Table 2. Outcomes in Patients With mRS 0 to 1 and Greater Than 1 at Day 30 in the Ticagrelor or Aspirin Group.
| Outcome | Ticagrelor (n = 5523) | Placebo (n = 5493) | HR (95% CI)a | P value | ||
|---|---|---|---|---|---|---|
| No. of patients (%) | Event rate (KM estimate), % | No. of patients (%) | Event rate (KM estimate), % | |||
| Primary end point (stroke or death) | ||||||
| With mRS 0-1 at day 30 | 70 (1.3) | 1.3 | 87 (1.6) | 1.5 | 0.79 (0.57-1.08) | .14 |
| With mRS >1 at day 30 | 221 (4.0) | 4.0 | 260 (4.7) | 4.7 | 0.83 (0.69-0.99) | .04 |
| Stroke | ||||||
| With mRS 0-1 at day 30 | 70 (1.3) | 1.3 | 87 (1.6) | 1.5 | 0.79 (0.57-1.08) | .14 |
| With mRS >1 at day 30 (including mRS 6) | 202 (3.7) | 3.7 | 245 (4.5) | 4.5 | 0.80 (0.67-0.97) | .02 |
| Death | 36 (0.7) | 0.6 | 27 (0.5) | 0.5 | 1.28 (0.77-2.11) | .34 |
| Secondary end point (ischemic stroke) | ||||||
| With mRS 0-1 at day 30 | 69 (1.3) | 1.2 | 87 (1.6) | 1.5 | 0.78 (0.57-1.07) | .12 |
| With mRS >1 at day 30 | 195 (3.5) | 3.5 | 243 (4.4) | 4.4 | 0.78 (0.65-0.94) | .01 |
| Safety end points | ||||||
| GUSTO severe bleedings | ||||||
| With mRS 0-1 at day 30 | 4 (0.1) | NA | 0 | NA | NA | NA |
| With mRS >1 at day 30 | 23 (0.4) | 0.4 | 7 (0.1) | 0.1 | 3.26 (1.40-7.59) | .006 |
| Intracranial hemorrhage or fatal bleedings | ||||||
| With mRS 0-1 at day 30 | 4 (0.1) | NA | 0 | NA | NA | NA |
| With mRS >1 at day 30 | 17 (0.3) | 0.3 | 6 (0.1) | 0.1 | 2.81 (1.11-7.12) | .03 |
| Fatal bleedings | 11 (0.2) | NA | 2 (0.0) | NA | NA | NA |
| Intracranial hemorrhage | ||||||
| With mRS 0-1 at day 30 | 4 (0.1) | 0 (0.0) | ||||
| With mRS >1 at day 30 | 15 (0.3) | 0.3 | 6 (0.1) | 0.1 | 2.48 (0.96-6.40) | .06 |
| Hemorrhagic stroke | ||||||
| With mRS 0-1 at day 30 | 1 (0.0) | NA | 0 | NA | NA | NA |
| With mRS >1 at day 30 | 9 (0.2) | NA | 2 (0.0) | NA | NA | NA |
| GUSTO moderate or severe bleedings | ||||||
| With mRS 0-1 at day 30 | 8 (0.1) | NA | 2 (0.0) | NA | NA | NA |
| With mRS >1 at day 30 | 26 (0.5) | 0.5 | 9 (0.2) | 0.2 | 2.87 (1.34-6.11) | .006 |
| Premature permanent discontinuation of study drugs owing to bleeding | ||||||
| With mRS 0-1 at day 30 | 87 (1.6) | 1.7 | 17 (0.3) | 0.3 | 5.07 (3.01-8.54) | <.001 |
| With mRS >1 at day 30 | 57 (1.0) | 1.1 | 13 (0.2) | 0.3 | 4.38 (2.40-8.00) | <.001 |
Abbreviations: GUSTO, Global Utilization of Streptokinase and Tissue-type Plasminogen Activator for Occluded Coronary Arteries Trial; HR, hazard ratio; KM, Kaplan-Meier; mRS, modified Rankin Scale score; NA, not applicable.
a
HR was not calculated if there were less than 15 events.