SPIRIT IV 2 Year Results and The SPIRIT Women Clinical Trial One Year Clinical Follow-up Alexandra Lansky, MD Associate Professor of Medicine Yale University School of Medicine On Behalf of the SPIRIT Women Investigators

Alexandra J. Lansky, MD I have no real or apparent conflicts of interest to report.

Fluorinated Copolymer XIENCE V: Design Components MULTI-LINK VISION Cobalt Chromium Stent MULTI-LINK VISION Stent Delivery System Drug Everolimus Drug Matrix Fluorinated Copolymer

Safety and Performance Post CE Mark Approval International XIENCE V Clinical Trials 2 year F/U Registry Enrollment Complete Enrollment Complete Enrollment Complete 5 year F/U 3 year F/U 3 year F/U 1 year F/U SPIRIT II SPIRIT III SPIRIT IV SPIRIT V XIENCE V USA XIENCE V India SPIRIT FIRST SPIRIT WOMEN Safety and Performance Europe N=60 Clinical Support for CE Launch International N=300 U.S. and Japan Approval U.S.: 65 sites Japan: 12 sites N=1380 (1,292/88) U.S. Continued Access Expanded Enrollment: N=3,690 Post CE Mark Approval International N=3,000 100 sites Registry N=2,700 Diabetic study N=325 Post CE Mark Approval International N=2,000 100 sites Single Arm Study N=1600 Randomized Sub Study N=454 U.S. Post Approval N=8000 India Post Approval N=1000 Anticipated Total # Patients = 18,000

Enrolled (N = 3,690) at 66 US sites SPIRIT IV TAXUS (N = 1,229) XIENCE V (N = 2,458) RVD: 2.5 – 3.75 mm LL: ≤ 28 mm Enrolled (N = 3,690) at 66 US sites Up to three de novo lesions, maximum of two lesions per epicardial vessel Randomized (N = 3,687)* Qced by Guoping Su, 2/8/10 Prospective, single-blind, active-controlled, randomized trial in 3,687 pts Clinical follow-up up to 5 years in all patients Primary endpoint: Target lesion failure (TLF) at 1 year Major secondary endpoints: Ischemia-driven target lesion revascularization (TLR) at 1 year; composite of cardiac death or target vessel myocardial infarction at 1 year All endpoints powered for sequential noninferiority and superiority testing

SPIRIT IV − Gender Subgroup Randomized (N=3,687) XIENCE V (N=2,458) TAXUS (N=1,229) Qced by Guoping Su, 2/8/10 Women (N=1,188) 32% Men (N=2,499) 68% XIENCE V (N=792) TAXUS (N=396) XIENCE V (N=1,666) TAXUS (N=833)

SPIRIT IV − Gender Subgroup: Baseline Demographics Women (N=1,188) Men (N=2,499) XIENCE V N=792 TAXUS N=396 P value N=1,666 N=833 Age (in years) 65 ± 11 66 ± 10 0.10 62 ± 10 0.40 Body Mass Index (kg/m2) 31 ± 7 0.91 30 ± 5 31 ± 6 0.11 Hypertension (%) 80.7 81.1 0.94 75.8 73.8 0.28 Diabetes Mellitus (%) 35.4 38.2 0.34 30.4 29.8 0.75 Current Smoker (%) 22.3 20.7 0.60 21.7 23.2 0.38 Prior MI (%) 16.5 12.9 0.12 23.3 1.00 Unstable Angina (%) 32.1 28.2 0.18 25.6 29.2 0.06 Qced by Guoping Su, 2/8/10 N = Number of patients

SPIRIT IV − Gender Subgroup: Baseline Lesion Characteristics Women (NL=1,456) Men (NL=3,271) XIENCE V NL=972 TAXUS NL=484 P value NL=2,170 NL=1,101 Lesion Location LAD (%) 42 41 0.74 40 39 0.82 LCX (%) 21 22 0.68 26 27 0.40 RCA (%) 37 0.95 35 34 0.61 LMCA (%) NA QCA RVD (mm) 2.67 ± 0.45 2.67 ± 0.44 0.96 2.78 ± 0.49 2.79 ± 0.47 0.52 MLD (mm) 0.76 ± 0.37 0.77 ± 0.38 0.57 0.74 ± 0.38 0.75 ± 0.39 0.46 % DS 71 ± 12 71 ± 13 0.42 73 ± 13 0.67 Lesion Length (mm) 14 ± 6 14 ± 7 0.54 15 ± 7 0.34 Qced by Guoping Su, 2/8/10 NL = Number of lesions

