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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. - PowerPoint PPT Presentation
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CLARIDI TrialCLARIDI TrialCLARIDI TrialCLARIDI Trial
Presented atPresented atThe Heart Rhythm Society Meeting The Heart Rhythm Society Meeting
May 2006May 2006
Presented by Dr. Johan De SutterPresented by Dr. Johan De Sutter
Cholesterol Lowering and Arrhythmias Recurrences Cholesterol Lowering and Arrhythmias Recurrences after Internal Defibrillator Implantation Trialafter Internal Defibrillator Implantation Trial
Cholesterol Lowering and Arrhythmias Recurrences Cholesterol Lowering and Arrhythmias Recurrences after Internal Defibrillator Implantation Trialafter Internal Defibrillator Implantation Trial
www.Clinicaltrialresults.org
CLARIDI Trial: BackgroundCLARIDI Trial: BackgroundCLARIDI Trial: BackgroundCLARIDI Trial: Background
• The goal of the trial was to evaluate the effect of lipid The goal of the trial was to evaluate the effect of lipid lowering therapy with atorvastatin compared with placebo lowering therapy with atorvastatin compared with placebo among patients with coronary artery disease and internal among patients with coronary artery disease and internal cardioverter defibrillator (ICD) implants.cardioverter defibrillator (ICD) implants.
• The goal of the trial was to evaluate the effect of lipid The goal of the trial was to evaluate the effect of lipid lowering therapy with atorvastatin compared with placebo lowering therapy with atorvastatin compared with placebo among patients with coronary artery disease and internal among patients with coronary artery disease and internal cardioverter defibrillator (ICD) implants.cardioverter defibrillator (ICD) implants.
Presented at HRS 2006Presented at HRS 2006
www.Clinicaltrialresults.org
CLARIDI Trial: Study DesignCLARIDI Trial: Study DesignCLARIDI Trial: Study DesignCLARIDI Trial: Study Design
Presented at HRS 2006Presented at HRS 2006
Primary Endpoint: First recurrence of an appropriate ICD therapy for VT or VFPrimary Endpoint: First recurrence of an appropriate ICD therapy for VT or VF Secondary Endpoint: Composite of death, MI coronary revascularization, or stroke; Secondary Endpoint: Composite of death, MI coronary revascularization, or stroke;
number of episodes of electrical storm; number of appropriate ICD therapiesnumber of episodes of electrical storm; number of appropriate ICD therapies
Primary Endpoint: First recurrence of an appropriate ICD therapy for VT or VFPrimary Endpoint: First recurrence of an appropriate ICD therapy for VT or VF Secondary Endpoint: Composite of death, MI coronary revascularization, or stroke; Secondary Endpoint: Composite of death, MI coronary revascularization, or stroke;
number of episodes of electrical storm; number of appropriate ICD therapiesnumber of episodes of electrical storm; number of appropriate ICD therapies
Atorvastatin 80 mgn=53
Atorvastatin 80 mgn=53
Placebo
n=53
Placebo
n=53
106 patients with coronary artery disease, life threatening ventricular arrhythmias 106 patients with coronary artery disease, life threatening ventricular arrhythmias requiring ICD implantation, total cholesterol <250mg/dl and not on statin therapyrequiring 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 VT87% had prior MI, 40% had CHF
106 patients with coronary artery disease, life threatening ventricular arrhythmias 106 patients with coronary artery disease, life threatening ventricular arrhythmias requiring ICD implantation, total cholesterol <250mg/dl and not on statin therapyrequiring 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 VT87% had prior MI, 40% had CHF
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CLARIDI Trial: LDL CholesterolCLARIDI Trial: LDL Cholesterol CLARIDI Trial: LDL CholesterolCLARIDI Trial: LDL Cholesterol
65
130
0
30
60
90
120
Baseline Follow-up
65
130
0
30
60
90
120
Baseline Follow-up
LDL Cholesterol in the atorvastatin groupLDL Cholesterol in the atorvastatin group
Mg
/dl
Mg
/dl
• LDL Cholesterol LDL Cholesterol was reduced in was reduced in the atorvastatin the atorvastatin group from 130 group from 130 mg/dl at baseline mg/dl at baseline to 65 mg/dl at to 65 mg/dl at follow-up, with follow-up, with no significant no significant change in the change in the placebo group.placebo group.
