Table 2.
Efficacy and safety outcomes in patients with NSTE-ACS
| Ticagrelor % (n) | Clopidogrel % (n) | HR (95% CI) | P-value | |
|---|---|---|---|---|
| Efficacy endpoints | ||||
| CV death/MI (excluding silent)/stroke | 10.0 (533) | 12.3 (630) | 0.83 (0.74, 0.93) | 0.0013 |
| All-cause death/MI(excl. silent)/stroke | 10.5 (557) | 13.0 (664) | 0.82 (0.73, 0.92) | 0.0006 |
| CV death/MI(all)/stroke/severe recurrent ischaemia/recurrent ischaemia/TIA/arterial thrombotic event | 15.5 (824) | 17.8 (918) | 0.88 (0.80, 0.96) | 0.0058 |
| Myocardial infarction (excluding silent) | 6.6 (345) | 7.7 (392) | 0.86 (0.74, 0.99) | 0.0419 |
| Cardiovascular death (includes vascular and unknown deaths) | 3.7 (194) | 4.9 (247) | 0.77 (0.64, 0.93) | 0.0070 |
| Stroke | 1.3 (69) | 1.4 (71) | 0.95 (0.69, 1.33) | 0.79 |
| All-cause death | 4.3 (224) | 5.8 (290) | 0.76 (0.64, 0.90) | 0.0020 |
| Safety endpoints | ||||
| Major bleeding (study criteria) | 13.4 (660) | 12.6 (618) | 1.07 (0.95, 1.19) | 0.26 |
| Major or minor bleeding (study criteria) | 18.2 (900) | 16.3 (794) | 1.14 (1.03, 1.25) | 0.0078 |
| Non-CABG related major bleeding (study criteria) | 4.8 (225) | 3.8 (176) | 1.28 (1.05, 1.56) | 0.0139 |
| Fatal bleeding | 0.3 (13) | 0.4 (18) | 0.72 (0.35, 1.47) | 0.37 |
| Life threatening or fatal bleeding (study criteria) | 6.6 (331) | 6.5 (315) | 1.05 (0.90, 1.22) | 0.56 |
| Intracranial bleeding | 0.3 (14) | 0.2 (7) | 2.01 (0.81, 4.99) | 0.13 |
| Other major bleeding | 7.2 (344) | 6.6 (318) | 1.08 (0.93, 1.25) | 0.34 |
| Major bleeding (TIMI criteria) | 9.2 (452) | 8.7 (422) | 1.07 (0.94, 1.22) | 0.33 |
| Major or minor bleeding (TIMI criteria) | 13.2 (653) | 12.3 (602) | 1.08 (0.97, 1.21) | 0.16 |
| Non-CABG related major bleeding (TIMI criteria) | 2.9 (137) | 2.2 (99) | 1.39 (1.07, 1.80) | 0.0131 |
| GUSTO severe bleeding | 3.1 (146) | 3.2 (151) | 0.96 (0.77, 1.21) | 0.74 |
| GUSTO moderate or severe bleeding | 8.6 (416) | 7.8 (382) | 1.08 (0.94, 1.25) | 0.25 |
Each treatment group is summarized as Kaplan–Meier rates at 360 days and total number of events during the study. P-values and hazard ratios (95% CI) come from unadjusted Cox models testing ticagrelor vs. clopidogrel.