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2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study

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. RESOLUTE Global Clinical Program. Enrollment Complete - In Follow Up. RESOLUTE 1.

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2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study

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  1. 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

  2. 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 2 yr Non-RCT Observational (R=2349) 2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2yr RESOLUTE US5 2yr 2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control RESOLUTE Japan R Japan SVS 2.25 Non-RCT vs. PG (R=65) < 1yr 38 mm sub-study Non-RCT vs. PG (R=114) RESOLUTE US < 1yr R-China RCT 1:1 RCT vs. Taxus (R=200; T=200) < 1yr Non-RCT Observational (R=312) < 1yr RESOLUTE Asia Non-RCT Observational (R=1800) < 1yr R-China Registry Enrolling / Planning Post-approval study (R=230) plan RI-US Registry 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 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) Hx Controls Performance Goals RESOLUTE US Clinical Study Design PI: M. Leon, L. Mauri, A. Yeung De Novo Native Coronary Lesion Vessel Diameter: 2.25 – 4.2 mm Lesion Length: ≤ 27 mm (≤ 35 mmlesions tx w/ 38 mm stent) N = max 1577 patients Up to 135 US sites Clinical endpoints 30d 6mo 8mo 9mo 12mo 18mo 2yr 3yr 4yr 5yr Angio/IVUS endpoints • Primary Endpoints: • 2.25–3.5 Clinical → Target Lesion Failure at 12mo • 2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo • 4.0 Angio → In-Segment LLL at 8mo • 38 mm Clinical → Target Lesion Failure at 12mo • Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines) Mauri L, et al. Am Heart J.2011;161:807-14.

  4. RESOLUTE US Key Eligibility Criteria KeyInclusion 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 KeyExclusion 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% Mauri L, et al. Am Heart J.2011;161:807-14.

  5. RESOLUTE US Patient Flow Chart Patients Enrolled N = 1402 1Yr Clinical Follow-up n = 1386 98.9% 2Yr Clinical Follow-up • n = 1359 • 96.9%

  6. RESOLUTE US Baseline Characteristics Yeung AC, et al. J Am Coll Cardiol.2011;57:1778-83.

  7. RESOLUTE US – All Patients Target Lesion Failure to 24 Months 25 RESOLUTE US (N=1402) RESOLUTE All Comers (N=1140) 20 RESOLUTE International (N=2349) 15 Cumulative Incidence of TLF (%) 11.2% 10 9.8% 7.3% 5 0 0 90 180 270 360 450 540 630 720 Time After Initial Procedure (Days) Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

  8. RESOLUTE US – All Patients Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=1359/1402) Events [%] 99/1359 58/1359 20/1359 26/1359 3/1359 ST (ARC Def/Prob) Cardiac Death TLF TLR TV-MI Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.

  9. RESOLUTE US – All Patients Clinical Outcomes at 12 and 24 Months

  10. DAPT to 24 Months RESOLUTE US, All Comers, International Trials 97.3 95.8 R-US (N=1402) 91.1 97.1 95.5 93.5 R-INT (N=2349) R-AC (N=1140) 93.8 93.1 73.8 84.1 67.2% Adherence to DAPT (%) 43.9% 18.6% Time After Initial Procedure (days)

  11. Def/probStent Thrombosis to 24 Months RESOLUTE US, All Comers, International Trials 25 RESOLUTE US (N=1402) RESOLUTE All Comers (N=1140) 20 RESOLUTE International (N=2349) 15 10 5 1.9% 1.0% 0 0.2% 0 90 180 270 360 450 540 630 720 Time After Initial Procedure (days) Error bars indicate a point-wise two-sided 95% confidence interval (±1.96*SE). Standard Error based on the Greenwood Formula.

  12. RESOLUTE US – All Patients Stent Thrombosis at 24 Months

  13. RESOLUTE US Main Study (2.5-3.5mm single lesion) Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=968/1001) Events [%] 57/968 10/968 17/968 33/968 1/968 ST (ARC Def/Prob) Cardiac Death TLF TV-MI TLR 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, Pnoninferiority<0.001)

  14. RESOLUTE US – 2.25mm Cohort Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=147/150) Events [%] 12/147 5/147 2/147 7/147 2/147 ST (ARC Def/Prob) Cardiac Death TLF TV-MI TLR Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.

  15. RESOLUTE US – Diabetic Patients Safety and Efficacy Outcomes at 24 Months Resolute ZES (n=474/482) Events [%] 42/474 10/474 7/474 27/474 0/474 ST (ARC Def/Prob) Cardiac Death TLF TV-MI TLR Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.

  16. RESOLUTE US – Diabetic Patients Safety and Efficacy Outcomes at 24 Months Diabetic (n=474/482) Non-Diabetic (n=885/920) Events [%] 3/885 42/474 57/885 10/474 10/885 7/474 19/885 27/474 31/885 0/474 ST (ARC Def/Prob) Cardiac Death TLF TV-MI TLR Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.

  17. RESOLUTE US Conclusions • Out to 2 years, the TLF (primary endpoint) was consistently low in all groups studied • All patients 7.3%, main cohort (2.5-3.5 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 profile • Very good outcomes in the diabetic subgroup • Low rate of TLF (8.9%) and TLR (5.7%) • No stent thrombosisout to 2 years

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