on behalf of the ABSORB II Investigators The 2-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 12 October 2015 - San Francisco, CA - U.S.A Plenary Session VII. First Report Investigations 1. 12:00pm

Presentor Disclosures Bernard Chevalier is a consultant for Abbott Vascular Patrick Serruys is a member of the international advisory board of Abbott Vascular

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

2-Year Patient Flowchart Intent To Treat N=501 Absorb BVS N=335 XIENCE N=166 Baseline 1 subject consent withdrawn N=334 30-day N=166 3 subjects consent withdrawn 1 subject died N=331 180-day N=165 2 subjects consent withdrawn 1 subject consent withdrawn N=329 1-year N=164 3 subjects consent withdrawn. 2 subjects died 1 subject consent withdrawn N=324 (96.7%) N=163 (98.2%) 2-year

1-year Summary Hierarchical PoCE*, % 7.3 9.1 0.47 0.0 0.6 0.33 4.5 1.2 Absorb BVS N=335 XIENCE N=166 p value Hierarchical PoCE*, % 7.3 9.1 0.47 All death (Non-hierarchical) 0.0 0.6 0.33 All MI (Non-hierarchical) 4.5 1.2 0.06 All revascularization (Non-hierarchical) 3.6 0.07  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. *Per ARC. Cutlip et al., Circulation. 2007;115:2344-2351

1-year Summary Hierarchical PoCE*, % 7.3 9.1 0.47 0.0 0.6 0.33 4.5 1.2 Absorb BVS N=335 XIENCE N=166 p value Hierarchical PoCE*, % 7.3 9.1 0.47 All death (Non-hierarchical) 0.0 0.6 0.33 All MI (Non-hierarchical) 4.5 1.2 0.06 All revascularization (Non-hierarchical) 3.6 0.07  Hierarchical DoCE* or TLF, % 4.8 3.0 0.35 Cardiac death (Non-hierarchical) 1.00 TV-MI (Non-hierarchical) 4.2 0.07 CI-TLR (Non-hierarchical) 1.8 0.69 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). *Per ARC. Cutlip et al., Circulation. 2007;115:2344-2351

2-year Clinical Outcomes Composite Endpoints Absorb BVS N=335 XIENCE N=166 p value PoCE (%) 11.6 12.8 0.70 PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation

2-year Clinical Outcomes Composite Endpoints Absorb BVS N=335 XIENCE N=166 p value PoCE (%) 11.6 12.8 0.70 MACE (%) 7.6 4.3 0.16 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)

2-year Clinical Outcomes Composite Endpoints Absorb BVS N=335 XIENCE N=166 p value PoCE (%) 11.6 12.8 0.70 MACE (%) 7.6 4.3 0.16 DoCE, TLF (%) 7.0 3.0 0.07 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)

2-year Clinical Outcomes Composite Endpoints Absorb BVS N=335 XIENCE N=166 p value PoCE (%) 11.6 12.8 0.70 MACE (%) 7.6 4.3 0.16 DoCE, TLF (%) 7.0 3.0 0.07 TVF (%) 8.5 6.7 0.48 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)

2-year Clinical Outcomes Composite Endpoints Absorb BVS N=335 XIENCE N=166 p value PoCE (%) 11.6 12.8 0.70 MACE (%) 7.6 4.3 0.16 DoCE, TLF (%) 7.0 3.0 0.07 TVF (%) 8.5 6.7 0.48 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)

Patient oriented Composite Endpoint (PoCE) 25 Absorb BVS XIENCE 20 HR [95% CI]= 0.90 [0.53,1.53] p=0.69 (Log rank test) 15 12.7% PoCE (%) ∆=-1.2% 10 11.5% 5 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) PoCE: All death, all myocardial infarction, and all revascularisation

Patient oriented Composite Endpoint (PoCE) 25 Absorb BVS XIENCE 20 37-day HR 37-758-day HR 1.75 [0.58,5.31] 0.69 [0.37,1.28] p=0.3151 p=0.2317 15 PoCE (%) 10.3% 10 4.2% ∆=-3.0% 7.3% ∆=1.8% 2.4% 5 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) PoCE: All death, all myocardial infarction, and all revascularisation

Major Adverse Cardiac Events (MACE) 25 Absorb BVS XIENCE 20 HR [95% CI]= 1.80 [0.78,4.17] p=0.16 (Log rank test) 15 MACE (%) 10 7.5% ∆=3.2% 5 4.3% 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) MACE: Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation

Major Adverse Cardiac Events (MACE) 25 Absorb BVS XIENCE 20 37-day HR 37-758-day HR 3.49 [0.79,15.34] 1.13 [0.39,3.24] p=0.0760 p=0.8242 15 MACE (%) 10 5 4.2% 3.5% ∆=3.0% ∆=0.4% 1.2% 3.1% 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) MACE: Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation

Device oriented Composite Endpoint (DoCE)/ Target Lesion Failure (TLF) 25 Absorb BVS XIENCE 20 HR [95% CI]= 2.32 [0.88,6.10] p=0.078 (Log rank test) 15 DoCE/TLF (%) 10 6.9% ∆=3.9% 5 3.0% 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

Device oriented Composite Endpoint (DOCE)/ Target Lesion Failure (TLF) DoCE/TLF (%) 5 10 15 20 25 Absorb BVS XIENCE Time Post Index Procedure (Months) 90 180 270 360 450 540 630 720 1.2% 3.9% 1.8% 3.2% ∆=2.7% 37-day HR 3.24 [0.73,14.33] p=0.0996 37-758-day HR 1.71 [0.47,6.20] p=0.4109 ∆=1.4% DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)

