Table 3A

Association between randomised treatment (apixaban vs VKA) and endpoints by prior oral anticoagulant status

EndpointPrior oral anticoagulant=YesPrior oral anticoagulant=NoInteraction p value
Apixaban
KM % (events)
VKA
KM % (events)
HR* (95% CI)
Apixaban vs VKA
Apixaban
KM % (events)
VKA
KM % (events)
HR* (95% CI)
Apixaban vs VKA
Primary endpoint
ISTH major/CRNM bleeding
 At 30 days4.4 (51)5.7 (58)0.77 (0.53 to 1.12)4.2 (45)7.5 (86)0.56 (0.39 to 0.80)0.23
 At 180 days11.3 (127)15.6 (152)0.70 (0.56 to 0.89)10.9 (113)15.6 (173)0.67 (0.53 to 0.85)0.787
ISTH major bleeding
 At 30 days1.0 (12)1.7 (17)0.62 (0.30 to 1.29)1.3 (14)2.1 (24)0.63 (0.32 to 1.21)0.98
 At 180 days3.4 (38)4.7 (45)0.70 (0.45 to 1.07)3.0 (31)5.2 (57)0.58 (0.37 to 0.89)0.54
Intracranial bleeding
 At 30 days0.0 (0)0.0 (0)---0.1 (1)0.3 (3)0.36 (0.04 to 3.49)---
 At 180 days0.2 (2)0.8 (7)0.25 (0.05 to 1.18)0.3 (3)0.5 (6)0.53 (0.13 to 2.11)0.47
Definite/probable stent thrombosis
 At 30 days0.3 (3)0.8 (8)0.33 (0.09 to 1.26)0.7 (8)0.7 (8)1.11 (0.42 to 2.95)0.16
 At 180 days0.3 (4)1.0 (10)0.36 (0.11 to 1.14)0.9 (10)0.7 (8)1.38 (0.55 to 3.50)0.07
All-cause death or Rehospitalisation
 At 30 days8.7 (103)9.9 (105)0.86 (0.66 to 1.13)9.5 (105)11.9 (145)0.80 (0.62 to 1.03)0.69
 180 days24.9 (293)27.9 (292)0.86 (0.73 to 1.01)22.9 (247)27.8 (333)0.80 (0.68 to 0.94)0.49
All-cause death or Ischaemic event
 At 30 days1.2 (14)2.3 (24)0.52 (0.27 to 1.00)2.4 (26)3.2 (39)0.73 (0.45 to 1.20)0.41
 At 180 days4.9 (58)5.9 (61)0.86 (0.60 to 1.22)7.9 (83)7.3 (88)1.04 (0.77 to 1.42)0.41
Cardiovascular death
 At 30 days0.4 (5)0.8 (8)0.56 (0.18 to 1.71)0.7 (8)1.0 (12)0.74 (0.30 to 1.80)0.70
 At 180 days2.0 (23)1.9 (20)1.07 (0.59 to 1.93)3.0 (33)2.8 (34)1.07 (0.66 to 1.73)0.99
Stroke
 At 30 days0.1 (1)0.3 (3)0.30 (0.03 to 2.86)0.3 (3)0.5 (6)0.55 (0.14– to 2.21)0.65
 At 180 days0.6 (7)0.9 (9)0.69 (0.26 to 1.86)0.6 (6)1.4 (17)0.39 (0.15 to 0.99)0.40
Myocardial infarction
 At 30 days0.5 (6)1.4 (15)0.36 (0.14 to 0.92)1.6 (18)1.7 (21)0.94 (0.50 to 1.77)0.09
 At 180 days2.0 (23)3.7 (38)0.56 (0.33 to 0.91)4.7 (48)3.4 (41)1.30 (0.86 to 1.97)0.01
  • *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.