Subcategories of cardiovascular hospitalization among different treatment arms
| . | DE 110 . | DE 150 . | Warfarin . | P-value from Fisher’s exact test . |
|---|---|---|---|---|
| Patients hospitalized | 2312 | 2430 | 2458 | |
| Patients dead or hospitalized | 2436 | 2569 | 2599 | |
| Patients with a cardiovascular hospitalization, N (%) | 952 (100%) | 982 (100%) | 986 (100%) | 0.74 |
| Myocardial infarction | 35 (3.7%) | 47 (4.8%) | 26 (2.6%) | 0.04 |
| New angina | 98 (10.3%) | 105 (10.7%) | 113 (11.5%) | 0.82 |
| Atherosclerosis relateda | 171 (18.0%) | 174 (17.7%) | 181 (18.4%) | 0.95 |
| Transcutaneous coronary, cerebrovascular, or peripheral procedureb | 65 (6.8%) | 69 (7.0%) | 68 (6.9%) | 0.99 |
| Valve or coronary artery bypass grafting surgery | 37 (3.9%) | 20 (2.0%) | 27 (2.7%) | 0.05 |
| AF and other supraventricular rhythm disorders | 287 (30.1%) | 358 (36.5%) | 357 (36.2%) | 0.04 |
| Ventricular arrhythmia or non-fatal cardiac arrest | 34 (3.6%) | 37 (3.8%) | 40 (4.1%) | 0.91 |
| Worsening congestive heart failure | 199 (20.9%) | 176 (17.9%) | 176 (17.8%) | 0.12 |
| Syncope | 29 (3.0%) | 45 (4.6%) | 40 (4.1%) | 0.25 |
| Implantation of a pacemaker, or a ICD | 118 (12.4%) | 107 (10.9%) | 91 (9.2%) | 0.06 |
| TIA or ischaemic stroke | 100 (10.5%) | 74 (7.5%) | 93 (9.4%) | 0.06 |
| Pulmonary embolism | 4 (0.4%) | 3 (0.3%) | 2 (0.2%) | 0.59 |
| Hypotension or hypertension | 30 (3.2%) | 28 (2.9%) | 32 (3.2%) | 0.87 |
| Major bleedingc | 26 (2.7%) | 45 (4.6%) | 40 (4.1%) | 0.10 |
| Cardiovascular infection | 2 (0.2%) | 3 (0.3%) | 1 (0.1%) | 0.62 |
| Patients with hospitalization due to any bleeding | 178 | 261 | 256 | 0.0004 |
| Patients hospitalized for non-cardiovascular reason | 1360 | 1448 | 1472 | 0.74 |
| . | DE 110 . | DE 150 . | Warfarin . | P-value from Fisher’s exact test . |
|---|---|---|---|---|
| Patients hospitalized | 2312 | 2430 | 2458 | |
| Patients dead or hospitalized | 2436 | 2569 | 2599 | |
| Patients with a cardiovascular hospitalization, N (%) | 952 (100%) | 982 (100%) | 986 (100%) | 0.74 |
| Myocardial infarction | 35 (3.7%) | 47 (4.8%) | 26 (2.6%) | 0.04 |
| New angina | 98 (10.3%) | 105 (10.7%) | 113 (11.5%) | 0.82 |
| Atherosclerosis relateda | 171 (18.0%) | 174 (17.7%) | 181 (18.4%) | 0.95 |
| Transcutaneous coronary, cerebrovascular, or peripheral procedureb | 65 (6.8%) | 69 (7.0%) | 68 (6.9%) | 0.99 |
| Valve or coronary artery bypass grafting surgery | 37 (3.9%) | 20 (2.0%) | 27 (2.7%) | 0.05 |
| AF and other supraventricular rhythm disorders | 287 (30.1%) | 358 (36.5%) | 357 (36.2%) | 0.04 |
| Ventricular arrhythmia or non-fatal cardiac arrest | 34 (3.6%) | 37 (3.8%) | 40 (4.1%) | 0.91 |
| Worsening congestive heart failure | 199 (20.9%) | 176 (17.9%) | 176 (17.8%) | 0.12 |
