Early and Late Stent Thrombosis Rates in 5,054 Real-World Patients from XIENCE V USA With and Without Dual Antiplatelet Therapy Interruptions James Hermiller, MD Heart Center of Indianapolis Indianapolis, USA On behalf of the XIENCE V USA Investigators

SE Rev. A Disclosures Research Consultant for – Abbott Vascular Consultant for – St. Jude Medical, Inc. – Boston Scientific Corporation Speaker Bureau for – Eli Lilly and Company 2

SE Rev. A Background XIENCE V in the SPIRIT II, III and IV trials has shown superior reductions in late loss, TLR and MACE, as well as significant reduction in stent thrombosis (ST) compared to Taxus Express; this was confirmed in COMPARE, a large, single-center, real-world prospective randomized trial of XIENCE V vs. Taxus Liberté. In addition to randomized controlled studies, large, prospective postmarket single arm studies are important to provide clinical outcomes in real-world patients reflecting both real-world medication adherence and physicians with a range of coronary stenting experiences. Previous studies have shown that dual antiplatelet therapy interruption prior to 6 months is associated with a high risk of stent thrombosis. More data is needed to address this practical problem clinicians face daily. 3

SE Rev. A Study Design XIENCE V USA is a prospective, multicenter, post-approval study designed to examine the safety of XIENCE V in an all-inclusive, consecutive, real-world patient population from real-world clinical settings. Primary Endpoint: ARC definite/probable stent thrombosis at 1 year adjudicated by an independent Clinical Events Committee – Overall population – Standard risk population Study Monitoring Plan – 30% of randomly selected patients monitored with source document verification – 100% source verification of all site reported endpoint events – 100% source verification of patient Informed Consent forms 4

SE Rev. A Study Organization 5 Principal Investigator James Hermiller, MD Heart Center of Indianapolis Indianapolis, IN Co-Principal Investigator Mitch Krucoff, MD Duke University Medical Center Durham, NC CEC Cardiovascular Research Foundation New York, NY DSMB Axio Research Seattle, WA CRO Covance Periapproval Service, Inc. Conshohocken, PA Sponsor Abbott Vascular Santa Clara, CA

SE Rev. A One-Year Follow-Up 6 Total Enrolled N = 5,054 Total Enrolled N = 5, ± 42 Days N = 4,887 (96.7%) 365 ± 42 Days N = 4,887 (96.7%) 30 ± 7 Days N = 5, ± 7 Days N = 5, ± 14 Days N = 4, ± 14 Days N = 4,935 1-Year Follow-up † Patients Who Terminated the Study Prior to 1-year* Lost to Follow-Up56 Withdrawal49 Patient Death59 Other3 *Early terminated patients without any ST event † Patients will be followed up yearly through 5 years 162 U.S. sites with patients enrolled

SE Rev. A Patient & Lesion Distribution 7 AMI 18.1% ACS 37.5% Renal Insufficiency 11.1% Multivessel Disease 40.8% EF < 30% 3.4% Multivessel Treated 13.8% Left Main 1.6% Graft Lesion 4.8% CTO Lesion 2.5% Direct Stenting 38.7% Restenosis Lesion 9.5% Ostial 11.9% Bifurcation 9.0% Diabetes 35.6% A Real-World Population

SE Rev. A DAPT Compliance 8 AspirinThienopyridineDAPT Baseline91.9%97.1%89.7% 14-day Visit91.5%96.5%89.2% 30-day Visit91.1%95.9%88.6% 180-day Visit87.9%92.9%85.0% 1-Year Visit83.0%87.3%79.4%

SE Rev. A 1 Year ST Rate (ARC Def/Prob) Overall Population 9 XIENCE V USA XIENCE V 0.84%

SE Rev. A 1 Year ST Rate (ARC Def/Prob) Overall Population 10 1 Kedhi E. et al Lancet. 2010; 375 (9710): COMPARE 1 XIENCE V USA XIENCE VTAXUSXIENCE V 0.84% 0.7% 3% p = 0.002

SE Rev. A 1 Year ST Rate (ARC Def/Prob) from Real-World Single-Arm Trials ST (ARC Def/Prob) (%) XV USAE-Five 2 N = 4,887N = 517 OLYMPIA Phase I 4 N = 7,832 ARRIVE 3 N = 7,274 Registry XIENCE VEndeavorTAXUS LibertéTAXUS EXPRESSStent 1 Urban PM et al. JACC 55 (10A), 2010; 2 Lotan C. et al. JACC 2 (12), 2009; 3 Lasala JM et al. Circ Cardiovas Interv 2 (4), 2009; 4 Ahmed AH et al. J Interven Cardiol 21(6), 2008` N = 15,147 E-SELECT 1 Cypher 11

