Table 1.
Major CRT trials with outcomes
Trial | Total No. of Subjects (% Female) | Inclusion Criteria | Randomization | HR for Events (95% CI) |
---|---|---|---|---|
COMPANION16 | 1520 (33) | LVEF ≤35%, NYHA class III–IV, QRSd ≥120 ms | OMT vs OMT + CRT‐D | HR for death: men, 0.63 (0.4‐0.9); women, 0.58 (0.25‐1.13) |
CARE‐HF14 | 813 (27) | LVEF ≤35%, NYHA class III–IV, QRSd ≥120 ms, LVEDD ≥30 mm | OMT vs OMT + CRT | HR for death or cardiac hospitalization: men, 0.62 (0.49‐0.79); women, 0.64 (0.42‐0.97) |
MADIT‐CRT17 | 1820 (25) | LVEF ≤30%, NYHA class I–II, QRSd ≥130 ms | ICD vs CRT‐D | HR for HF event or death: men, 0.76 (0.59‐0.97); women, 0.37 (0.22‐0.61) |
RAFT15 | 1798 (17) | LVEF ≤30%, NYHA class II–III, QRSd ≥120 ms | ICD vs CRT‐D | HR death or HF admission: men, 0.82 (0.7‐0.95); women, 0.52 (0.35‐0.85). Difference between men and women is not significant (P = 0.09). |
MIRACLE13 | 453 (32) | LVEF ≤35%, NYHA class III–IV, QRSd ≥130 ms | Placebo vs CRT | Women, but not men, with CRT experienced longer times to first HF hospitalization or death (HR in women: 0.157). |
Abbreviations: 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; HF, heart failure; HR, hazard ratio; ICD, implantable cardioverter‐defibrillator; LVEDD, left ventricular end‐diastolic diameter; LVEF, left ventricular ejection fraction; MADIT‐CRT, Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy; MIRACLE, Multicenter InSync Randomized Clinical Evaluation; NYHA, New York Heart Association; OMT, optimal medical therapy; QRSd, QRS duration; RAFT, Resynchronization for Ambulatory Heart Failure; REVERSE, Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction.
Reproduced with permission and modified from Tompkins et al.34