1 / 8

CLARIDI Trial

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.

emile
Télécharger la présentation

CLARIDI Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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 HRS2006

  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

More Related