Efficacy and safety of four-factor prothrombin complex concentrate fixed, weight-based dosing for reversal of warfarin anticoagulation

Figures & data

Table 1. Patient characteristics.

Patient demographics	N = 227
Median age in years (range)	74 (40–95)
Median weight in kg (range)	76 (44–200)
Males	127 (56%)
Medical history	N = 227
Atrial fibrillation	154 (68%)
DVT	49 (22%)
Stroke	47 (21%)
Indication for PCC	N = 227
Active bleeding	85 (37.4%)
Intracranial	29 (12.7%)
Gastrointestinal	28 (12.3%)
Trauma	9 (4.0%)
Other	19 (8.4%)
Reversal for procedure	50 (22.0%)
Reversal for surgery	67 (29.5%)
Other not already listed	25 (11.1%)

Table 2. PCC doses, adjunctive therapy and responses.

PCC dose	N = 227
1000 IU	3 (1.3%)
1500 IU	40 (17.6%)
2000 IU	93 (41.0%)
2500 IU	55 (24.2%)
3000 IU	36 (15.9%)
Adjunctive therapy	N = 227
Additional dose of PCC within 6 h	1 (0.4%)
FFP within 6 h prior to PCC	17 (7.4%)
FFP within 6 h post-PCC	33 (14.5%)
Vitamin K within 6 h of PCC	147 (64.7%)
INRs	N = 227
Median Pre-PCC INR (range)	2.9 (1.5–10.0)
Median Post-PCC INR (range)	1.3 (1.0–3.7)
Completion of Procedures/Surgeries
% of patients with pre-planned procedure that was completed	95.0% (57 of N = 60)
% of patients with pre-planned surgery that was completed	95.7% (67 of N = 70)
Thrombosis^a
Total thrombotic events within 30 days of PCC	4 (1.8%)
DVT^b	3 (1.3%)
Ischemic Foot^b	1 (0.4%)
Stroke^c	1 (0.4%)
Death due to thrombosis^c	1 (0.4%)

Table 3. Proportion of patients within various INR ranges achieving post-PCC INR ≤ 1.5.

INR range pre-PCC	Proportion with post-PCC INR ≤ 1.5 (N = 227)	p-value (2 tailed, mid p value exact)	95% Confidence interval	Total patients reaching target INR ≤ 1.5
1.5–3.0	94/121 (77.7%)	Reference	Reference	150 (66.1%)
3.1–4.5	29/44 (65.9%)	0.0843	−1.22–25.92%
>4.5	27/62 (43.5%)	<0.0001*	24.34–53.01%