Table 1.
Study | n | Inclusion Criteria | QRS (ms) | Design | Blinding | Control | Intervention | Follow-Up (months) |
Primary End Point | Results |
---|---|---|---|---|---|---|---|---|---|---|
MIRACLE (4) | 453 | NYHA functional class III or IV, LVEF ≤ 35%, LVEDD ≥ 55 mm, SR |
≥130 | Parallel | Double blind |
CRT-Off | CRT-On | 6 | 6MWD, NYHA functional class, MLHFQ score |
↑ 6MWD (p = 0.005), improved NYHA functional class (p < 0.001), ↓ MLHFQ score (p = 0.001) |
MIRACLE-ICD (5) | 369 | NYHA functional class III or IV, LVEF ≤ 35%, LVEDD ≥ 55 mm, ICD indicated, SR |
≥130 | Parallel | Double blind |
CRT-D (CRT-Off) |
CRT-D (CRT-On) | 6 | Peak VO2, NYHA class, MLHFQ score |
↑ 6MWD (p = 0.36), improved NYHA functional class (p = 0.007), ↓ MLHFQ score (p = 0.02) |
Contak CD (6) | 490 | NYHA functional class II–IV, LVEF ≤ 35%, ICD indicated, SR |
≥120 | Parallel | Double blind |
CRT-D (CRT-Off) |
CRT-D (CRT-On) | 6 | Composite: all-cause mortality, HF hospitalization, VT/VF requiring intervention |
RRR 15% (p = 0.35) |
COMPANION (1) | 1,520 | NYHA functional class III or IV, LVEF ≤ 35%, LVEDD ≥ 60 mm, SR |
≥120 | 1:2:2 | — | Medical therapy |
CRT-P, CRT-D | 16.2 (median) | All-cause mortality or hospitalization |
CRT-P HR: 0.81 (95% CI: 0.69−0.96; p = 0.014); CRT-D HR: 0.80 (95% CI: 0.68–0.95; p = 0.010) |
CARE-HF (3) | 813 | NYHA functional class III or IV, LVEF ≤ 35%, SR |
≥150, 120−150 + echocardiographic dyssynchrony |
Parallel | — | Medical therapy |
CRT-P | 29.4 (mean) | All-cause mortality or CV hospitalization |
HR: 0.63 (95% CI: 0.51−0.77; p < 0.001) |
CARE-HF Extended (2) |
37.4 | All-cause mortality | HR: 0.60 (95% CI: 0.47−0.77; p < 0.0001) |
CARE-HF = Cardiac Resynchronization–Heart Failure; CI = confidence interval; COMPANION = Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure; CRT = cardiac resynchronization therapy; CRT-D = cardiac resynchronization therapy with defibrillator; CRT-P = cardiac resynchronization therapy only; HF = heart failure; HR = hazard ratio; ICD = implantable cardioverter-defibrillator; LVEDD = left ventricular end-diastolic dimension; LVEF = left ventricular ejection fraction; MIRACLE = Multicenter InSync Randomized Clinical Evaluation; MIRACLE-ICD = Multicenter InSync ICD Randomized Clinical Evaluation; MLHFQ = Minnesota Living With Heart Failure Questionnaire; NYHA = New York Heart Association; RRR = relative risk ratio; 6MWD = 6-minute walk distance; SR = sinus rhythm; VF = ventricular fibrillation; VO2 = oxygen consumption; VT = ventricular tachycardia; ↑ = increased; ↓ = decreased.