Table 3. Outcomes by Sex and Randomized Treatment Assignment at 12 Months After Randomization.
| Outcomes | Women (n = 1698), No. (%)a | Absolute risk difference (95% CI) | Men (n = 5421), No. (%)a | Absolute risk difference (95% CI) | P for interactionc | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ticagrelor + placebo (n = 846) | Ticagrelor + aspirin (n = 852) | Adjusted HR (95% CI)b | P value | Ticagrelor + placebo (n = 2709) | Ticagrelor + aspirin (n = 2712) | Adjusted HR (95% CI)b | P value | ||||
| Bleeding outcomes d | |||||||||||
| BARC 2, 3, or 5 | 42 (5.0) | 72 (8.6) | 0.62 (0.42 to 0.92) | .02 | −3.6 (−6.0 to −1.2) | 99 (3.7) | 178 (6.6) | 0.57 (0.44 to 0.73) | <.001 | −2.9 (−4.1 to −1.7) | .69 |
| BARC 3 or 5 | 14 (1.7) | 20 (2.4) | 0.78 (0.39 to 1.58) | .49 | −0.7 (−2.1 to 0.6) | 20 (0.8) | 49 (1.8) | 0.42 (0.25 to 0.71) | .001 | −1.0 (−1.7 to −0.5) | .18 |
| TIMI major | 3 (0.4) | 10 (1.2) | 0.31 (0.09 to 1.15) | .08 | −0.8 (−1.7 to 0.0) | 14 (0.5) | 24 (0.9) | 0.62 (0.32 to 1.21) | .16 | −0.4 (−0.8 to 0.1) | .34 |
| GUSTO moderate or severe | 9 (1.1) | 16 (1.9) | 0.59 (0.26 to 1.34) | .21 | −0.8 (−2.0 to 0.3) | 17 (0.6) | 33 (1.2) | 0.53 (0.29 to 0.95) | .03 | −0.6 (−1.1 to −0.1) | .85 |
| ISTH major | 15 (1.8) | 20 (2.4) | 0.78 (0.39 to 1.58) | .49 | −0.6 (−2.0 to 0.8) | 24 (0.9) | 52 (1.9) | 0.48 (0.29 to 0.77) | .003 | −1.0 (−1.7 to −0.4) | .26 |
| Ischemic outcomes e | |||||||||||
| Death, MI, or stroke | 29 (3.5) | 29 (3.5) | 1.04 (0.61 to 1.77) | .88 | 0.0 (−1.8 to 1.7) | 106 (4.0) | 108 (4.1) | 1.06 (0.80 to 1.39) | .69 | −0.1 (−1.1 to 1.0) | .95 |
| CV death, MI, or ischemic stroke | 27 (3.2) | 27 (3.3) | 1.06 (0.61 to 1.84) | .84 | −0.1 (−1.7 to 1.7) | 99 (3.7) | 103 (3.9) | 1.03 (0.78 to 1.36) | .85 | −0.1 (−1.2 to 0.9) | >.99 |
| All-cause death | 3 (0.4) | 12 (1.4) | 0.17 (0.04 to 0.78) | .02 | −1.1 (−2.0 to −0.2) | 31 (1.2) | 33 (1.2) | 1.00 (0.61 to 1.64) | >.99 | −0.1 (−0.7 to 0.5) | .03 |
| CV death | 2 (0.2) | 9 (1.1) | 0.12 (0.02 to 0.97) | .046 | −0.9 (−1.6 to −0.1) | 24 (0.9) | 28 (1.1) | 0.89 (0.51 to 1.54) | .68 | −0.1 (−0.7 to 0.4) | .07 |
| MI | 21 (2.5) | 20 (2.4) | 1.14 (0.60 to 2.15) | .69 | 0.1 (−1.4 to 1.6) | 74 (2.8) | 75 (2.8) | 1.07 (0.77 to 1.49) | .68 | 0.0 (−0.9 to 0.9) | .98 |
| Ischemic stroke | 5 (0.6) | 2 (0.2) | 2.15 (0.41 to 11.3) | .36 | 0.4 (−0.3 to 1.0) | 11 (0.4) | 6 (0.2) | 1.87 (0.69 to 5.06) | .22 | 0.2 (−0.1 to 0.5) | .66 |
| Stent thrombosis (definite/probable) | 2 (0.2) | 4 (0.5) | 0.58 (0.10 to 3.29) | .54 | −0.2 (−0.8 to 0.3) | 12 (0.5) | 15 (0.6) | 0.83 (0.39 to 1.77) | .62 | −0.1 (−0.5 to 0.3) | .67 |
Abbreviations: BARC, Bleeding Academic Research Consortium; CV, cardiovascular; GUSTO, Global Utilization of Streptokinase and TPA for Occluded Arteries; HR, hazard ratio; ISTH, International Society on Thrombosis and Hemostasis; MI, myocardial infarction; TIMI, Thrombolysis in Myocardial Infarction.
The percentages represent Kaplan-Meier rates at 12 months after randomization.
Model adjusted for age (years), non-White race, region of enrollment, insulin-treated diabetes, chronic kidney disease, current smoking, hypercholesteremia, previous percutaneous coronary intervention, multivessel coronary artery disease, indication for percutaneous coronary intervention, and lesion calcification.
Interaction test between randomized treatment assignment and sex after model adjustment.
Bleeding outcomes were performed in the intention-to-treat cohort, including 1698 women (846 in the ticagrelor + placebo group; 852 in the ticagrelor + aspirin group) and 5421 men (2709 in the ticagrelor + placebo group; 2712 in the ticagrelor + aspirin group).
Ischemic outcomes were performed in the per-protocol cohort, including 1676 women (840 in the ticagrelor + placebo group; 836 in the ticagrelor + aspirin group) and 5363 men (2684 in the ticagrelor + placebo group; 2679 in the ticagrelor + aspirin group).