Table 3

Efficacy and safety outcomes stratified by age

OutcomesAgen/N (%)HR/OR (95% CI)*Log-rank p value
Efficacy outcomes
 Stroke<65207/3251 (6.4)------
65–80188/2755 (6.8)0.98 (0.79 to 1.20)0.82
≥8039/406 (9.6)1.39 (0.96 to 2.02)0.08
 Stroke within 30 days<65172/3251 (5.3)------
65–80156/2755 (5.7)1.01 (0.80 to 1.26)0.96
≥8033/406 (8.1)1.45 (0.97 to 2.18)0.07
 Ischaemic stroke<65203/3251 (6.2)------
65–80186/2755 (6.8)0.98 (0.80 to 1.21)0.85
≥8038/406 (9.4)1.37 (0.94 to 1.99)0.10
 Composite vascular events†<65246/3251 (7.6)------
65–80229/2755 (8.3)1.00 (0.83 to 1.21)0.97
≥8047/406 (11.6)1.41 (1.00 to 1.98)0.048
 Disabling stroke‡<6582/3251 (2.5)------
65–8078/2755 (2.8)1.05 (0.76 to 1.46)0.75
≥8029/406 (7.1)2.43 (1.52 to 3.88)0.0002
Safety outcomes
 Severe or moderate bleeding<657/3251 (0.2)------
65–809/2755 (0.3)1.78 (0.63 to 5.05)0.28
≥804/406 (1.0)8.40 (1.95 to 36.21)0.004
 Any bleeding<65138/3251 (4.2)------
65–8094/2755 (3.4)0.81 (0.62 to 1.07)0.14
≥8018/406 (4.4)0.99 (0.59 to 1.68)0.98
 Intracranial haemorrhage<655/3251 (0.2)------
65–802/2755 (0.1)0.47 (0.08 to 2.72)0.45
≥802/406 (0.5)2.86 (0.41 to 20.17)0.29
 Mortality<659/3251 (0.3)------
65–8012/2755 (0.4)1.39 (0.55 to 3.50)0.49
≥806/406 (1.5)7.56 (2.23 to 25.70)0.001
  • *Adjusted for sex, medical history (hypertension, diabetes mellitus, dyslipidaemia, previous ischaemic stroke), current smoking and drinking, median time to randomisation, and previous antiplatelet therapy and lipid-lowering therapy.

  • †Composite vascular events included ischaemic stroke, haemorrhagic stroke, transient ischaemic stroke, myocardial infarction or death from vascular causes.

  • ‡A stroke was defined as disabling if the patient had a modified Rankin scale score of >1.