Table 1. Demographic and Baseline Characteristics of Participants in the Per-Protocol Populationa.
| No. (%) of Patients | ||||||||
|---|---|---|---|---|---|---|---|---|
| Postoperative Osocimab, mg/kg | Preoperative Osocimab, mg/kg | Enoxaparin (n = 76) |
Apixaban (n = 83) |
|||||
| 0.3 (n = 76) |
0.6 (n = 51) |
1.2 (n = 79) |
1.8 (n = 78) |
0.3 (n = 77) |
1.8 (n = 80) |
|||
| Age, mean (SD), y | 65.6 (7.7) | 66.1 (9.9) | 66.1 (8.4) | 68.0 (7.4) | 66.2 (8.2) | 67.8 (7.3) | 67.0 (8.8) | 64.9 (8.4) |
| Women | 53 (69.7) | 35 (68.6) | 59 (74.7) | 51 (65.4) | 58 (75.3) | 60 (75.0) | 55 (72.4) | 65 (78.3) |
| Men | 23 (30.3) | 16 (31.4) | 20 (25.3) | 27 (34.6) | 19 (24.7) | 20 (25.0) | 21 (27.6) | 18 (21.7) |
| Race, No.b | 75 | 51 | 77 | 77 | 75 | 78 | 74 | 82 |
| White | 73 (97.3) | 48 (94.1) | 75 (97.4) | 77 (100) | 75 (100) | 77 (98.7) | 72 (97.3) | 77 (93.9) |
| Black | 2 (2.7) | 3 (5.9) | 1 (1.3) | 0 | 0 | 0 | 2 (2.7) | 5 (6.1) |
| Asian | 0 | 0 | 1 (1.3) | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiianc | 0 | 0 | 0 | 0 | 0 | 1 (1.3) | 0 | 0 |
| Weight, mean (SD), kg | 88.1 (16.9) | 85.0 (13.5) | 88.6 (17.3) | 84.6 (14.1) | 86.5 (18.7) | 88.9 (16.0) | 87.9 (17.9) | 87.2 (16.7) |
| BMI, mean (SD) | 32.5 (5.5) | 31.2 (5.1) | 33.4 (5.6) | 31.3 (5.3) | 32.2 (6.3) | 33.8 (5.9) | 32.4 (5.5) | 32.6 (5.8) |
| Creatinine clearance, mean (SD), mL/min/1.73 m2 | 88.5 (24.8) | 85.8 (23.3) | 85.0 (24.0) | 82.4 (22.0) | 81.5 (18.4) | 84.1 (21.5) | 82.4 (17.8) | 86.8 (17.8) |
| Duration of surgery, median (IQR), min | 90 (75-110) | 85 (70-105) | 85 (75-106) | 80 (70-100) | 80 (70-105) | 85 (72.5-102) | 85 (65-109) | 85 (75-105) |
| Type of anesthesia | ||||||||
| Spinald | 63 (82.9) | 41 (80.4) | 63 (79.7) | 66 (84.6) | 0 | 1 (1.2) | 33 (43.4) | 37 (44.6) |
| General | 13 (17.1) | 7 (13.7) | 12 (15.2) | 12 (15.4) | 77 (100) | 79 (98.8) | 43 (56.6) | 43 (51.8) |
| Other | 0 | 3 (5.9) | 4 (5.1) | 0 | 0 | 0 | 0 | 3 (3.6) |
| Tourniquet applied | 55 (72.4) | 33 (64.7) | 50 (63.3) | 39 (50.0) | 51 (66.2) | 51 (63.8) | 47 (61.8) | 56 (67.5) |
| Duration of tourniquet use, median (IQR), min | 65 (44-90) | 65 (50-89) | 76 (62.5-95) | 70 (52-85) | 79 (69-95) | 75 (61-85) | 74 (55-95) | 69 (50-99) |
| aPTT at baseline, mean (SD), s | 29.6 (2.2) | 30.6 (6.6) | 29.3 (2.9) | 29.6 (2.9) | 32.4 (22.6) | 29.4 (2.3) | 29.5 (2.2) | 29.8 (2.7) |
| Duration of comparator treatment, median (range), d | 13 (10-16) | 12 (4-16) | ||||||
Abbreviations: aPTT, activated partial thromboplastin time; BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; IQR, interquartile range.
SI conversion factor: to convert creatinine clearance from mL/min/1.73 m2 to mL/s/m2, multiply by 0.0167.
The per-protocol population included all patients who received at least 1 dose of study medication who could be evaluated for the primary efficacy outcome and did not have an important deviation from the protocol with an impact on the primary efficacy variable.
Excluding those for whom race was not reported.
Or other Pacific Islander.
Spinal anesthesia was an exclusion criterion for preoperative administration of osocimab; however, 1 patient receiving osocimab 1.8 mg/kg preoperatively accidentally underwent spinal anesthesia without complications.