Table 2. Clinical Outcomes by Sex and Randomized Treatment Assignment at 11 mo After Randomization (12-mo Follow-Up)a.
| Outcome | Male patients | Female patients | P value for interaction | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbreviated DAPT (n = 1590) | Standard DAPT (n = 1581) | HR (95% CI) | Com-Nogue risk difference (95% CI) | P value | Abbreviated DAPT (n = 705) | Standard DAPT (n = 703) | HR (95% CI) | Com-Nogue risk difference (95% CI) | P value | ||
| NACE | 120 (7.6) | 123 (7.8) | 0.97 (0.75 to 1.24) | −0.24 (−2.10 to 1.62) | .79 | 52 (7.4) | 59 (8.4) | 0.87 (0.60 to 1.26) | −1.01 (−3.84 to 1.81) | .47 | .65 |
| MACCE | 104 (6.5) | 89 (5.6) | 1.17 (0.88 to 1.55) | 0.91 (−0.76 to 2.58) | .29 | 34 (4.8) | 49 (7.0) | 0.68 (0.44 to 1.05) | −2.15 (−4.62 to 0.32) | .09 | .04 |
| MCB | 100 (6.3) | 150 (9.5) | 0.65 (0.50 to 0.84) | −3.21 (−5.11 to −1.31) | .001 | 48 (6.8) | 61 (8.7) | 0.77 (0.53 to 1.12) | −1.94 (−4.77 to 0.89) | .17 | .46 |
| Death | 55 (3.5) | 52 (3.3) | 1.05 (0.72 to 1.54) | 0.17 (−1.10 to 1.43) | .80 | 20 (2.8) | 29 (4.1) | 0.68 (0.39 to 1.21) | −1.29 (−3.21 to 0.63) | .19 | .22 |
| Cardiovascular | 26 (1.6) | 28 (1.8) | 0.92 (0.54 to 1.57) | −0.14 (−1.05 to 0.78) | .77 | 11 (1.6) | 16 (2.3) | 0.68 (0.32 to 1.47) | −0.73 (−2.18 to 0.72) | .33 | .52 |
| Noncardiovascular | 21 (1.3) | 20 (1.3) | 1.04 (0.57 to 1.93) | 0.06 (−0.74 to 0.86) | .89 | 8 (1.1) | 8 (1.1) | 0.99 (0.37 to 2.63) | −0.01 (−1.13 to 1.12) | .98 | .93 |
| Cerebrovascular accident | 11 (0.7) | 19 (1.2) | 0.57 (0.27 to 1.21) | −0.52 (−1.20 to 0.17) | .14 | 6 (0.9) | 13 (1.8) | 0.46 (0.17 to 1.20) | −1.03 (−2.26 to 0.20) | .11 | .71 |
| Strokeb | 8 (0.5) | 14 (0.9) | 0.57 (0.24 to 1.35) | −0.39 (−0.98 to 0.20) | .20 | 4 (0.6) | 9 (1.3) | 0.44 (0.14 to 1.43) | −0.74 (−1.76 to 0.28) | .17 | .73 |
| Ischemic | 7 (0.5) | 9 (0.6) | 0.77 (0.29 to 2.08) | −0.13 (−0.63 to 0.37) | .61 | 4 (0.6) | 9 (1.3) | 0.44 (0.14 to 1.43) | −0.74 (−1.76 to 0.28) | .17 | .47 |
| Hemorrhagic | 1 (0.1) | 5 (0.3) | 0.20 (0.02 to 1.70) | −0.26 (−0.57 to 0.05) | .14 | 0 | 0 | NA | NA | NA | NA |
| TIA | 3 (0.2) | 5 (0.3) | 0.60 (0.14 to 2.49) | −0.13 (−0.49 to 0.23) | .48 | 2 (0.3) | 4 (0.6) | 0.50 (0.09 to 2.70) | −0.29 (−0.98 to 0.40) | .42 | .87 |
| Myocardial infarction | 49 (3.1) | 32 (2.0) | 1.53 (0.98 to 2.39) | 1.08 (−0.04 to 2.19) | .06 | 11 (1.6) | 17 (2.4) | 0.64 (0.30 to 1.36) | −0.88 (−2.37 to 0.61) | .24 | .051 |
| Definite or probable stent thrombosis | 11 (0.7) | 5 (0.3) | 2.19 (0.76 to 6.31) | 0.38 (−0.12 to 0.89) | .15 | 3 (0.4) | 4 (0.6) | 0.74 (0.17 to 3.31) | −0.15 (−0.90 to 0.60) | .70 | .25 |