SPIRIT IV − Gender Subgroup: Clinical Outcomes at 2 Years Women (N=1,188) Men (N=2,499) XIENCE V N=792 TAXUS N=396 P value XIENCE V N=1,666 TAXUS N=833 TLF (%)* 6.9 10.8 0.03 7.3 9.6 0.048 Cardiac Death (%)** 0.9 1.8 0.25 1.0 0.83 Target Vessel MI (%)** 2.4 3.9 0.14 2.3 3.3 0.18 Ischemia-driven TLR (%)** 4.1 0.02 4.9 6.7 0.09 MACE (%)* 7.1 11.3 7.5 0.08 Stent thrombosis (ARC def/prob) (%) 0.26 1.57 0.49 1.12 0.12 Bleeding complications (%) 6.1 0.37 3.7 3.0 0.48 Qced by Guoping Su, 2/8/10 TLF = cardiac death, target vessel MI, and ischemia-driven TLR; MACE = cardiac death, MI, ischemia-driven TLR; *Hierarchical subject count; **Non-hierarchical subject count.

Pinteraction (Women vs. Men) = 0.24 SPIRIT IV − Women Subgroup: Stent Thrombosis (ARC Definition)* at 2 Years Acute (0 – 24 hours) Subacute (>24 hours – 30 days) Late (>30 days – 2 years)** XIENCE V N=792 0.26% p=0.02 Qced by Guoping Su, 2/8/10, table 19.2 TAXUS N=396 1.57% Stent Thrombosis (%) Pinteraction (Women vs. Men) = 0.24 *Definite or Probable per ARC definition; **Categorical data, 730 ± 28 days

Pinteraction (Women vs. Men) = 0.24 SPIRIT IV − Men Subgroup: Stent Thrombosis (ARC Definition)* at 2 Years Acute (0 – 24 hours) Subacute (>24 hours – 30 days) Late (>30 days – 2 years)** XIENCE V N=1,665 0.49% p=0.12 Qced by Guoping Su, 2/8/10, table 19.3 TAXUS N=833 1.12% Stent Thrombosis (%) Pinteraction (Women vs. Men) = 0.24 *Definite or Probable per ARC definition; **Categorical data, 730 ± 28 days

PURPOSE and METHODS The SPIRIT Women Study provides an evaluation of the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent (EES) in the female population undergoing stent implantation*. SPIRIT Women is a prospective, open-label, single arm, all-comer multi-center study conducted at 73 sites outside of the United States. 1572 female patients were enrolled between July 2007 and March 2009. Maximum of 4 planned XIENCE V EESCC, Target lesions must be de novo Reference diameter between 2.5 mm and 4.0 mm Lesion length ≤ 28 mm. SPIRIT Women is the first major interventional trial with drug eluting stents to focus on women and specific aspects of their health in relation to CAD

SPIRIT WOMEN Global Site Distribution Hungary (2) Israel (1) Italy (12) Latvia (1) Netherlands (5) Norway (2) Poland (2) Austria (3) Belgium (3) Denmark (1) France (8) Germany (15) Portugal (4) South Africa (2) Spain (5) Switzerland (3) UK (4) Australia (2) Hong Kong (4) India (6) Malaysia (1) China (6) Argentina (2) Brazil (4) Venezuela (1)

STUDY DESIGN SPIRIT WOMEN RCT N  450 2 : 1 XIENCE V N = 300 Prospective, double arm, multi-centre study performed in parallel with a prospective, single arm study CYPHER Select Plus™* N = 150 SPIRIT WOMEN SAS N  1600 Primary endpoint: In-stent late loss at 270 days Primary endpoint: Composite endpoint at 1 year (All death, MI, TVR) PI: Marie-Claude Morice, MD, Massy, France Co-PI: Dr Stephan Windecker, MD, Bern, Switzerland Steering Committee: MG Modena, Modena, Italy, G Mikhail, London, UK, F Mauri, Barcelona, Spain, R Strasser, Dresden, Germany, L Grinfeld, Buenos Aires, Argentina Angiographic Core Lab: BioClinica, Leiden, The Netherlands All Events adjudicated by an independent CEC to Academic Research Consortium (ARC) Definitions CEC: K Koch, A Hoye, C Hanet, D McClean, E McFadden, V Umans, P Agostoni DSMB: J Tijssen, W Wijns, P Urban, K Fox Sponsor: Abbott Vascular SAS Enrollment Complete: 27 March 2009 * Cypher Select Plus Coronary Stent System is a registered trademark of Cordis or its affiliates.

