Andexanet alfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis
There is limited information directly comparing andexanet alfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban or rivaroxaban. The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban...
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| Veröffentlicht in: | The American journal of emergency medicine 2022-05, Vol.55, p.16-19 |
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| creator | Parsels, Katie A. Seabury, Robert W. Zyck, Stephanie Miller, Christopher D. Krishnamurthy, Satish Darko, William Probst, Luke A. Latorre, Julius Gene Cwikla, Gregory M. Feldman, Elizabeth A. |
| description | There is limited information directly comparing andexanet alfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban or rivaroxaban.
The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban or rivaroxaban.
This retrospective, matched, cohort analysis was conducted at a single healthcare system. Patients were matched based on baseline ICH volume. The primary outcome was good or excellent ICH hemostasis, which was defined as a 35% or less increase in ICH volume within 24 h following AA or 4F-PCC administration. The secondary outcome was thrombotic events within 14 days following AA or 4F-PCC administration.
In total, 26 AA and 26 4F-PCC patients were included in this matched cohort analysis. Both groups had comparable rates of good or excellent ICH hemostasis (AA: 92.3% vs. 4F-PCC: 88.5%, p = 1.000). Thrombotic events within 14-days were not significantly different (AA: 26.9% vs. 4F-PCC: 11.5%, p = 0.159).
This study found no significant differences in good or excellent ICH hemostasis within 24-h or new thrombotic events within 14-days in a cohort given AA or 4F-PCC for ICH while on apixaban or rivaroxaban. However, this single-center analysis is underpowered due to sample size constraints, therefore further high-quality research comparing AA safety and effectiveness versus 4F-PCC is needed. |
| doi_str_mv | 10.1016/j.ajem.2022.02.036 |
| format | Article |
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The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban or rivaroxaban.
This retrospective, matched, cohort analysis was conducted at a single healthcare system. Patients were matched based on baseline ICH volume. The primary outcome was good or excellent ICH hemostasis, which was defined as a 35% or less increase in ICH volume within 24 h following AA or 4F-PCC administration. The secondary outcome was thrombotic events within 14 days following AA or 4F-PCC administration.
In total, 26 AA and 26 4F-PCC patients were included in this matched cohort analysis. Both groups had comparable rates of good or excellent ICH hemostasis (AA: 92.3% vs. 4F-PCC: 88.5%, p = 1.000). Thrombotic events within 14-days were not significantly different (AA: 26.9% vs. 4F-PCC: 11.5%, p = 0.159).
This study found no significant differences in good or excellent ICH hemostasis within 24-h or new thrombotic events within 14-days in a cohort given AA or 4F-PCC for ICH while on apixaban or rivaroxaban. However, this single-center analysis is underpowered due to sample size constraints, therefore further high-quality research comparing AA safety and effectiveness versus 4F-PCC is needed.</description><identifier>ISSN: 0735-6757</identifier><identifier>EISSN: 1532-8171</identifier><identifier>DOI: 10.1016/j.ajem.2022.02.036</identifier><identifier>PMID: 35245776</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Anticoagulants ; Anticoagulants - adverse effects ; Blood Coagulation Factors - therapeutic use ; Brain hemorrhage ; Cohort analysis ; Cohort Studies ; Demographics ; Direct-acting oral anticoagulants ; Emergency medical care ; Factor Xa ; Factor Xa Inhibitors - adverse effects ; Hemorrhage ; Hemostasis ; Humans ; Intracranial hemorrhage ; Intracranial Hemorrhages - chemically induced ; Intracranial Hemorrhages - drug therapy ; Length of stay ; Magnetic resonance imaging ; Neurosurgery ; Patients ; Prothrombin ; Prothrombin complex concentrate ; Pyrazoles ; Pyridones ; Recombinant Proteins ; Retrospective Studies ; Rivaroxaban - adverse effects ; Safety ; Thrombosis</subject><ispartof>The American journal of emergency medicine, 2022-05, Vol.55, p.16-19</ispartof><rights>2022</rights><rights>Copyright © 2022. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited May 2022</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-4c448bb6903256465921441c3fe72b588abd56f76bf3b6adbe27f55adb18af013</citedby><cites>FETCH-LOGICAL-c384t-4c448bb6903256465921441c3fe72b588abd56f76bf3b6adbe27f55adb18af013</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2650242935?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994,64384,64386,64388,72240</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35245776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Parsels, Katie A.</creatorcontrib><creatorcontrib>Seabury, Robert W.</creatorcontrib><creatorcontrib>Zyck, Stephanie</creatorcontrib><creatorcontrib>Miller, Christopher D.</creatorcontrib><creatorcontrib>Krishnamurthy, Satish</creatorcontrib><creatorcontrib>Darko, William</creatorcontrib><creatorcontrib>Probst, Luke A.</creatorcontrib><creatorcontrib>Latorre, Julius Gene</creatorcontrib><creatorcontrib>Cwikla, Gregory M.</creatorcontrib><creatorcontrib>Feldman, Elizabeth A.</creatorcontrib><title>Andexanet alfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis</title><title>The American journal of emergency medicine</title><addtitle>Am J Emerg Med</addtitle><description>There is limited information directly comparing andexanet alfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban or rivaroxaban.
