2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study Laura Mauri MD, MSc on behalf of the RESOLUTE US Investigators Brigham and Women’s Hospital Boston, MA ACC 2012

Enrollment Complete - In Follow Up RESOLUTE 1 Non-RCT First-in-Human (R=139) 5 yr RESOLUTE AC 2,3 1:1 RCT vs. Xience V (R=1140; X=1152) 2 yr Non-RCT Observational (R=2349) 2 yr 2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2 yr RESOLUTE US – 3.5 mm Non-RCT (R=100) vs. Hx Control RESOLUTE Japan 2 yr R Japan SVS 2.25 Non-RCT vs. PG (R=65) < 1yr 38 mm sub-study Non-RCT vs. PG (R=114) < 1yr RESOLUTE Asia Non-RCT Observational (R=312) < 1yr RI-US Registry Post-approval study (R=230) plan RESOLUTE US RESOLUTE Global Clinical Program RESOLUTE Global Clinical Program Enrolling / Planning 1:1 RCT vs. Taxus (R=200; T=200) R-China RCT < 1yr RESOLUTE Int 4 RESOLUTE Int 4 1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377: Neumann FJ, et al. EuroIntervention. 2012;7(10): Yeung AC, et al. JACC. 2011;57: R-China Registry Non-RCT Observational (R=1800) < 1yr

Hx Controls Performance Goals Resolute stent 2.25–3.5 Clinical (n=1242) 2.25–3.5 Angio/IVUS (n=100) 4.0 Angio (n=60) 38mm Clinical (n=110–175) RESOLUTE US PI: M. Leon, L. Mauri, A. Yeung Primary Endpoints: 2.25–3.5 Clinical → Target Lesion Failure at 12mo2.25–3.5 Clinical → Target Lesion Failure at 12mo 2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo 4.0 Angio → In-Segment LLL at 8mo4.0 Angio → In-Segment LLL at 8mo 38 mm Clinical → Target Lesion Failure at 12mo38 mm Clinical → Target Lesion Failure at 12mo Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines) De Novo Native Coronary Lesion Vessel Diameter: 2.25 – 4.2 mm Lesion Length: ≤ 27 mm (≤ 35 mmlesions tx w/ 38 mm stent) (≤ 35 mm lesions tx w/ 38 mm stent) Clinical endpoints Angio/IVUS endpoints 6mo4yr3yr2yr12mo18mo8mo5yr9mo30d N = max 1577 patients Up to 135 US sites Clinical Study Design Mauri L, et al. Am Heart J. 2011;161:

Key Inclusion Criteria Clinical evidence of ischemic coronary disease Single or double de novo lesion in native coronary artery Target lesion ≤27mm in length, diameter stenosis ≥50% <100%, and target RVD ≥2.25mm ≤4.2mm Target vessel TIMI flow ≥2 Patient is able to take DAPT for at least 6 months Treatment of up to two lesions, if the lesions are located in separate target vessels Key Exclusion Criteria Acute MI within 72 hours of index procedure Previous PCI of target vessel within 9 months pre-procedure Planned PCI of any vessel within 30 days post-procedure Hx stroke or TIA within 6 months LVEF <30% RESOLUTE US Key Eligibility Criteria Mauri L, et al. Am Heart J. 2011;161:

RESOLUTE US Patient Flow Chart 1Yr Clinical Follow-up n = % 1Yr Clinical Follow-up n = % Patients Enrolled N = 1402 Patients Enrolled N = Yr Clinical Follow-up n = % 2Yr Clinical Follow-up n = %

RESOLUTE US % All Patients (2.25 mm – 4.00 mm diameter) N = 1402 Patients / 1573 Lesions Age, years (mean ± SD) 64.1±10.7 Male68.3 Diabetes mellitus 34.4 IDDM9.6 Prior PCI 32.7 Reason for revascularization: Stable angina 56.1 Unstable angina 41.9 Myocardial infarction 2.1 LAD45.9 RVD (mm) 2.6 ± 0.5 Type B2/C lesion 75.2 Two vessel treatment 10.4 Stents per patient (mean ± SD) 1.2 ± 0.5 Stent length per patient (mm) 22.4 ± 10.5 Baseline Characteristics Yeung AC, et al. J Am Coll Cardiol. 2011;57:

