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RE synchronization re VE rses R emodeling in S ystolic left v E ntricular dysfunction:

RE synchronization re VE rses R emodeling in S ystolic left v E ntricular dysfunction: Results of the REVERSE Trial Cecilia Linde, Stockholm, Sweden William T. Abraham, Columbus, U.S Michael R. Gold, Charleston, U.S. Jean-Claude Daubert, Rennes, France On Behalf of the REVERSE

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RE synchronization re VE rses R emodeling in S ystolic left v E ntricular dysfunction:

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  1. REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction: Results of the REVERSE Trial Cecilia Linde, Stockholm, Sweden William T. Abraham, Columbus, U.S Michael R. Gold, Charleston, U.S. Jean-Claude Daubert, Rennes, France On Behalf of the REVERSE Investigators and Coordinators

  2. Acknowledgments Steering Committee W. T. Abraham, J-C. Daubert (study initiator), C. Linde (coordinating clinical Investigator), M. Gold Echo Core Labs Ghio, S, St. John Sutton, MG Adverse Events Advisory Committee D. Böcker, J. P. Boehmer, J. G. F. Cleland, M. Gold, J. T. Heywood, A. Miller (chair) Data Monitoring Committee J. Aranda, J. Cohn (chair), P. Grambsch; M. Komajda Investigators Austria: H. Mayr, A. Teubl; Belgium: R. Willems; Canada:C. Simpson; Czech Republic: J. Lukl; Denmark: H. Eiskjær, C. Hassager, M. Møller, T. Vesterlund; France: E. Aliot, P. Chevalier, J-C. Daubert, J-M. Davy, P. Djiane, H. Le Marec; Germany: G. Groth, G. Klein, T. Lawo, C. Reithmann; Hungary: T. Forster, T. Szili-Török; Ireland: R. Sheahan; Italy: S. Lombroso, M. Lunati, L. Padeletti, M. Santini; Netherlands: B. Dijkman; Norway: S. Færestrand, F. T. Gjestvang; Spain: I. Fernandez Lozano, R. Muñoz Aguilera, A. Quesada Dorador; Sweden: C. Linde, F. Maru, K. Säfström; United Kingdom: G. Goode;United States: U. Birgersdotter-Green, J. Boehmer, E. Chung, S. Compton, J. Dinerman, D. Feldman, R. Fishel, G. J. Gallinghouse, M. Gold, S. Hankins, J. Herre, M. Hess, E. Horn, S. Hsu, S. Hustead, S. Jennison, E. Johnson, W. B. Johnson, G. Jones, R. Malik, A. Merliss, S. Mester, S. Moore, N. Nasir, F. Pelosi, Jr., D. Renlund, K. Rist, R. Sangrigoli, R. Silverman, D. Smull, K. Stein, L. Stevenson, J. Stone, N. Sweitzer, D. Venesy, L. Zaman. Sponsor Medtronic Inc.

  3. Presenter Disclosure Information Cecilia Linde, MD, PhD The following relationships exist related to this presentation: • Consulting Fees, Medtronic and St. Jude, moderate level • Research Grants, Medtronic and the Sweden Heart and Lung Foundation, • significant level

  4. Purpose and Design • To determine the effects of CRT with or without an ICD on disease progression over 12 months in patients with asymptomatic and mildly symptomatic heart failure and ventricular dysynchrony • Randomized, double-blind, parallel-controlled clinical trial

  5. Inclusion Criteria • NYHA Class II or I (previously symptomatic) • QRS  120 ms; LVEF  40%; LVEDD  55 mm • Optimal medical therapy (OMT) • Without permanent cardiac pacing • With or without an ICD indication

  6. Study Schematic Baseline Assessment Successful CRT Implant CRT OFF (OMT ± ICD) 1 12 Months Randomized 1:2 2 CRT ON (OMT ± ICD) U.S., Canada: at 12 Months, all patients recommended CRT ON Europe: at 24 Months, all patients recommended CRT ON

  7. End Points • Primary: HF Clinical Composite Response, comparing the proportion of patients worsened in CRT OFF vs. CRT ON groups • Composite includes: all-cause mortality, HF hospitalizations, crossover due to worsening HF, NYHA class, and the patient global assessment assessed in double blind manner • Prospectively Powered Secondary: Left Ventricular End Systolic Volume Index (LVESVi) comparing CRT OFF vs. CRT ON subjects • LVESVi is assessed by two core labs (1 in Europe, 1 in U.S)

  8. Enrollment and Randomization 684 Enrolled (2004-2006) -42 ineligible or withdrew 642 Implant Attempts -21 unsuccessful implant 621 Successful CRT Implants (97%) -11 exits after successful implant 610 Patients Randomized U.S. 343 (56%); Europe 262 (43%); Canada 5 (<1%) CRT OFF191 Patients CRT ON419 Patients - 594/598 completed 12 month follow-up - 12 deaths (2%) - 0 lost to follow-up, 0 exits

  9. Baseline Characteristics of Randomized Cohort (n=610)

  10. 100% 16% 21% 80% 30% 60% 39% 40% 54% 20% 40% 0% CRT OFF CRT ON Primary End Point: Clinical Composite Response Pre-Specified Analysis Proportion Worsened Conventional Analysis Distribution Worsened/Unchanged /Improved 100% 16% Worsened 21% Worsened 80% Unchanged 60% P=0.004 P=0.10 84% 40% 79% Improved / Unchanged Improved 20% 0% CRT OFF CRT ON

  11. Powered Secondary End Point: LVESVi(ml/m2) P<0.0001 115 110 105 ) 100 2 CRT OFF 95 D = -1.3 LVESVi (ml/m 90 85 CRT ON D = -18.4 80 75 70 Baseline 12 Months n=487

  12. 34 32 30 28 26 24 22 20 Other Remodeling Parameters LVEDVi (ml/m2) P<0.0001 LVEF (%) P<0.0001 150 CRT OFF ∆ = -1.4 140 CRT ON ∆ = 3.8 130 120 CRT ON ∆ = -20.5 CRT OFF ∆ = 0.6 110 100 90 Baseline 12 Months Baseline 12 Months n=487

  13. Other Secondary Endpoints NYHA P=0.06 6-Min Walk Test P=0.26 MN LWHF P=0.26

  14. Time to First HF Hospitalization % of Patients Hospitalized for HF P=0.03 Hazard Ratio=0.47 CRT OFF CRT ON Months Since Randomization Number at Risk CRT OFF 191 187 181 176 119 CRT ON 419 415 411 409 251

  15. Safety • 97% implant success rate • 9.5 % LV-lead related complications • 66 in 59 / 621 successfully implanted patients • LV lead dislodgements, diaphragmatic stimulation, subclavian vein thrombosis, etc.

  16. Conclusion REVERSE is the first large, randomized, double-blind study to show that CRT in asymptomatic and mildly symptomatic heart failure patients on optimal medical therapy: • Reverses LV remodeling • Reduces the risk of heart failure hospitalization • May improve clinical outcome as assessed by the clinical composite response measure Note: FDA has not yet reviewed the clinical data to determine whether or not CRT systems are safe and effective in this patient population.

  17. Backup Slides

  18. Clinical Composite Response Details Worsened Improved *Note: Data in table is listed in hierarchical order (subjects are included only in one sub-category)

  19. Most Common Procedure Related Complications

  20. Reasons for Missing Paired LVESVi data Note: Subjects are included in the first sub-category, reading down

  21. Causes of Death

  22. LVESVi(ml/m2) by NYHA Class

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