Introduction
Materials and methods
Database
Permission
Cohort selection
Study outcome
Baseline Data
Statistical analysis
Results
Baseline Characteristics
|
Andexanet alfa (N = 85)
|
4 F-PCC (N = 170)
|
p-value
|
Standardized difference
|
---|---|---|---|---|
Age, mean (SD) | 76.1 (10.0) | 71.8 (12.0) | 0.004 | 0.381 |
Race, n (%) | 0.005 | |||
Black
| 9 (10.6%) | 44 (25.9%) | 0.377 | |
Other/unknown
| 6 (7.1%) | < 5 | 0.242 | |
White
| 70 (82.4%) | 122 (71.8%) | 0.245 | |
Sex, n (%) | 0.373 | |||
Female
| 0 (0%) | < 5 | 0.189 | |
Male
| 85 (100%) | 166 (97.7%) | 0.189 | |
History of atrial fibrillation, n (%) | 74 (87.1%) | 124 (72.9%) | 0.017 | 0.359 |
History of deep vein thrombosis, n (%) | 13 (15.3%) | 25 (14.7%) | 1 | 0.016 |
Charlson comorbidity Index | ||||
Mean (SD)
| 5.42 (3.28) | 5.71 (3.35) | 0.515 | 0.087 |
Median (IQR)
| 5 (3–7) | 5 (3–8) | 0.497 | |
Bleed type, n (%) | 0.421 | |||
GI
| 39 (45.9%) | 90 (52.9%) | 0.141 | |
ICH
| 25 (29.4%) | 49 (28.8%) | 0.013 | |
Other
| 21 (24.7%) | 31 (18.2%) | 0.161 | |
Anticoagulant, n (%) | < 0.001 | |||
Apixaban
| 67 (78.8%) | 81 (47.7%) | 0.632 | |
Edoxaban
| < 5 | 0 (0%) | 0.188 | |
Enoxaparin
| < 5 | 64 (37.7%) | 0.837 | |
Rivaroxaban
| 16 (18.8%) | 25 (14.7%) | 0.112 | |
Ventilation, n (%) | 16 (18.8%) | 49 (28.8%) | 0.115 | 0.229 |
Invasive ventilation, n (%) | 9 (10.6%) | 34 (20%) | 0.086 | 0.251 |
Concomitant Medications, n (%) | ||||
Plasma
| 7 (8.2%) | 26 (15.3%) | 0.166 | 0.21 |
Cryoprecipitates
| < 5 | 9 (5.3%) | 0.21 | 0.212 |
Transfusion
| 7 (8.2%) | 27 (15.9%) | 0.134 | 0.225 |
Tranexamic acid
| < 5 | < 5 | 1 | 0.047 |
Vitamin K
| 9 (10.6%) | 75 (44.1%) | < 0.001 | 0.713 |
Platelets
| 9 (10.6%) | 20 (11.8%) | 0.944 | 0.037 |
Red blood cells
| 28 (32.9%) | 66 (38.8%) | 0.435 | 0.122 |
Activated 4 F-PCC
| 6 (7.1%) | 6 (3.5%) | 0.347 | 0.167 |
Year, n (%) | < 0.001 | |||
2014–2016
| 0 (0%) | 32 (18.8%) | 0.568 | |
2017–2018
| 0 (0%) | 58 (34.1%) | 0.814 | |
2019–2020
| 85 (100%) | 80 (47.1%) | 1.108 |
Primary outcomes: In-hospital and 30-day mortality
Mortality and Discharge |
Andexanet alfa
|
4 F-PCC
|
p-value
|
OR (95%CI)
|
---|---|---|---|---|
N = 85
|
N = 170
| |||
In-hospital mortality, n (%) | 9 (10.6%) | 43 (25.3%) | 0.01 | 0.35 (0.15–0.73) |
30-day mortality, n (%)a | 17 (20%) | 55 (32.4%) | 0.039 | 0.52 (0.28–0.96) |
Discharge disposition, n (%) | ||||
Home
| 49 (57.7%) | 82 (48.2%) | 0.127 | 1.46 (0.87–2.50)b |
VA/Community nursing home