SE Rev. A STANDARD RISK COHORT 12

SE Rev. A Standard Risk Cohort Standard Risk Cohort (N = 1,827, 36% of Total) Lesion length ≤ 28mm RVD between 2.5mm and 4.25mm None of the following: – CTO – Graft lesion – Bifurcation with side branch ≥ 2mm – Ostial – LM – ISR – > 2 lesions stented in the same vessel – > 2 vessels treated – AMI – Renal insufficiency – EF < 30% – Staged Procedure 13

SE Rev. A 14 XIENCE V 0.34% 1-Year ST Rate (ARC Def/Prob) Standard Risk Cohort *XIENCE V USA patients who have lesion length ≤ 28mm, RVD between 2.5mm and 4.25mm and do not have any one of the following: CTO, graft lesion, bifurcation with side branch ≥ 2mm, ostial, LM, ISR, > 2 lesions stented in the same vessel, > 2 vessels treated, AMI, renal insufficiency, EF < 30%, staged procedure. †The number of standard risk patients who have reached 1 year for ST analysis. Total number of standard risk cohort is 1,827, with 54 patients terminated before 1 year without ST event and therefore excluded in this analysis. XIENCE V USA Standard Risk* (N = 1,773 † )

SE Rev. A 15 SPIRIT III & SPIRIT IV** XIENCE VTAXUSXIENCE V 0.34% 0.4% 1.0% p = 0.03 *XIENCE V USA patients who have lesion length ≤ 28mm, RVD between 2.5mm and 4.25mm and do not have any one of the following: CTO, graft lesion, bifurcation with side branch ≥ 2mm, ostial, LM, ISR, > 2 lesions stented in the same vessel, > 2 vessels treated, AMI, renal insufficiency, EF < 30%, staged procedure. †The number of standard risk patients who have reached 1 year for ST analysis. Total number of standard risk cohort is 1,827, with 54 patients terminated before 1 year without ST event and therefore excluded in this analysis. ** Presented by Dr. James Hermiller at SCAI 2010 XIENCE V USA Standard Risk* (N = 1,773 † ) 1-Year ST Rate (ARC Def/Prob) Standard Risk Cohort

SE Rev. A REAL-WORLD DAPT INTERRUPTION ANALYSIS 16

SE Rev. A Temporary Interruption % (N) 5.6% (N = 243) Number of Interruptions1.1 ± 0.5 (N = 243) Days to First Interruption (days)134.3 ± (N = 243) Duration of Interruption (days)20.3 ± 46.9 (N = 243) Top 3 Reasons for Interruption Surgical Procedure = 35.4% Adverse Event** = 30.5% Patient Non-compliance = 9.5% Permanent Discontinuation % (N) 8.5% (N = 366) Days to Discontinuation (days)239.2 ± (N = 366) Top 3 Reasons for DiscontinuationAdverse Event** = 21.9% Surgical Procedure = 10.7% Increased Bleeding Risk = 9.6% DAPT Interruption Pattern* 17 *Out to 1 year **Adverse Events include all events regardless of their severity and/or relationship with drugs or device

SE Rev. A Late ST Rates (30 Days - 1 Year) After DAPT Interruption Subsequent Late ST (ARC Def/Prob) (%) No InterruptionInterruption After 30 Days* 13/35000/292 Interruption After 180 Days* 2/435 Interruption After 90 Days* 1/378 Overall 18 *Out to 1 year

SE Rev. A Late ST Rates (30 Days - 1 Year) After DAPT Interruption Subsequent Late ST (ARC Def/Prob) (%) No InterruptionInterruption After 30 Days* 13/35000/292 Interruption After 180 Days* 2/435 Interruption After 90 Days* 1/3782/12720/1570/1470/120 Overall Standard Risk 19 *Out to 1 year

SE Rev. A Summary XIENCE V demonstrates low rates of 1 year stent thrombosis (0.84%) and late stent thrombosis (0.39%) in the overall real-world cohort XIENCE V demonstrates low rates of 1 year stent thrombosis (0.34%) and late stent thrombosis (0.11%) in standard risk patients. XIENCE V demonstrates an absence of stent thrombosis in standard risk patients with DAPT interruptions after 30 days and in the overall real-world cohort after 6 months. 20

SE Rev. A Conclusions In a complex real-world population of ~5,000 patients, XIENCE V USA demonstrates very low stent thrombosis rates for the XIENCE V stent In a real-world experience of unanticipated DAPT interruption, XIENCE V had an observed zero ST event rate for DAPT interruption beyond 6 months. 21

SE Rev. A 22