Table 2. Efficacy endpoints in the intention-to-treat and per-protocol populations.
Number of events in the intention-to-treat population | Number of events in the per-protocol population | |||||
---|---|---|---|---|---|---|
Aspirin (n=6270) | Placebo (n=6276) | Hazard ratio (95% CI); p value | Aspirin (n=3790) | Placebo (n=3912) | Hazard ratio (95% CI); p value | |
Myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischaemic attack | 269 (4·29%) | 281 (4·48%) | 0·96 (0·81–1·13); p=0·6038 | 129 (3·40%) | 164 (4·19%) | 0·81 (0·64–1·02); p=0·0756 |
Myocardial infarction, stroke, or cardiovascular death | 208 (3·32%) | 218 (3·47%) | 0·95 (0·79–1·15); p=0·6190 | 103 (2·72%) | 135 (3·45%) | 0·79 (0·61–1·02); p=0·0661 |
Myocardial infarction* | 95 (1·52%) | 112 (1·78%) | 0·85 (0·64–1·11); p=0·2325 | 37(0·98%) | 72 (1·84%) | 0·53 (0·36–0·79); p=0·0014 |
Non-fatal myocardial infarction | 88 (1·40%) | 98 (1·56%) | 0·90 (0·67–1·20); p=0·4562 | 32 (0·84%) | 60 (1·53%) | 0·55 (0·36–0·84); p=0·0056 |
Stroke* | 75 (1·20%) | 67 (1·07%) | 1·12 (0·80–1·55); p=0·5072 | 40 (1·06%) | 37 (0·95%) | 1·12 (0·71–1·75); p=0·6291 |
Cardiovascular death | 38 (0·61%) | 39 (0·62%) | 0·97 (0·62–1·52); p=0·9010 | 26 (0·69%) | 26 (0·66%) | 1·03 (0·60–1·77); p=0·9161 |
Unstable angina | 20 (0·32%) | 20 (0·32%) | 1·00 (0·54–1·86); p=0·9979 | 8 (0·21%) | 11 (0·28%) | 0·75 (0·30–1·87); p=0·5380 |
Transient ischaemic attack | 42 (0·67%) | 45 (0·72%) | 0·93 (0·61–1·42); p=0·7455 | 19 (0·50%) | 19 (0·49%) | 1·03 (0·55–1·95); p=0·9181 |
Any death | 160 (2·55%) | 161 (2·57%) | 0·99 (0·80–1·24); p=0·9459 | 108 (2·85%) | 101 (2·58%) | 1·10 (0·84–1·45); p=0·4796 |
Fatal or non-fatal.