www.Clinicaltrialresults.org
CLARIDI Trial: Primary EndpointCLARIDI Trial: Primary EndpointCLARIDI Trial: Primary EndpointCLARIDI Trial: Primary Endpoint
Presented at HRS 2006Presented at HRS 2006
• The primary The primary endpoint of ICD endpoint of ICD therapy therapy occurred less occurred less frequently in the frequently in the atorvastatin atorvastatin group compared group compared with placebo with placebo (21% vs. 38%, (21% vs. 38%, hazard ratio [HR] hazard ratio [HR] 0.47, p=0.040)0.47, p=0.040)
21%
38%
0%
10%
20%
30%
40%
Atorvastatin Placebo
21%
38%
0%
10%
20%
30%
40%
Atorvastatin Placebo
Primary Endpoint of ICD Therapy p=0.040
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CLARIDI Trial: Secondary Composite EndpointCLARIDI Trial: Secondary Composite EndpointCLARIDI Trial: Secondary Composite EndpointCLARIDI Trial: Secondary Composite Endpoint
Presented at HRS 2006Presented at HRS 2006
• There was no There was no difference in the difference in the secondary secondary composite composite endpoint of death, endpoint of death, MI, MI, revascularization revascularization or stroke (9% vs. or stroke (9% vs. 6%, p=0.72)6%, p=0.72)
9%
6%
0%
2%
4%
6%
8%
10%
Atorvastatin Placebo
9%
6%
0%
2%
4%
6%
8%
10%
Atorvastatin Placebo
Secondary Composite Endpoint of Death, MI, Revascularization, or Stroke
p=0.72
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CLARIDI Trial: Adverse EventsCLARIDI Trial: Adverse EventsCLARIDI Trial: Adverse EventsCLARIDI Trial: Adverse Events
Presented at HRS 2006Presented at HRS 2006
• Treatment related Treatment related adverse events adverse events occurred in 11% occurred in 11% of the atorvastatin of the atorvastatin group and 4% of group and 4% of the placebo group the placebo group (p=27), the (p=27), the majority of which majority of which were were gastrointestinal gastrointestinal (9% vs. 4%).(9% vs. 4%).
11%
4%
0%
3%
6%
9%
12%
Atorvastatin Placebo
11%
4%
0%
3%
6%
9%
12%
Atorvastatin Placebo
Treatment related adverse events (%) p=0.27
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CLARIDI Trial: SummaryCLARIDI Trial: SummaryCLARIDI Trial: SummaryCLARIDI Trial: Summary
• Among patients with coronary artery disease and an ICD implant, Among patients with coronary artery disease and an ICD implant, treatment with atorvastatin was associated with a reduction in the treatment with atorvastatin was associated with a reduction in the need for ICD therapies for VT or VF by one year compared with need for ICD therapies for VT or VF by one year compared with placebo. placebo.
• While statin therapy has been shown to be effective in reducing While statin therapy has been shown to be effective in reducing clinical events following an acute coronary syndrome, the effect of clinical events following an acute coronary syndrome, the effect of statin therapy on ventricular arrhythmias has not previously been statin therapy on ventricular arrhythmias has not previously been demonstrated in a randomized manner. demonstrated in a randomized manner.
• The present trial suggests an arrhythmic benefit of intensive lipid-The present trial suggests an arrhythmic benefit of intensive lipid-lowering therapy in an ICD population. lowering therapy in an ICD population.
• These results require further confirmation in a larger randomized trial.These results require further confirmation in a larger randomized trial.
• Among patients with coronary artery disease and an ICD implant, Among patients with coronary artery disease and an ICD implant, treatment with atorvastatin was associated with a reduction in the treatment with atorvastatin was associated with a reduction in the need for ICD therapies for VT or VF by one year compared with need for ICD therapies for VT or VF by one year compared with placebo. placebo.
• While statin therapy has been shown to be effective in reducing While statin therapy has been shown to be effective in reducing clinical events following an acute coronary syndrome, the effect of clinical events following an acute coronary syndrome, the effect of statin therapy on ventricular arrhythmias has not previously been statin therapy on ventricular arrhythmias has not previously been demonstrated in a randomized manner. demonstrated in a randomized manner.
• The present trial suggests an arrhythmic benefit of intensive lipid-The present trial suggests an arrhythmic benefit of intensive lipid-lowering therapy in an ICD population. lowering therapy in an ICD population.
• These results require further confirmation in a larger randomized trial.These results require further confirmation in a larger randomized trial.
Presented at HRS 2006Presented at HRS 2006
