Endpoint | Prior oral anticoagulant=Yes | Prior oral anticoagulant=No | Interaction p value | ||||
Aspirin KM % (events) | Placebo KM % (events) | HR* (95% CI) Aspirin vs placebo | Aspirin KM % (events) | Placebo KM % (events) | HR* (95% CI) Aspirin vs Placebo | ||
Primary Endpoint ISTH major/CRNM bleeding | |||||||
At 30 days | 7.1 (78) | 2.9 (32) | 2.49 (1.65 to 3.76) | 7.8 (87) | 4.0 (45) | 1.98 (1.38 to 2.83) | 0.41 |
At 180 days | 17.0 (179) | 9.6 (100) | 1.91 (1.50 to 2.44) | 17.3 (185) | 9.5 (101) | 1.88 (1.48 to 2.39) | 0.93 |
ISTH major bleeding | |||||||
At 30 days | 1.8 (19) | 0.9 (10) | 1.91 (0.89 to 4.12) | 2.7 (30) | 1.0 (11) | 2.77 (1.39 to 5.52) | 0.48 |
At 180 days | 4.8 (49) | 3.3 (34) | 1.50 (0.97 to 2.33) | 5.5 (58) | 3.0 (31) | 1.93 (1.25 to 2.99) | 0.43 |
Intracranial bleeding | |||||||
At 30 days | 0.0 (0) | 0.0 (0) | --- | 0.2 (2) | 0.2 (2) | 1.01 (0.14 to 7.15) | --- |
At 180 days | 0.3 (3) | 0.6 (6) | 0.51 (0.127 to 2.035) | 0.5 (5) | 0.4 (4) | 1.29 (0.35 to 4.79) | 0.34 |
Definite/Probable stent thrombosis | |||||||
At 30 days | 0.4 (4) | 0.6 (7) | 0.57 (0.17 to 1.95) | 0.4 (4) | 1.0 (12) | 0.33 (0.11 to 1.03) | 0.52 |
At 180 days | 0.5 (5) | 0.8 (9) | 0.56 (0.19 to 1.66) | 0.5 (6) | 1.0 (12) | 0.500 (0.19 to 1.33) | 0.89 |
All-cause death or rehospitalisation | |||||||
At 30 days | 9.9 (111) | 8.6 (97) | 1.15 (0.88 to 1.51) | 11.7 (136) | 9.8 (114) | 1.20 (0.94 to 1.54) | 0.81 |
At 180 days | 26.4 (292) | 26.2 (293) | 1.01 (0.86 to 1.18) | 27.0 (307) | 23.9 (273) | 1.16 (0.98 to 1.36) | 0.24 |
All-cause death or ischaemic event | |||||||
At 30 days | 1.4 (16) | 2.0 (22) | 0.73 (0.38 to 1.38) | 2.2 (25) | 3.4 (40) | 0.62 (0.38 to 1.03) | 0.71 |
At 180 days | 5.2 (57) | 5.6 (62) | 0.93 (0.65 to 1.33) | 6.9 (78) | 8.2 (93) | 0.84 (0.62 to 1.13) | 0.66 |
Cardiovascular death | |||||||
At 30 days | 0.7 (8) | 0.4 (5) | 1.60 (0.52 to 4.90) | 0.5 (6) | 1.2 (14) | 0.43 (0.16 to 1.11) | 0.079 |
At 180 days | 2.0 (22) | 1.9 (21) | 1.10 (0.61 to 1.98) | 2.6 (30) | 3.2 (37) | 0.81 (0.50 to 1.32) | 0.45 |
Stroke | |||||||
At 30 days | 0.1 (1) | 0.3 (3) | 0.33 (0.04 to 3.21) | 0.5 (6) | 0.3 (3) | 2.00 (0.50 to 8.01) | 0.19 |
At 180 days | 0.7 (8) | 0.8 (8) | 1.00 (0.38 to 2.67) | 1.1 (12) | 1.0 (11) | 1.10 (0.48 to 2.48) | 0.89 |
Myocardial infarction | |||||||
At 30 days | 0.6 (7) | 1.2 (14) | 0.50 (0.20 to 1.24) | 1.1 (13) | 2.2 (26) | 0.50 (0.26 to 0.97) | 0.99 |
At 180 days | 2.4 (26) | 3.1 (35) | 0.75 (0.45 to 1.23) | 3.7 (41) | 4.4 (48) | 0.85 (0.56 to 1.30) | 0.69 |
*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.
CRNM, clinically relevant non-major; ISTH, International Society on Thrombosis and Haemostasis; KM, Kaplan-Meier; VKA, vitamin K antagonist.