1440
1620
HR [95% CI]= 2.04 [0.98,4.24]
p=0.050 (Log rank test)
11.1%
5.6%
BVS
XIENCE 5 10 15 20 25
1152
1260
1440
1620
HR [95% CI]= 1.44 [0.15,13.80]
p=0.75 (Log rank test)
1.0%
0.7%
Δ = 0.3%
Source doc:
Data package: Abs2_4Y_KM_Karine_
DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

10. Patient oriented Composite Endpoint (PoCE)/DMR
POCE / DMR per WHO (%) 5 10 15 20 25 30
Time Post Index Procedure (Days)
180
360
540
720
900
1080
1260
1440
1620
HR [95% CI]= 0.85 [0.58,1.27]
p=0.43 (Log rank test)
20.9%
24.2%
BVS
XIENCE
Source doc:
Data package: Abs2_4Y_KM_Karine_
PoCE=DMR: All Death, all Myocardial infarction, and all Revascularisation

11. Patient oriented Composite Endpoint (PoCE)/DMR
POCE / DMR per WHO (%) 5 10 15 20 25 30
Time Post Index Procedure (Days)
180
360
540
720
900
1080
1260
1440
1620
HR [95% CI]= 0.90 [0.61,1.33]
p=0.60 (Log rank test)
22.9%
24.9%
BVS
XIENCE 5 10 15 20 25 30
1152
1260
1440
1620
HR [95% CI]= 3.14 [0.71,13.93]
p=0.11 (Log rank test)
4.3%
1.4%
Δ = 2.9%
Source doc:
Data package: Abs2_4Y_KM_Karine_
PoCE=DMR: All Death, all Myocardial infarction, and all Revascularisation

12. 4-year Clinical Outcomes Composite Endpoints
Absorb BVS
N=335
XIENCE
N=166
p value
PoCE (%)
23.6
26.7
0.4682
MACE (%)
12.4
8.0
0.1545
DoCE, TLF (%)
11.5
6.0
0.0628
TVF (%)
14.0
0.9970
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)

13. Clinical Outcomes Non Hierarchical Events
3-4 years
Absorb BVS
N=335
XIENCE
N=166
p value
Death* n(%)
2(0.7)
1(0.7)
1.0000
Cardiac
1(0.3)
0.5408
Vascular
0(0.0)
Non-cardiovascular
Myocardial Infarction n(%)
Q-wave
Non Q-wave
All Revascularization* n(%)
10(3.3)
0.1142
All TLR
All NTL-TVR
4(1.3)
0.3102
All NTVR
6(2.0)
0.4373
*Per ARC. Cutlip et al., Circulation. 2007;115:

14. Definite/Probable Scaffold/Stent Thrombosis*
ARCST DPr (%) 5 10 15 20 25
Time Post Index Procedure (Days)
180
360
540
720
900
1080
1260
1440
1620
HR [95% CI]= NA [NA]
p=0.033 (Log rank test)
2.8%
0.0%
BVS
XIENCE
Source doc:
Data package: Abs2_4Y_KM_Karine_
*Per ARC. Cutlip et al., Circulation. 2007;115:

15. Definite/Probable Scaffold/Stent Thrombosis*
ARCST DPr (%) 5 10 15 20 25
Time Post Index Procedure (Days)
180
360
540
720
900
1080
1260
1440
1620
HR [95% CI]= NA [NA]
p=0.033 (Log rank test)
2.8%
0.0%
BVS
XIENCE
No stent/scaffold thrombosis between 3 and 4 years” 5 10 15 20 25
1152
1260
1440
1620
HR [95% CI]= NA [NA]
p= (Log rank test)
0.0%
Source doc:
Data package: Abs2_4Y_KM_Karine_
*Per ARC. Cutlip et al., Circulation. 2007;115:

16. Scaffold/Stent Thrombosis
4 years
Absorb BVS
N=335
XIENCE
N=166
p value
Definite ST* days (%)
2.6
0.0
0.0583
Acute/sub-acute (0-30 days
0.6
1.0000
Late ( days)
Very late (365 – days)
1.8
0.1851
Very late between 3 – 4 year follow-up (N) NA
Definite/Probable ST* days(%)
3.0
0.0347
Acute/sub-acute (0-30 days)
1.000
0.3
Very late (365 – 1488 days)
*Per ARC. Cutlip et al., Circulation. 2007;115:

17. Post-Procedure Usage of Antiplatelet Medication through 4 years
Absorb BVS
N=335
XIENCE
N=166
p value
On Aspirin (%)
at 1 year
95.8
95.2
0.7473
at 4 years
84.4
81.3
0.3794
On DAPT (%)
81.0
80.7
0.9357
at 2 years
28.6
28.9
0.9442
at 3 years
29.8
27.7
0.6254
25.9
21.1
0.2372

18. 4-year Summary Excluding Subjects with ST
Absorb BVS
N= 326
XIENCE
N= 166
p value
Hierarchical PoCE*, %
21.3
26.7
0.2025
All death (Non-hierarchical)
3.0
4.7
0.3503
All MI (Non-hierarchical)
5.9
3.3
0.2398
All revascularization (Non-hierarchical)
15.1
22.7
0.0457
Hierarchical DoCE* or TLF, %
8.9
6.0
0.2893
Cardiac death (Non-hierarchical)
1.0
2.7
0.2254
TV-MI (Non-hierarchical)
4.6
1.3
0.0762
CI-TLR (Non-hierarchical)
3.9
2.0
0.4042
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).
Source docs:
Data package: Additional analysis -> Analysis excluding ST
Abs2_Adhoc_T14-1_HiAE_WHO_EXCST_4Y
Abs2_Adhoc15_NhiAE_EXCST_4Y
*Per ARC. Cutlip et al., Circulation. 2007;115:

19. 4-year Summary of Subjects on DAPT at 4 Years
Absorb BVS
N= 86
XIENCE
N= 35
p value
Hierarchical PoCE*, %
37.2
42.9
0.5633
All death (Non-hierarchical)
0.0
1.0000
All MI (Non-hierarchical)
10.5
5.7
0.5076
All revascularization (Non-hierarchical)
33.7
0.3435
Hierarchical DoCE* or TLF, %
17.4
0.1472
Cardiac death (Non-hierarchical)
TV-MI (Non-hierarchical)
0.0578
CI-TLR (Non-hierarchical)
12.8
0.3429
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).
Source doc:
Data package: Additional analysis -> Analysis for patients still on DAPT at 4Y
Tables: Abs2_Adhoc_T14-1_HiAE_WHO_DAPT_4Y; Abs2_Adhoc15_NhiAE_DAPT_4Y
*Per ARC. Cutlip et al., Circulation. 2007;115:

20. Limitations The ABSORB II study was not powered for clinical endpoints
Patients in the ABSORB II Study were enrolled before the current recommendations for scaffold implantation

21. Conclusions
The Absorb scaffold polymer has been reported to be completely bio-resorbed by 3 years. Between 3 and 4 years follow up
there were no ST events in the Absorb arm
DOCE/TLF events were similar between Absorb and Xience
In a trial which was not powered for clinical events, at 4 years there were no statistically significant differences in the clinical outcomes between the two arms:
PoCE (all death, all MI and all revascularization) Absorb BVS: 23.6% vs XIENCE: 26.7%, p=0.47
DoCE/TLF (cardiac death, TV-MI and TLR) Absorb BVS: 11.5% vs XIENCE: 6.0%, p=0.06
The exploratory observations presented in this report are hypothesis generating and need to be confirmed in larger randomized trials such as ABSORB III and ABSORB IV