Thrombosis Update (Dec 2020)
The outcome of three-factor Prothrombin Complex Concentrate (3F-PCC) in warfarin reversal: A single center retrospective cohort study
Abstract
Introduction: Three-factor Prothrombin Complex Concentrate (3F-PCC) containing factors II, IX and X was introduced to Malaysian public hospitals for warfarin reversal since 2017. Local studies on the outcomes of 3F-PCC use are limited. Objective: This study aimed to determine the extent of target international normalized ratio (INR) achievement and adverse drug reactions (ADRs) associated with 3F-PCC use in warfarin reversal. Materials and methods: This retrospective cohort study analyzed data from adult patients on warfarin who received 3F-PCC for anticoagulation reversal between September 2017 to January 2020. Study endpoints included achievement of target INR, ADRs and in-hospital mortality. Results: Seventy-seven patients with a median age of 65.0 (55.5–75.0) years comprising of 50.6% (n = 39) men were included. Fifty-one patients required 3F-PCC for life-threatening (29.9%, n = 23) and clinically significant (36.4%, n = 28) bleeding. Initial INRs ranged from 1.69 to undetectable high (>24). All patients had INR reduction, of which 40.3% (n = 31) achieved target INR whereas 6.5% (n = 5) achieved INR below target range. Median INR reduced from 4.14 (2.89–8.13) to 1.57 (1.33–1.97). Race, gender, age, initial INR and concomitant use of adjuvant reversal therapy did not affect target INR achievement. Three (3.9%) out of four ADRs observed were associated with mortality including suspected acute coronary syndrome (n = 2) and disseminated intravascular coagulopathy (n = 1) among those with life-threatening bleeding. The incidence of in-hospital mortality was 19.5% (n = 15). Conclusion: The use of 3F-PCC (Prothrombinex-VF®) produces variable reduction in INR in our population without apparent risk of thromboembolic events and in-hospital mortality.
