Table 1. Baseline characteristics of patients.
| Safety population ( N = 36) | Patients with baseline antifactor Xa activity ≥40 ng/mL ( N = 28) | Patients with baseline antifactor Xa activity ≥75 ng/mL ( N = 20) | |
|---|---|---|---|
| Age (y), mean ± SD | 81.5 ± 6.3 | 81.4 ± 6.3 | 81.2 ± 6.9 |
| Male sex, n (%) | 22 (61.1) | 18 (64.3) | 13 (65.0) |
| White race, n (%) | 31 (86.1) | 24 (85.7) | 17 (85.0) |
| Body mass index (kg/m 2 ), mean ± SD | 25.1 ± 3.7 | 24.9 ± 3.3 | 24.1 ± 2.6 |
| Estimated creatinine clearance, a n (%) | |||
| Missing data | 1 (2.8) | 1 (3.6) | 0 (0) |
| <30 mL/min | 5 (13.9) | 3 (10.7) | 2 (10.0) |
| 30–59.9 mL/min | 17 (47.2) | 16 (57.1) | 13 (65.0) |
| ≥60 mL/min | 13 (36.1) | 8 (28.6) | 5 (25.0) |
| Primary indication for anticoagulation, b n (%) | |||
| Atrial fibrillation | 33 (91.7) | 26 (92.9) | 19 (95.0) |
| Atrial flutter | 1 (2.8) | 1 (3.6) | 0 (0) |
| Venous thromboembolism c | 2 (5.6) | 1 (3.6) | 1 (5.0) |
| Medical history, n (%) | |||
| Myocardial infarction | 3 (8.3) | 3 (10.7) | 3 (15.0) |
| Stroke | 8 (22.2) | 8 (28.6) | 7 (35.0) |
| Deep-vein thrombosis | 3 (8.3) | 2 (7.1) | 2 (10.0) |
| Atrial fibrillation | 33 (91.7) | 26 (92.9) | 19 (95.0) |
| Heart failure | 7 (19.4) | 6 (21.4) | 3 (15.0) |
| Diabetes mellitus | 4 (11.1) | 3 (10.7) | 2 (10.0) |
| Hypertension | 33 (91.7) | 26 (92.9) | 18 (90.0) |
| CHA 2 DS 2 -VASc score, median (IQR) d | 4 (3–5) | 4 (3–5) | 4 (3–5) |
| HAS-BLED score, median (IQR) d | 2 (2–3) | 2 (2–3) | 2 (2–3) |
| Hemoglobin (g/L), mean ± SD | 118.2 ± 31.1 | 121.2 ± 31.7 | 121.9 ± 30.8 |
| Platelet count (10 9 /L), mean ± SD | 224.5 ± 80.0 | 226.1 ± 86.0 | 223.6 ± 90.8 |
| Primary site of bleeding, n (%) | |||
| Intracranial, any | 29 (80.6) | 22 (78.6) | 16 (80.0) |
| Intracranial, associated with trauma e | 6 (20.7) | 4 (18.2) | 3 (18.8) |
| Gastrointestinal | 7 (19.4) | 6 (21.4) | 4 (20.0) |
| Edoxaban dosage, n (%) | |||
| 60 mg once daily | 20 (55.6) | 16 (57.1) | 13 (65.0) |
| 30 mg once daily | 15 (41.7) | 11 (39.3) | 6 (30.0) |
| 15 mg once daily | 1 (2.8) | 1 (3.6) | 1 (5.0) |
| Baseline antifactor Xa activity (ng/mL), median (IQR) | 95.1 (57.1–196.8) | 121.1 (70.3–202.4) | 160.5 (106.2–222.2) |
| Time from last dose of edoxaban to andexanet bolus (h), median (IQR) | 9.2 (6.2–13.0) | 9.4 (6.0–12.9) | 8.7 (5.2–11.5) |
| Time from presentation at the emergency department to andexanet bolus (h), median (IQR) | 2.8 (1.8–4.3) | 2.9 (2.3–4.3) | 2.8 (2.0–3.9) |
Abbreviations: INR, international normalized ratio; IQR, interquartile range; SD, standard deviation.
Creatinine clearance estimated according to the Cockcroft–Gault formula.
If >1 primary indication for anticoagulation recorded: if atrial fibrillation was present, this was listed as the primary indication; if present, venous thromboembolism was considered primary in the remaining patients.
Venous thromboembolism refers to prevention or treatment of deep-vein thrombosis and pulmonary embolism.
Reported for patients with atrial fibrillation or atrial flutter. The CHA 2 DS 2 -VASc score ranges from 0 to 9 (congestive heart failure [1], hypertension [1], age ≥75 years [2], diabetes [1], prior stroke or transient ischemic attack [2], vascular disease [1], age 65–74 years [1], female sex [1]). A modified HAS-BLED score is reported, ranging from 0 to 7 (hypertension [systolic blood pressure >160 mm Hg at baseline [1], abnormal kidney function [1], abnormal liver function [1], prior stroke [1], bleeding history [not including the qualifying bleeding event] or anemia [1], age >65 years [1], concomitant use of antiplatelet agents or nonsteroidal anti-inflammatory drugs [1]). As opposed to the original HAS-BLED score, the categories labile INR (not applicable) and alcohol use (data not available) were not considered.
Denominators for percentage with traumatic intracranial hemorrhage are all patients with any intracranial hemorrhage.