Table 2. Two-Year Clinical Outcomes by Sex.
| Clinical outcome | No. (Kaplan-Meier %) | Hazard ratio (95% CI) | P value | ||
|---|---|---|---|---|---|
| Men (n = 1694) | Women (n = 738) | Unadjusted | Adjusted | ||
| Death, MI, or ST (primary safety end point) | 222 (13.6) | 105 (14.7) | 1.11 (0.88-1.40) | 1.00 (0.78-1.28) | .98 |
| Clinically driven TLR (primary efficacy end point) | 150 (9.5) | 63 (9.2) | 0.98 (0.73-1.32) | 0.95 (0.70-1.31) | .77 |
| All death | 214 (13.0) | 106 (14.6) | 1.16 (0.92-1.47) | 1.05 (0.82-1.35) | .67 |
| Cardiac death | 101 (6.3) | 55 (7.8) | 1.28 (0.92-1.78) | 1.10 (0.77-1.57) | .59 |
| Target vessel MI | 118 (7.2) | 51 (7.2) | 1.01 (0.73-1.40) | 0.89 (0.63-1.27) | .52 |
| Definite or probable ST | 34 (2.1) | 18 (2.5) | 1.23 (0.70-2.18) | 1.23 (0.67-2.27) | .51 |
| Definite ST | 24 (1.5) | 10 (1.4) | 0.97 (0.46-2.03) | 1.08 (0.49-2.34) | .85 |
| Acute | 5 (0.3) | 3 (0.4) | 1.38 (0.33-5.77) | 1.28 (0.28 -5.88) | .75 |
| Subacute | 5 (0.3) | 4 (0.6) | 1.85 (0.50-6.88) | 2.50 (0.59 -1.61) | .21 |
| Late | 15 (0.9) | 2 (0.3) | 0.31 (0.07-1.36) | 0.35 (0.08-1.57) | .17 |
| Very late | 1 (0.1) | 1 (0.2) | 2.36 (0.15-37.71) | 3.45 (0.16-77.05) | .43 |
| Probable ST | 10 (0.6) | 8 (1.1) | 1.86 (0.73-4.71) | 1.46 (0.53-4.03) | .47 |
| Clinically indicated TVR | 169 (10.7) | 68 (9.9) | 0.94 (0.71-1.24) | 0.94 (0.70-1.27) | .69 |
| Any BARC bleeding | 372 (22.9) | 144 (20.3) | 0.90 (0.75-1.09) | 0.89 (0.73-1.10) | .28 |
| BARC types 2-5 | 292 (18.1) | 118 (16.6) | 0.96 (0.77-1.18) | 0.95 (0.75-1.20) | .68 |
| BARC types 3-5 | 138 (8.6) | 72 (10.2) | 1.24 (0.93-1.65) | 1.25 (0.92-1.69) | .16 |
Abbreviations: BARC, Bleeding Academic Research Consortium scale; MI, myocardial infarction; ST, stent thrombosis; TLR, target lesion revascularization; TVR, target vessel revascularization.