| Definite stent thrombosis | 9 (0.6) | 4 (0.3) | 2.24 (0.69 to 7.27) | 0.32 (−0.13 to 0.77) | .18 | 2 (0.3) | 3 (0.4) | 0.66 (0.11 to 3.93) | −0.15 (−0.79 to 0.49) | .65 | .26 |
| Probable stent thrombosis | 2 (0.1) | 1 (0.1) | 1.99 (0.18 to 21.94) | 0.06 (−0.16 to 0.28) | .57 | 1 (0.1) | 1 (0.1) | 0.99 (0.06 to 15.90) | 0.00 (−0.40 to 0.39) | >.99 | .71 |
| Bleeding BARC classification | |||||||||||
| Type 1 | 45 (2.8) | 76 (4.8) | 0.58 (0.40 to 0.84) | −2.00 (−3.35 to −0.65) | .004 | 20 (2.8) | 33 (4.7) | 0.59 (0.34 to 1.03) | −1.89 (−3.90 to 0.12) | .07 | .97 |
| Type 2 | 74 (4.7) | 104 (6.6) | 0.70 (0.52 to 0.94) | −1.95 (−3.57 to −0.32) | .02 | 28 (4.0) | 48 (6.8) | 0.57 (0.36 to 0.90) | −2.94 (−5.33 to −0.54) | .02 | .47 |
| Type 3 | 31 (1.9) | 42 (2.7) | 0.73 (0.46 to 1.16) | −0.70 (−1.76 to 0.35) | .18 | 22 (3.1) | 17 (2.4) | 1.29 (0.68 to 2.42) | 0.70 (−1.04 to 2.44) | .44 | .16 |
| Type 3a | 18 (1.1) | 22 (1.4) | 0.81 (0.44 to 1.51) | −0.25 (−1.04 to 0.53) | .51 | 8 (1.1) | 8 (1.1) | 0.99 (0.37 to 2.64) | −0.01 (−1.13 to 1.12) | .98 | .74 |
| Type 3b | 11 (0.7) | 12 (0.8) | 0.91 (0.40 to 2.06) | −0.06 (−0.66 to 0.54) | .82 | 10 (1.4) | 8 (1.1) | 1.24 (0.49 to 3.14) | 0.28 (−0.92 to 1.47) | .65 | .62 |
| Type 3c | 3 (0.2) | 8 (0.5) | 0.37 (0.10 to 1.40) | −0.32 (−0.74 to 0.09) | .14 | 4 (0.6) | 1 (0.1) | 3.96 (0.44 to 35.46) | 0.43 (−0.20 to 1.06) | .22 | .07 |
| Type 4 | 0 | 0 | NA | NA | NA | 0 | 0 | NA | NA | NA | NA |
| Type 5 | 2 (0.1) | 8 (0.5) | 0.25 (0.05 to 1.17) | −0.39 (−0.79 to 0.01) | .08 | 0 | 0 | NA | NA | NA | NA |
| Type 5a | 0 | 2 (0.1) | 0.20 (0.01 to 4.16) | −0.13 (−0.31 to 0.05) | .25 | 0 | 0 | NA | NA | NA | NA |
| Type 5b | 2 (0.1) | 6 (0.4) | 0.33 (0.07 to 1.64) | −0.26 (−0.62 to 0.10) | .18 | 0 | 0 | NA | NA | NA | NA |
| Type 3 or 5 | 33 (2.1) | 50 (3.2) | 0.65 (0.42 to 1.01) | −1.09 (−2.21 to 0.04) | .06 | 22 (3.1) | 17 (2.4) | 1.29 (0.68 to 2.42) | 0.70 (−1.04 to 2.44) | .44 | .08 |
Abbreviations: BARC, Bleeding Academic Research Consortium; DAPT, dual antiplatelet therapy; HR, hazard ratio; MACCE, major adverse cardiac and cerebral event; MCB, major or clinically relevant nonmajor bleeding; NA, not applicable; NACE, net adverse clinical event; TIA, transient ischemic attack.
a
Data are expressed as No. of first events of each type (Kaplan-Meier failure %). Hazard ratios (95% CI) are calculated using Cox proportional hazards regression time-to–first event analyses in the intention-to-treat population. Continuity-corrected risk ratios (95% CI) were calculated in case of zero events with a Fisher exact test P value. An interaction P value was tested for a modifying effect of sex (male or female) on the HR scale.
b
Includes undetermined strokes.