Table 1.
Baseline Characteristics. a
| Characteristic | Andexanet alfa (N = 16) | 4F-PCC (N = 16) |
|---|---|---|
| Age—year | 69.1 ± 9.4 | 69.0 ± 17.2 |
| Male | 8 (50.0) | 11 (68.8) |
| Weight—kg | 94.4 ± 26.0 | 86.4 ± 30.1 |
| Body mass index—kg/m2 | 32.7 ± 9.1 | 29.6 ± 9.2 |
| Estimated creatinine clearance | ||
| <30 mL/min | 2 (12.5) | 3 (18.8) |
| 30 to 60 mL/min | 6 (37.5) | 5 (31.3) |
| >60 mL/min | 8 (50.0) | 8 (50.0) |
| Primary indication for anticoagulation | ||
| Atrial fibrillation | 11 (68.8) | 14 (87.5) |
| Venous thromboembolism | 5 (31.3) | 2 (12.5) |
| Past medical history | ||
| Myocardial infarction | 3 (18.8) | 1 (6.3) |
| Stroke | 0 (0) | 3 (18.8) |
| Deep-vein thrombosis | 5 (31.3) | 1 (6.3) |
| Pulmonary embolism | 1 (6.3) | 1 (6.3) |
| Heart failure | 4 (25.0) | 6 (37.5) |
| Diabetes mellitus | 3 (18.8) | 5 (31.3) |
| Concomitant antiplatelet therapy | 5 (31.3) | 3 (18.8) |
| FXa inhibitor | ||
| Apixaban | 11 (68.8) | 7 (43.8) |
| Rivaroxaban | 5 (31.3) | 9 (56.3) |
| Time since last FXa-inhibitor dose | ||
| <8 h | 3 (18.8) | 1 (6.3) |
| 8-18 h | 6 (37.5) | 8 (50.0) |
| Unknown | 7 (43.8) | 7 (43.8) |
| Heparin exposure within 12 h prior to reversal agent | 3 (18.8) | 0 (0) |
| Site of bleeding | ||
| Intracranial | 7 (43.8) | 10 (62.5) |
| Nonintracranial | 9 (56.3) | 6 (37.5) |
| GCS score b | 15 [8-15] | 13 [11-15] |
| ICH GCS score c | 8 [6-12] | 13 [11-14] |
| Non-ICH GCS score d | 15 [15-15] | 14 [11-15] |
| Hemodynamically unstable e | 6 (37.5) | 4 (25.0) |
Abbreviations: 4F-PCC, 4-factor prothrombin complex concentrate; GCS, Glasgow Coma Scale; ICH, intracranial hemorrhage; FXa, factor Xa.
a
Data presented as mean ± SD, no. (%), or median [IQR]. No significant differences between the groups were observed at baseline.
b
Baseline GCS scores were not reported for 2 patients in the andexanet alfa group.
c
Median GCS scores for 7 andexanet alfa patients and 10 4F-PCC patients.
d
Median GCS scores for 7 andexanet alfa patients and 6 4F-PCC patients.
e
Hemodynamically unstable defined as mean arterial pressure (MAP) <65 mm Hg and/or requiring vasopressor support.