Table 2.
Observed cumulative event rate (%) of clinical outcomes and number of events prevented or harms caused, applying trial results to UK patients who survived myocardial infarction (MI) defined in study (with 95% CI)
| Population based observational data | PEGASUS-TIMI-54 trial placebo arm (n=7067) | |||
|---|---|---|---|---|
| All post-MI survivors “real world” (n=7238) | Met trial inclusion criteria “high risk” (n=5279) | Met trial inclusion and exclusion criteria “target” (n=1676) | ||
| MI/stroke/fatal cardiovascular disease | ||||
| 3 year cumulative risk (%) | 17.2 (16.0 to 18.5) | 21.7 (20.1 to 23.3) | 18.8 (16.3 to 21.8) | 9.04 |
| No of events prevented/year/per 10 000 patients treated applying risk reduction in PEGASUS-TIMI-54 trial* | 92 (86 to 99) | 116 (108 to 125) | 101 (87 to 117) | — |
| Fatal, severe, or intracranial bleeding | ||||
| 3 year cumulative risk (%) | 2.3 (1.8 to 2.9) | 3.0 (2.4 to 3.8) | 3.0 (2.0 to 4.4) | 1.26 |
| No of excess harms/year/10 000 patients treated applying risk increase in PEGASUS-TIMI-54 trial* | 58 (45 to 73) | 75 (60 to 95) | 75 (50 to 110) | — |
*PEGASUS-TIMI-54 trial estimates (ticagrelor 60 mg v placebo; intention to treat estimates) for cardiovascular death, stroke, or myocardial infarction (hazard ratio 0.84, main report4), TIMI major bleeding (relative risk 1.75, supplementary appendix in main report4) were used to calculate cardiovascular events prevented and harms caused per 10 000 treated per year.