Table 1.
Number of events and hazard ratio of first hospitalization according to pre-specified reasons during the on-study period
| Reason for hospitalization | Placebo (n = 2327) | Dronedarone (n = 2301) | HR (95% CI) | Log-rank test P value |
|---|---|---|---|---|
| CV hospitalizations | ||||
| AF and other supraventricular rhythm disorders | 510 | 335 | 0.626 (0.546–0.719) | <0.0001 |
| Worsening CHF, including pulmonary oedema or dyspnoea of cardiac origin | 132 | 112 | 0.855 (0.665–1.100) | 0.2207 |
| Acute coronary syndromea | 89 | 62 | 0.699 (0.506–0.967) | 0.0296 |
| Implantation of a pacemaker, implantable cardioverter defibrillator, or other cardiac device | 81 | 64 | 0.793 (0.572–1.101) | 0.1655 |
| Stable angina pectoris or atypical chest pain | 63 | 56 | 0.898 (0.626–1.287) | 0.5561 |
| TIA or stroke (except for intracranial haemorrhage) | 61 | 43 | 0.708 (0.480–1.047) | 0.0819 |
| Transcutaneous coronary, cerebrovascular, or peripheral procedure | 48 | 44 | 0.925 (0.615–1.393) | 0.7102 |
| CV surgery except for cardiac transplantation | 43 | 35 | 0.820 (0.525–1.281) | 0.3824 |
| Hypotension, hypertension; except for syncope | 38 | 30 | 0.797 (0.494–1.286) | 0.3509 |
| Major bleeding (requiring two or more units of blood or any intracranial haemorrhage) | 33 | 36 | 1.103 (0.688–1.769) | 0.6839 |
| Syncope | 32 | 27 | 0.853 (0.511–1.424) | 0.5418 |
| Atherosclerosis related (if not otherwise specified) | 14 | 16 | 1.151 (0.562–2.358) | 0.7004 |
| Ventricular arrhythmia or non-fatal cardiac arrest | 12 | 13 | 1.091 (0.498–2.391) | 0.8277 |
| Pulmonary embolism or deep vein thrombosis | 6 | 14 | 2.337 (0.898–6.082) | 0.0730 |
| Ventricular extrasystoles | 1 | 1 | 1.007 (0.063–16.106) | 0.9958 |
| Cardiac transplantation | 1 | 0 | NC | NC |
| CV infection | 0 | 4 | NC | NC |
| Non-CV hospitalizations | 533 | 516 | 0.982 (0.870–1.108) | 0.7688 |
NC, not calculable.
aAcute coronary syndrome includes myocardial infarction or unstable angina.