The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban or rivaroxaban.
This retrospective, matched, cohort analysis was conducted at a single healthcare system. Patients were matched based on baseline ICH volume. The primary outcome was good or excellent ICH hemostasis, which was defined as a 35% or less increase in ICH volume within 24 h following AA or 4F-PCC administration. The secondary outcome was thrombotic events within 14 days following AA or 4F-PCC administration.
In total, 26 AA and 26 4F-PCC patients were included in this matched cohort analysis. Both groups had comparable rates of good or excellent ICH hemostasis (AA: 92.3% vs. 4F-PCC: 88.5%, p = 1.000). Thrombotic events within 14-days were not significantly different (AA: 26.9% vs. 4F-PCC: 11.5%, p = 0.159).
This study found no significant differences in good or excellent ICH hemostasis within 24-h or new thrombotic events within 14-days in a cohort given AA or 4F-PCC for ICH while on apixaban or rivaroxaban. However, this single-center analysis is underpowered due to sample size constraints, therefore further high-quality research comparing AA safety and effectiveness versus 4F-PCC is needed.</description><subject>Anticoagulants</subject><subject>Anticoagulants - adverse effects</subject><subject>Blood Coagulation Factors - therapeutic use</subject><subject>Brain hemorrhage</subject><subject>Cohort analysis</subject><subject>Cohort Studies</subject><subject>Demographics</subject><subject>Direct-acting oral anticoagulants</subject><subject>Emergency medical care</subject><subject>Factor Xa</subject><subject>Factor Xa Inhibitors - adverse effects</subject><subject>Hemorrhage</subject><subject>Hemostasis</subject><subject>Humans</subject><subject>Intracranial hemorrhage</subject><subject>Intracranial Hemorrhages - chemically induced</subject><subject>Intracranial Hemorrhages - drug therapy</subject><subject>Length of stay</subject><subject>Magnetic resonance imaging</subject><subject>Neurosurgery</subject><subject>Patients</subject><subject>Prothrombin</subject><subject>Prothrombin complex concentrate</subject><subject>Pyrazoles</subject><subject>Pyridones</subject><subject>Recombinant Proteins</subject><subject>Retrospective Studies</subject><subject>Rivaroxaban - adverse effects</subject><subject>Safety</subject><subject>Thrombosis</subject><issn>0735-6757</issn><issn>1532-8171</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9UU2P0zAQjRCILQt_gAOyxGWRNsXfSVdcqooFpJXgAGfLccYbV4ldbLe0_5Sfg0MXDhyQRhqP_eZ55r2qeknwkmAi326XegvTkmJKl7gEk4-qBRGM1i1pyONqgRsmatmI5qJ6ltIWY0K44E-rCyYoF00jF9XPte_hqD1kpEerEVgLJrsDeEgJad-jpC3kEzpATPuEbNjH2mqTQ0S7GPIQw9Q5j0yYdiMcS_YGfI46A7rit_WXzeYNKu9uvjNRe6dHNMAUYhz0PaAfgxsBBY_0zh11pz0qxNEddAy_yxu0Rsn5-xHqmRfiNYqQY0i785jXaNLZDNCXn4cQyxZej6fk0vPqidVjghcP-bL6dvv-6-Zjfff5w6fN-q42rOW55obztuvkCjMqJJdiRQnnxDALDe1E2-quF9I2srOsk7rvgDZWiHIgrbaYsMvq6sxb1Pi-h5TV5JKBcSyahn1SVDJJOGtoW6Cv_4Fui5pl3hklMOV0xURB0TPKlC1TBKt20U06nhTBavZdbdXsu5p9V7gEk6Xp1QP1vpug_9vyx-gCeHcGQNHi4CCqZBwUr3oXi5KqD-5__L8ACl7DQA</recordid><startdate>202205</startdate><enddate>202205</enddate><creator>Parsels, Katie A.</creator><creator>Seabury, Robert W.</creator><creator>Zyck, Stephanie</creator><creator>Miller, Christopher D.</creator><creator>Krishnamurthy, Satish</creator><creator>Darko, William</creator><creator>Probst, Luke A.</creator><creator>Latorre, Julius Gene</creator><creator>Cwikla, Gregory M.</creator><creator>Feldman, Elizabeth A.</creator><general>Elsevier Inc</general><general>Elsevier Limited</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>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>202205</creationdate><title>Andexanet alfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis</title><author>Parsels, Katie A. ; Seabury, Robert W. ; Zyck, Stephanie ; Miller, Christopher D. ; Krishnamurthy, Satish ; Darko, William ; Probst, Luke A. ; Latorre, Julius Gene ; Cwikla, Gregory M. ; Feldman, Elizabeth A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-4c448bb6903256465921441c3fe72b588abd56f76bf3b6adbe27f55adb18af013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Anticoagulants</topic><topic>Anticoagulants - adverse effects</topic><topic>Blood Coagulation Factors - therapeutic use</topic><topic>Brain hemorrhage</topic><topic>Cohort analysis</topic><topic>Cohort Studies</topic><topic>Demographics</topic><topic>Direct-acting oral anticoagulants</topic><topic>Emergency medical care</topic><topic>Factor Xa</topic><topic>Factor Xa Inhibitors - adverse effects</topic><topic>Hemorrhage</topic><topic>Hemostasis</topic><topic>Humans</topic><topic>Intracranial hemorrhage</topic><topic>Intracranial Hemorrhages - chemically induced</topic><topic>Intracranial Hemorrhages - drug therapy</topic><topic>Length of stay</topic><topic>Magnetic resonance imaging</topic><topic>Neurosurgery</topic><topic>Patients</topic><topic>Prothrombin</topic><topic>Prothrombin complex concentrate</topic><topic>Pyrazoles</topic><topic>Pyridones</topic><topic>Recombinant Proteins</topic><topic>Retrospective Studies</topic><topic>Rivaroxaban - adverse effects</topic><topic>Safety</topic><topic>Thrombosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Parsels, Katie A.</creatorcontrib><creatorcontrib>Seabury, Robert W.</creatorcontrib><creatorcontrib>Zyck, Stephanie</creatorcontrib><creatorcontrib>Miller, Christopher D.</creatorcontrib><creatorcontrib>Krishnamurthy, Satish</creatorcontrib><creatorcontrib>Darko, William</creatorcontrib><creatorcontrib>Probst, Luke A.</creatorcontrib><creatorcontrib>Latorre, Julius Gene</creatorcontrib><creatorcontrib>Cwikla, Gregory M.</creatorcontrib><creatorcontrib>Feldman, Elizabeth A.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American journal of emergency medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Parsels, Katie A.</au><au>Seabury, Robert W.</au><au>Zyck, Stephanie</au><au>Miller, Christopher D.</au><au>Krishnamurthy, Satish</au><au>Darko, William</au><au>Probst, Luke A.</au><au>Latorre, Julius Gene</au><au>Cwikla, Gregory M.</au><au>Feldman, Elizabeth A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Andexanet alfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis</atitle><jtitle>The American journal of emergency medicine</jtitle><addtitle>Am J Emerg Med</addtitle><date>2022-05</date><risdate>2022</risdate><volume>55</volume><spage>16</spage><epage>19</epage><pages>16-19</pages><issn>0735-6757</issn><eissn>1532-8171</eissn><abstract>There is limited information directly comparing andexanet alfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban or rivaroxaban.
The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban or rivaroxaban.
This retrospective, matched, cohort analysis was conducted at a single healthcare system. Patients were matched based on baseline ICH volume. The primary outcome was good or excellent ICH hemostasis, which was defined as a 35% or less increase in ICH volume within 24 h following AA or 4F-PCC administration. The secondary outcome was thrombotic events within 14 days following AA or 4F-PCC administration.
In total, 26 AA and 26 4F-PCC patients were included in this matched cohort analysis. Both groups had comparable rates of good or excellent ICH hemostasis (AA: 92.3% vs. 4F-PCC: 88.5%, p = 1.000). Thrombotic events within 14-days were not significantly different (AA: 26.9% vs. 4F-PCC: 11.5%, p = 0.159).
This study found no significant differences in good or excellent ICH hemostasis within 24-h or new thrombotic events within 14-days in a cohort given AA or 4F-PCC for ICH while on apixaban or rivaroxaban. However, this single-center analysis is underpowered due to sample size constraints, therefore further high-quality research comparing AA safety and effectiveness versus 4F-PCC is needed.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>35245776</pmid><doi>10.1016/j.ajem.2022.02.036</doi><tpages>4</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0735-6757 |
| ispartof | The American journal of emergency medicine, 2022-05, Vol.55, p.16-19 |
| issn | 0735-6757 1532-8171 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Anticoagulants Anticoagulants - adverse effects Blood Coagulation Factors - therapeutic use Brain hemorrhage Cohort analysis Cohort Studies Demographics Direct-acting oral anticoagulants Emergency medical care Factor Xa Factor Xa Inhibitors - adverse effects Hemorrhage Hemostasis Humans Intracranial hemorrhage Intracranial Hemorrhages - chemically induced Intracranial Hemorrhages - drug therapy Length of stay Magnetic resonance imaging Neurosurgery Patients Prothrombin Prothrombin complex concentrate Pyrazoles Pyridones Recombinant Proteins Retrospective Studies Rivaroxaban - adverse effects Safety Thrombosis |
| title | Andexanet alfa effectiveness and safety versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage while on apixaban or rivaroxaban: A single-center, retrospective, matched cohort analysis |
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