Title of Trial
Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic heart Failure (COMPANION) Trial

Date and Location of Presentation
American College of Cardiology 2003

Date and citation of primary publication(s) or References
Not yet published

Purpose of the Trial
Evaluate the effects of cardiac resynchronization therapy and use of the implantable defibrillator in patients with chronic heart failure

Study Category
Pacing & ICD

Patient Population
Inclusion Criteria

• Class III or IV heart failure, normal sinus rhythm, left ventricular ejection fraction < 0.35, left ventricular end diatolic volume > 60 mm, QRS interval > 120 ms and PP interval > 150 ms

Exclusion Criteria

• Pacemker or defibrillator, cardiac or cerebral ischemic event within the last 3 months, atrial arrhythmias in the last month, systolic blood pressure > 170 mm Hg or < 80 mm Hg, heart rate > 140 beats per minute, serum creatinine > 3.0 mg/dl, serum aminotransferase level more than three times the upper limit of normal.

Study Design
Randomized parallel open-label 3 arm study. Patients randomized 1:2:2 ratio to optimal medical therapy (beta-blockers, ACEI or ARB, spironolactone, and diuretic as required) (OPT); optimal medical therapy and cardiac resynchronization therapy (CRT) ; or optimal medical therapy, cardiac resynchronization, and defibrillator (CRT-D).

Primary Endpoints
Composite all-cause mortality and all-cause hospitalization

Secondary Endpoints
All-cause mortality, cardiac morbidity, and exercise performance

Baseline Characteristics
Patient number: 1,634 patients
Mean Age: ?
Gender: ?
Other characteristics: ?

Time to Follow-up
1 year analysis. Study stopped prematurely due to therapy effect

Results
A 5-10% adverse event rate was associated with device therapy. For combined all cause mortality and all cause hospitalization, the event rate at one year for optimal medical therapy was 67.7%. A 19% reduction in the primary endpoint was observed in the cardiac resynchronization and the cardiac resynchronization plus defibrillator arms. All cause mortality was 19% for the optimal medical therapy group. Cardiac resynchronization therapy was associated with a nonsignificant 24% reduction while cardiac resynchronization plus defibrillator was associated with a highly significant 43% reduction (p= 0.002). Cardiac resynchronization appeared to interact favorably with medical therapy such as beta blockade or aldosterone antagonism.

Outcome	OPT event rate (%)	CRT rate reduction (%)	P CRT vs. OPT	CRT-D rate reduction (%)	P CRT-D vs. OPT
Combined all-cause mortality and all-cause hospitalization	67.7	18.6	.015	19.3	0.005
Combined all-cause mortality and heart failure hospitalization	46.1	35.8	<0.001	39.5	<0.001
All-cause mortality	19.0	23.9	0.12	43.4	0.002

Sponsor: Guidant

Trial Status:  Completed, final analysis pending