1. 12-month clinical and 13-month angiographic outcomes from a randomized trial evaluating the Absorb Bioresorbable Vascular Scaffold vs. metallic drug-eluting stent in de novo native coronary artery lesions
ABSORB JAPAN
Takeshi Kimura M.D. and Gregg W. Stone M.D. on behalf of the ABSORB Japan Investigators

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
ABBOTT Vascular

3. ABSORB Japan Randomized 2:1 BVS
Prospective, randomized, active control, single-blind, non-inferiority, multi-center Japanese study
Inclusion: Patients with up to 2 de novo target lesions in separate native coronary arteries
Lesion length ≤ 24 mm, Dmax ≥ 2.5 mm to ≤ 3.75 mm, %DS ≥50% to <100%
Exclusion: AMI, EF <30%, eGFR <30 mL/min/1.73m2,
LMCA, Ostial lesion, Excessive vessel tortuosity, Heavy calcification,
Myocardial bridge, Bifurcation with side branch ≥2 mm
Randomized 2:1
BVS
Tx. with single study device Diameter: 2.5, mm
Length: 8, 12, 18, 28 mm
CoCr-EES Tx. with single study device Diameter: 2.5, mm
Length: 8, 12, 18, 28 mm
Primary Clinical Endpoint: Target Lesion Failure (TLF): Cardiac death, TV-MI, ID-TLR at 12 months
Major Secondary Angiographic Endpoint: In-segment Late Lumen Loss at 13 months

4. Patient Flow Chart EES (N=1618) BES (N=1617) BVS (N=266) BES (N=1601)
ABSORB Japan
Randomized
(N=400)
Enrollment from 38 Japanese centers
Between April 27, 2013 and December 27, 2013
BVS (N=266)
CoCr-EES (N=134)
Withdraw consent without POCE: 1
Withdraw consent without POCE: 1
EES (N=1618)
BES
(N=1617)
Intention-to-treat Population (N=398)
BVS (N=265)
CoCr-EES (N=133)
BVS (N=266)
BES (N=263)
12-Month Clinical FU Complete (N=397: 99.7%) )
BES
(N=1601)
BVS (N=264)
Between May and October 2011, 3241 patients were randomized from 98 Japanese centers.
After excluding 6 patients who withdrew consent, the ITT population consisted of 3235 patients.
Complete 2-year clinical follow-up was achieved in 98.4% of patients.
CoCr-EES (N=133)
13-Month Angiographic FU Qualified (N=378: 95.0%)
BVS (N=252)
CoCr-EES (N=126)

5. Baseline Patient Characteristics
ABSORB Japan
Baseline Patient Characteristics
BVS
(266 Patients)
CoCr-EES
(134 Patients)
P-value
Age (years)
67.1 ± 9.4
67.3 ± 9.6
0.90
Male
79%
74%
0.25
BMI (kg/m2)
24.0 ± 3.0
24.3 ± 3.0
0.41
Current Tobacco Use
20%
22%
0.69
Stable CAD
90%
84%
0.054
Diabetes
36%
0.96
Prior PCI/CABG
38%
0.70
Prior MI
16%
24%
0.06
eGFR <60 (mL/min)
32%
28%
0.37

6. Baseline QCA ABSORB Japan BVS (275 Lesions) CoCr-EES (137 Lesions)
P-value
Lesion Length (mm)
13.4 ± 5.3
13.3 ± 5.5
0.87
Pre RVD (mm)
2.71 ± 0.45
2.79 ± 0.46
0.10
Pre MLD (mm)
0.96 ± 0.33
0.99 ± 0.36
0.40
Pre %DS (%)
64.5 ± 11.1
64.7 ± 10.9
0.91

7. Procedural Information
ABSORB Japan
Procedural Information
BVS
(266 Patients)
(275 Lesions)
CoCr-EES
(134 Patients)
(137 Lesions)
P-value
Single Target Lesion
97%
98%
0.76
Non-study Lesion Treated
7.5%
1.00
% Pre-Dilatation
100%
% Post Dilatation
82%
77%
0.25
Bailout Procedure
1.8% (5/275)
0.7% (1/137)
0.67
- By BVS 4
0.31
- By CoCr-EES 1
Total Device Length (mm)
20.2 ± 5.8
19.5 ± 5.8
0.22

