Table 3.
Hospitalizations in patients randomized to digoxin or placebo, by causes for hospitalization*
| Placebo (N=496) | Digoxin (N=492) | ARD† | Hazard ratio (95% confidence intervals)‡ | ||
|---|---|---|---|---|---|
| Number of events at study end: n (%) | % | At 2 years | At study end | ||
| All-cause | 330 (66.5%) | 332 (67.5%) | 1 | 1.06 (0.89–1.25); P=0.533 | 1.03 (0.89–1.20); P=0.683 |
| Cardiovascular | 225 (45.4%) | 241 (49.0%) | 3.6 | 1.08 (0.88–1.32); P=0.456 | 1.10 (0.92–1.32); P=0.301 |
| Worsening heart failure | 108 (21.8%) | 89 (18.1%) | −3.7 | 0.66 (0.47–0.91); P=0.012 | 0.79 (0.59–1.04); P=0.094 |
| Ventricular arrhythmia, cardiac arrest | 5 (1%) | 8 (1.6%) | 0.6 | 1.67 (0.40–6.98); P=0.484 | 1.60 (0.52–4.89); P=0.410 |
| Supraventricular arrhythmia§ | 31 (6.3%) | 32 (6.5%) | 0.2 | 0.92 (0.52–1.62); P=0.775 | 1.04 (0.63–1.70); P=0.881 |
| Atrioventricular block, bradyarrhythmia | 2 (0.4%) | 6 (1.2%) | 0.8 | 6.06 (0.73–50.37); P=0.095 | 3.03 (0.61–15.02); P=0.174 |
| Suspected digoxin toxicity | 3 (0.6%) | 9 (1.8%) | 1.2 | 8.12 (1.02–64.90); P=0.048 | 3.05 (0.83–11.26); P=0.095 |
| Myocardial infarction | 22 (4.4%) | 32 (6.5%) | 2.1 | 1.25 (0.65–2.42); P=0.500 | 1.46 (0.85–2.51); P=0.173 |
| Unstable angina | 62 (12.5%) | 82 (16.7%) | 4.2 | 1.76 (1.20–2.59); P=0.004 | 1.37 (0.99–1.91); P=0.061 |
| Stroke | 24 (4.8%) | 21 (4.3%) | − 0.5 | 0.61 (0.29–1.28); P=0.192 | 0.86 (0.48–1.55); P=0.625 |
| Coronary revascularization¶ | 15 (3.0%) | 17 (3.5%) | 0.5 | 1.10 (0.47–2.60); P=0.823 | 1.14 (0.57–2.29); P=0.706 |
| Cardiac transplantation | 1 (0.2%) | 1 (0.2%) | 0.0 | – – – | 0.99 (0.62–15.84); P=0.995 |
| Other cardiovascular** | 57 (11.5%) | 66 (13.4%) | 1.9 | 1.25 (0.82–1.90); P=0.298 | 1.18 (0.83–1.69); P=0.353 |
| Respiratory infection | 46 (9.3%) | 33 (6.7%) | − 2.6 | 0.60 (0.33–1.09); P=0.094 | 0.70 (0.45–1.10); P=0.120 |
| Other non-cardiac and nonvascular | 196 (39.5%) | 194 (39.4%) | − 0.1 | 1.06 (0.84–1.32); P=0.647 | 1.00 (0.82–1.22); P=0.970 |
| Unspecified | 5 (1%) | 2 (0.4%) | − 0.6 | 0.33 (0.04–3.21); P=0.342 | 0.39 (0.08–2.03); P=0.266 |
| Number of hospitalizations | 949 | 985 | |||
Data shown include the first hospitalization of each patient due to each cause.
Absolute differences were calculated by subtracting the percentage of patients hospitalized in the placebo group from the percentage of patients hospitalized in the digoxin group.
Hazard ratios and confidence intervals (CI) were estimated from a Cox proportional-hazards models that used the first hospitalization of each patient for each reason.
This category includes atrioventricular block and bradyarrhythmia.
This category includes coronary-artery bypass grafting and percutaneous transluminal coronary angioplasty.
This category includes embolism, venous thrombosis, peripheral vascular disease, hypertension, other vascular surgery, cardiac catheterization, other types of catheterization, pacemaker implantation, installation of automatic implantable cardiac defibrillator, electrophysiologic testing, transplant-related evaluation, nonspecific chest pain, atherosclerotic heart disease, hypotension, orthostatic hypotension, and valve operation.