Prothrombin complex concentrate for reversal of vitamin K antagonist treatment in bleeding and non-bleeding patients

Abstract

of findings for the main comparison. Prothrombin complex concentrate versus any comparator for reversal of vitamin K antagonist treatment in bleeding and non-bleeding patients Prothrombin complex concentrate versus any comparator for reversal of vitamin K antagonist treatment in bleeding and non-bleeding patients Patient or population: patients with vitamin K antagonist-induced bleeding requiring acute intervention Setting: acute medical and operative setting Intervention: prothrombin complex concentrate Illustrative comparative risks* (95% CI) Assumed risk Corresponding risk Outcomes Control Prothrombin complex concentrate Prothrombin complex concentrate for reversal of vitamin K antagonist treatment in bleeding and non-bleeding patients (Review)

Prothrombin Complex Concentrate Reduces Blood Product Utilization in Heart Transplantation

“…Alternative options for warfarin reversal before heart transplantation have been proposed. A novel group of agents termed prothrombin complex concentrate (PCC) acts by immediately replacing the vitamin K–dependent coagulation factors II, VII, IX, and X that have been depleted by warfarin therapy . PCCs are designated as four‐factor PCC (4‐F PCC) or three‐factor PCC (3‐F PCC), depending on the presence of therapeutic levels of factor VII .…”

“…A novel group of agents termed prothrombin complex concentrate (PCC) acts by immediately replacing the vitamin K-dependent coagulation factors II, VII, IX, and X that have been depleted by warfarin therapy. 5 PCCs are designated as four-factor PCC (4-F PCC) or three-factor PCC (3-F PCC), depending on the presence of therapeutic levels of factor VII. 6,7 The objective of this study was to compare the use of 4-F PCC to FFP for warfarin reversal before heart transplantation.…”

On‐label compared to off‐label four‐factor prothrombin complex concentrate use: a retrospective, observational study

“…2,3 The most important complication of VKAs is hemorrhage, with the incidence of major bleeding events reported to be 2% to 5% per year. [4][5][6] Hylek et al 7 reported the incidence of major bleeding to be as high as 13.1 per 100 person-years in elderly patients, suggesting underestimation of the risk of bleeding with the use of VKAs in actual clinical practice. Furthermore, major bleeding can be immediately life threatening.…”

“…Furthermore, a Cochrane database systematic review found that the use of PCC does not appear to reduce mortality or transfusion requirements but demonstrates the possibility of reversing VKA-induced coagulopathy without the need for transfusion of FFP. 13 Of note, the authors reported that all the included trials have high risk of bias and are underpowered to detect mortality, benefit, or harm. However, none of the aforementioned studies evaluate the use of 4F-PCC for off-label reasons, particularly for patients with major acute bleeding not due to VKA-induced coagulopathy.…”

Hemorrhage After Lunch?

“…Light and transient bleedings (subclinical hematomae) are common in patients taking regularly VKAs, ranges between 10-20% of patients per year. In severe bleedings induced by VKAs routine use of prothrombin complex concentrate or infusion of fresh frozen plasma is recommended (the superiority between them is not possible, today [12]). Due to the strong laboratory control, Adam et al [13] reported better adherence to VKA oral anticoagulants compared to non-VKA oral anticoagulants.…”