Table 1.
Study details of clinical trials evaluating implantable cardioverter-defibrillator use in non-ischaemic cardiomyopathy
| CAT | AMIOVIRT | DEFINITE | SCD-HeFT | COMPANION | DANISH | |
|---|---|---|---|---|---|---|
| No. of patients randomized | 104 | 103 | 458 | 2521 | 1520 | 1116 |
| No. of patients with NICM (%) | 104 (100) | 103 (100) | 458 (100) | 792 (47.3) | 682 (44.0) | 1116 (100) |
| Year of publication | 2002 | 2003 | 2004 | 2005 | 2004 | 2016 |
| Trial details | ||||||
| Design | ICD vs. OMT | ICD vs. OMT | ICD vs. amiodarone | ICD vs. amiodarone vs. placebo | OMT vs. CRT-P vs. CRT-D | ICD vs. OMT |
| Inclusion criteria | LVEF ≤ 30%, NYHA II–III | LVEF ≤ 35%; DCM; NSVT; NYHA I–III | LVEF ≤ 35%; DCM; NSVT or PVCs; NYHA I–III | LVEF ≤ 35%; NYHA II–III | NYHA III–IV; QRS duration ≥120 ms | LVEF ≤ 35%; NT-pro-BNP >200 pg/mL; NYHA II–IV |
| Duration of follow-up (months) | 66 ± 26.4 (mean) | 24 ± 14.4 (mean) | 29 ± 14.4 (mean) | 45.5 (median) | 14.8–16.0 (median) | 67.6 (median) |
| Primary endpoint | All-cause mortality | All-cause mortality | All-cause mortality | All-cause mortality | All-cause mortality/ hospitalization | All-cause mortality |
| Baseline characteristics | ||||||
| Mean age (years) | 52 | 59 | 58 | 60 | 67 | 64 |
| Male (%) | 86 | 71 | 71 | 77 | 68 | 73 |
| HTN (%) | n/a | 63 | n/a | 56 | n/a | 32 |
| Diabetes (%) | n/a | 34 | 23 | 31 | 41 | 19 |
| Medication | ||||||
| Beta-blocker (%) | 4 | 51.5 | 86 | 69 | 67 | 92 |
| ACE inhibitor/ARB (%) | 94% | 85 | 97 | 94 | 89 | 96 |
| MRA (%) | n/a | 20 | NR | 20 | 55 | 59 |
| Number with CRT (%) | 0 | 0 | 0 | 0 | 100% | 58 |
| Main result | ||||||
| ICD therapy did not reduce mortality, P = 0.55 | ICD therapy did not reduce mortality, P = 0.80 | ICD therapy resulted in 35% RR reduction, P = 0.08 | ICD therapy resulted in 23% RR reduction in all-cause mortality, P = 0.007 | CRT-D therapy resulted in a 36% RR reduction in mortality P = 0.001 | ICD therapy did not reduce mortality P = 0.28 | |
ACEI, angiotensin-converting enzyme inhibitor; AMIOVIRT, Amiodarone vs. Implantable Defibrillator Randomized Trial; ARB, angiotensin receptor blocker; CAT, Cardiomyopathy Trial; COMPANION, Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure trial; CRT, cardiac resynchronization therapy; DANISH, Danish Study to Assess the Efficacy of ICDs in Patients with Non-Ischaemic Systolic Heart Failure on Mortality; DEFINITE, Defibrillators in Non-Ischaemic Cardiomyopathy Treatment Evaluation; HTN, Hypertension; ICD, implantable cardioverter-defibrillator; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist, n/a, not available; NICM, non-ischaemic cardiomyopathy; NSVT, non-sustained ventricular tachycardia; NYHA, New York Heart Association; OMT, optimal medical therapy; PVCs, premature ventricular contractions; RR, relative risk; SCD-HeFT, Sudden Cardiac Death in Heart Failure Trial; Y, Year.