Defibrillator versus β-blockers for unexplained death in Thailand (DEBUT) -: A randomized clinical trial

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.