Cumulative Incidence of TLF (%) Time After Initial Procedure (Days) RESOLUTE US (N=1402) RESOLUTE US – All Patients Target Lesion Failure to 24 Months Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula % RESOLUTE All Comers (N=1140) RESOLUTE International (N=2349) 11.2% 9.8%

RESOLUTE US – All Patients Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=1359/1402) TLR Cardiac Death TV-MI ST (ARC Def/Prob) TLF Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven. Events [%] 99/ /135920/13593/135926/1359

RESOLUTE US – All Patients %12M n = M n = 1359 Death (all) Cardiac MI (target vessel) Q Wave Non Q wave Cardiac death + target vessel MI ST Def/Prob (all) Early (0-30 days) Late ( days) Very late (>360 days) TLR TVR TLF (cardiac death, TV-MI, TLR) TVF Clinical Outcomes at 12 and 24 Months

DAPT to 24 Months Adherence to DAPT (%) Time After Initial Procedure (days) RESOLUTE US, All Comers, International Trials % % % R-US (N=1402) R-AC (N=1140) R-INT (N=2349)

Def/prob Stent Thrombosis to 24 Months RESOLUTE US, All Comers, International Trials Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula Time After Initial Procedure (days) % 1.0% RESOLUTE All Comers (N=1140) RESOLUTE International (N=2349) RESOLUTE US (N=1402) 0.2%

% (n) 30 Days n= Year n= Year n=1359 Stent thrombosis (ARC def/prob) 0.1 (1)0.1 (2)0.2 (3) Early (< 30 days)0.1 (1) Late ( days)n/a0.1 (1) Very Late (>360 days)n/a 0.1 (1) RESOLUTE US – All Patients Stent Thrombosis at 24 Months

RESOLUTE US Main Study ( mm single lesion) Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=968/1001) TLR Cardiac Death TV-MI ST (ARC Def/Prob) TLF Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR (ischemia driven). TLF rate at 2 years for Endeavor ZES was 8.1% (Post-hoc analysis, P noninferiority <0.001) Events [%] 57/968 10/96817/9681/96833/968

RESOLUTE US – 2.25mm Cohort Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=147/150) TLR Cardiac Death TV-MI ST (ARC Def/Prob) TLF Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven. Events [%] 12/147 5/1472/147 7/147

RESOLUTE US – Diabetic Patients Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=474/482) TLR Cardiac Death TV-MI ST (ARC Def/Prob) TLF Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven. Events [%] 42/474 10/4747/4740/47427/474

RESOLUTE US – Diabetic Patients Safety and Efficacy Outcomes at 24 Months Diabetic (n=474/482) TLR Cardiac Death TV-MI ST (ARC Def/Prob) TLF Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven. Events [%] 57/885 10/88519/885 3/885 31/885 Non-Diabetic (n=885/920) 42/474 10/4747/4740/47427/474

RESOLUTE US Out to 2 years, the TLF (primary endpoint) was consistently low in all groups studiedOut to 2 years, the TLF (primary endpoint) was consistently low in all groups studied –All patients 7.3%, main cohort ( single lesion) 5.9%, small vessels (2.25 mm) 8.2% Stent thrombosis was very low (0.2%) with only 1 new ST event after 1 year, indicating a favorable safety profileStent thrombosis was very low (0.2%) with only 1 new ST event after 1 year, indicating a favorable safety profile Very good outcomes in the diabetic subgroupVery good outcomes in the diabetic subgroup –Low rate of TLF (8.9%) and TLR (5.7%) –No stent thrombosis out to 2 years Conclusions