FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2919989385> ?p ?o ?g. }

• W2919989385 endingPage "1239" @default.
• W2919989385 startingPage "1239" @default.
• W2919989385 abstract "Abstract Background: Traditional prothrombin time (PT) based international normalized ratio (INR) is often highly variable. Often this is caused by rapid factor VII reductions due to its short (4 hour) half-life. Thus, factor VII variation is an important confounder during vitamin K antagonist (VKA) dosing. Furthermore, prior studies have demonstrated that factor VII reductions only minimally influence the antithrombotic effect and bleeding risk of VKA, the clinical effect depending mainly on controlled reduction of factors II and X. Therefore, ignoring the influence of FVII during VKA monitoring has the potential to simplify management and outcome. The Fiix prothrombin time (Fiix-PT) is a new modified PT that is only affected by reduced factors II and X. The Fiix-PT is not affected by variations in factor VII. Hence, the Fiix normalized ratio (Fiix-NR) fluctuates less than the standard standard PT-INR. In the double-blind randomized clinical Fiix-trial, published in 2015, monitoring of warfarin with with Fiix-PT (Fiix-NR) was compared to standard high time-in-range PT-INR monitoring. Fiix-NR monitoring led to improved time-in-range, reduced testing frequency, reduced dose-adjustment need and a 50% reduction in thromboembolism (TE). Bleeding did not increase and it occurred at a low rate in both trial arms. Subsequently starting on July 1st 2015 we replaced the PT-INR with Fiix-NR in our anticoagulation monitoring practice. Aim: We compared anticoagulation outcome and dosing frequency during 12 months prior to switching from PT-INR based management (Pre-Fiix monitoring period) and during 12 months following switch to Fiix-NR monitoring (Fiix monitoring period). Methods: This is a retrospective before and after study involving unselected patients managed at a single anticoagulation management service at the Landspitali University Hospital in Reykjavik, Iceland. All patients on warfarin during two consecutive twelve month periods were analysed irrespective of indication or anticoagulation target range. Pre-Fiix patients analysis was based on events occuring during months -12 to -1 before replacing the PT with Fiix PT and the Fiix patients´outcome was analysed during months +4 to +15. Three transitional months were excluded. All patients were dosed by specialized staff using the DAWN anticoagulation software®. Hospital chart diagnostic codes were reviewed for occurrence of TE or major bleeding (MB) during the two separate monitoring periods.Surrogate assessments included the number of tests, testing intervals and dose adjustment frequencies and will be analyzed later. Results: During the Pre-Fiix period 2,345 patients were managed with PT-INR for 1,984 patient years (0.85 years/patient) and during the Fiix period 1,909 patients were managed with Fiix-NR for 1,643 patient years (0.86 y/pt). Indications for warfarin were identical during both periods (atrial fibrillation 57%, venous thromboembolism 26%, prosthetic heart valves 5% and other 12%). The INR target range during both periods was 2.0-3.0 in 92% and 2.5-3.5 in 6%. Clinical outcome with respect to TE and MB is shown in the figure. Overall the point estimates were suggestive of a 34-52% reduction of TE with Fiix-NR monitoring whereas major bleeding was similar. The reduction in untoward events in the Fiix group was statistically significant for composite new TE (OR 0.63;0.41-0.97) and total stroke (ischemic and hemorrhagic, OR 0.57;CI 0.33-0.98), mainly driven by reduced cerebral infarction. Intracranial bleeding occurred in 0.76% in the Pre-Fiix group and in 0.37% in the Fiix montoring group (n.s., OR 0.51;0.19-1.32). The median time-within-Target-range (TTR, Rosendaal method) was similar in both groups (75 vs 76%, respectively), despite dose adjustment frequency being reduced by 18% in the Fiix monitoring group (OR 0.82;CI 0.79-0.85, p <0.0001). Conclusions: These results are in agreement with the results of the Fiix-trial and show that ignoring factor VII during VKA monitoring is safe and leads to reduction in thromboembolism without increasing bleeding. Although TTR was identical in both groups, the dose adjustment need was reduced possibly indicating that less anticoagulation variability in the Fiix-NR group explains reduced thromboembolism. Figure Figure. Disclosures Gudmundsdottir: Hart Biologicals Ltd: Consultancy, Patents & Royalties: Hart Biologicals Ltd is commercializing the Fiix-PT which will be ready for marketing in Europe in the beginning of year 2019 and possibly later that year in the USA. Patent fees will be paid to Fiix Diagnostics Ltd once the test is commercialized.; Fiix Diagnostics Ltd: Equity Ownership, Patents & Royalties: The Fiix prothrombin time (Fiix-PT) is a patented invention of P. T. Onundarson and B.R. Gudmundsdottir that is owned by Fiix Diagnostics Ltd, a start-up company founded by the inventors. . Onundarson:Hart Biologicals Ltd: Consultancy, Other: Hart Biologicals Ltd is commercializing the Fiix-PT which will be ready for marketing in Europe in the beginning of year 2019 and possibly later that year in the USA. Patent fees will be paid to Fiix Diagnostics Ltd once the test is commercialized.; Fiix Diagnostics Ltd: Equity Ownership, Patents & Royalties: The Fiix prothrombin time (Fiix-PT) is a patented invention of P. T. Onundarson and B.R. Gudmundsdottir that is owned by Fiix Diagnostics Ltd, a start-up company founded by the inventors. ." @default.
