MADIT-CRT

The Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy (MADIT-CRT)

MADIT-CRT is an important continuation of Boston Scientific’s sponsorship of landmark clinical trials such as MADIT, MADIT II, and COMPANION. MADIT-CRT is the world’s largest randomized NYHA Class I/II CRT-D trial and provides clinical evidence that early intervention with CRT can reduce death and heart failure events.

Status: Study met its primary endpoint June 2009


Results

  • MADIT-CRT provides clinical evidence that in high-risk* NYHA Class I and II patients with LBBB, early CRT intervention reduces the relative risk of all-cause mortality or first heart failure event by 57% when compared to ICD therapy (p < 0.001).2

Further analysis shows:

  • These impressive results were driven by a 35% relative reduction in the risk of all-cause mortality (p = 0.048) and a 63% relative reduction in the risk of first heart failure events (p < 0.001).1
  • Notably, in the MADIT-CRT LBBB subgroup, 82% of the first heart failure events involved hospitalization.
  • The Kaplan-Meier analysis reveals that improvement in the CRT-D arm is seen remarkably early — within a few months after implant — and continues for the duration of the trial.
  • Delaying that first heart failure event in Class I and II patients is critical — in the MADIT-CRT trial, patients were 8 times more likely to have a recurring HF event after the initial event.
  • Early CRT intervention reduces the relative risk of recurrent heart failure events by 43% in high-risk,3 NYHA Class I and II patients with LBBB.  

In an exploratory analysis that is hypothesis-generating only, the MADIT-CRT LBBB subgroup experienced a 12% increase in LVEF with a CRT-D, as compared to a 3% increase with an ICD. Also, patients with a CRT-D experienced a greater reduction in left ventricular volumes.

* CRT therapy was ON during echographic measurements and may have influenced the results.

Design

Patient Population

MADIT-CRT is the largest randomized NYHA Class I / II CRT-D trial to date

• Full Trial Population: 1820 patients
• LBBB Population: 1281 patients

Inclusion Criteria:

  • Male and female
  • Over 21 years of age
  • NYHA functional Class II, non-ischemic or ischemic cardiomyopathy or
  • NYHA functional Class I, ischemic cardiomyopathy and
  • Left ventricular dysfunction (LVEF ≤ 0.30) and
  • Prolonged intraventricular conduction (QRS duration ≥ 130 ms) and
  • Optimal HF pharmacologic therapy (OPT)

110 centers in 14 countries

Clinical Relevance

  • To determine whether CRT-D in high-risk* heart failure patients will reduce the combined endpoint of all cause mortality or HF intervention when compared to ICD therapy.
  • Primary Endpoint: all-cause mortality or heart failure intervention, whichever occurs first.
  • MADIT-CRT is an important continuation of Boston Scientific’s sponsorship of landmark clinical trials such as MADIT, MADIT II, and COMPANION.  MADIT-CRT may prove that early intervention with CRT can slow the progression of heart failure.

Top