8. Acute Success and Procedure Duration
ABSORB Japan
Acute Success and Procedure Duration
Devise Success Procedure Success Procedure Duration
P=1.00
P=0.72
P=0.04
49.8±24.8 min
44.9±21.7 min
BVS CoCr-EES BVS CoCr-EES
BVS CoCr-EES
Device success: Successful deployment of the assigned device at the target lesion with <30% residual stenosis
Procedure success: Device success without TLF during the hospital stay (maximum of 7 days)

9. Balloon Diameters and Inflation Pressure
ABSORB Japan
Balloon Diameters and Inflation Pressure
Nominal Nominal Expected Nominal Expected Expected
Pre-dilatation
11.6 ± 3.8 atm.
11.9 ± 3.7 atm.
P=0.52
Deployment
10.4 ± 3.0 atm.
11.2 ± 2.7 atm.
P=0.003
Post-dilatation
15.5 ± 4.2 atm.
16.0 ± 3.9 atm.
P=0.24
Final Balloon
14.7 ± 4.1 atm.
15.1 ± 4.1 atm.
P=0.36
Inflation
Pressure
Pre-dilatation
Deployment
Post-dilatation
Final
Expected diameter was calculated based on the compliance chart of the device

10. Post Procedural QCA ABSORB Japan BVS (275 Lesions) CoCr-EES
P-value
RVD Post (mm)
2.75 ± 0.42
2.85 ± 0.43
0.03
In-Device MLD Post (mm)
2.43 ± 0.37
2.64 ± 0.40
<0.0001
In-Device %DS Post (%)
11.6 ± 7.5
7.3 ± 8.1
In-Segment MLD Post (mm)
2.20 ± 0.39
2.27 ± 0.43
0.15
In-Segment %DS Post (%)
20.0 ± 6.7
20.6 ± 8.80
0.49
In-Device Acute Gain (mm)
1.47 ± 0.40
1.65 ± 0.40
In-Segment Acute Gain (%)
1.25 ± 0.41
1.28 ± 0.45

11. Primary Endpoint: 12-Month TLF (through 393 days)
ABSORB Japan
Primary Endpoint: 12-Month TLF (through 393 days)
12-Month TLF
Upper 95% Confidence Limit of the Difference
P=0.85
NI Margin = 8.6%
Non-inferiority P <
0.39% ●
3.95%
BVS CoCr-EES
The one-sided upper 95% confidence limit for the 0.39% observed difference in event rates was 3.95%, suggesting that any absolute difference between the 2 devices is likely to be small.
Likelihood score method by Farrington and Manning

12. 12-Month Clinical Outcomes (~393-Day )
ABSORB Japan
12-Month Clinical Outcomes (~393-Day )
BVS
(N=266)
CoCr-EES
(N=134)
P-value
TLF (CD/TV-MI/ID-TLR)
4.2% (11/265)
3.8% (5/133)
0.85
- Cardiac Death
0.0% (0/265)
0.0% (0/133)
1.00
- Target Vessel MI
3.4% (9/265)
2.3% (3/133)
0.76
- Ischemia driven-TLR
2.6% (7/265)

13. 12-Month Definite/Probable ST
ABSORB Japan
12-Month Definite/Probable ST
0 days
37 days
208 days
393 days
BVS at Risk
266
262
260
257
CoCr-EES at Risk
134
132
131

14. BVS ST Case 1 64 year-old male, Stable angina, Diabetes
ABSORB Japan
BVS ST Case 1
64 year-old male, Stable angina, Diabetes
Subacute Definite ST
Pre
Post
Day-4
Lesion Length=13.8 mm
RVD=2.45 mm
%DS=54.5%
Pre-dilatation: NCB (2.5 mm, 14 atm)
BVS: 2.5x18 mm at 12 atm
Post-dilatation NCB (2.75 mm, 18 atm)
Final in-scaffold MLD=2.27 mm
Final in-segment MLD=2.05 mm
Chest pain while playing tennis
No APT issue
CK: 1259 U/L

