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Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients Trial - OPTIC
Description:
The goal of the trial was to evaluate if antiarrhythmic therapy would reduce shocks (appropriate or inappropriate) compared to beta-blocker therapy in patients receiving an implantable cardioverter defibrillator (ICD).
Study Design
Study Design:
Patients Enrolled: 412
Mean Follow Up: One year
Mean Patient Age: Mean age 64 years
Female: 19
Patient Populations:
Receiving a St. Jude Medical dual-chamber ICD; presence of one of the following: 1) spontaneous VT; or 2) left ventricular (LV) ejection fraction ≤40% with either spontaneous VF or inducible VT or VF.
Exclusions:
Long QT, need for class I or III antiarrhythmic therapy, prior chronic treatment with amiodarone or sotalol, or contraindication to any randomized therapy
Primary Endpoints:
First occurrence of any shock delivered by the ICD
Drug/Procedures Used:
Patients receiving a St. Jude Medical dual-chamber ICD and meeting the inclusion criteria were randomized to one of three groups: 1) beta-blocker therapy with metoprolol, carvedolol, or bisoprolol; 2) amiodarone (800 mg load plus 200 mg/day) plus a beta-blocker; or 3) sotalol (160 mg/day).
Principal Findings:
Baseline clinical characteristics were similar between the treatment groups, with 80% of patients having had a prior myocardial infarction (MI), 29% having inducible ventricular tachycardia (VT) or ventricular fibrillation (VF), and 71% spontaneous VT or VF. Any shock by one year occurred in 38.5% of the beta-blocker alone group, 24.3% of the sotalol group, and 10.3% of the amiodarone plus beta-blocker group (p=0.055 for sotalol vs. beta-blocker alone comparison; p<0.0001 for amiodarone plus beta-blocker vs. beta-blocker alone comparison; p=0.02 for amiodarone plus beta-blocker vs. sotalol comparison). In an analysis excluding shocks received during the first 21 days, shocks occurred in 33.2% of the beta-blocker alone group, 20.8% of the sotalol group, and 6.6% of the amiodarone plus beta-blocker group (p=0.014 for sotalol vs. beta-blocker alone comparison; p<0.0001 for amiodarone plus beta-blocker vs. beta-blocker alone comparison; p=0.0057 for amiodarone plus beta-blocker vs. sotalol comparison).
Appropriate shocks occurred in 22.0% in the beta-blocker alone group, 15.1% of the sotalol group, and 6.7% of the amiodarone plus beta-blocker group (p=0.004 for amiodarone plus beta-blocker vs. beta-blocker alone comparison), whereas inappropriate shocks occurred in 15.4% of the beta-blocker alone group, 9.4% of the sotalol group, and 3.3% of the amiodarone plus beta-blocker group (p=0.20 for sotalol vs. beta-blocker alone comparison; p=0.006 for amiodarone plus beta-blocker vs. beta-blocker alone comparison). Mean number of shocks per patient was 4.32 in the beta-blocker alone group, 0.93 in the sotalol group, and 0.51 of the amiodarone plus beta-blocker group. Adverse events were similar in the three groups.
Interpretation:
Among patients receiving a dual-chamber ICD for spontaneous or inducible VT or VF, sotalol therapy and amiodarone plus beta-blocker therapy were associated with reductions in shocks at one year compared with beta-blocker therapy alone. The reductions in the amiodarone plus beta-blocker group were greater than the sotalol group.
Treatment with ICD therapy has been shown to reduce mortality in patients with VT or VF. However, the shocks the device delivers are very painful to the patient and often anxiety-provoking. While beta-blocker therapy has been shown to reduce the number of shocks, the rate of shocks remains high.
The present study sought to further reduce the number of shocks by adding on amiodarone therapy or sotalol. Both therapies were associated with reductions in shock without an increase in adverse events, suggesting these therapies may improve the quality of life in patients implanted with an ICD.
References:
Connolly SJ, et al. Comparison of beta-Blockers, Amiodarone Plus beta-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators. JAMA. 2006;295:165-171.
Presented by Dr. Stuart J. Connolly at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Keywords: Myocardial Infarction, Tachycardia, Ventricular, Quality of Life, Ventricular Fibrillation, Sotalol, Bisoprolol, Metoprolol, Defibrillators, Implantable
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