Table 2

Clinical outcomes*

P2Y12iAspirinHR (95% CI)P value
N=297N=778
No. events (% per patient-year)
Primary efficacy end point37 (6.76)79 (5.28)1.31 (0.88 to 1.94)0.178
Secondary efficacy end point
 Ischaemic stroke12 (2.16)15 (0.98)2.17 (1.02 to 4.64)0.041
 Haemorrhagic stroke5 (0.89)8 (0.52)1.67 (0.55 to 5.10)0.364
 Myocardial infarction2 (0.36)6 (0.39)0.87 (0.18 to 4.31)0.865
 Unstable angina requiring revascularisation4 (0.72)13 (0.85)0.82 (0.27 to 2.51)0.727
 Systemic embolism1 (0.18)00.105
 Percutaneous coronary intervention†4 (0.72)15 (0.98)0.73 (0.24 to 2.19)0.57
 Coronary artery bypass grafting†0 (0.00)1 (0.06)0.666
Death from any cause25 (4.44)44 (2.85)1.67 (1.02 to 2.74)0.041
 Cardiovascular death14 (2.49)27 (1.75)1.43 (0.75 to 2.74)0.272
 Non-cardiovascular death11 (1.95)17 (1.10)2.09 (0.96 to 4.53)0.057
Net adverse clinical events36 (6.55)91 (6.17)1.09 (0.74 to 1.61)0.655
Primary safety end point13 (2.35)44 (2.95)0.79 (0.43 to 1.47)0.456
Secondary safety end point
 Any bleeding55 (11.06)174 (13.07)0.84 (0.62 to 1.13)0.247
 Minor bleeding49 (9.74)141 (10.26)0.93 (0.67 to 1.29)0.679
  • *Estimations of cumulative event rates by the Kaplan-Meier method, comparisons of incidence rates by the log-rank test and group comparisons by the Cox proportional-hazards model.

  • †Not including revascularisation for stenosis observed prior to enrolment in this study, acute myocardial infarction or unstable angina.

  • P2Y12i, P2Y12 inhibitor.