0. Runlin Gao, M.D. On behalf of ABSORB China Investigators
ABSORB China: Two-Year Clinical Results in Patients with Coronary Artery Disease Randomized to the Absorb Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stents
Runlin Gao, M.D.
On behalf of ABSORB China Investigators

1. Disclosures Runlin Gao has received a research grant
from Abbott Vascular.

2. Background
Previous 1-year results from ABSORB China showed that the primary endpoint of the study was successfully met and Absorb BVS was comparable to XIENCE V in safety and effectiveness at 1 year.
It remains to be determined whether the good clinical outcomes of the Absorb BVS will sustain longer term.

3. ABSORB China
Prospective, randomized, active control, open-label, multicenter study in 480 subjects enrolled from 24 sites in China
Inclusion: Up to 2 de novo lesions in separate native coronary arteries
Lesion length ≤24 mm, RVD ≥2.5 mm - ≤3.75 mm, %DS ≥50% - <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
1: 1 Randomization
Absorb BVS Treat with single study device Diameters: 2.5, mm
Lengths: 8, 12, 18, 28 mm
XIENCE V
Treat with single study device Diameters: 2.5, mm
Lengths: 8, 12, 18, 28 mm
Primary Endpoint: In-Segment Late Loss at 1 Year
in the Per-Treatment-Evaluable (PTE) Population*
* Treated with only the study device (Absorb BVS or XIENCE V) and with no mixed devices at target lesion and no pre-specified major protocol deviations 3

4. Study Organization Principal Investigator: Runlin Gao, MD
Co-Principal Investigators:
Yuejin Yang, MD, PhD, Yaling Han, MD, PhD, Yong Huo, MD
Study Chairman:
Gregg. W. Stone, MD
Angiographic Core Laboratory:
Beth Israel Deaconess Medical Center, Inc.
Data Safety Monitoring Board:
CCRF (Beijing) Consulting Co. Ltd.
Clinical Events Committee:
Sponsor:
Abbott Vascular 4

5. Primary Endpoint: In-Segment Late Loss at 1 Year (PTE)
PTE=459 subjects; 86.3% had the angiogram for the Primary Endpoint Analysis
NI Margin = 0.15 mm
1-Year In-segment LL
Absorb BVS vs. XIENCE V
0.19 ± 0.38 mm (n=200) vs ± 0.38 mm (n=196)
Difference = 0.06 mm [ -0.02, 0.14 ]
PNI = 0.01
Difference (Absorb BVS – XIENCE V) 5

6. Patient Flow and Follow-up (ITT)
Randomized
(N=480)
Absorb BVS
(N=241)
XIENCE V (N=239)
Withdrawal (n= 3)
Withdrawal (n=2) & Death (n=5)
Absorb BVS
(N=238)
1-Year Clinical F/U 98.5%
XIENCE V (N=232)
Withdrawal (n= 1) & Death (n=1)
Death (n=1)
Absorb BVS
(N=236)
2-Year Clinical F/U 96.3%
XIENCE V (N=231)

7. 2-Year Clinical Composite Endpoints
Absorb BVS
(N=241)
XIENCE V
(N=239)
P-Value
PoCE (DMR)
10.1% (24/237)
11.4% (27/237)
0.66
DoCE (TLF)
4.2% (10/237)
4.6% (11/237)
0.82
MACE
5.1% (12/237)
1.00
TVF
5.5% (13/237)
6.8% (16/237)
0.57
PoCE=patient-oriented composite endpoint (all-cause death, all MI*, or any revascularization); DoCE=device-oriented composite endpoint (cardiac death, TV-MI*, or ID-TLR); * CK-MB > 5x ULN for peri-procedural PCI MI

8. 2-Year Clinical Component Endpoints
Absorb BVS
(N=241)
XIENCE V
(N=239)
P-Value
All-cause death
0.4% (1/237)
2.5% (6/237)
0.12
- Cardiac death
1.3% (3/237)
0.62
All MI*
3.0% (7/237)
2.1% (5/237)
0.56
- TV-MI*
0.8% (2/237)
0.45
All revascularization
8.9% (21/237)
8.4% (20/237)
0.87
- ID-TLR
3.4% (8/237)
0.59
* CK-MB > 5x ULN for peri-procedural PCI MI

9. Target Lesion Failure (TLF)10
Absorb BVS
XIENCE V 9
2-year HR [95% CI]= 0.90 [0.38,2.11]
p=0.80 (Log rank test) 8 7
2-year 6
1-year
TLF (%)
4.7% 5
4.2% 4
4.2% 3
3.4% 2 1 60
120
180
240
300
360
420
480
540
600
660
720
780
Time After Index Procedure (Days)
Time (days) 37
208
298
393
758
Absorb BVS (# At Risk)
238
235
234
230
227
XIENCE V (# At Risk )
237
229
225
223

10. Cardiac Death Cardiac Death (%) Time After Index Procedure (Days) 5
Absorb BVS
XIENCE V
2-year
HR [95% CI]= 0.33 [0.03,3.16]
p=0.31 (Log rank test) 4 3
Cardiac Death (%)
1-year
2-year 2
1.3%
1.3% 1
0.4%
0.0% 60
120
180
240
300
360
420
480
540
600
660
720
780
Time After Index Procedure (Days)
Time (days) 37
208
298
393
758
Absorb BVS (# At Risk)
238
237
236
232
229
XIENCE V (# At Risk)
231
227
225

