COMPANION TRIAL Comparison of Medical Therapy, Pacing, Defibrillation in Chronic Heart Failure

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COMPANION TRIALComparison of Medical Therapy,
Pacing, Defibrillation in Chronic Heart Failure

• Hrach Ike Kasaryan

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Purpose?

• The trial was set up to compare optimal medical
  therapy (beta blockers, Ace, etc.) for
  Symptomatic Congestive Heart Failure to optimal
  medical therapy with Cardiac Resynchronization
  therapy(CRT) and to optimal therapy with CRT and
  ICD

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Trial Set Up

• Prospective, parallel, double blind, randomized
• The trial was set up to recruit 2200 patients
  however the trial was stopped early due to the
  significant findings
• In actuality 1600 patients where randomized to
  three different arms of the study

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Trial Set Up

• First group was randomized to optimal medical
  therapy for Heart Failure (beta blockers,
  diuretics, ACE or ARB, spironolactone, and/or
  dig)
• The second group was optimal medical therapy plus
  CRT device
• The third group was optimal medical therapy plus
  CRT and ICD device (CRT-D)

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Inclusion Criteria

• Moderate to severe symptomatic heart failure
  (class III or IV NYHA CHF)
• QRS duration greater than 120 ms
• P-R gt 150 ms
• Hospitalization at least once for CHF in the past
  year / out patient visit with inotropes given /
  or ER visit with IV CHF drugs administered
• No indication for an ICD or Pacemaker

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End Points

• Patients where followed out for 12 months
• Main end points of the study where all cause
  death and all cause hospitalizations
• Secondary end points looked at numerous measures
  of cardiovascular morbidity

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Results

• The trial was stopped early in Nov. 2002 by an
  independent data and safety monitoring board
• At the time the trial was stopped there was
  already a 20 reduction in the primary end points
  in both the CRT and CRT-D arms

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Results
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Results

• Hospitalizations for CHF where already shown in
  Miracle to be decreased, and was consistent with
  the findings in COMPANION
• Companion CRT 35.8 / CRT-D 39.5
• MIRACLE CRT arm reduced 39

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Results

• In addition hospitalization in total where
  decreased in COMPANION by 19.3 in CRT-D arm and
  18.6 in CRT arm
• However, the hospitalizations related to
  complications of the device (malfunction,
  infection, morbidities) where not included in the
  study numbers which may leave some eye brows
  raised.

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Results

• And due to the large number, mortality was also
  examined and showed a decrease by 23.9 CRT arm
  and 43!! In the CRT-D arm
• In the other two sets, there was no real
  difference between the CRT arm and the CRT-D arm
  but in overall mortality, CRT-D showed an extra
  benefit by 20!!
• This would be expected because ICD already have a
  significant effect on overall mortality

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Results

• What is also worth mentioning was that this extra
  benefit of the ICD was in non-ischemic patients
  which was not previously studied

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Conclusions

• CRT reduces CHF morbidity and mortality
  significantly
• CRT-D reduces mortality additionally by 20 in
  non-ischemic patients
• HOW ARE WE GOING TO PAY FOR ALL THESE PATIENTS TO
  GET DEVICES??