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Published on: February 28, 2012
Defibrillator Versus beta-Blockers for Unexplained Death in Thailand (DEBUT): a randomized clinical trial
Koonlawee Nademanee1, Gumpanart Veerakul, Morton Mower
1Pacific Rim Electrophysiology Research Institute, Los Angeles, Cal, USA. wee@pacificrimep.com
Insights
Sudden Unexplained Death Syndrome (SUDS) patients benefit from implantable cardioverter defibrillators (ICDs). ICDs provided full protection from death related to primary ventricular fibrillation (VF), outperforming beta-blockers in a clinical trial.
Area of Science:
- Cardiology
- Clinical Trials
- Sudden Cardiac Death Research
Background:
- Sudden Unexplained Death Syndrome (SUDS) is a primary cause of mortality in young, healthy Southeast Asian men.
- The efficacy of implantable cardioverter defibrillators (ICDs) for reducing mortality in SUDS patients is not well-established.
- This study addresses the uncertainty surrounding ICD use in SUDS survivors.
Purpose of the Study:
- To compare the effectiveness of ICDs versus beta-blockers in reducing all-cause mortality in Sudden Unexplained Death Syndrome survivors.
- To evaluate the impact of these treatments on recurrent ventricular tachycardia/ventricular fibrillation (VF) and cardiac arrest.
Main Methods:
- The Defibrillator Versus beta-Blockers for Unexplained Death in Thailand (DEBUT) study was a two-phase randomized clinical trial.
- 86 SUDS survivors and probable survivors were randomized to receive either an ICD or propranolol.
- The primary endpoint was all-cause mortality, with a secondary endpoint of recurrent VF or cardiac arrest over a 3-year follow-up.
Main Results:
- During the 3-year follow-up, all 4 deaths occurred in the beta-blocker group (P=0.02).
- No deaths were observed in the ICD group.
- Seven patients in the ICD arm experienced recurrent VF, all successfully treated by the device.
Conclusions:
- Implantable cardioverter defibrillator (ICD) treatment offers complete protection against death from primary ventricular fibrillation (VF) in the SUDS population.
- ICD therapy is demonstrably superior to beta-blockade treatment for mortality reduction in SUDS patients.
Background:
Sudden Unexplained Death Syndrome (SUDS) is the leading cause of death in young, healthy, Southeast Asian men. The role of an implantable cardioverter defibrillator (ICD) for mortality reduction in these patients remains unclear.
Methods And Results:
The Defibrillator Versus beta-Blockers for Unexplained Death in Thailand (DEBUT) study is a randomized, clinical trial conducted in 2 phases (pilot study followed by the main trial) to compare the annual all-cause mortality rates among SUDS patients treated with beta-blockers versus that among those treated with an ICD. A total of 86 patients who were SUDS survivors and probable SUDS survivors were randomized to receive an ICD or propranolol (20 patients were in the pilot study and 66 were in the main trial). The primary end point was death from all causes. The secondary end point was recurrent ventricular tachycardia/ventricular fibrillation (VF) or cardiac arrest. During the 3-year follow-up period of the main trial, there were 4 deaths; all occurred in the beta-blocker group (P=0.02). Seven subjects in the ICD arm had recurrent VF, and all were effectively treated by the ICD. On the basis of the main trial results, the Data Safety Monitoring Board stopped the study. In total (both from the Pilot study and the main trial), there were 7 deaths (18%) in the beta-blocker group and no deaths in the ICD group, but there were a total of 12 ICD patients receiving ICD discharges due to recurrent VF.
Conclusions:
ICD treatment provides full protection from death related to primary VF in a SUDS population and is superior to beta-blockade treatment.
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