Ocurrences after Internal Defibrillator Implantation
Ocurrences after Internal Defibrillator Implantation
Cholesterol Lowering and Arrhythmias Recurrences after Internal Defibrillator Implantation (CLARIDI, presented at HRS)
Year Presented
2006
Description
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.
Drugs/Procedures Used
Patients with coronary artery disease and an ICD were randomized in a double-blind manner to atorvastatin 80 mg (n=53) or placebo (n=53).
Principal Findings
ICDs were implanted within the month prior to enrollment in 69% of patients, and 65% received the ICD for sustained VT. Prior MI was present in 87% of patients and CHF in 40%.
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. 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). There was no difference in the secondary composite endpoint of death, MI, revascularization or stroke (9% for atorvastatin vs 6% for placebo, p=0.72). Treatment related adverse events occurred in 11% of the atorvastatin group and 4% of the placebo group (p=0.27), the majority of which were gastrointestinal (9% vs 4%).
Interpretation
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 and arrhythmic benefit of intensive lipid-lowering therapy in an ICD population.
Conditions
Therapies
Study Design
Placebo controlled. Randomized. Blinded.
Patients Screened: 155
Patients Enrolled: 106
Mean Follow-Up: 12 months
Mean Patient Age: Mean age 67 years
% Female: 6
Mean Ejection Fraction: Mean ejection fraction 40%
Primary Endpoints
First recurrence of an appropriate ICD therapy for VT or VF
Secondary Endpoints
Composite of death, MI, coronary revascularization, or stroke; number of episodes of electrical storm; number of appropriate ICD therapies
Patient Population
Coronary artery disease, life-threatening ventricular arrhythmias requiring ICD implantation, total cholesterol <250 mg/dl and not on statin therapy
Exclusions:
Ventricular arrhythmia in the actue phase of MI (within 48 hours)
Presented by Johan De Sutter, MD at the Heart Rhythm Society Meeting, Boston, MA, May 2006
Cholesterol Lowering and Arrhythmias Recurrences after Internal Defibrillator Implantation (CLARIDI, presented at HRS)
Year Presented
2006
Description
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.
Drugs/Procedures Used
Patients with coronary artery disease and an ICD were randomized in a double-blind manner to atorvastatin 80 mg (n=53) or placebo (n=53).
Principal Findings
ICDs were implanted within the month prior to enrollment in 69% of patients, and 65% received the ICD for sustained VT. Prior MI was present in 87% of patients and CHF in 40%.
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. 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). There was no difference in the secondary composite endpoint of death, MI, revascularization or stroke (9% for atorvastatin vs 6% for placebo, p=0.72). Treatment related adverse events occurred in 11% of the atorvastatin group and 4% of the placebo group (p=0.27), the majority of which were gastrointestinal (9% vs 4%).
Interpretation
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 and arrhythmic benefit of intensive lipid-lowering therapy in an ICD population.
Conditions
Coronary heart disease
Arrhythmias
Therapies
Lipid-lowering agent
Lipid-lowering agent / HMG CoA Reductase Inhibitor / Atorvastatin
Study Design
Placebo controlled. Randomized. Blinded.
Patients Screened: 155
Patients Enrolled: 106
Mean Follow-Up: 12 months
Mean Patient Age: Mean age 67 years
% Female: 6
Mean Ejection Fraction: Mean ejection fraction 40%
Primary Endpoints
First recurrence of an appropriate ICD therapy for VT or VF
Secondary Endpoints
Composite of death, MI, coronary revascularization, or stroke; number of episodes of electrical storm; number of appropriate ICD therapies
Patient Population
Coronary artery disease, life-threatening ventricular arrhythmias requiring ICD implantation, total cholesterol <250 mg/dl and not on statin therapy
Exclusions:
Ventricular arrhythmia in the actue phase of MI (within 48 hours)
Presented by Johan De Sutter, MD at the Heart Rhythm Society Meeting, Boston, MA, May 2006