One-year retrospective analysis of anti-FXa apixaban and rivaroxaban levels demonstrates utility for management decisions in various urgent and nonurgent clinical situations

Abstract Objectives Quantification of direct oral anticoagulant (DOAC) plasma levels can guide clinical management, but insight into clinical scenarios surrounding DOAC-calibrated anti-FXa assays is limited. Methods Apixaban- and rivaroxaban-calibrated chromogenic anti-Xa assays performed over a 1-y...

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Veröffentlicht in:American journal of clinical pathology 2023-12, Vol.160 (6), p.571-584
Hauptverfasser: Lucas, Fabienne, Lewis, Joshua, Grandoni, Jessica, Sylvester, Katelyn W, Bernier, Thomas D, Ting, Clara, Sek, Rebecca, Ballard, Kathleen, Connors, Jean M, Battinelli, Elisabeth M
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container_end_page 584
container_issue 6
container_start_page 571
container_title American journal of clinical pathology
container_volume 160
creator Lucas, Fabienne
Lewis, Joshua
Grandoni, Jessica
Sylvester, Katelyn W
Bernier, Thomas D
Ting, Clara
Sek, Rebecca
Ballard, Kathleen
Connors, Jean M
Battinelli, Elisabeth M
description Abstract Objectives Quantification of direct oral anticoagulant (DOAC) plasma levels can guide clinical management, but insight into clinical scenarios surrounding DOAC-calibrated anti-FXa assays is limited. Methods Apixaban- and rivaroxaban-calibrated chromogenic anti-Xa assays performed over a 1-year period were retrospectively analyzed. Patient demographics, DOAC history, concomitant medications, and renal/liver comorbidities were obtained. Indications for testing and associated clinical actions were reviewed. Machine learning (ML) models predicting clinical actions were evaluated. Results In total, 371 anti-FXa apixaban and 89 anti-FXa rivaroxaban tests were performed for 259 and 67 patients in recurring urgent (acute bleeding, unplanned procedures) and nonurgent situations, including several scenarios not captured by existing testing recommendations (eg, drug monitoring, recurrent thromboembolic events, bleeding tendency). In urgent settings, andexanet reversal was guided by radiologic and clinical findings over DOAC levels in 14 of 32 instances, while 51% of apixaban patients qualified for nonreversal strategies through the availability of levels. Levels also informed procedure/intervention timing and supported management decisions when DOAC clearance or DOAC target levels were in question. The importance of clinical context was emphasized by exploratory ML models predicting particular clinical actions. Conclusions Although clinical situations are complex, DOAC testing facilitates clinical decision-making, including reversal, justifying more widespread implementation of these assays.
doi_str_mv 10.1093/ajcp/aqad085
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Methods Apixaban- and rivaroxaban-calibrated chromogenic anti-Xa assays performed over a 1-year period were retrospectively analyzed. Patient demographics, DOAC history, concomitant medications, and renal/liver comorbidities were obtained. Indications for testing and associated clinical actions were reviewed. Machine learning (ML) models predicting clinical actions were evaluated. Results In total, 371 anti-FXa apixaban and 89 anti-FXa rivaroxaban tests were performed for 259 and 67 patients in recurring urgent (acute bleeding, unplanned procedures) and nonurgent situations, including several scenarios not captured by existing testing recommendations (eg, drug monitoring, recurrent thromboembolic events, bleeding tendency). In urgent settings, andexanet reversal was guided by radiologic and clinical findings over DOAC levels in 14 of 32 instances, while 51% of apixaban patients qualified for nonreversal strategies through the availability of levels. Levels also informed procedure/intervention timing and supported management decisions when DOAC clearance or DOAC target levels were in question. The importance of clinical context was emphasized by exploratory ML models predicting particular clinical actions. Conclusions Although clinical situations are complex, DOAC testing facilitates clinical decision-making, including reversal, justifying more widespread implementation of these assays.</description><identifier>ISSN: 0002-9173</identifier><identifier>ISSN: 1943-7722</identifier><identifier>EISSN: 1943-7722</identifier><identifier>DOI: 10.1093/ajcp/aqad085</identifier><identifier>PMID: 37549067</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Anticoagulants ; Apixaban ; Clopidogrel ; Comorbidity ; Factor Xa Inhibitors - therapeutic use ; Health aspects ; Hemorrhage - chemically induced ; Hemorrhage - drug therapy ; Humans ; Machine learning ; Medical research ; Medicine, Experimental ; Pyridones - analysis ; Pyridones - therapeutic use ; Respiratory agents ; Retrospective Studies ; Rivaroxaban ; Rivaroxaban - analysis ; Rivaroxaban - therapeutic use ; Ticagrelor</subject><ispartof>American journal of clinical pathology, 2023-12, Vol.160 (6), p.571-584</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2023</rights><rights>The Author(s) 2023. