Table 3.
Individual mortality or hospitalization endpoints during the first 2 years after randomization by digoxin and placebo in subgroups of high-risk heart failurepatients in the Digitalis Investigation Group trial
| Outcomes | % (events) |
Absolute risk differencea | Hazard ratio (95% CI) | P-value | |
|---|---|---|---|---|---|
| Digoxin | Placebo | ||||
| NYHA class III–IV | (n = 1118) | (n = 1105) | |||
| All-cause mortality | 30% (340) | 30% (330) | 0% | 1.00 (0.86–1.16) | 0.988 |
| CV mortality | 25% (276) | 25% (277) | 0% | 0.97 (0.82–1.14) | 0.686 |
| HF mortality | 12% (130) | 13% (147) | –1% | 0.86 (0.68–1.09) | 0.204 |
| All-cause hospitalization | 61% (678) | 64% (709) | –3% | 0.86 (0.78–0.96) | 0.005 |
| CV hospitalization | 47% (525) | 53% (590) | –6% | 0.79 (0.70–0.88) | <0.001 |
| HF hospitalization | 26% (290) | 37% (404) | –11% | 0.63 (0.54–0.74) | <0.001 |
| All-cause mortality or HF hospitalization | 44% (491) | 51% (565) | –7% | 0.76 (0.68–0.86) | <0.001 |
| CV mortality or HF hospitalization | 39% (441) | 48% (533) | –9% | 0.73 (0.64–0.82) | <0.001 |
| LVEF <25% | (n = 1127) | (n = 1129) | |||
| All-cause mortality | 29% (321) | 29% (329) | 0% | 0.96 (0.82–1.12) | 0.600 |
| CV mortality | 24% (273) | 25% (287) | –1% | 0.94 (0.79–1.10) | 0.433 |
| HF mortality | 10% (116) | 13% (144) | –3% | 0.79 (0.62–1.01) | 0.062 |
| All-cause hospitalization | 54% (603) | 61% (683) | –7% | 0.79 (0.71–0.88) | <0.001 |
| CV hospitalization | 42% (475) | 50% (569) | –8% | 0.75 (0.66–0.84) | <0.001 |
| HF hospitalization | 24% (271) | 36% (406) | –12% | 0.60 (0.51–0.70) | <0.001 |
| All-cause mortality or HF hospitalization | 41% (466) | 50% (568) | –9% | 0.73 (0.65–0.83) | <0.001 |
| CV mortality or HF hospitalization | 38% (433) | 48% (542) | –10% | 0.71 (0.63–0.81) | <0.001 |
| Cardiothoracic ratio >55% | (n = 1175) | (n = 1170) | |||
| All-cause mortality | 29% (335) | 28% (332) | +1% | 0.99 (0.85–1.16) | 0.933 |
| CV mortality | 23% (274) | 24% (277) | –1% | 0.97 (0.82–1.15) | 0.759 |
| HF mortality | 9% (107) | 13% (148) | –4% | 0.71 (0.56–0.91) | 0.007 |
| All-cause hospitalization | 57% (667) | 62% (727) | –5% | 0.83 (0.74–0.92) | <0.001 |
| CV hospitalization | 44% (521) | 53% (615) | –9% | 0.76 (0.68–0.86) | <0.001 |
| HF hospitalization | 27% (311) | 36% (421) | –9% | 0.67 (0.58–0.77) | <0.001 |
| All-cause mortality or HF hospitalization | 43% (506) | 50% (579) | –7% | 0.79 (0.70–0.89) | <0.001 |
| CV mortality or HF hospitalization | 40% (465) | 46% (543) | –6% | 0.77 (0.68–0.87) | <0.001 |
| High risk (any of the above) | (n = 2191) | (n = 2176) | |||
| All-cause mortality | 26% (570) | 26% (567) | 0% | 0.99 (0.88–1.11) | 0.806 |
| CV mortality | 21% (467) | 22% (475) | –1% | 0.96 (0.85–1.10) | 0.574 |
| HF mortality | 9% (192) | 11% (235) | –2% | 0.80 (0.66–0.97) | 0.023 |
| All-cause hospitalization | 55% (1204) | 60% (1309) | –5% | 0.84 (0.78–0.91) | <0.001 |
| CV hospitalization | 43% (935) | 49% (1076) | –6% | 0.79 (0.72–0.86) | <0.001 |
| HF hospitalization | 23% (509) | 33% (718) | –10% | 0.64 (0.57–0.72) | <0.001 |
| All-cause mortality or HF hospitalization | 39% (859) | 46% (1008) | –7% | 0.77 (0.70–0.84) | <0.001 |
| CV mortality or HF hospitalization | 36% (784) | 44% (946) | –8% | 0.75 (0.68–0.82) | <0.001 |
CI, confidence interval; CV, cardiovascular; HF, heart failure.
aAbsolute risk differences were calculated by subtracting percentage events in patients receiving placebo from those in patients receiving digoxin.