Table 1:
Demographic and baseline characteristics (ITT-E population)
| 4F-PCC (n=87) | Plasma (n=81) | |
|---|---|---|
| Sex | ||
| Female | 37 (43%) | 31 (38%) |
| Male | 50 (57%) | 50(62%) |
| Age, years | 69·4 (13·5) | 66·0 (13·2) |
| Region | ||
| USA | 44 (51%) | 37 (46%) |
| Europe/Lebanon | 43 (49%) | 44 (54%) |
| Body-mass index, kg/m2 | 27·9 (6·4) | 28·5 (7·9) |
| Baseline INR | 2·90 (2·0–17·0) | 2·90 (2·0–26·7) |
| Type of surgery or procedure | ||
| Cranial neurosurgical | 1 (1%) | 1 (1%) |
| Cardiothoracic surgical | 3 (3%) | 3 (4%) |
| Major orthopaedic surgical | 20 (23%) | 15 (19%) |
| Other surgical | 50 (57%) | 47 (58%) |
| Invasive | 13 (15%) | 15 (19%) |
| Vitamin K dose | ||
| Oral vitamin K dose ≤2 mg | 6 (7%) | 2 (2%) |
| Oral vitamin K dose >2 mg | 9 (10%) | 10 (12%) |
| Any IV vitamin K | 70 (80%) | 69 (85%) |
| No vitamin K | 1 (1%) | 0 |
| Not available | 1 (1%) | 0 |
| Reason for oral VKA therapy | ||
| Arrhythmia | 42 (48%) | 31 (38%) |
| Vascular disease | 17 (20%) | 18 (22%) |
| Artificial heart valve or joint | 13 (15%) | 14 (17%) |
| Thromboembolic event | 12 (14%) | 16 (20%) |
| Other | 3 (3%) | 2 (2%) |
Data are n (%), mean (SD), or median (IQR). 4F-PCC=four-factor prothrombin complex concentrate. INR=international normalised ratio. ITT-E=intention-to-treat efficacy. IV=intravenous. VKA=vitamin K antagonist.