Table 6: Mortality Rates From: FDA Clinical Review*.
| CRT-D† Number (%) N = 595 |
CRT-P† Number (%) N = 617 |
OPT† Number (%) N = 308 |
||
|---|---|---|---|---|
| Total deaths | 105 (17.6) | 131 (21.2) | 77 (25.0) | |
| Cardiac deaths | 76 (12.8) | 109 (17.7) | 58 (18.8) | |
| Pump failure deaths | 52 (8.7) | 53 (8.6) | 34 (11.0) | |
| Sudden cardiac deaths | 17 (2.9) | 48 (7.8) | 18 (5.8) | |
| Ischemic deaths | 4 (0.7) | 2 (0.3) | 4 (1.3) | |
| Implant procedure deaths | 2 (0.3) | 6 (1.0) | 0 (0.0) | |
| Other cardiac procedure deaths | 0 (0.0) | 0 (0.0) | 2 (0.6) | |
| Hyperkalemic deaths | 1 (0.2) | 0 (0.0) | 0 (0.0) | |
| Deaths within 30 days of randomization | 7 (1.2) | 11 (1.8) | 3 (1.0) | |
†
CRT-D indicates cardiac resynchronization therapy with defibrillation; CRT-P, cardiac resynchronization therapy only; OPT, optimal pharmacologic therapy.
*
From Food and Drug Administration. Clinical Review. COMPANION (Comparison of Medical Therapy, Pacing and Defibrillatin in Heart Failure). PMA P030005. June 14, 2004. www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4063b1_07_P010012.S026%20FDA%20clinical%20%20review%20-%20Final.doc (Accessed June 2005) (18)