Coronary Artery Bypass Graft (CABG) Patch Trial
Condition: Arrhythmia; Cardiovascular Diseases; Coronary Disease; Death, Sudden, Cardiac; Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Ventricular Arrhythmia
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Arrhythmias, Cardiac; Coronary Disease; Myocardial Ischemia; Death, Sudden, Cardiac; Death, Sudden
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve
      survival in coronary heart disease patients at high risk of death, especially arrhythmic
      death.
    

Detailed description: 
      BACKGROUND:

      Management strategies are urgently needed for the problem of sudden cardiac death, the most
      common single, non-accidental cause of death in adults in North America. Many consider that
      the problem of sudden cardiac death has reached epidemic proportions. Contemporary
      prophylactic management of sudden cardiac death includes identification of high risk
      populations, based on underlying structural heart disease, degree of left ventricular
      dysfunction, and evidence of a ventricular arrhythmia propensity. Populations with the
      highest sudden death cardiac risk, notably those patients resuscitated from spontaneous
      episodes of sustained ventricular tachyarrhythmias, have been used as test populations for
      the development of effective prophylactic approaches. However, in such populations, ethical
      considerations have precluded the use of untreated control groups. Furthermore, such patients
      comprise only a small proportion of the total patient population that could benefit from an
      effective prophylactic strategy. The largest 'at-risk' group are those patients with coronary
      artery disease and depressed left ventricular function who have, but have not yet expressed,
      a ventricular tachyarrhythmia propensity. The major advantages of a controlled trial of
      prophylactic therapy in the latter population are evaluation of sudden death prophylaxis in
      the larger 'at-risk' population and the opportunity to do so with an untreated control group.
      The 'window of opportunity' for such comparisons has been closed in resuscitated patients for
      some time and is in danger of closing in the larger population. The total absence of
      controlled efficacy data for ICD use despite 30,000 implanted units of this expensive
      technology argues strongly for the timely acquisition of controlled data in the larger
      population before the therapy is embraced any further.

      DESIGN NARRATIVE:

      Randomized, non-blind. Patients were randomized during surgery for coronary artery bypass
      graft to receive ICD or not, and followed and censored at 42 months at 35 centers. The
      primary endpoint was all-cause mortality. The trial described morbidity of ICD treatment,
      evaluated the effect of ICD therapy on quality of life, and compared health care costs of ICD
      treatment to those in the control group. Anti-arrhythmic treatment of unsustained arrhythmia
      was prohibited; anti-arrhythmic drug use, when indicated, was documented; and aspirin was
      prescribed unless contraindications existed. Recruitment was extended through December 1995
      in order to accrue 900 patients, instead of the original 800 projected. As of February 1996,
      900 patients had been recruited. In April 1997, the DSMB recommended that the trial be
      stopped because there was sufficient evidence to conclude that there was no difference
      between the treatment and control groups. Follow-up was extended for two years beyond the
      original termination date.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the old format Protocol Registration and Results System (PRS).
    

Intervention name(s): defibrillators, implantable
Intervention type(s): Device
Allocation: Randomized
Primary purpose: Treatment