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

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

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.

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, 3.0. 3.5 mm Lengths: 8, 12, 18, 28 mm XIENCE V Treat with single study device Diameters: 2.5, 3.0. 3.5 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

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

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. 0.13 ± 0.38 mm (n=196) Difference = 0.06 mm [ -0.02, 0.14 ] PNI = 0.01 Difference (Absorb BVS – XIENCE V) 5

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)

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

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

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

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

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

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

Scaffold/Stent Thrombosis Absorb BVS (N=241) XIENCE V (N=239) P-Value All (0 - 730 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 (31- 365 days) 0.0% (0/238) 0.0% (0/232) Very Late (366- 730 days) Absorb BVS (N=241) XIENCE V (N=239) P-Value All (0 - 730 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 (31- 365 days) 0.0% (0/238) 0.0% (0/232) Very Late (366- 730 days) There were 1 probable, subacute (1-30d) ST and 1 definite, very late ST in the Absorb BVS arm.

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

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

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

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.

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.

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