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MADIT Randomized Trial to Reduce Inappropriate Therapy (MADIT-RIT)

MADIT Randomized Trial to Reduce Inappropriate Therapy (MADIT-RIT). Arthur J. Moss, MD for the MADIT-RIT Executive Committee AHA Late Breaking Trials November 6, 2012 Los Angles, CA. DISCLOSURE INFORMATION Arthur J. Moss, MD. Company Relationship Boston Scientific Research Grant

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MADIT Randomized Trial to Reduce Inappropriate Therapy (MADIT-RIT)

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  1. MADIT Randomized Trial to Reduce Inappropriate Therapy (MADIT-RIT) Arthur J. Moss, MD for the MADIT-RIT Executive Committee AHA Late Breaking Trials November 6, 2012 Los Angles, CA

  2. DISCLOSURE INFORMATIONArthur J. Moss, MD CompanyRelationship Boston Scientific Research Grant Hold no stock or stock options in any device company. Not a member of any corporate advisory group or speakers’ bureau.

  3. MADIT-RIT: BACKGROUND • ICD is highly effective in reducing mortality in high-risk cardiac pts. • Despite sophisticated device-detection algorithms, 8-40% of ICD therapies are inappropriate with adverse side effects • Question: can ICD devices be reprogrammed to safely reduce inappropriate therapies?

  4. MADIT-RIT: Hypothesis Hypothesis Dual-chamber ICD or CRT-D devices with: - high-ratecutoff(>200bpm), or - duration-delay (initial 60sec monitoring delay @>170bpm) plus rhythm ID detection will be associated with fewer 1st inappropriate therapies than standard/conventional programming (2.5sec delay @ >170bpm) without increase in mortality Randomized, 3-arm study using Boston Scientific devices

  5. MADIT-RIT: Three Treatment Arms* Randomization Arms * All programming is within approved labeling

  6. MADIT-RIT: ELIGIBILITY Inclusion Criteria - I0 prevention patients with no Hx of VT/VF - Sinus rhythm at enrollment; Hx PAF ok - Pt. on stable, optimal pharmacologic therapy - Age >21 yrs; informed consent Exclusion Criteria - Pt. with pacemaker, ICD or CRT-D device - CABG or PTCA in past 3 months - MI (enzyme +) or AF in past 3 months - 2nd or 3rd degree heart block - NYHA IV - Chronic AF - Renal disease:BUN>50mg/dlor Creatinine>2.5mg/dL

  7. MADIT-RIT: Prespecified End Points MADIT-RIT Primary Endpoint PRIMARY (90% power for hazard ratio 0.5 at p<0.05) • Firstepisode of inappropriate therapy - B arm vs. A arm - C arm vs. A arm • Rationale for firstinappropriate therapy (IT) - Expect reprogramming to be common after IT - Protocol allows reprogramming after IT SECONDARY • All-cause mortality • Syncope

  8. MADIT-RIT: POPULATION • 1,500 pts. enrolled from 98 centers in US, Canada, Europe, Israel & Japan • Average follow-up = 1.4 years

  9. Baseline Demographic and Clinical Characteristics(no significant differences in 22 variables among the 3 Rx groups) Variable Therapy Group A B C Conventional High-rate Duration-delay >170bpm >200bpm >170bpm (n=514) (n=500) (n=486) Age, yrs 64 63 62 Male, % 70 71 72 Ischemic, % 53 54 52 EF, % 26 26 26

  10. Cumulative Probability of First Inappropriate Therapy by Treatment Group

  11. Figure 2. Cumulative Probability of Death by Treatment Group

  12. Frequency and Hazard Ratios for Inappropriate Therapy, Death, and Syncope by Treatment Group

  13. Arrhythmias Triggering First Inappropriate Therapies Treatment Group A B C Arrhythmias(# Pts. 1stInapp. Therapies) At Fib/Flut 24 11 5 Regular SVT 78 9 17 Other 3 1 4 Note: marked reduction in patients with1st inappropriate therapies in High-rate (B) and Duration-delay (C) groups for At Fib/Flut and Regular SVT when compared to Conventional therapy (A).

  14. Any Appropriate and Inappropriate Therapy by Treatment Group Treatment Group P-value A B C B v A C v A n=514 n=500 n=486 no. of patients (% of Rx group) Any Appropriate Therapy Shock 28 (5) 26 (5) 19 (4) 0.860.25 ATP111 (22)38 (8)20 (4)<0.001 <0.001 Any Inappropriate Therapy Shock31 (6)14 (3) 15 (3)0.010.03 ATP104 (20) 20 (4) 25 (5)<0.001<0.001

  15. MADIT-RIT: CONCLUSIONS Improved ICD programming at high-rate (>200 bpm) or 60sec duration-delay is associated with: 1) ~75% reduction in 1st inappropriate therapy; 2) ~50% reduction in all-cause mortality We believe the decrease in mortality is related to the reduction in adverse inappropriate shock and ATP therapies.

  16. THANK YOU

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