SHOULD KCENTRA BE ADDED FOR TREATMENT IN EMERGENCY WARFARIN REVERSAL?
Author(s)
Oh J1, Tsitarava M2, Loh FE1
1Touro College of Pharmacy, New York, NY, USA, 2Touro College of Pharmacy, Brooklyn, NY, USA
Presentation Documents
METHODS: PubMed, Embase, CINAHL, and Google Scholar were searched for studies pertaining to keywords 'prothrombin complex concentrate' or 'Kcentra' including clinical trials, controlled clinical trials, randomized controlled trials, case reports, and observational human studies published in English between 2008 to 2018. The 53 articles were further screened based on inclusion and exclusion criteria: (1) Kcentra or PCC is used for treatment of warfarin reversal, (2) study design is either clinical trial, controlled clinical trial, randomized controlled trial, case report/series, observational human study, or cost-effectiveness analysis, (2) published between 2008 to 2018, and (3) full texts available in English.
RESULTS: Eleven articles were included in this study. 8 studies found Kcentra to have a positive outcome, 1 study found it to be neutral, and 2 studies found it to have both positive and neutral outcomes. Four-factor prothrombin complex concentrate (PCC-4), which includes Kcentra, was shown to be non-inferior in 5 studies and superior in 6 studies compared to Fresh Frozen Plasma (FFP). Refaai et. al. found significantly shorter median infusion time (P < 0.0001), median infusion volume (P < 0.0001), and median time from study treatment initiation to first procedure (P = 0.037) in PCC-4 group compared to plasma. A study done in U.K. found Kcentra to be cost-effective in emergency treatment of Warfarin reversal.
CONCLUSIONS: Kcentra is effective for treatment in Emergency Warfarin reversal and may also be non-inferior or even superior to FFP. Prothrombin complex concentrate is a relatively new drug in United States and long-term effects are not clear. Further study with a long-term follow-up is needed to determine the safety, efficacy, and cost effectiveness of prothrombin complex concentrate.
Conference/Value in Health Info
Value in Health, Vol. 21, S3 (October 2018)
Code
PCV12
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Cardiovascular Disorders