Medtronic Plc. · NYSE:MDT

Medtronic — Technical Presentation (2020)

25 slides from Medtronic's technical presentation, 2020

  1. Slide 1: One Month Dual Antiplatelet Therapy in High Bleeding Risk Patients: Primary Results of Onyx ONE Clear

    One Month Dual Antiplatelet Therapy in High Bleeding Risk Patients: Primary Results of Onyx ONE Clear Ajay J. Kirtane, MD, SM Columbia University Irving Medical Center /New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA email: akirtane@columbia.edu twitter:

  2. Slide 2: Disclosure Statement of Financial Interest

    Disclosure Statement of Financial Interest Ajay J. Kirtane Institutional funding to Columbia University and/or Cardiovascular Research Foundation from: – Medtronic, Boston Scientific Corporation, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical Personal: CME/conference honor

  3. Slide 3: Background

    Background • Up to 40% of patients undergoing PCI have high bleeding risk (HBR) characteristics • Guidelines recommend 3-6 months of DAPT for HBR patients undergoing PCI with consideration for DAPT duration as short as 1 month in selected patients • Resolute Onyx™ is a thin strutted, conformable ste

  4. Slide 4: Objective

    Objective To evaluate the safety and efficacy of the Resolute Onyx stent among HBR patients undergoing PCI with planned 1-month DAPT 1. Extension of Onyx ONE RCT results 2. Patient enrollment from USA and Japan 3. Prospective, single arm trial design 4. Powered analysis to support indication approva

  5. Slide 5: Rationale for Prospective Single Arm Design in US/Japan

    Rationale for Prospective Single Arm Design in US/Japan • No approved DES with 1-month DAPT in conjunction with limited BMS use precluding 1-month RCT designs like Onyx ONE RCT • Extension of Onyx ONE RCT data to US and Japan with – Similar inclusion / exclusion criteria – Similar case report forms

  6. Slide 6: Study Design

    Study Design Prospective, Multicenter, Single-arm Study High Bleeding Risk patients undergoing PCI (no lesion, vessel limitations) Resolute Onyx™ ZES Resolute Onyx ZES with 1 Month DAPT with 1 Month DAPT US & Japan (N=700 + max 100) from Onyx ONE RCT (N=1000) Clinical Follow-up 1mo 2mo 6mo 1yr 2yr P

  7. Slide 7: HBR Inclusion Criteria (One or More)

    HBR Inclusion Criteria (One or More)  Elderly (age ≥75 years)  Thrombocytopenia (<100,000/mm3)  OAC planned after PCI  Cancer diagnosed or treated within 3 yrs  Renal failure (CrCl <40 ml/min)  Stroke within 1 year or any prior ICH  Planned surgery <1 year  Severe chronic liver disease  Ane

  8. Slide 8: Antithrombotic Therapy

    Antithrombotic Therapy PCI • After PCI, DAPT was prescribed for 1-month, including: – Daily dose of aspirin (75-100 mg) AND – P2Y12 inhibitor (clopidogrel preferred, others allowed) P2Y12 ASA • Patients receiving OAC could receive single or dual antiplatelet therapy during this 1st month after PCI 1

  9. Slide 9: Sample Size Calculation

    Sample Size Calculation Primary Endpoint Cardiac death or MI Definition “1-month clear” Expected event rate1 6.8% • Event-free2 in 1st month Performance goal 9.7% • Adherent to DAPT for 1st month One-sided type I error (α) 0.025 = Effective analysis population Power >97% Effective sample size 1360 p

  10. Slide 10: Trial Organization

    Trial Organization Principal Investigators D. Kandzari, A. Kirtane (Co-PIs) Executive Committee G. Stone (Program Chair), A. Abizaid, E. Kedhi, A. Latib, R. Mehran, M. Price, D. Simon, S. Windecker, S. Worthley, A. Zaman DSMB JP. Carrozza (Chair) Cardiovascular Research Foundation, New York NY, USA

  11. Slide 11: Participating Centers

    Participating Centers United States Japan ▪ Texas: J Choi, S Potluri, T Tolleson, A Shah ▪ Fukuoka: K Ando ▪ New York: R Caputo, T Nazif, L Gruberg ▪ Kanagawa: S Saito, Y Ikari ▪ Alabama: M Kanitkar ▪ Tokyo: K Kozuma ▪ South Carolina: B McLaurin ▪ Kumamoto: T Sakamoto ▪ Ohio: T Smith, NH Kander, J L

  12. Slide 12: Top Enrolling Sites

    Top Enrolling Sites Site PI Hospital Location Patients Choi, James Baylor Heart & Vascular Hospital Dallas, TX 78 Caputo, Ronald Saint Joseph's Hospital Health Center Syracuse, NY 71 Kanitkar, Mihir Huntsville Hospital Huntsville, AL 57 McLaurin, Brent AnMed Health Medical Center Anderson, SC 54 Pot

  13. Slide 13: Patient Flowchart

    Patient Flowchart Onyx ONE US/Japan Onyx ONE RCT (N=752: US 713 + Japan 39) Resolute Onyx pts (N=1019) 1 Japanese patient not eligible yet for 1-yr 1 patient did not consent follow-up at time of database snapshot for data use outside of Onyx ONE RCT Onyx ONE As-Treated population (N=1769) 263 Not “1

