Table 3. Clinical outcomes by sex and randomized treatment assignment at 12 months after randomization.
| Variables | Women (n = 795), No. (%)a | Men (n = 2,198), No. (%)a | P for interactionc | Adjusted P for interactionc | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| P2Y12 inhibitor monotherapy (n = 408) | Dual antiplatelet therapy (n = 387) | HR (95% CI)c | P value | Adjusted HR (95% CI)c | P value | P2Y12 inhibitor monotherapy (n = 1,087) | Dual antiplatelet therapy (n = 1,111) | HR (95% CI)c | P value | Adjusted HR (95% CI)c | P value | |||
| Primary endpoint (MACCE)a | 14 (3.4) | 12 (3.1) | 1.14 (0.53–2.47) | 0.732 | 1.16 (0.50–2.68) | 0.727 | 28 (2.6) | 24 (2.2) | 1.20 (0.70–2.07) | 0.514 | 1.15 (0.66–2.00) | 0.620 | 0.922 | 0.834 |
| All-cause death | 7 (1.7) | 5 (1.3) | 1.36 (0.43–4.29) | 0.597 | 1.85 (0.51–6.77) | 0.353 | 14 (1.3) | 13 (1.2) | 1.10 (0.52–2.35) | 0.798 | 1.14 (0.53–2.48) | 0.734 | 0.761 | 0.875 |
| Myocardial infarction | 3 (0.7) | 8 (2.1) | 0.37 (0.10–1.38) | 0.139 | 0.38 (0.10–1.50) | 0.169 | 8 (0.7) | 9 (0.8) | 0.91 (0.35–2.36) | 0.847 | 0.83 (0.32–2.17) | 0.707 | 0.275 | 0.331 |
| Stroke | 4 (1.0) | 1 (0.3) | 3.95 (0.44–35.35) | 0.219 | 3.07 (0.32–29.76) | 0.332 | 7 (0.6) | 4 (0.4) | 1.79 (0.53–6.13) | 0.351 | 1.60 (0.46–5.55) | 0.459 | 0.542 | 0.534 |
| Cardiac death | 2 (0.5) | 4 (1.0) | 0.49 (0.09–2.69) | 0.413 | 0.54 (0.09–3.17) | 0.496 | 9 (0.8) | 9 (0.8) | 1.02 (0.41–2.58) | 0.960 | 0.97 (0.38–2.45) | 0.960 | 0.453 | 0.540 |
| Stent thrombosis | 0 | 0 | - | - | - | - | 3 (0.3) | 2 (0.2) | 1.53 (0.26–9.18) | 0.639 | 1.73 (0.24–12.69) | 0.590 | ||
| Bleeding BARC type 2-5 | 7 (1.7) | 16 (4.1) | 0.42 (0.17–1.03) | 0.058 | 0.40 (0.16–0.98) | 0.045 | 21 (1.9) | 33 (3.0) | 0.65 (0.38–1.12) | 0.122 | 0.63 (0.37–1.10) | 0.104 | 0.420 | 0.410 |
| Major bleedingb | 5 (1.2) | 2 (0.5) | 2.49 (0.48–12.81) | 0.276 | 2.21 (0.42–11.65) | 0.348 | 7 (0.6) | 12 (1.1) | 0.60 (0.24–1.52) | 0.278 | 0.58 (0.23–1.48) | 0.256 | 0.140 | 0.159 |
| Target vessel revascularization | 4 (1.0) | 4 (1.0) | 0.99 (0.25–3.94) | 0.984 | 1.02 (0.24–4.31) | 0.980 | 8 (0.7) | 15 (1.4) | 0.55 (0.12–1.29) | 0.169 | 0.44 (0.18–1.09) | 0.076 | 0.488 | 0.324 |
Data are presented for the intention-to-treat population. The percentages are Kaplan-Meier estimates.
HR = hazard ratio, CI = confidence interval, MACCE = major adverse cardiac and cerebrovascular events, BARC = Bleeding Academic Research Consortium.
aA composite of all-cause mortality, myocardial infarction, or stroke.
bBARC type 3 to 5 bleeding.
Primary endpoint is defined as a composite of all-cause death, myocardial infarction, or stroke at 12 months after the index procedure.
cModel adjusted for age, Body-mass index, hypertension, diabetes mellitus, dyslipidemia, current smoking, previous revascularization, previous myocardial infarction, chronic renal failure, left ventricular ejection fraction, clinical presentation of ST-segment elevation myocardial infarction, transradial approach, multivessel disease, left main disease, Left anterior descending artery disease, and thrombotic lesion.