| Syncope | 29 (3.0%) | 45 (4.6%) | 40 (4.1%) | 0.25 |
| Implantation of a pacemaker, or a ICD | 118 (12.4%) | 107 (10.9%) | 91 (9.2%) | 0.06 |
| TIA or ischaemic stroke | 100 (10.5%) | 74 (7.5%) | 93 (9.4%) | 0.06 |
| Pulmonary embolism | 4 (0.4%) | 3 (0.3%) | 2 (0.2%) | 0.59 |
| Hypotension or hypertension | 30 (3.2%) | 28 (2.9%) | 32 (3.2%) | 0.87 |
| Major bleedingc | 26 (2.7%) | 45 (4.6%) | 40 (4.1%) | 0.10 |
| Cardiovascular infection | 2 (0.2%) | 3 (0.3%) | 1 (0.1%) | 0.62 |
| Patients with hospitalization due to any bleeding | 178 | 261 | 256 | 0.0004 |
| Patients hospitalized for non-cardiovascular reason | 1360 | 1448 | 1472 | 0.74 |
Only first hospitalization is considered. Multiple reasons are allowed for a single patient.
AF, atrial fibrillation; CABG, coronary artery bypass grafting; DE, dabigatran etexilate; ICD, implantable cardioverter-defibrillator; MBE, major bleeding event; PTCA, percutaneous transluminal coronary angioplasty; TIA, transient ischaemic attack.
New angina, or CABG surgery, or PTCA surgery, or carotid endarterectomy, or peripheral angioplasty/surgery, or limb amputation.
PTCA surgery, or carotid endarterectomy, or peripheral angioplasty/surgery, or limb amputation.
Major bleeding: hospitalization with admission due to outcome event MBE requiring two or more units of blood or any intracranial haemorrhage.
Subcategories of cardiovascular hospitalization among different treatment arms
| . | DE 110 . | DE 150 . | Warfarin . | P-value from Fisher’s exact test . |
|---|---|---|---|---|
| Patients hospitalized | 2312 | 2430 | 2458 | |
| Patients dead or hospitalized | 2436 | 2569 | 2599 | |
| Patients with a cardiovascular hospitalization, N (%) | 952 (100%) | 982 (100%) | 986 (100%) | 0.74 |
| Myocardial infarction | 35 (3.7%) | 47 (4.8%) | 26 (2.6%) | 0.04 |
| New angina | 98 (10.3%) | 105 (10.7%) | 113 (11.5%) | 0.82 |
| Atherosclerosis relateda | 171 (18.0%) | 174 (17.7%) | 181 (18.4%) | 0.95 |
| Transcutaneous coronary, cerebrovascular, or peripheral procedureb | 65 (6.8%) | 69 (7.0%) | 68 (6.9%) | 0.99 |
| Valve or coronary artery bypass grafting surgery | 37 (3.9%) | 20 (2.0%) | 27 (2.7%) | 0.05 |
| AF and other supraventricular rhythm disorders | 287 (30.1%) | 358 (36.5%) | 357 (36.2%) | 0.04 |
| Ventricular arrhythmia or non-fatal cardiac arrest | 34 (3.6%) | 37 (3.8%) | 40 (4.1%) | 0.91 |
| Worsening congestive heart failure | 199 (20.9%) | 176 (17.9%) | 176 (17.8%) | 0.12 |
| Syncope | 29 (3.0%) | 45 (4.6%) | 40 (4.1%) | 0.25 |
| Implantation of a pacemaker, or a ICD | 118 (12.4%) | 107 (10.9%) | 91 (9.2%) | 0.06 |
| TIA or ischaemic stroke | 100 (10.5%) | 74 (7.5%) | 93 (9.4%) | 0.06 |
| Pulmonary embolism | 4 (0.4%) | 3 (0.3%) | 2 (0.2%) | 0.59 |