  14. Slide 14: Baseline Characteristics

    Baseline Characteristics % or mean ± SD Onyx ONE Onyx ONE Onyx ONE Clear RCT1 US/Japan1 (N=1506) (N=905) (N= 601) Age (yrs) 74.0 ± 9.5 73.8 ± 9.6 74.2 ± 9.5 Female 32.3 32.2 32.6 Diabetes 39.4 37.2 42.6 Hypertension 84.0 80.0 90.0 Hyperlipidemia 72.4 64.4 84.5 Previous MI 26.3 26.0 26.8 Previous rev

  15. Slide 15: HBR Inclusion Criteria

    HBR Inclusion Criteria Elderly (age ≥75 yr) 59.0 OAC 41.0 Mean 1.6 Anemia or transfusion 14.4 criteria / pt Renal failure 12.5 Active or recent cancer 7.4 Planned surgery 6.6 Expected DAPT non-compliance 4.2 44% met ≥ 2 Long-term NSAID or steroids 3.1 HBR criteria Hospital for bleeding 2.8 Stroke <

  16. Slide 16: Lesion Characteristics

    Lesion Characteristics % or mean ± SD Onyx ONE Onyx ONE Onyx ONE Clear RCT1 US/Japan1 (N=1506) (N=905) (N= 601) Radial access 65.8 75.3 51.7 Staged procedure (performed) 3.3 2.8 4.0 Lesion location LAD 52.5 54.6 49.3 LCX 27.8 26.6 29.6 RCA 34.2 35.4 32.4 Left main 1.3 1.3 1.2 Bypass graft 4.1 2.5 6.

  17. Slide 17: Procedural Characteristics

    Procedural Characteristics % or mean ± SD Onyx ONE Onyx ONE Onyx ONE Clear RCT1 US/Japan1 (N=1506) (N=905) (N= 601) Pre-procedural QCA Lesion length (mm) 20.8 ± 13.0 21.2 ± 12.7 20.1 ± 13.5 RVD (mm) 2.82 ± 0.48 2.83 ± 0.46 2.80 ± 0.51 MLD (mm) 0.89 ± 0.41 0.88 ± 0.41 0.91 ± 0.40 % Diameter stenosis

  18. Slide 18: Antithrombotic Therapy Transition After PCI

    Antithrombotic Therapy Transition After PCI 100% ASA 57% 96.9% P2Y12 ASA 43% 59% 80% 89.3% P2Y12 41% Percent of Patients 60% N = 1506 SAPT 40% DAPT OAC only 20% 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 Months Post-Index Procedure Onyx ONE Clear

  19. Slide 19: Primary Endpoint: Cardiac death or MI between 1-12 months

    Primary Endpoint: Cardiac death or MI between 1-12 months Onyx ONE Clear Performance Upper 1-sided P-value (N=1506) Goal 97.5% CI: 7.0% 9.7% 8.4% <0.001 0 2% 4% 6% 8% 10% Primary Endpoint Met Onyx ONE Clear

  20. Slide 20: Cumulative Incidence of Cardiac Death or MI

    Kaplan Meier Estimate: Cardiac death or MI between 1-12 months 30 Cumulative Incidence of Cardiac Death or MI (%) 20 10 7.4% 0 0 1 2 4 6 8 10 12 Number at risk Months after PCI ZES 1506 1439 1352 “1-Month clear” is determined on day of transition from DAPT to SAPT (between days 27-35 post-PCI) Onyx

  21. Slide 21: Clinical Outcomes between 1-12 months

    Clinical Outcomes between 1-12 months 15 ONE Clear n = 1491 Primary Event rates (%) 10 Endpoint BARC 1-5 bleeding: 13.1% BARC 2-5 bleeding: 11.7% 7.0 4.8 5 4.0 3.4 3.4 2.6 1.5 0.7 0 Cardiac Cardiac Non-cardiac MI TLR Def/Prob ST Stroke BARC 3-5 death/ MI death death (clinically Bleeding driven) Pati

  22. Slide 22: Kaplan Meier Estimate: MI and ST

    Kaplan Meier Estimate: MI and ST between 1-12 months 10 Myocardial Infarction Stent Thrombosis (ARC definite/probable) Cumulative Incidence (%) 8 6 5.1% 4 2 0.7% 0 0 1 2 4 6 8 10 12 Months after PCI Number at risk MI 1506 1439 1352 ST 1506 1466 1403 Onyx ONE Clear

  23. Slide 23: Subgroup Results

    Subgroup Results Cardiac Death / MI between 1-12 months n = 1491 30 Yes No Event rates (%) 20 13.4 10 9.1 8.5 7.5 7.9 7.6 7.9 6.7 6.0 6.1 6.2 5.6 5.6 4.8 N 559 932 694 733 583 908 481 1010 869 622 187 1304 655 836 0 1 US region ACS Diabetes Female sex Complex Renal failure Stent length >30mm 1 Compl

  24. Slide 24: Limitations

    Limitations • While prospectively enrolled, Onyx ONE CLEAR employed a non- randomized study design with pooling of patient data across different geographies from the Onyx ONE RCT • The study was underpowered for low frequency events such as ST • The tradeoff between ischemic events and bleeding even

  25. Slide 25: Conclusions

    Conclusions • Onyx ONE Clear extends the findings of the Onyx ONE Global RCT to HBR patients treated with 1-month of DAPT in the United States/Japan • Onyx ONE Clear met its primary endpoint, with favorable rates of ischemic outcomes from 1-12 months after DAPT discontinuation within a high risk pop

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