Table 3B

Association between randomised treatment (aspirin vs placebo) and endpoints by prior oral anticoagulant status

EndpointPrior oral anticoagulant=YesPrior oral anticoagulant=NoInteraction 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 days7.1 (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 days17.0 (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 days1.8 (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 days4.8 (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 days0.0 (0)0.0 (0)---0.2 (2)0.2 (2)1.01 (0.14 to 7.15)---
 At 180 days0.3 (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 days0.4 (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 days0.5 (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 days9.9 (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 days26.4 (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 days1.4 (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 days5.2 (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 days0.7 (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 days2.0 (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 days0.1 (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 days0.7 (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 days0.6 (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 days2.4 (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.