(Circulation. 1999;99:1416-1421.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Mechanisms of Death in the CABG Patch Trial
A Randomized Trial of Implantable Cardiac Defibrillator Prophylaxis in Patients at High Risk of Death After Coronary Artery Bypass Graft Surgery
From Columbia University (J.T.B., W.W., P.B.N., R.C.S.), New York, NY; Vanderbilt University School of Medicine (J.N.R.), Nashville, Tenn; Washington University School of Medicine (R.E.K.), St Louis, Mo; Allegheny University Medical Center (C.D.G.), Philadelphia, Pa; and New England Medical Center (N.A.M.E.), Boston, Mass.
Correspondence to J. Thomas Bigger, Jr, MD, The CABG Patch Trial Data Coordinating Center, Columbia University, PH 103-D, 630 W 168th St, New York, NY 10032. E-mail jtb2{at}columbia.edu
Background—The CABG Patch trial compared prophylactic implantable cardiac-defibrillator (ICD) implantation with no antiarrhythmic therapy in coronary bypass surgery patients who had a left ventricular ejection fraction <0.36 and an abnormal signal-averaged ECG. There were 102 deaths among the 446 ICD group patients and 96 deaths among the 454 control group patients, a hazard ratio of 1.07 (P=0.63). The mechanisms of death were classified, and hypotheses were tested about the effects of ICD therapy on arrhythmic and nonarrhythmic cardiac deaths in the CABG Patch Trial and the Multicenter Automatic Defibrillator Implantation Trial (MADIT).
Methods and Results—The 198 deaths in the trial were reviewed by an independent Events Committee and classified by the method of Hinkle and Thaler. Only 54 deaths (27%) occurred out of hospital; 145 deaths (73%) were witnessed. Seventy-nine (82%) of the 96 deaths in the control group and 76 (75%) of the 102 deaths in the ICD group were due to cardiac causes. Cumulative arrhythmic mortality at 42 months was 6.9% in the control group and 4.0% in the ICD group (P=0.057). Cumulative nonarrhythmic cardiac mortality at 42 months was 12.4% in the control group and 13.0% in the ICD group (P=0.275). Death due to pump failure was significantly associated with death >1 hour from the onset of symptoms, dyspnea within 7 days of death, and overt heart failure within 7 days of death.
Conclusions—In the CABG Patch Trial, ICD therapy reduced arrhythmic death 45% without significant effect on nonarrhythmic deaths. Because 71% of the deaths were nonarrhythmic, total mortality was not significantly reduced.
Key Words: trials • heart-assist device • bypass
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