Home » Clinical Trials In Cardiac Rhythm Management » COMPANION and MADIT II: An Overview
COMPANION Trial1 |
MADIT II2 |
|
Milestone |
The first heart failure device trial powered to study death and hospitalization in heart failure patients on optimal pharmacological therapy (OPT) |
The first trial to show the life-saving benefits of ICDs without requiring patients to have documented history of abnormal heart rhythms |
Primary Endpoint |
All-cause mortality or first hospitalization* |
Mortality |
Enrollment Size |
1520 patients at 128 US centers |
1232 patients at 76 US centers |
Patient Population |
Heart failure patients (NYHA class III and IV)
Ejection fraction (EF) < 35%
Ischemic and non-ischemic
QRS > 120 ms, PR interval > 150 ms
Hospitalized for heart failure treatment or equivalent > 1 month but < 12 months prior
Already prescribed to OPT
No clinical indication for implantable cardioverter defibrillator (ICD) or pacemaker
|
Heart attack survivors with EF < 30%
|
Therapy |
Cardiac resynchronization therapy pacemaker (CRT-P) and cardiac resynchronization therapy defibrillator (CRT-D). OPT required in all arms. |
ICD therapy. Conventional medical therapy recommended in all arms. |
Description of Therapy |
CRT provides pacing stimulation to the right ventricle and left ventricle to synchronize the heart's pumping action. The therapy can also combine defibrillation (CRT-D) to deliver high-energy therapy in case of an uncontrollably fast and/or deadly heart rhythm. |
ICDs provide high-energy therapy (defibrillation) to restore a normal heartbeat in case of an uncontrollably fast and/or deadly heart rhythm. |
Trial Design |
Three patient groups (randomization 1:2:2): OPT
OPT + CRT-P
OPT + CRT-D
|
Two patient groups (randomization 2:3): OPT
OPT + ICD
|
Key Finding |
CRT-P and CRT-D, in combination with OPT, reduced the risk of all-cause mortality or first hospitalization by 19% and 20% respectively vs. OPT alone (adjusted P values 0.015 and 0.011, respectively). CRT-D, in combination with OPT, reduced the risk of all-cause mortality by 36% (adjusted P value 0.004). P values adjusted for sequential monitoring. Alpha allocation: CRT-P = 0.02; CRT-D = 0.03. |
Use of ICDs resulted in a 31% reduction in the risk of death in heart attack survivors (P value = 0.016). |
The brief summaries above are based on clinical information consistent with current labeling and are not based on published COMPANION trial results.
* 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). NOTE: Hospitalizations associated with a device implant attempt or re-attempt are excluded.