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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
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DISCLOSURE INFORMATION Arthur 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.
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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?
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MADIT-RIT: Hypothesis Hypothesis Dual-chamber ICD or CRT-D devices with: - high-rate cutoff (>200bpm), or - duration-delay (initial 60sec monitoring delay @>170bpm) plus rhythm ID detection will be associated with fewer 1 st inappropriate therapies than standard/conventional programming (2.5sec delay @ >170bpm) without increase in mortality Randomized, 3-arm study using Boston Scientific devices
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Randomization Arms Arm A (Conventional) Arm B (High-rate) Arm C (Duration-delay) Zone 1: >170 bpm, 2.5s delay 170 bpm >170 bpm, 60s delay Onset/Stability Detection Enhancements ON Monitor onlyRhythm ID Detection Enhancements ON ATP + Shock Zone 2: >200 bpm, 1s delay>200 bpm, 2.5s delay>200 bpm, 12s delay Quick Convert ATP Shock Quick Convert ATP Shock Rhythm ID Detection Enhancements ON ATP + Shock Zone 3 : >250 bpm, 2.5s delay Quick Convert ATP + Shock * All programming is within approved labeling MADIT-RIT: Three Treatment Arms*
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MADIT-RIT: ELIGIBILITY Inclusion Criteria - I 0 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 - 2 nd or 3 rd degree heart block - NYHA IV - Chronic AF - Renal disease:BUN>50mg/dlor Creatinine>2.5mg/dL
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MADIT-RIT Primary Endpoint PRIMARY (90% power for hazard ratio 0.5 at p<0.05) First episode of inappropriate therapy - B arm vs. A arm - C arm vs. A arm Rationale for first inappropriate therapy (IT) - Expect reprogramming to be common after IT - Protocol allows reprogramming after IT SECONDARY All-cause mortality Syncope MADIT-RIT: Prespecified End Points
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MADIT-RIT: POPULATION 1,500 pts. enrolled from 98 centers in US, Canada, Europe, Israel & Japan Average follow-up = 1.4 years
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Baseline Demographic and Clinical Characteristics (no significant differences in 22 variables among the 3 Rx groups) VariableTherapy Group ABC Conventional High-rate Duration-delay >170bpm >200bpm>170bpm (n=514) (n=500) (n=486) Age, yrs6463 62 Male, %7071 72 Ischemic, %53 54 52 EF, %2626 26
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Cumulative Probability of First Inappropriate Therapy by Treatment Group
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Figure 2. Cumulative Probability of Death by Treatment Group
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Treatment Groups Treatment Group Comparisons Events# of patients B vs. AC vs. A A B C Hazard RatioP-value Hazard RatioP-value n=514 n=500 n=486 First Inappropriate Rx 105 21 26 0.21 <0.001 0.24<0.001 Death 1 st Syncope 34 16 21 23 22 23 0.45 1.32 0.01 0.39 0.56 1.09 0.06 0.80 FREQUENCY AND HAZARD RATIOS FOR INAPPROPRIATE THERAPY, DEATH, AND SYNCOPE BY TREATMENT GROUP
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Arrhythmias Triggering First Inappropriate Therapies Treatment Group A B C Arrhythmias (# Pts. 1 st Inapp. Therapies) At Fib/Flut 24 11 5 Regular SVT 78 9 17 Other 3 1 4 Note: marked reduction in patients with1 st inappropriate therapies in High-rate (B) and Duration-delay (C) groups for At Fib/Flut and Regular SVT when compared to Conventional therapy (A).
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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) 0.86 0.25 ATP 111 (22) 38 (8) 20 (4) <0.001 <0.001 Any Inappropriate Therapy Shock 31 (6) 14 (3) 15 (3) 0.01 0.03 ATP 104 (20) 20 (4) 25 (5) <0.001 <0.001 Any Appropriate and Inappropriate Therapy by Treatment Group
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MADIT-RIT: CONCLUSIONS Improved ICD programming at high-rate (>200 bpm) or 60sec duration-delay is associated with: 1) ~75% reduction in 1 st 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.
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THANK YOU
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