End point | Real world N=596 | Clinical trial N=356 | Crude HR (95% CI) |
---|---|---|---|
Composite of primary end point | 53 (8.9) | 51 (14.3) | 0.83 (0.56 to 1.23) |
Total death | 9 (1.5) | 13 (3.7) | 0.57 (0.24 to 1.35) |
Cardiovascular death | 3 (0.5) | 4 (1.1) | 0.53 (0.12 to 2.38) |
Cardiac arrhythmic | 1 (0.2) | 1 (0.3) | |
Cardiac non-arrhythmic | – | 1 (0.3) | |
Vascular non-cardiac | 2 (0.3) | 2 (0.6) | |
Cardiovascular hospitalisation | 50 (8.4) | 48 (13.5) | 0.84 (0.56 to 1.26) |
Arrhythmic events | 31 (5.2) | 18 (5.1) | |
Atrial fibrillation | 26 (4.4) | 15 (4.2) | |
Syncope | 3 (0.5) | 3 (0.8) | |
Sustained ventricular tachycardia | 2 (0.3) | – | |
Cardiac arrest | – | – | |
Heart failure | 4 (0.7) | 14 (3.9) | |
Acute myocardial infarction | 5 (0.8) | 4 (1.1) | |
Stroke | 2 (0.3) | 3 (0.8) | |
Systemic emboli | – | – | |
Major bleeding | 5 (0.8) | 6 (1.7) | |
Life-threatening effects of drugs | 3 (0.5) | 3 (0.8) |
Values are the number of patients and percentages for each discrete variable.