Comparison of clinical trials evaluating cardiac resynchronization therapy in mild to moderate heart failure

Cardiol J. 2010;17(6):543-8.

Abstract

Recently, three large randomized clinical trials: REVERSE, MADIT-CRT, and RAFT were completed aiming to determine the effects of cardiac resynchronization therapy (CRT) or CRT with defibrillator (CRT-D) in less advanced, predominantly NYHA class II heart failure (HF) patients. The REVERSE trial, significantly smaller than the other two trials, could be considered as a phase II study indicating that mild-to-moderate HF patients show symptomatic and hemodynamic improvement in response to CRT. The MADIT-CRT and RAFT are considered as definitive trials with large patient populations of about 1,800 patients each, and HF event/hospitalization or death as the primary endpoint. Both trials showed a significant reduction in the risk of primary endpoints: a 34% reduction in MADIT-CRT and 25% reduction in RAFT. However, RAFT also showed a significant reduction in mortality which was not observed in MADIT-CRT. The clinical characteristics of patients studied in both trials were different despite somewhat similar entry criteria. RAFT enrolled more advanced HF patients (including 20% NYHA class III patients) than MADIT-CRT. In the CRT-D arm, RAFT patients had about 20% two-year mortality in comparison to approximately 6% two-year mortality in MADIT-CRT. Mortality in RAFT was in similar to those observed in CRT-D patients in the COMPANION trial (estimated 25% two-year mortality), and in the CRT arm of the CARE-HF trial (estimated 18% two-year mortality), both older studies which enrolled NYHA class III and IV HF patients. Based on the above comparison, one could conclude that RAFT enrolled moderate-to-advanced HF patients whereas MADIT-CRT enrolled truly mild-to-moderate patients.

MeSH terms

  • Cardiac Resynchronization Therapy* / adverse effects
  • Cardiac Resynchronization Therapy* / mortality
  • Evidence-Based Medicine
  • Heart Failure / mortality
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Hemodynamics
  • Hospitalization
  • Humans
  • Kaplan-Meier Estimate
  • Patient Selection
  • Randomized Controlled Trials as Topic / methods*
  • Recovery of Function
  • Research Design*
  • Risk Assessment
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome