Randomised comparisons using routine data
vascular death, bleeding, ischaemic stroke
BLEEDING, MYOCARDIAL INFARCTION, TRANSIENT ISCHAEMIC ATTACK, ISCHAEMIC STROKE, BLEEDS, INTRACRANIAL HAEMORRHAGE, EVENTS
For the any major bleeding outcome, there were no important differences between estimates of the relative effects of aspirin versus placebo using routine data alone and published results based on adjudicated direct-participant follow-up (adjudicated direct-participant follow-up: aspirin 314 (4.1%) versus placebo 245 (3.2%); RR 1.29, 95% CI 1.09 to 1.52; versus routine data: 327 (4.2%) versus 272 (3.5%); RR 1.21, 95% CI 1.03 to 1.41; difference in point estimate: −0.08, 95% CI −0.28 to +0.12; Effect of allocation to aspirin vs placebo on any major bleeding. Log-rank methods were used to calculate the rate ratio and 95% CIs. *The pre-adjudicated direct follow-up outcome included all eye bleeds.
Observed absolute effects of allocation to aspirin (A) vs placebo (P) for routine data follow-up. Data expressed as numbers of events per 5000 person-years. Plus-minus value are mean SEs. Serious vascular events include non-fatal myocardial infarction, ischaemic stroke, transient ischaemic attack or vascular death (excluding intracranial haemorrhage).