Table 2. Fractional polynomial models and adjusted hazard ratios (95% confidence intervals) of included variables for major bleeding, major GI bleeding, and intracranial hemorrhage.
| Variable name | Major bleeding | Major GI bleeding | Intracranial hemorrhage |
|---|---|---|---|
| Randomized treatment arm | |||
| Warfarin vs. aspirin | 1.88 (1.33–2.65) | 0.93 (0.51–1.68) | 5.18 (2.67–10.03) |
| DOAC, therapeutic dose vs. aspirin | 1.58 (1.15–2.18) | 1.19 (0.68–2.08) | 1.60 (0.92–2.79) |
| Rivaroxaban alone vs. aspirin | 1.57 (1.29–1.92) | 1.70 (1.21–2.39) | 1.49 (0.91–2.45) |
| Rivaroxaban plus aspirin vs. aspirin | 1.77 (1.46–2.15) | 2.45 (1.78–3.37) | 1.10 (0.65–1.87) |
| Baseline biometrics | |||
| Age (per 10 units increase) | 1.68 (1.57–1.80) | 1.94 (1.74–2.17) | 1.78 (1.52–2.09) |
| Female | 1.01 (0.90–1.14) | 1.02 (0.84–1.24) | 0.86 (0.64–1.15) |
| Asian race (vs. non–Asian) | 1.14 (0.99–1.31) | 1.24 (0.99–1.56) | 2.03 (1.55–2.66) |
| Diastolic blood pressure (per five units increase) | 0.94 (0.92–0.96) | 0.90 (0.87–0.93) | N/A |
| Pulse pressure (per five units increase) | 1.02 (1.01–1.04) | N/A | N/A |
| Weight | Selected in transformation a | Selected in transformation a | N/A |
| Creatinine | Selected in transformation a | Selected in transformation a | N/A |
| Medical history | |||
| Diabetes | 1.13 (1.02–1.25) | N/A | N/A |
| Cancer | 1.19 (1.04–1.37) | N/A | N/A |
| Heart failure | 1.07 (0.96–1.19) | 1.22 (1.03–1.45) | N/A |
| Hypertension | 1.16 (1.03–1.30) | 1.22 (1.01–1.48) | 1.26 (0.93–1.71) |
| Peripheral artery disease | 1.11 (0.96–1.28) | N/A | N/A |
| Smoking: former vs. never | 1.37 (1.23–1.52) | 1.50 (1.26–1.78) | 1.25 (0.96–1.64) |
| Smoking: current vs. never | 1.52 (1.30–1.79) | 1.77 (1.36–2.31) | 1.38 (0.92–2.06) |
| Stroke | 1.14 (0.98–1.32) | N/A | 2.21 (1.62–3.02) |
| Prerandomization medication use | |||
| NSAID | 1.21 (1.02–1.43) | 1.32 (1.01–1.73) | N/A |
| Diuretic | 1.12 (1.02–1.24) | 1.22 (1.04–1.43) | 0.79 (0.60–1.02) |
Abbreviations: DOAC, direct oral anticoagulant; GI, gastrointestinal; NSAID, nonsteroidal anti-inflammatory drug.
Note: Variables/transformations not selected for a specific model are denoted by “N/A”.
a
Weight (kg) transformed to (weight) −2 *10 4 and log(weight) in the major bleeding model, and log(weight)*10 and log(weight) 2 in the major GI bleeding model. Creatinine (µmol/L) transformed to creatinine 3 *(1/10) 5 and creatinine 3 *log(creatinine)*(1/10) 5 in the major bleeding model, and creatinine 3 *(1/10 5 ) and creatinine 3 *log(creatinine)*(1/10 5 ) in the major GI bleeding model. Adjusted hazard ratios for transformed variables not shown due to difficulty in interpreting their values.