1. The Heart Rhythm Society Meeting Presented by Dr. Johan De Sutter
Cholesterol Lowering and Arrhythmias Recurrences after Internal Defibrillator Implantation Trial
CLARIDI Trial
Presented at
The Heart Rhythm Society Meeting
May 2006
Presented by Dr. Johan De Sutter

2. CLARIDI Trial: Background
The goal of the trial was to evaluate the effect of lipid lowering therapy with atorvastatin compared with placebo among patients with coronary artery disease and internal cardioverter defibrillator (ICD) implants.
Presented at HRS 2006

3. CLARIDI Trial: Study Design
106 patients with coronary artery disease, life threatening ventricular arrhythmias requiring ICD implantation, total cholesterol <250mg/dl and not on statin therapy
Placebo Controlled. Randomized. Blinded.
6% female, mean age 67 years, , mean ejection fraction 40%, mean follow-up 1 year
69% had ICD’s implanted within the month prior to enrollment, 65% received the ICD for sustained VT
87% had prior MI, 40% had CHF
Atorvastatin
80 mg
n=53
Placebo
n=53
Primary Endpoint: First recurrence of an appropriate ICD therapy for VT or VF
Secondary Endpoint: Composite of death, MI coronary revascularization, or stroke; number of episodes of electrical storm; number of appropriate ICD therapies
Presented at HRS 2006

4. CLARIDI Trial: LDL Cholesterol
LDL Cholesterol in the atorvastatin group
LDL Cholesterol was reduced in the atorvastatin group from 130 mg/dl at baseline to 65 mg/dl at follow-up, with no significant change in the placebo group.
Mg/dl

5. CLARIDI Trial: Primary Endpoint
Primary Endpoint of ICD Therapy
p=0.040
The primary endpoint of ICD therapy occurred less frequently in the atorvastatin group compared with placebo (21% vs. 38%, hazard ratio [HR] 0.47, p=0.040)
Presented at HRS 2006

6. CLARIDI Trial: Secondary Composite Endpoint
Secondary Composite Endpoint of Death, MI, Revascularization, or Stroke
p=0.72
There was no difference in the secondary composite endpoint of death, MI, revascularization or stroke (9% vs. 6%, p=0.72)
Presented at HRS 2006

7. CLARIDI Trial: Adverse Events
Treatment related adverse events (%)
p=0.27
Treatment related adverse events occurred in 11% of the atorvastatin group and 4% of the placebo group (p=27), the majority of which were gastrointestinal (9% vs. 4%).
Presented at HRS 2006

8. CLARIDI Trial: Summary
Among patients with coronary artery disease and an ICD implant, treatment with atorvastatin was associated with a reduction in the need for ICD therapies for VT or VF by one year compared with placebo.
While statin therapy has been shown to be effective in reducing clinical events following an acute coronary syndrome, the effect of statin therapy on ventricular arrhythmias has not previously been demonstrated in a randomized manner.
The present trial suggests an arrhythmic benefit of intensive lipid-lowering therapy in an ICD population.
These results require further confirmation in a larger randomized trial.
Presented at HRS 2006