Table 2.
Incidences of safety and effectiveness outcomes
| BMI (kg/m2) | ||||
|---|---|---|---|---|
| Underweight (< 18.5) | Normal (18.5 to < 25) | Overweight (25 to < 30) | Obese (≥ 30) | |
| Incidence, events per 100 patient-years (95% CI) | ||||
| Safety outcome | (n = 542) | (n = 4410) | (n = 2167) | (n = 499) |
| Any bleeding | 11.72 (8.33–15.11) | 8.42 (7.47–9.36) | 7.04 (5.82–8.26) | 5.47 (3.23–7.70) |
| Major bleeding | 2.19 (0.76–3.62) | 1.87 (1.43–2.30) | 1.71 (1.12–2.31) | 1.63 (0.42–2.84) |
| Fatal | 0.24 (0.00–0.72) | 0.11 (0.00–0.21) | 0.32 (0.06–0.58) | 0 (0) |
| Critical organ bleeding | 0.73 (0.00–1.55) | 0.85 (0.56–1.14) | 0.96 (0.52–1.41) | 0 (0) |
| Intracranial hemorrhage | 0.73 (0.00–1.55) | 0.77 (0.49–1.05) | 0.80 (0.40–1.21) | 0 (0) |
| Hemoglobin decrease ≥ 2 g/dl | 0.73 (0.00–1.55) | 0.69 (0.43–0.96) | 0.53 (0.20–0.86) | 1.16 (0.14–2.18) |
| Transfusion of ≥ 2 units of packed RBC or whole blood | 0.48 (0.00–1.16) | 0.21 (0.07–0.36) | 0.16 (0.00–0.34) | 0.23 (0.00–0.69) |
| All-cause mortality | 10.66 (7.51–13.81) | 1.91 (1.47–2.35) | 1.76 (1.16–2.36) | 0.93 (0.02–1.84) |
| Effectiveness outcome | (n = 540) | (n = 4392) | (n = 2161) | (n = 497) |
|---|---|---|---|---|
| Stroke/non-CNS SE/MI | 3.67 (1.81–5.53) | 1.69 (1.27–2.10) | 1.77 (1.17–2.38) | 1.63 (0.42–2.84) |
| Stroke | 2.94 (1.28–4.60) | 1.55 (1.15–1.95) | 1.61 (1.04–2.19) | 1.16 (0.14–2.18) |
| Ischemic stroke | 2.20 (0.76–3.64) | 1.07 (0.74–1.40) | 1.07 (0.60–1.54) | 1.16 (0.14–2.18) |
BMI body mass index, CI confidence interval, CNS central nervous system, MI myocardial infarction, RBC red blood cell, SE systemic embolism