On behalf of J. Belardi, M. Leon, L. Mauri, Two-Year Outcomes of Patients Treated with the Resolute Zotarolimus-Eluting Stent in Different Indications: ST Elevation Myocardial Infarction versus Acute Coronary Syndrome Without ST Segment Elevation versus Stable Angina: A Pooled Analysis from the RESOLUTE Clinical Program P. Widimský, On behalf of J. Belardi, M. Leon, L. Mauri, I. Meredith, F-J. Neumann, S. Saito, P. Serruys, S. Silber, S. Windecker, A. Yeung and the RESOLUTE Clinical Program Investigators ACC 2012

Background Stent thrombosis (ST) with first generation DES has been a concern, in particular (very) late ST. The risk of ST in patients with STEMI is known to be higher than in patients treated for other indications. E.g., in the HORIZONS-AMI (STEMI <12h) the 2-yr ST rate was 4.1% with both BMS and PES. There are limited data on patients treated with the Resolute ZES stratified by different clinical presentations: STEMI, non-ST elevated acute coronary syndrome (Non-STEACS) and stable angina (SA).

RESOLUTE Global Clinical Program Enrollment Complete - In Follow Up RESOLUTE1 Non-RCT First-in-Human (R=139) 5 yr RESOLUTE AC2,3 1:1 RCT vs. Xience V (R=1140; X=1152) 2 yr RESOLUTE Int4 Non-RCT Observational (R=2349) 2 yr RESOLUTE US5 2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2 yr RESOLUTE Japan 2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control 2 yr R Japan SVS 2.25 Non-RCT vs. PG (R=65) < 1yr RESOLUTE US 38 mm sub-study Non-RCT vs. PG (R=114) < 1yr R-China RCT 1:1 RCT vs. Taxus (R=200; T=200) < 1yr RESOLUTE Asia Non-RCT Observational (R=312) < 1yr R-China Registry Non-RCT Observational (R=1800) < 1yr Enrolling / Planning RI-US Registry Post-approval study (R=230) plan 1 Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2 Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3 Silber S, et al. Lancet. 2011;377:1241-47. 4 Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5 Yeung AC, et al. JACC. 2011;57:1778-83. 3

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Methods RESOLUTE All Comers N = 1140 (R-ZES arm) RESOLUTE International N = 2349 STEMI N = 335 Non-STEACS N = 1416 Stable Angina N = 1260 Pooled patient level data from 2 all comer trials and stratified by clinical indication at time of procedure: STEMI was defined as STEMI with onset of symptoms ≤ 24h Non-STEACS included all patients with non-STEMI and unstable angina

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Baseline Patient Characteristics % STEMI N=335 Non-STEACS N=1416 SA N=1260 Age (yr) 59.8 ± 11.3 63.8 ± 11.6 64.9 ± 10.1 Female 23.9 23.1 23.3 Diabetes mellitus 19.1 28.5 29.2 Hypertension 51.9 69.1 74.4 Hyperlipidemia 41.5 63.5 71.3 History of smoking 67.8 55.4 55.2 Current smoker 45.7 26.2 16.4 Family history of CAD 33.7 30.5 36.5 Prior MI 11.3 27.2 29.4 Prior PCI 27.9 37.6 Prior CABG 0.9 8.0 12.3

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Lesion and Procedure Characteristics STEMI N=335 pts, 477 lesions Non-STEACS N=1416 pts, 2089 lesions SA N=1260 pts, 1782 lesions Multivessel stenting (%) 12.2 20.4 16.5 B2/C lesion type (%) 73.7 62.6 61.9 RVD (mm)1 2.89 ± 0.51 2.85 ± 0.51 2.83 ± 0.52 MLD (mm)1 0.40 ± 0.51 0.63 ± 0.49 0.65 ± 0.48 Diameter Stenosis (%)1 85.5 ± 17.9 77.2 ± 17.0 76.5 ± 17.3 Lesion Length (mm)1 16.8 ± 9.0 16.5± 9.6 16.7± 11.4 Long lesions (>27 mm, %)1 15.7 15.4 15.0 Small vessel (≤ 2.75mm, %)1 48.0 51.2 53.4 Bifurcation (%) 20.3 20.1 20.8 Total occlusion (%) 49.9 11.1 8.8 Complex patients (%)2 100.0 69.8 56.0 1 In RESOLUTE International (R-INT) trial angiographic measurements are site reported. 2 Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI = 0).

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Clinical Outcomes at 30 Days % STEMI n = 332 Non-STEACS n = 1412 SA n = 1257 Death (all) 0.6 0.4 0.1 Cardiac 0.0 Target vessel MI (all) 1.2 2.8 3.3 Cardiac death + target vessel MI 1.8 3.1 ST def/prob 0.7 Early (0 – 30d) LST (>30d – 1yr) -- VLST (>1 yr) TLR (clinically driven) 2.1 1.1 TVR (clinically driven) 2.7 0.8 1.3 TLF (cardiac death, target vessel MI, TLR) 3.0 3.4 3.8

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Clinical Outcomes at 2 Years % STEMI n = 329 Non-STEACS n = 1387 SA n = 1235 Death (all) 2.1 4.8 3.7 Cardiac 1.8 3.2 2.0 Target vessel MI (all) 4.5 4.0 Cardiac death + target vessel MI 3.6 7.3 5.7 ST def/prob 2.4 1.2 1.1 Early (0 – 30d) 0.6 0.7 LST (>30d – 1yr) 0.4 0.2 VLST (>1 yr) 0.0 TLR (clinically driven) 5.5 5.2 5.4 TVR (clinically driven) 7.0 6.8 TLF (cardiac death, target vessel MI, TLR) 7.9 11.0 10.1

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Outcomes at 2 Years Event Rates (%) Cardiac Death TV-MI TLR ST ARC Def/Prob TLR is ischemia driven.

RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina Conclusions The implantation of Resolute ZES in the acute phase of STEMI as well as in other clinical presentations appears to be safe and effective and the long term outcomes are very favorable, especially considering previously published outcomes in STEMI patients. Late and very late stent thrombosis is extremely rare with R-ZES implantation irrespective of the original clinical presentation.