Table 3.
Efficacy and safety of treatment. Values are Kaplan-Meier estimates of percentage rate of end point (numbers) at 12 months
| Ticagrelor (n=2601) | Clopidogrel (n=2615) | Hazard ratio (95% CI) | P value* | |
|---|---|---|---|---|
| Primary objective | ||||
| Cardiovascular death + myocardial infarction (excluding silent) + stroke | 12.0 (295) | 14.3 (346) | 0.85 (0.73 to1.00) | 0.045 |
| Secondary objectives | ||||
| Myocardial infarction | 7.2 (176) | 7.8 (187) | 0.94 (0.77 to 1.15) | 0.555 |
| Cardiovascular death | 5.5 (132) | 7.2 (173) | 0.76 (0.61 to 0.96) | 0.019 |
| All cause death | 6.1 (147) | 8.2 (195) | 0.75 (0.61 to 0.93) | 0.010 |
| Non-cardiovascular death | 0.6 (15) | 1.0 (22) | 0.68 (0.35 to 1.31) | 0.252 |
| Stroke: | 2.1 (50) | 1.7 (37) | 1.35 (0.89 to 2.07) | 0.162 |
| Ischaemic | 1.5 (37) | 1.4 (32) | 0.530 | |
| Haemorrhagic | 0.5 (11) | 0.2 (4) | 0.069 | |
| Unknown | 0.2 (5) | 0.06 (1) | 0.124 | |
| Cardiovascular death + myocardial infarction + stroke + composite ischaemic events† + other arterial thrombotic events | 18.6 (460) | 20.3 (492) | 0.94 (0.82 to 1.06) | 0.309 |
| Primary safety objective | ||||
| Total major bleeding | 11.9 (272) | 10.3 (238) | 1.17 (0.98 to 1.39) | 0.079 |
| Life threatening or fatal bleeding | 5.5 (125) | 5.6 (129) | 0.99 (0.77 to 1.26) | 0.911 |
| Intracranial bleeding | 0.5 (11) | 0.2 (4) | 2.83 (0.90 to 8.90) | 0.075 |
| Other major bleeding | 6.8 (154) | 4.9 (114) | 1.38 (1.09 to 1.76) | 0.009 |
| Secondary safety objectives—components of major bleeding events | ||||
| Non-CABG related | 4.0 (90) | 3.1 (71) | 1.30 (0.95 to 1.77) | 0.103 |
| CABG related | 8.3 (189) | 7.5 (174) | 1.11 (0.90 to 1.36) | 0.335 |
| Coronary procedure related | 9.2 (211) | 8.2 (191) | 1.13 (0.93 to 1.37) | 0.231 |
| Non-coronary procedure related | 0.04 (1) | 0.4 (7) | 0.15 (0.02 to 1.19) | 0.072 |
| Secondary safety objectives—major or minor bleeding events | ||||
| Total | 16.4 (378) | 14.4 (332) | 1.17 (1.01 to 1.36) | 0.0358 |
| Non-CABG related | 8.3 (190) | 6.7 (151) | 1.29 (1.04 to 1.60) | 0.0182 |
| CABG related | 8.9 (202) | 8.5 (196) | 1.05 (0.86 to 1.28) | 0.6341 |
| Coronary procedure related | 10.8 (250) | 10.0 (235) | 1.09 (0.91 to 1.30) | 0.3657 |
| Non-coronary procedure related | 0.5 (11) | 0.8 (16) | 0.70 (0.33 to 1.51) | 0.3632 |
| Other safety objectives | ||||
| TIMI defined cut-off point for major bleeding: | ||||
| Total | 7.9 (181) | 7.2 (164) | 1.13 (0.91 to 1.39) | 0.270 |
| Non-CABG related | 2.8 (61) | 2.2 (47) | 1.33 (0.91 to 1.94) | 0.142 |
| CABG related | 5.4 (124) | 5.3 (122) | 1.03 (0.80 to 1.33) | 0.799 |
| Transfusion of blood products: | ||||
| PRBCs or whole blood | 7.6 (174) | 7.2 (172) | 1.03 (0.83 to 1.27) | 0.804 |
| Platelets | 1.3 (30) | 1.2 (27) | 1.13 (0.67 to 1.90) | 0.645 |
| Fresh frozen plasma | 2.4 (55) | 2.2 (50) | 1.12 (0.76 to 1.64) | 0.565 |
CABG=coronary artery bypass grafting; PRBC=packed red blood cells; TIMI=Thrombolysis In Myocardial Infarction.
*From univariate Cox model.
†Severe recurrent cardiac ischaemia, recurrent cardiac ischaemia, and transitory ischaemic attack.