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1. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure
Purpose
To determine whether amiodarone or a conservatively programmed, shock-only ICD would reduce the risk of death in patients with mild-to-moderate congestive heart failure
Reference
Bardy GH, Lee KL, Mark DB et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Eng J Med 2005;352:225–237
2. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure - TRIAL DESIGN -
Design
Multicenter, randomized, placebo-cobtrolled
Patients
2521 patients, = 18 yrs with NYHA class II or III chronic,stable CHF due to ischemic or non-ischemic causes and LVEF of = 35%
Follow up and primary endpoint
Primary endpoint: death from any cause. Median 45 months follow-up
Treatment
Amiodarone (800 mg daily, loading dose then 200-400 mg/day); or ICD with detection rate of = 187 bpm; or placebo
Mean follow up expressed as 58 months but changed to (more readable) 4.8 years – OK?Mean follow up expressed as 58 months but changed to (more readable) 4.8 years – OK?
3. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure - TRIAL DESIGN continued-
4. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure - RESULTS -
There was no significant difference between amiodarone and placebo in terms of risk of death. ICD Therapy was associated with a significantly reduced risk of death:
Amiodarone (28% deaths) versus placebo (29%). Hazard ratio 1.06 (97.5% CI), p=0.53
ICD (22%) versus placebo (29%). Hazard ratio 0.77 (97.5% CI), p=0.007
Relative risk reduction of 23% for patients with ICD versus placebo – absolute risk reduction of 7.2% at 5 years
No change in results dependent on ischemic or non-ischemic CHF
Patients with NYHA class III CHF: 44% increase in relative risk in amiodarone compared with placebo – no increase in patients with NYHA class II
46% relative reduction in risk of death in NYHA class II patients with ICD compared with placebo (11.9% absolute reduction at 5 years) – no decrease in NYHA class III patients
5. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure - RESULTS continued -
6. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure - RESULTS continued -
7. SCD-HeFT: Amiodarone or implantable ICD for congestive heart failure - SUMMARY -
In patients with mild-to-moderate CHF, conservatively programmed, shock-only ICD significantly reduces risk of death
Amiodarone had no benefit compared with placebo in treating patients with mild-to-moderate CHF
ICD Therapy had significant benefit in patients with NYHA class II CHF, but no significant effect in patients with NYHA class III CHF
Amiodarone had no benefit in patients with NYHA class II CHF, and showed a significant reduction in survival in patients with NYHA class III CHF compared to placebo