• W2919989385 created "2019-03-11" @default.
• W2919989385 creator A5005255396 @default.
• W2919989385 creator A5008965041 @default.
• W2919989385 creator A5013715552 @default.
• W2919989385 date "2018-11-29" @default.
• W2919989385 modified "2023-10-18" @default.
• W2919989385 title "Replacing PT-INR Monitoring of Warfarin with Fiix-NR in Clinical Practice Reduces Thromboembolism without Increasing Bleeding Despite Reduced Number of Dose Adjustments" @default.
• W2919989385 doi "https://doi.org/10.1182/blood-2018-99-116731" @default.
• W2919989385 hasPublicationYear "2018" @default.
• W2919989385 type Work @default.
• W2919989385 sameAs 2919989385 @default.
• W2919989385 citedByCount "1" @default.
• W2919989385 countsByYear W29199893852020 @default.
• W2919989385 crossrefType "journal-article" @default.
• W2919989385 hasAuthorship W2919989385A5005255396 @default.
• W2919989385 hasAuthorship W2919989385A5008965041 @default.
• W2919989385 hasAuthorship W2919989385A5013715552 @default.
• W2919989385 hasBestOaLocation W29199893851 @default.
• W2919989385 hasConcept C126322002 @default.
• W2919989385 hasConcept C139719470 @default.
• W2919989385 hasConcept C162324750 @default.
• W2919989385 hasConcept C168563851 @default.
• W2919989385 hasConcept C2776301958 @default.
• W2919989385 hasConcept C2776704044 @default.
• W2919989385 hasConcept C2777015399 @default.
• W2919989385 hasConcept C2777091921 @default.
• W2919989385 hasConcept C2777288759 @default.
• W2919989385 hasConcept C2779161974 @default.
• W2919989385 hasConcept C2780434524 @default.
• W2919989385 hasConcept C2993590494 @default.
• W2919989385 hasConcept C3019316490 @default.
• W2919989385 hasConcept C42219234 @default.
• W2919989385 hasConcept C71924100 @default.
• W2919989385 hasConceptScore W2919989385C126322002 @default.
• W2919989385 hasConceptScore W2919989385C139719470 @default.
• W2919989385 hasConceptScore W2919989385C162324750 @default.
• W2919989385 hasConceptScore W2919989385C168563851 @default.
• W2919989385 hasConceptScore W2919989385C2776301958 @default.
• W2919989385 hasConceptScore W2919989385C2776704044 @default.
• W2919989385 hasConceptScore W2919989385C2777015399 @default.
• W2919989385 hasConceptScore W2919989385C2777091921 @default.
• W2919989385 hasConceptScore W2919989385C2777288759 @default.
• W2919989385 hasConceptScore W2919989385C2779161974 @default.
• W2919989385 hasConceptScore W2919989385C2780434524 @default.
• W2919989385 hasConceptScore W2919989385C2993590494 @default.
• W2919989385 hasConceptScore W2919989385C3019316490 @default.
• W2919989385 hasConceptScore W2919989385C42219234 @default.
• W2919989385 hasConceptScore W2919989385C71924100 @default.
• W2919989385 hasIssue "Supplement 1" @default.
• W2919989385 hasLocation W29199893851 @default.
• W2919989385 hasOpenAccess W2919989385 @default.
• W2919989385 hasPrimaryLocation W29199893851 @default.
• W2919989385 hasRelatedWork W104778587 @default.
• W2919989385 hasRelatedWork W1966222151 @default.
• W2919989385 hasRelatedWork W2008481069 @default.
• W2919989385 hasRelatedWork W2017041661 @default.
• W2919989385 hasRelatedWork W2320334092 @default.
• W2919989385 hasRelatedWork W2320375690 @default.
• W2919989385 hasRelatedWork W2919989385 @default.
• W2919989385 hasRelatedWork W3093241499 @default.
• W2919989385 hasRelatedWork W3205542196 @default.
• W2919989385 hasRelatedWork W4241175062 @default.
• W2919989385 hasVolume "132" @default.
• W2919989385 isParatext "false" @default.
• W2919989385 isRetracted "false" @default.
• W2919989385 magId "2919989385" @default.
• W2919989385 workType "article" @default.