| Hypotension or hypertension | 30 (3.2%) | 28 (2.9%) | 32 (3.2%) | 0.87 |
| Major bleedingc | 26 (2.7%) | 45 (4.6%) | 40 (4.1%) | 0.10 |
| Cardiovascular infection | 2 (0.2%) | 3 (0.3%) | 1 (0.1%) | 0.62 |
| Patients with hospitalization due to any bleeding | 178 | 261 | 256 | 0.0004 |
| Patients hospitalized for non-cardiovascular reason | 1360 | 1448 | 1472 | 0.74 |
| . | DE 110 . | DE 150 . | Warfarin . | P-value from Fisher’s exact test . |
|---|---|---|---|---|
| Patients hospitalized | 2312 | 2430 | 2458 | |
| Patients dead or hospitalized | 2436 | 2569 | 2599 | |
| Patients with a cardiovascular hospitalization, N (%) | 952 (100%) | 982 (100%) | 986 (100%) | 0.74 |
| Myocardial infarction | 35 (3.7%) | 47 (4.8%) | 26 (2.6%) | 0.04 |
| New angina | 98 (10.3%) | 105 (10.7%) | 113 (11.5%) | 0.82 |
| Atherosclerosis relateda | 171 (18.0%) | 174 (17.7%) | 181 (18.4%) | 0.95 |
| Transcutaneous coronary, cerebrovascular, or peripheral procedureb | 65 (6.8%) | 69 (7.0%) | 68 (6.9%) | 0.99 |
| Valve or coronary artery bypass grafting surgery | 37 (3.9%) | 20 (2.0%) | 27 (2.7%) | 0.05 |
| AF and other supraventricular rhythm disorders | 287 (30.1%) | 358 (36.5%) | 357 (36.2%) | 0.04 |
| Ventricular arrhythmia or non-fatal cardiac arrest | 34 (3.6%) | 37 (3.8%) | 40 (4.1%) | 0.91 |
| Worsening congestive heart failure | 199 (20.9%) | 176 (17.9%) | 176 (17.8%) | 0.12 |
| Syncope | 29 (3.0%) | 45 (4.6%) | 40 (4.1%) | 0.25 |
| Implantation of a pacemaker, or a ICD | 118 (12.4%) | 107 (10.9%) | 91 (9.2%) | 0.06 |
| TIA or ischaemic stroke | 100 (10.5%) | 74 (7.5%) | 93 (9.4%) | 0.06 |
| Pulmonary embolism | 4 (0.4%) | 3 (0.3%) | 2 (0.2%) | 0.59 |
| Hypotension or hypertension | 30 (3.2%) | 28 (2.9%) | 32 (3.2%) | 0.87 |
| Major bleedingc | 26 (2.7%) | 45 (4.6%) | 40 (4.1%) | 0.10 |
| Cardiovascular infection | 2 (0.2%) | 3 (0.3%) | 1 (0.1%) | 0.62 |
| Patients with hospitalization due to any bleeding | 178 | 261 | 256 | 0.0004 |
| Patients hospitalized for non-cardiovascular reason | 1360 | 1448 | 1472 | 0.74 |
Only first hospitalization is considered. Multiple reasons are allowed for a single patient.
AF, atrial fibrillation; CABG, coronary artery bypass grafting; DE, dabigatran etexilate; ICD, implantable cardioverter-defibrillator; MBE, major bleeding event; PTCA, percutaneous transluminal coronary angioplasty; TIA, transient ischaemic attack.
New angina, or CABG surgery, or PTCA surgery, or carotid endarterectomy, or peripheral angioplasty/surgery, or limb amputation.
PTCA surgery, or carotid endarterectomy, or peripheral angioplasty/surgery, or limb amputation.
Major bleeding: hospitalization with admission due to outcome event MBE requiring two or more units of blood or any intracranial haemorrhage.
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