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COMPANION, MADIT II, and SCD-HeFT

An Overview of Recent Landmark Clinical Device Trials

COMPANION MADIT II SCD-HeFT
Name of Study Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure Multicenter Automatic Defibrillator Implantation Trial II Sudden Cardiac Death in Heart Failure Trial
Patient Population Heart failure patients (NYHA class III-IV) with EF ≤ 35%, QRS ≥ 120 ms, PR interval > 150 ms Heart attack survivors with prior MI and EF ≤ 30% Heart failure patients (NYHA class II / III) with EF ≤ 35%
Primary Endpoint Combination of all-cause mortality or first hospitalization* as measured by time to first event All-cause mortality All-cause mortality
Device/Drug Evaluated Guidant cardiac resynchronization therapy device with or without defibrillation (CRT-D or CRT-P) ICD ICD or amiodarone
Trial Design Three patient groups (randomized 1:2:2)
  1. Optimal Pharmacologic Therapy (OPT)
  2. OPT + CRT-P
  3. OPT + CRT-D
 Two patient groups (randomized 2:3)
  1. Conventional therapy (CT)
  2. CT + ICD
 Three patient groups (randomized 1:1:1)
  1. Conventional drug therapy + placebo
  2. Conventional drug therapy + amiodarone
  3. Conventional drug therapy + ICD
Trial size: 1520 patients, 128 centers Trial size: 1232 patients, 76 centers Trial size: 2521 patients, 148 centers
Key Finding CRT-P and CRT-D, in combination with OPT, reduce the risk of all-cause mortality or first hospitalization* by 19% and 20% respectively, relative to OPT alone

CRT-D, in combination with OPT, reduces the risk of all-cause mortality by 36% relative to OPT alone 		A 31% reduction in the risk of all-cause mortality in heart attack survivors due to ICDs A 23% reduction in the risk of death in ICD compared to conventional therapy plus placebo
Milestones Largest heart failure device (CRT) trial to date

Largest heart failure device (CRT) trial to date to study death and hospitalization in heart failure patients

Guidant CRT-D indication expands heart failure therapy options for more patients 		First trial to show the life-saving benefits of ICDs without requiring patients to have a documented history of abnormal heart rhythms First study use of an ICD in a heart failure population


* Hospitalization is defined as either care provided at a hospital for any reason in which the duration is associated with a date change, or use of intravenous inotropes and/or vasoactive drugs for a duration > 4 hours (inpatient or outpatient)

  1. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-2150.
  2. Moss AJ, Zareba W, Hall WJ, et al, for the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.
  3. Bardy GH, Lee KL, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225-237.

ICD Instructions for Use Summary
CRT-D Systems Instructions for Use Summary
CRT-P Systems Instructions for Use Summary