Endpoint | Prior OAC | Unadjusted | Adjusted* | |||
Yes KM% (events) | No KM% (events) | HR (95% CI) Prior OAC Yes vs No | P value | HR (95% CI) Prior OAC Yes vs No | P value | |
Primary endpoint ISTH major/CRNM bleeding | ||||||
At 30 days | 5.1 (111) | 5.9 (131) | 0.87 (0.67 to 1.12) | 0.27 | 0.82 (0.63 to 1.06) | 0.13 |
At 180 days | 13.5 (282) | 13.5 (288) | 1.004 (0.85 to 1.18) | 0.96 | 0.98 (0.83 to 1.16) | 0.80 |
ISTH major bleeding | ||||||
At 30 days | 1.2 (30) | 1.8 (39) | 0.79 (0.49 to 1.27) | 0.33 | 0.65 (0.39 to 1.07) | 0.093 |
At 180 days | 4.2 (86) | 4.3 (90) | 1.00 (0.74 to 1.34) | 0.99 | 0.90 (0.66 to 1.22) | 0.48 |
Intracranial bleeding | ||||||
At 30 days | 0.00 (0) | 0.2 (4) | – | – | – | – |
At 180 days | 0.5 (10) | 0.4 (9) | 1.13 (0.46 to 2.79) | 0.79 | 0.96 (0.38 to 2.40) | 0.92 |
Definite/probable stent thrombosis | ||||||
At 30 days | 0.5 (11) | 0.7 (16) | 0.71 (0.33 to 1.53) | 0.38 | 0.73 (0.33 to 1.59) | 0.43 |
At 180 days | 0.6 (14) | 0.8 (18) | 0.801 (0.40 to 1.61) | 0.53 | 0.81 (0.40 to 1.66) | 0.57 |
All-cause death or rehospitalisaAtion | ||||||
At 30 days | 9.2 (208) | 10.8 (250) | 0.86 (0.71 to 1.030) | 0.099 | 0.86 (0.71 to 1.04) | 0.11 |
At 180 days | 26.3 (585) | 25.4 (580) | 1.04 (0.93 to 1.17) | 0.46 | 1.02 (0.90 to 1.14) | 0.80 |
All-cause death or ischaemic event | ||||||
At 30 days | 1.7 (38) | 2.8 (65) | 0.60 (0.40 to 0.90) | 0.012 | 0.61 (0.41 to 0.92) | 0.019 |
At 180 days | 5.4 (119) | 7.6(171) | 0.72 (0.57 to 0.91) | 0.006 | 0.70 (0.55 to 0.88) | 0.003 |
Cardiovascular death | ||||||
At 30 days | 0.6 (13) | 0.9 (20) | 0.67 (0.33 to 1.35) | 0.26 | 0.70 (0.34 to 1.42) | 0.32 |
At 180 days | 1.9 (43) | 2.9 (67) | 0.67 (0.46 to 0.98) | 0.04 | 0.61 (0.42 to 0.90) | 0.013 |
Stroke | ||||||
At 30 days | 0.2 (4) | 0.4 (9) | 0.46 (0.14 to 1.49) | 0.19 | 0.53 (0.16 to 1.74) | 0.29 |
At 180 days | 0.8 (16) | 1.0 (23) | 0.71 (0.38 to 1.35) | 0.29 | 0.74 (0.39 to 1.43) | 0.37 |
Myocardial infarction | ||||||
At 30 days | 0.9 (21) | 1.7 (39) | 0.55 (0.33 to 0.94) | 0.029 | 0.59 (0.34 to 1.01) | 0.053 |
At 180 days | 2.8 (61) | 4.0 (89) | 0.72 (0.52 to 0.99) | 0.044 | 0.73 (0.53 to 1.02) | 0.065 |
HRs in the ‘at 30 days’ rows include events from randomisation to 30 days. HRs in the ‘at 180 days’ rows include events from randomisation to 180 days.
*Adjusted by age, sex, race, hypertension, heart failure, diabetes, prior stroke, TIA or thromboembolism, qualifying index event and time from index event to randomisation.
CRNM, clinically relevant non-major; ISTH, International Society on Thrombosis and Haemostasis; KM, Kaplan-Meier; OAC, oral anticoagulation; TIA, transient ischaemic attack.