| 17 (20%) | 27 (15.9%) | ||
VA domiciliary
| 0 (0%) | < 5 | ||
Other hospital/medical center
| 8 (9.4%) | 14 (8.2%) | ||
Died
| 9 (10.6%) | 43 (25.3%) | ||
Missing
| < 5 | < 5 | ||
Length of stay outcomes, full cohort
|
Andexanet alfa
|
4 F-PCC
|
p-value
|
OR (95%CI)
|
N = 85
|
N = 170
| |||
Hospital length of stay in days, mean (SD) | 11.3 (18.2) | 12.0 (17.6) | 0.746 | N/A |
Hospital length of stay, median (IQR) | 7 (3–10) | 6 (2.3–14.8) | 0.709 | N/A |
ICU length of stay, mean (SD) | 4.2 (8.03) | 3.9 (6.0) | 0.743 | N/A |
ICU length of stay, median (IQR) | 1 (0–4) | 2 (0–5) | 0.626 | N/A |
Length of stay outcomes among those surviving hospitalization
|
Andexanet alfa
|
4 F-PCC
|
p-value
|
OR (95%CI)
|
N = 76
|
N = 127
| |||
Hospital length of stay in days, mean (SD) | 9.6 (14.8) | 13.6 (19.2) | 0.097 | N/A |
Hospital length of stay, median (IQR) | 6 (3–10) | 7 (4–18) | 0.255 | N/A |
ICU length of stay, mean (SD) | 4.0 (7.7) | 3.7 (4.8) | 0.806 | N/A |
ICU length of stay, median (IQR) | 1 (0–4) | 2 (0–5) | 0.262 | N/A |
In-hospital Mortality
|
30-day Mortality
| |
---|---|---|
Variable
|
HR (95% CI)
|
HR (95% CI)
|
Andexanet alfa vs. 4 F-PCC (ref) | 0.34 (0.16–0.74) | 0.54 (0.31–0.95) |
Age | 1.01 (0.98–1.04) | 1.02 (0.99–1.04) |
White vs. non-white (ref) | 1.33 (0.65–2.72) | 1.07 (0.60–1.91) |
Male vs. Female (ref) | 0.13 (0.03–0.62) | 0.25 (0.06–1.12) |
Charlson Comorbidity Index | 1.11 (1.02–1.20) | 1.09 (1.02–1.16) |
Bleed type: ICH vs. GI (ref) | 1.02 (0.49–2.10) | 1.20 (0.68–2.12) |
Bleed type: other vs. GI (ref) | 0.65 (0.30–1.42) | 0.68 (0.35–1.32) |
Ventilation vs. no ventilation (ref) | 3.03 (1.58–5.80) | 3.64 (2.14–6.18) |
Transfusion vs. no transfusion (ref) | 1.63 (0.83–3.17) | 1.10 (0.59–2.04) |
In-hospital Mortality
|
30-day Mortality
| |
---|---|---|
Variable
|
HR (95% CI)
|
HR (95% CI)
|
Andexanet alfa vs. 4 F-PCC (ref) | 0.31 (0.14–0.71) | 0.54 (0.30–0.98) |
Age | 1.01 (0.98–1.05) | 1.03 (0.99–1.06) |
White vs. non-white (ref) | 1.55 (0.73–3.30) | 1.03 (0.57–1.86) |
Male vs. Female (ref) | 0.09 (0.02–0.36) | 0.21 (0.03–1.65) |
Charlson Comorbidity Index | 1.14 (1.06–1.23) | 1.10 (1.02–1.18) |
Bleed type: ICH vs. GI (ref) | 1.23 (0.57–2.67) | 1.32 (0.70–2.47) |
Bleed type: other vs. GI (ref) | 0.57 (0.27–1.20) | 0.43 (0.21–0.89) |
Ventilation vs. no ventilation (ref) | 3.53 (1.74–7.19) | 5.74 (3.10-10.65) |
Transfusion vs. no transfusion (ref) | 1.72 (0.80–3.73) | 1.12 (0.57–2.20) |