11. TV-MI Target Vessel MI (%) Time After Index Procedure (Days) 10
Absorb BVS
XIENCE V 9 8
2-year
HR [95% CI]= 2.48 [0.48,12.78]
p=0.26 (Log rank test) 7 6
Target Vessel MI (%) 5 4
1-year
2-year 3
2.1%
1.7% 2 1
0.8%
0.8% 60
120
180
240
300
360
420
480
540
600
660
720
780
Time After Index Procedure (Days)
Time (days) 37
208
298
393
758
Absorb BVS (# At Risk)
238
235
234
231
XIENCE V (# At Risk)
237
230
229

12. ID-TLR ID-TLR (%) Time After Index Procedure (Days) Absorb BVS
XIENCE V 5
2-year 4
1-year
3.4% 3
2.5%
ID-TLR (%)
2.6% 2
2.1%
2-year
HR [95% CI]= 1.31 [0.45,3.77] 1
p=0.62 (Log rank test) 60
120
180
240
300
360
420
480
540
600
660
720
780
Time After Index Procedure (Days)
Time (days) 37
208
298
393
758
Absorb BVS ( # At Risk)
238
237
236
232
229
XIENCE V (# At Risk)
231
227
225

13. Scaffold/Stent Thrombosis
Absorb BVS
(N=241)
XIENCE V
(N=239)
P-Value
All ( days)
0.8% (2/237)
0.0% (0/231)
0.50
    Definite
0.4% (1/237)
1.00
    Probable
Early (0 – 30 days)
0.4% (1/238)
0.0% (0/236)
Late ( days)
0.0% (0/238)
0.0% (0/232)
Very Late ( days)
Absorb BVS
(N=241)
XIENCE V
(N=239)
P-Value
All ( days)
0.8% (2/237)
0.0% (0/231)
0.50
    Definite
0.4% (1/237)
1.00
    Probable
Early (0 – 30 days)
0.4% (1/238)
0.0% (0/236)
Late ( days)
0.0% (0/238)
0.0% (0/232)
Very Late ( days)
There were 1 probable, subacute (1-30d) ST and 1 definite, very late ST in the Absorb BVS arm.

14. Predictor Analysis of 2-Year TLF
Variables OR
[95%CI]
Treatment (Absorb BVS vs XIENCE V)
0.90
[0.38, 2.16]
Age (years)
1.02
[0.98, 1.06]
Gender (female vs male)
0.80
[0.29, 2.24]
Current Tobacco Use (yes vs no)
2.73
[1.13, 6.62]
Any Diabetes (yes vs no)
0.97
[0.35, 2.70]
Diabetes Requiring Rx (yes vs no)
1.18
[0.42, 3.31]
Diabetes Requiring Insulin (yes vs no)
1.82
[0.51, 6.47]
Hypertension Requiring Rx (yes vs no)
0.63
[0.26, 1.52]
Hypercholesterolemia Requiring Rx (yes vs no)
0.97
[0.39, 2.39]
Prior Cardiac Interventions (yes vs no)
1.06
[0.24, 4.71]
Angina (yes vs no)
0.55
[0.20, 1.56]
Prior MI (yes vs no)
2.05
[0.77, 5.47]
Number of Treated Target Lesions (≥2 vs 1)
0.79
[0.10, 6.12]
Number of Diseased Vessel (≥2 vs 1)
1.37
[0.57, 3.30]
Target Vessel (LAD vs no-LAD)
0.82
[0.34, 1.97]
Moderate/Severe Calcification (yes vs no)
2.52
[0.98, 6.46]
Pre-Procedure RVD (mm)
2.07
[0.80, 5.36]
Pre-Procedure MLD (mm)
0.85
[0.28, 2.59]
Target Lesion Length (mm)
1.07
[0.98, 1.17]
Bifurcation (yes vs no)
1.33
[0.55, 3.21]
ACC/AHA Lesion Class
2.14
[0.62, 7.39]
Post-Procedure Dissection (yes vs no)
7.49
[0.75, 75.2]
Post-Procedure RVD (mm)
2.21
[0.83, 5.88]
Post-Procedure In-Segment MLD (mm)
0.70
[0.24, 2.10]
Post Dilatation (yes vs no)
0.56
[0.23, 1.35]
Max. Balloon Pressure Over the Entire Procedure (atm)
0.90
[0.79, 1.03]
0.001
0.01
0.1 1 10
100
1000
Odds Ratio (OR) 14

15. Predictors of 2-Year TLF
Variable P
Value
Odds Ratio
[95% CI]
Moderate/Severe Calcification
(yes vs. no)
0.032
2.86
[1.10, 7.49]
Current Tobacco Use
0.039
2.61
[1.05, 6.47]
Calcification (moderate/severe) and smoking are two predictors of 2-year TLF

16. Limitations Open-label study (potential for bias)
The primary endpoint was an objective measure of in- segment late loss analyzed by an independent angiographic core lab
Clinical events were adjudicated by an independent CEC
Non-complex patients and lesions enrolled
Study population is typical of pivotal studies for approval
Sample size not powered for clinical endpoints

17. Summary and Conclusion (1)
Trial well conducted:
High clinical f/u rate: 1-year = 98.5%; 2-year = 96.3%
Independent CEC, angiographic core lab, and DSMB
100% data monitoring conducted by the sponsor
Additionally, an independent, third-party data verification by the sites’ GCP offices was performed as mandated by the new GCP regulations in China.
ABSORB China met its primary endpoint of non- inferiority between Absorb BVS and XIENCE V for in- segment late loss at 1 year.

18. Summary and Conclusion (2)
The rates of clinical events, including TLF, cardiac death, TV-MI, ID-TLR, and device thrombosis were generally low and comparable between Absorb BVS and XIENCE V at 1 year.
This trend of low event rates and comparable results between treatment arms continued at 2 years.
Calcification (moderate/severe) and smoking are two predictors of 2-year TLF.

19. Thank you