15. BVS ST Case 2 55 year-old male, Stable angina Subacute Definite ST
ABSORB Japan
BVS ST Case 2
55 year-old male, Stable angina
Subacute Definite ST
Pre
Post
Day-4
Lesion Length=12.5 mm
RVD=2.8 mm
%DS=55.1%
Pre-dilatation: SCB (3.0 mm, 6 atm)
BVS: 3.0x18 mm at 16 atm
Post-dilatation NCB (3.5 mm, 12 atm)
Final in-scaffold MLD=2.4 mm
Final in-segment MLD=2.11 mm
No APT issue
CK: 5292 U/L

16. BVS ST Case 3 64 year-old male, Stable angina Subacute Definite ST
ABSORB Japan
BVS ST Case 3
64 year-old male, Stable angina
Subacute Definite ST
Pre
Post
Day-5
Lesion Length=12.7 mm
RVD=2.32 mm
%DS=61.2%
Pre-dilatation: SCB (2.25 mm, 14 atm)
BVS: 2.5x18 mm at 8 atm
Post-dilatation NCB (2.75 mm, 18 atm)
Final in-scaffold MLD=1.69 mm
Final in-segment MLD=1.51 mm
No APT issue
CK: 2090 U/L

17. BVS ST Case ４ 75 year-old female, Silent ischemia, Diabetes
ABSORB Japan
BVS ST Case ４
75 year-old female, Silent ischemia, Diabetes
Late Definite ST
Pre
Post
Day-139
Lesion Length=20.3 mm
RVD=2.00 mm
%DS=71.8%
Pre-dilatation: SCB (2.5 mm, 10 atm)
BVS: 2.5x18 mm at 10 atm
No post-dilatation
Final in-scaffold MLD=1.84 mm
Final in-segment MLD=1.70 mm
Discontinuation of both APT
CK: 738 U/L

18. Major Secondary Angiographic Endpoint: 13-Month In-Segment LLL
ABSORB Japan
Major Secondary Angiographic Endpoint: 13-Month In-Segment LLL
13-Month In-segment LLL
Upper 95% Confidence Limit of the Difference
NI Margin = mm
P=0.74
Non-inferiority P <
0.01 mm
0.13 mm
0.12 mm ●
0.07 mm
BVS CoCr-EES
Asymptotic test statistic based on Z test

19. Cumulative Distribution Function Curves for In-segment MLD
ABSORB Japan
Cumulative Distribution Function Curves for In-segment MLD
Pre
0.96±0.33 mm
0.99±0.36 mm
P=0.42
Follow-up
2.08±0.45 mm
2.15±0.50 mm
P=0.18
Post
2.21±0.39 mm
2.26±0.43 mm
P=0.19

20. ABSORB Japan Imaging Follow-up
Clinical FU
Imaging FU
The ABSORB Japan had an extensive imaging follow-up protocol
including angiography, IVUS, OCT, and MSCT.
Post-procedure intracoronary imaging evaluation was mandatory
in the IVUS and OCT-1 groups, while it was not allowed in the OCT-2 group.

21. Impact of Post-procedure Intracoronary Imaging
ABSORB Japan
Impact of Post-procedure Intracoronary Imaging
In-device MLD
BVS
CoCr-EES
P=0.90
P=0.72
P=0.16
P=0.44
Imaging
No imaging
Post Procedure 13M F/U
Post Procedure 13M F/U
No complications were noted by the post-procedure intracoronary imaging after BVS implantation.
However, in both BVS and EES groups, post-procedure intracoronary imaging did not affect
the in-device MLD at post-procedure and at 13-month follow-up.

22. Typical Images – Mid LAD
Excellent BVS MSCT and Matched QCA
MSCT
QCA
Proximal Mean
2.21
2.26
In-device MLD
1.79
1.795
Distal Mean
2.53
2.16
QCA: 2.62 ± 0.45 mm
MSCT: 2.01 ± 0.39 mm
QCA in-device MLD (mm)
QCA: 2.28 ± 0.45 mm
MSCT: 2.30 ± 0.44 mm
MSCT in-device MLD (mm)

23. Conclusions In the ABSORB Japan trial, BVS demonstrated a similar
mid-term (12-month) clinical safety and efficacy profile as CoCr-EES,
with comparable 13-month angiographic outcomes.
These positive results lay a solid foundation for continued evaluation of long term outcomes in patients undergoing percutaneous coronary intervention with Absorb BVS.