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>COPYRIGHT 2023 Oxford University Press</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0002-4388-0349 ; 0000-0003-1916-047X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37549067$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lucas, Fabienne</creatorcontrib><creatorcontrib>Lewis, Joshua</creatorcontrib><creatorcontrib>Grandoni, Jessica</creatorcontrib><creatorcontrib>Sylvester, Katelyn W</creatorcontrib><creatorcontrib>Bernier, Thomas D</creatorcontrib><creatorcontrib>Ting, Clara</creatorcontrib><creatorcontrib>Sek, Rebecca</creatorcontrib><creatorcontrib>Ballard, Kathleen</creatorcontrib><creatorcontrib>Connors, Jean M</creatorcontrib><creatorcontrib>Battinelli, Elisabeth M</creatorcontrib><title>One-year retrospective analysis of anti-FXa apixaban and rivaroxaban levels demonstrates utility for management decisions in various urgent and nonurgent clinical situations</title><title>American journal of clinical pathology</title><addtitle>Am J Clin Pathol</addtitle><description>Abstract Objectives Quantification of direct oral anticoagulant (DOAC) plasma levels can guide clinical management, but insight into clinical scenarios surrounding DOAC-calibrated anti-FXa assays is limited. Methods Apixaban- and rivaroxaban-calibrated chromogenic anti-Xa assays performed over a 1-year period were retrospectively analyzed. Patient demographics, DOAC history, concomitant medications, and renal/liver comorbidities were obtained. Indications for testing and associated clinical actions were reviewed. Machine learning (ML) models predicting clinical actions were evaluated. Results In total, 371 anti-FXa apixaban and 89 anti-FXa rivaroxaban tests were performed for 259 and 67 patients in recurring urgent (acute bleeding, unplanned procedures) and nonurgent situations, including several scenarios not captured by existing testing recommendations (eg, drug monitoring, recurrent thromboembolic events, bleeding tendency). In urgent settings, andexanet reversal was guided by radiologic and clinical findings over DOAC levels in 14 of 32 instances, while 51% of apixaban patients qualified for nonreversal strategies through the availability of levels. Levels also informed procedure/intervention timing and supported management decisions when DOAC clearance or DOAC target levels were in question. The importance of clinical context was emphasized by exploratory ML models predicting particular clinical actions. Conclusions Although clinical situations are complex, DOAC testing facilitates clinical decision-making, including reversal, justifying more widespread implementation of these assays.</description><subject>Anticoagulants</subject><subject>Apixaban</subject><subject>Clopidogrel</subject><subject>Comorbidity</subject><subject>Factor Xa Inhibitors - therapeutic use</subject><subject>Health aspects</subject><subject>Hemorrhage - chemically induced</subject><subject>Hemorrhage - drug therapy</subject><subject>Humans</subject><subject>Machine learning</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Pyridones - analysis</subject><subject>Pyridones - therapeutic use</subject><subject>Respiratory agents</subject><subject>Retrospective Studies</subject><subject>Rivaroxaban</subject><subject>Rivaroxaban - analysis</subject><subject>Rivaroxaban - therapeutic use</subject><subject>Ticagrelor</subject><issn>0002-9173</issn><issn>1943-7722</issn><issn>1943-7722</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUFrFTEQx4Mo9rV68ywBD_bgtkk2-7J7LMWqUOhFwdsyLzt5pGSTbZJ9-D6U39Es-xQEkRySmfzmz8z8CXnD2RVnXX0Nj3q6hicYWNs8IxveybpSSojnZMMYE1XHVX1GzlN6ZIyLlsmX5KxWjezYVm3IzweP1REh0og5hjShzvaAFDy4Y7KJBlPe2VZ334HCZH_ADnzJDDTaA8Swxg4P6BIdcAw-5QgZE52zdTYfqQmRjkVujyP6XBhtky0YtZ4WBRvmwsb98rfI-uBPkXbWWw2OJptnyEvNK_LCgEv4-nRfkG93H7_efq7uHz59ub25r3QtVa6aujMARu12RopOi-1guqHhettsm66WjW5QSZQDlpW1XA87JTSXgEKC6doG6gtyuepOMTzNmHI_2qTROfBY-u1FK5WSrRSyoO9WdA8Oe-tNKPPrBe9vlFJMcNWKQl39gyqnrMzq4NHYkv-r4MNaoIspKaLpp2hHiMees37xvV9870--F_ztqeF5N-LwB_5tdAHer0CYp_9L_QIJmrwf</recordid><startdate>20231201</startdate><enddate>20231201</enddate><creator>Lucas, Fabienne</creator><creator>Lewis, Joshua</creator><creator>Grandoni, Jessica</creator><creator>Sylvester, Katelyn W</creator><creator>Bernier, Thomas D</creator><creator>Ting, Clara</creator><creator>Sek, Rebecca</creator><creator>Ballard, Kathleen</creator><creator>Connors, Jean M</creator><creator>Battinelli, Elisabeth M</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4388-0349</orcidid><orcidid>https://orcid.org/0000-0003-1916-047X</orcidid></search><sort><creationdate>20231201</creationdate><title>One-year retrospective analysis of anti-FXa apixaban and rivaroxaban levels demonstrates utility for management decisions in various urgent and