CLINICAL STUDY POPULATION Intent to Treat Baseline and 30 Days 5: Informed Consent Withdrawn 6: Lost to Follow-up 1: Missed Visit N = 1560 240 Days A high 98% of patients returned for 1 year follow-up 3: Informed Consent Withdrawn 4: Lost to Follow-up 3: Missed Visit N = 1550 1-Year Clinical Follow-up 99% at 1 Year

BASELINE DEMOGRAPHICS Age 67 Years Prior MI 26% Unstable Angina 37% Multi Vessel Disease 36% Prior Cardiac Intervention 17% Braunwald Class lll 16% ‘Real World’ N=1572 Diabetes 34% Current Smoker 14% Hypertension 78% IDDM 11% Hypercholesterolemia 64% Family History CAD 36% Prior Oophorectomy 9% Prior Hysterectomy 20% General Obesity 27% Central Obesity* 71% Post Menopausal 94% *Waist circumference >88 cm

BASELINE LESION CHARACTERISTICS* Left Main 1% Mean Lesion Length 15mm RVD ≤2.75mm 47% Lesion length ≥20mm 29% Mean % DS 83% Mean RVD 2.9mm ‘Real World’ NL=2250 Lesions Thrombus 6% All lesion characteristics were visually assessed by the investigator. 47% of patients had a RVD <= 2.74. 72% of patients had type B2 or C lesions and moderate to severe calcium was present in 30% of lesions. The mean lesion length was 15mm and 29% of lesions were >=20mm. Eccentric 44% Moderate or Severe Calcium 30% Lesion Angulation >45º 23% >1 Target Lesion 32% Target Lesions Treated/Patient 1.4 ACC Lesion B2 or C 72% *Visually assessed by Investigator

PRIMARY ENDPOINT RESULTS* 1 YEAR ARC DEFINED PRIMARY ENDPOINT RESULTS* All Death, MI and TVR % 6 9 12 15 3 XIENCE V 37 393 Days Post Index Procedure 7,8% 12% The 12% composite endpoint rate was mainly driven by the high MI rate of 9%. Out of 139 MI events, 110 were peri-procedural MI events. *Previous MI rates in SPIRIT III and SPIRIT IV were adjudicated using historical WHO definition. Events in SPIRIT Women were adjudicated according to Academic Research Consortium (ARC) Definitions (Peri-procedural MI=Troponin >3 times ULN)

1 YEAR ARC DEFINED CLINICAL RESULTS Non-Hierarchical N=1550 All Death (%) Cardiac Death 1.6 0.8 All ARC Defined MI* (%) ARC Defined Peri-procedural MI ARC Defined TV MI** 9.2 7.1# 8.7 ARC Defined Q-Wave TV MI 0.1 ARC Defined Non Q-Wave TV MI 8.6 TLR (%) 2.4 by PCI 2.1 by CABG 0.3 TVR including TLR (%) 3.0 2.7 Low rates of TLR and TVR for this complex patient and lesion population. #111 out of 1572 patients (7.1%) had an ARC Defined Peri-procedural MI All revascularizations are considered clinically indicated

1 YEAR ARC DEFINED STENT THROMBOSIS *90% of patients on Clopidogrel and 96% on Aspirin at 1 year follow-up No subacute definite stent thromboses occurred

CONCLUSIONS Results of the SPIRIT IV trial at 2 years demonstrated that women treated with XIENCE V EES had sustained superior safety and effectiveness with an 83% RRR in stent thrombosis compared to the Taxus stent SPIRIT Women is the first prospective post-market study in an exclusively female “all comers” population evaluating high risk women XIENCE V® has proven safe and effective with low rates of Target Lesion Revascularization (2.4%) and Stent Thrombosis (0.59%) despite the complexity of the population