Transcript Trial - Clinical Trial Results

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
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.
www.Clinicaltrialresults.org
Presented at HRS 2006
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
www.Clinicaltrialresults.org
Presented at HRS 2006
CLARIDI Trial: LDL Cholesterol
LDL Cholesterol in the atorvastatin group
130
120
Mg/dl
90
65
60
30
0
Baseline
www.Clinicaltrialresults.org
Follow-up
• 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.
CLARIDI Trial: Primary Endpoint
Primary Endpoint of ICD Therapy
p=0.040
40%
38%
30%
21%
20%
10%
0%
Atorvastatin
www.Clinicaltrialresults.org
• 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)
Placebo
Presented at HRS 2006
CLARIDI Trial: Secondary Composite Endpoint
Secondary Composite Endpoint of Death, MI,
Revascularization, or Stroke
10%
9%
p=0.72
8%
6%
6%
4%
2%
• There was no
difference in the
secondary
composite
endpoint of
death, MI,
revascularization
or stroke (9% vs.
6%, p=0.72)
0%
Atorvastatin
www.Clinicaltrialresults.org
Placebo
Presented at HRS 2006
CLARIDI Trial: Adverse Events
Treatment related adverse events (%)
p=0.27
12%
11%
9%
6%
4%
3%
0%
Atorvastatin
www.Clinicaltrialresults.org
• 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%).
Placebo
Presented at HRS 2006
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 lipidlowering therapy in an ICD population.
• These results require further confirmation in a larger randomized trial.
www.Clinicaltrialresults.org
Presented at HRS 2006