Title of Trial
Defibrillator versus Beta-blockers for Unexplained Death in Thailand (DEBUT)

Date and citation of primary publication(s) or References
Nademani K et al. Circulation 2003;107:2221-2226.

Purpose of the Trial
The aim of this trial is to compare the annual mortality rates among Sudden Unexplained Death Syndrome (SUDS) patients randomized to treatment with beta-blockers versus patients randomized to treatment with defibrillators.

Study Category
Sudden Cardiac Death, ICD, & Syncope

Patient Population
SUDS survivors: Patients without structural abnormalities of the heart who survived an unexpected VF arrest or cardiac arrest after successful resuscitation

Probable SUDS patients: Patients without structural abnormalities of the heart who experienced symptoms indicative of the clinical presentation of SUDS, especially during sleep. Clinical presentations included agonal respirations, transient episodes of stress, abnormal respirations associated with grasping and groaning, syncope, or seizure-like symptoms.

Inclusion Criteria

• Patient without structural abnormalities of the heart who survived VF or cardiac arrest
• Patient without structural abnormalities of the heart with ECG abnormalities showing a RBBB-like pattern with ST elevation in the right precordial leads (V₁ to V₃) and inducible VT/VF in the electrophysiology laboratory before randomization.

Exclusion Criteria

• Abnormal cardiac catheterization
• Inability to provide written informed consent

Study Design
Randomized clinical trial

Primary Endpoint

• All cause death

Secondary Endpoints

• Recurrent VT/VF or cardiac arrest

Baseline Characteristics
Patient number: 86
Mean Age: 41 years
Gender: % female; 2%
Other characteristics: Two phases of the trial: Pilot phase (20 patients) and main trial (66 patients)

Time to Follow-up
Up to 3 years

Results
During the 3-year follow-up period of the main trial, there were 4 deaths, all of which occurred in the beta-blocker group (p =0.02) Seven deaths occurred, when data from both the pilot and main trials were combined. Again, all of these deaths occurred in the beta-blocker group. No deaths occurred in the defibrillator group. Seven subjects in the defibrillator arm of the main trial had recurrent VF and all were effectively treated by the defibrillator. When data from both the pilot and main trials were combined, twelve defibrillator patients received shocks due to recurrent VF.

Sponsor
Cardiac Rhythm Management and Guidant Incorporation, St Paul, Minnesota

Trial Status: Completed

Review written by Samir Saba, MD