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

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

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, 3.0. 3.5 mm Length: 8, 12, 18, 28 mm CoCr-EES Tx. with single study device Diameter: 2.5, 3.0. 3.5 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

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)

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

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

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

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)

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

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

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 < 0.0001 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-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)

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

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

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

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

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

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 = 0.195 mm P=0.74 Non-inferiority P < 0.0001 0.01 mm 0.13 mm 0.12 mm ● 0.07 mm BVS CoCr-EES Asymptotic test statistic based on Z test

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

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.

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.

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)

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.