OVMC Landmark Trials Series

1. SCD-HEFT:
AMIODARONE OR AN IMPLANTABLE
CARDIOVERTER-DEFIBRILLATOR FOR
CONGESTIVE HEART FAILURE
BARDY GH, LEE KL, MARK DB, POOLE JE, PACKER DL, ET AL. N ENGL J MED. 2005 JAN
20;352(3):225-37.
SALT-E: OVMC LANDMARK TRIAL SERIES
2016
ACCESS ON WEBSITE: HTTP://TINYURL.COM/SALTE2

2. CLINICAL QUESTION
 ICD placement in post-MI patients with LVEF ≤ 30% was shown to improve
survival (MADIT-II, 2002)
 What is the role of ICDs and amiodarone in patients with heart failure with
reduced EF regardless of MI history?

3. STUDY DESIGN
 Multicenter
 double-blinded, parallel-group, randomized placebo-controlled trial
 N = 2521
 Amiodarone (n = 845)
 Shock-only ICD (n = 829)
 Placebo (n = 847)
 Median follow up: 45.5 month

4. STUDY DESIGN (CONT’D)
 Inclusion criteria
 Age > 18 years
 NYHA class II-III chronic stable HF due to ischemic or nonischemic causes
 LVEF ≤ 35%

5. INTERVENTION
 Randomized to ICD vs amiodarone vs placebo
 All patient received conventional medical therapy as well

6. OUTCOMES
 Primary outcome: all-cause mortality
 ICD vs placebo: 22% vs 29% (p = 0.007)
 Amiodarone vs placebo: 28 vs 29% (p = 0.53)
 Subgroup analysis
 NYHA class III
 Amiodarone -- 44% increase in risk of death compared to placebo (HR 1.44, 97.5 CI 1.05 –
1.97)
 ICD therapy -- no reduction in risk of death with ID therapy compared to placebo

7. CRITICISMS
 Based on subgroup analysis, ICD therapy only shown to have significant benefit in
patients with NYHA class II, but not in those with NYHA class III

8. BOTTOM LINE
 ICDs reduce mortality compared to conventional therapy or amiodarone among
patients with HF with EF<35%, NYHA II/III

9. DISCUSSION QUESTION
Patients with what types of heart failure and what ejection
fraction should be considered for ICD placement?
Why don’t we use amiodarone for patient’s with HFrEF?
What is the primary end-point for this study?

10. CLINICAL APPLICATION
 You are in clinic seeing Mr. Rodriguez, a 59YO M with
DM, HTN, HL, OSA, obesity, and CAD s/p MI in 2013 with
two stents placed in his LAD. Most recent ejection
fraction was 15-20%. He denies shortness of breath at
rest but states that he has difficulty breathing after
walking 2-3 blocks. Current medications include
atorvastatin 80 mg PO daily, lasix 20 mg PO daily, Coreg
12.5 mg PO BID, and benazepril 40 mg PO daily.What is
the most appropriate next step in management?