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Prothrombin Complex Concentrate in Direct Oral Anticoagulant Reversal: A Systematic Scoping Review
Nazedah Ain Ibrahim1, Jiaa Yinn Tang2, Hayati Alwani Yahaya2
1Department of Pharmacy, Hospital Tunku Azizah, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, Malaysia.
Insights
Prothrombin complex concentrates (PCC) can reverse direct oral anticoagulants (DOAC) when specific agents are unavailable. This review examines PCC effectiveness and safety for DOAC reversal in Malaysia.
Area of Science:
- Pharmacology
- Hematology
- Clinical Medicine
Background:
- Direct oral anticoagulants (DOAC) are alternatives to warfarin for anticoagulation.
- Malaysia lacks widespread availability of specific DOAC reversal agents like idarucizumab and andexanet alfa.
- Prothrombin complex concentrates (PCC) are recommended for life-threatening DOAC bleeding in the absence of specific agents.
Purpose of the Study:
- To evaluate the effectiveness and safety of PCC in reversing DOAC.
- To provide insights into the current use of PCC for DOAC reversal in Malaysia.
Main Methods:
- A scoping review of studies from 2016-2020 using PubMed, Wiley, Sage, and Google Scholar.
- Inclusion of clinical studies on PCC utilization for DOAC reversal, adhering to PRISMA extension for Scoping Reviews.
- Study registered with the National Medical Research Register, Malaysia.
Main Results:
- Twenty studies met inclusion criteria, all describing PCC use for DOAC reversal (25-50 u/kg doses).
- Hemostatic effectiveness was reported in 15 studies, often using International Society on Thrombosis and Haemostasis (ISTH) criteria.
- All 20 studies assessed PCC safety, including thrombotic events and mortality risks.
Conclusions:
- High-quality research is needed to further understand PCC effectiveness and safety for hemostasis.
- PCC serves as a viable option for DOAC reversal when specific agents are unavailable or the DOAC type is unknown.
Background:
Direct oral anticoagulants (DOAC) have emerged as an alternative to warfarin for treating venous thromboembolism and stroke prevention in atrial fibrillation. Reversal agents such as idarucizumab and andexanet alfa are not widely and readily available in Malaysia. In their absence, international guidelines recommend the administration of prothrombin complex concentrates (PCC) in life-threatening bleeding caused by DOAC.
Objective:
To describe the reported PCC effectiveness and safety in reversing the anticoagulant effects of DOAC and provide better insight into its current practice in Malaysia.
Methods:
This scoping review was conducted using the following databases: PubMed, Wiley Online Library, Sage Journals, and Google Scholar from 2016 until 2020. Clinical studies focusing on the utilization of PCC in the reversal of DOAC and fulfills the PRISMA extension for Scoping Reviews checklist were included. This review was registered with the National Medical Research Register, Malaysia (NMRR ID-22-01355-DC3).
Results:
The systematic search retrieved 599 studies, 20 of which met the inclusion criteria. All studies described the use of PCC as a reversal agent for DOAC, with doses ranging between 25 and 50 u/kg. Hemostatic effectiveness was reported in 15 studies, 12 of which used the International Society on Thrombosis and Haemostasis (ISTH) criteria. All 20 studies assessed the safety of PCC in terms of overall risk of thrombotic events and mortality.
Conclusions:
Further high-quality studies are essential to deepen understanding regarding PCC effectiveness and safety in achieving clinical hemostasis. However, this review provides the information regarding PCC as an option when DOAC-specific reversal agents are unavailable, or the type of DOAC is unknown.
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