nonurgent clinical situations</title><author>Lucas, Fabienne ; Lewis, Joshua ; Grandoni, Jessica ; Sylvester, Katelyn W ; Bernier, Thomas D ; Ting, Clara ; Sek, Rebecca ; Ballard, Kathleen ; Connors, Jean M ; Battinelli, Elisabeth M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c347t-539faaf7bbf429c26df9d51c65659345c5e74e4de08581cdb72c14ae24af985a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Anticoagulants</topic><topic>Apixaban</topic><topic>Clopidogrel</topic><topic>Comorbidity</topic><topic>Factor Xa Inhibitors - therapeutic use</topic><topic>Health aspects</topic><topic>Hemorrhage - chemically induced</topic><topic>Hemorrhage - drug therapy</topic><topic>Humans</topic><topic>Machine learning</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Pyridones - analysis</topic><topic>Pyridones - therapeutic use</topic><topic>Respiratory agents</topic><topic>Retrospective Studies</topic><topic>Rivaroxaban</topic><topic>Rivaroxaban - analysis</topic><topic>Rivaroxaban - therapeutic use</topic><topic>Ticagrelor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lucas, Fabienne</creatorcontrib><creatorcontrib>Lewis, Joshua</creatorcontrib><creatorcontrib>Grandoni, Jessica</creatorcontrib><creatorcontrib>Sylvester, Katelyn W</creatorcontrib><creatorcontrib>Bernier, Thomas D</creatorcontrib><creatorcontrib>Ting, Clara</creatorcontrib><creatorcontrib>Sek, Rebecca</creatorcontrib><creatorcontrib>Ballard, Kathleen</creatorcontrib><creatorcontrib>Connors, Jean M</creatorcontrib><creatorcontrib>Battinelli, Elisabeth M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of clinical pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lucas, Fabienne</au><au>Lewis, Joshua</au><au>Grandoni, Jessica</au><au>Sylvester, Katelyn W</au><au>Bernier, Thomas D</au><au>Ting, Clara</au><au>Sek, Rebecca</au><au>Ballard, Kathleen</au><au>Connors, Jean M</au><au>Battinelli, Elisabeth M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>One-year retrospective analysis of anti-FXa apixaban and rivaroxaban levels demonstrates utility for management decisions in various urgent and nonurgent clinical situations</atitle><jtitle>American journal of clinical pathology</jtitle><addtitle>Am J Clin Pathol</addtitle><date>2023-12-01</date><risdate>2023</risdate><volume>160</volume><issue>6</issue><spage>571</spage><epage>584</epage><pages>571-584</pages><issn>0002-9173</issn><issn>1943-7722</issn><eissn>1943-7722</eissn><abstract>Abstract Objectives Quantification of direct oral anticoagulant (DOAC) plasma levels can guide clinical management, but insight into clinical scenarios surrounding DOAC-calibrated anti-FXa assays is limited. Methods Apixaban- and rivaroxaban-calibrated chromogenic anti-Xa assays performed over a 1-year period were retrospectively analyzed. Patient demographics, DOAC history, concomitant medications, and renal/liver comorbidities were obtained. Indications for testing and associated clinical actions were reviewed. Machine learning (ML) models predicting clinical actions were evaluated. Results In total, 371 anti-FXa apixaban and 89 anti-FXa rivaroxaban tests were performed for 259 and 67 patients in recurring urgent (acute bleeding, unplanned procedures) and nonurgent situations, including several scenarios not captured by existing testing recommendations (eg, drug monitoring, recurrent thromboembolic events, bleeding tendency). In urgent settings, andexanet reversal was guided by radiologic and clinical findings over DOAC levels in 14 of 32 instances, while 51% of apixaban patients qualified for nonreversal strategies through the availability of levels. Levels also informed procedure/intervention timing and supported management decisions when DOAC clearance or DOAC target levels were in question. The importance of clinical context was emphasized by exploratory ML models predicting particular clinical actions. Conclusions Although clinical situations are complex, DOAC testing facilitates clinical decision-making, including reversal, justifying more widespread implementation of these assays.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>37549067</pmid><doi>10.1093/ajcp/aqad085</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0002-4388-0349</orcidid><orcidid>https://orcid.org/0000-0003-1916-047X</orcidid></addata></record>
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subjects Anticoagulants
Apixaban
Clopidogrel
Comorbidity
Factor Xa Inhibitors - therapeutic use
Health aspects
Hemorrhage - chemically induced
Hemorrhage - drug therapy
Humans
Machine learning
Medical research
Medicine, Experimental
Pyridones - analysis
Pyridones - therapeutic use
Respiratory agents
Retrospective Studies
Rivaroxaban
Rivaroxaban - analysis
Rivaroxaban - therapeutic use
Ticagrelor
title One-year retrospective analysis of anti-FXa apixaban and rivaroxaban levels demonstrates utility for management decisions in various urgent and nonurgent clinical situations
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