Target Vessel Failure (TVF) 25 Absorb BVS XIENCE 20 HR [95% CI]= 1.28 [0.64,2.57] p=0.49 (Log rank test) 15 TVF (%) 10 8.5% ∆=1.8% 5 6.7% 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) TVF : Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation

Target Vessel Failure (TVF) 25 Absorb BVS XIENCE 20 37-day HR 37-758-day HR 2.33 [0.67,8.10] 0.89 [0.37,2.12] p=0.1683 p=0.7914 15 TVF (%) 10 4.2% 4.9% 5 ∆=2.4% ∆=-0.4% 1.8% 4.5% 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) TVF : Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation

Clinical Outcomes Non Hierarchical Events 2 years Absorb BVS N=335 XIENCE N=166 p value Death* (%) 1.2 0.6 0.67 Cardiac 0.0 0.55 Non cardiovascular 1.00 *Per ARC. Cutlip et al., Circulation. 2007;115:2344-2351

Clinical Outcomes Non Hierarchical Events 2 years Absorb BVS N=335 XIENCE N=166 p value Death* (%) 1.2 0.6 0.67 Cardiac 0.0 0.55 Non cardiovascular 1.00 Myocardial Infarction (%) 5.8 2.4 0.10 Q-wave 1.5 Non Q-wave 4.3 1.8 0.16 *Per ARC. Cutlip et al., Circulation. 2007;115:2344-2351

Clinical Outcomes Non Hierarchical Events 2 years Absorb BVS N=335 XIENCE N=166 p value Death* (%) 1.2 0.6 0.67 Cardiac 0.0 0.55 Non cardiovascular 1.00 Myocardial Infarction (%) 5.8 2.4 0.10 Q-wave 1.5 Non Q-wave 4.3 1.8 0.16 Definite/Probable ST* (%) 0.17 Acute/sub-acute (0-30 days) Late (31-365 days) 0.3 Very late (365 – 758 days) *Per ARC. Cutlip et al., Circulation. 2007;115:2344-2351

Post-Procedure Usage of Antiplatelet Medication through 2 years Absorb BVS N=335 XIENCE N=166 p value On Aspirin (%) at 1 year 95.8 95.2 0.75 at 2 years 92.2 0.99 On DAPT (%) 81.7 81.3 0.91 36.2 34.3 0.68

Very Late Scaffold Thrombosis Cases

IVUS Post procedure Proximal MSA frame Proximal D-max 3.00 mm, Distal D-Max 3.01 mm Absorb 3.0x18 mm, 10 atm MLD 1.84 mm Pre-dilatation Hiryu 2.75x10 mm MLD 3.44 mm %DS 39.0 Post-dilate Hiryu 3.25x10, 10 atm %DS 20.5 acute gain 1.6 mm Malapposed struts IVUS Post procedure Possible cause : 1.Proximal stent malapposition 2.Suboptimal expansion definite very late ST 447 days Proximal MSA frame SA 7.23 mm2 VD 3.03 mm LA 5.85 mm2 LD 2.73 mm LA 9.51 mm2 LD 3.48 mm Residual stenosis 21.5% Malapposition at proximal edge Suboptimal expansion DAPT: Aspirin only at time of the event

definite very late ST 602 days Proximal D-max 2.58 mm, Distal D-Max 2.84 mm Pre-dilatation Apex 3.0x12 mm Absorb 3.0x18 mm 10 atm = 3.20 mm No post-dilatation Proximal edge MLA frame VA 20.77 mm2 VD 5.14 mm LA 6.26 mm2 LD 2.82 mm VA 18.36 mm2 VD 4.84 mm SA 5.13 mm2 SD 2.56 mm Plaque burden 69.8% Incomplete coverage at distal edge Suboptimal expansion RAS 31.8%, Expansion index 0.59, definite very late ST 602 days Possible cause : 1. Suboptimal expansion 2. Incomplete coverage at edges DAPT: Aspirin only at time of the event

Revascularizations* Non Hierarchical Events 2 years Absorb BVS N=335 XIENCE N=166 p value TLR (%) 2.7 1.8 0.76 NTL-TVR (%) 1.5 2.4 0.49 NTVR (%) 5.5 0.13 All revascularization 5.8 9.1 0.17 *Clinically indicated revascularizations per ARC. Cutlip et al., Circulation. 2007;115:2344-2351

Clinically Indicated Target Lesion Revascularization (CI-TLR) 5 10 15 20 25 Absorb BVS XIENCE Time Post Index Procedure (Months) 90 180 270 360 450 540 630 720 HR [95% CI]= 1.49 [0.40,5.52] p=0.54 (Log rank test) 2.7% 1.8% ∆=0.9%

Limitations The ABSORB II study was not powered for clinical endpoints The 2-year endpoint represents a non pre-specified interim analysis Investigators long experience with XIENCE as compared to Absorb BVS might have impacted the results

Conclusions At 2 years there were no significant differences in the clinical outcomes between the two arms: PoCE (all death, all MI and all revascularization) Absorb BVS: 11.6% vs XIENCE: 12.8%, p=0.70 DoCE/TLF (cardiac death, TV-MI and TLR) Absorb BVS: 7.0% vs XIENCE: 3.0%, p=0.07 The exploratory observations presented in this report are hypothesis generating and need to be confirmed in larger randomized trials such as ABSORB III