Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation and Severe Kidney Disease or Undergoing Hemodialysis
Patients with nonvalvular atrial fibrillation with stage 4 or 5 chronic kidney disease or undergoing hemodialysis were excluded from phase III randomized trials of nonvitamin K antagonist oral anticoagulants (NOACs). We sought to evaluate the effectiveness and safety of rivaroxaban compared with war...
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| Veröffentlicht in: | The American journal of medicine 2019-09, Vol.132 (9), p.1078-1083 |
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| creator | Coleman, Craig I. Kreutz, Reinhold Sood, Nitesh A. Bunz, Thomas J. Eriksson, Daniel Meinecke, Anna-Katharina Baker, William L. |
| description | Patients with nonvalvular atrial fibrillation with stage 4 or 5 chronic kidney disease or undergoing hemodialysis were excluded from phase III randomized trials of nonvitamin K antagonist oral anticoagulants (NOACs). We sought to evaluate the effectiveness and safety of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis in routine practice.
Using MarketScan data from January 2012 to December 2017, we identified patients on oral anticoagulant (OAC) with naïve nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis and with ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between the rivaroxaban and warfarin cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores calculated using generalized boosted models and 10,000 regression trees (absolute standardized differences |
| doi_str_mv | 10.1016/j.amjmed.2019.04.013 |
| format | Article |
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Using MarketScan data from January 2012 to December 2017, we identified patients on oral anticoagulant (OAC) with naïve nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis and with ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between the rivaroxaban and warfarin cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores calculated using generalized boosted models and 10,000 regression trees (absolute standardized differences <0.1 achieved for all covariates after adjustment). Patients were followed until a stroke/systemic embolism or major bleeding event, OAC discontinuation/switch, insurance disenrollment, or end of data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the OAC cohorts were calculated using Cox regression.
We identified 1896 rivaroxaban (38.7% received a dose <20 mg/d) and 4848 warfarin users. Eighty-eight percent of included patients had stage 5 chronic kidney disease or were undergoing hemodialysis. Rivaroxaban did not significantly reduce stroke or systemic embolism (HR = 0.55, 95% CI = 0.27-1.10) or ischemic stroke (HR = 0.67, 95% CI = 0.30-1.50) alone, but it was associated with a significant 32% (95% CI = 1-53%) reduction in major bleeding risk compared with warfarin.
Among patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis, rivaroxaban appears associated with significantly less major bleeding compared to warfarin.</description><identifier>ISSN: 0002-9343</identifier><identifier>EISSN: 1555-7162</identifier><identifier>DOI: 10.1016/j.amjmed.2019.04.013</identifier><identifier>PMID: 31054829</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Administration, Oral ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anticoagulants - therapeutic use ; Atrial fibrillation ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - epidemiology ; Databases, Factual ; Embolism - epidemiology ; End-stage kidney disease ; Factor Xa Inhibitors - therapeutic use ; Female ; Hemodialysis ; Hemorrhage - epidemiology ; Humans ; Male ; Middle Aged ; Oral anticoagulation ; Renal Dialysis ; Renal Insufficiency, Chronic - epidemiology ; Renal Insufficiency, Chronic - therapy ; Retrospective Studies ; Rivaroxaban ; Rivaroxaban - therapeutic use ; Stroke - epidemiology ; United States - epidemiology ; Warfarin ; Warfarin - therapeutic use ; Young Adult</subject><ispartof>The American journal of medicine, 2019-09, Vol.132 (9), p.1078-1083</ispartof><rights>2019 Elsevier Inc.</rights><rights>Copyright © 2019 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c328t-d4e27c25193cf662d125818a7fafc7067c4f687e9a37b619d19a3612332fe4833</citedby><cites>FETCH-LOGICAL-c328t-d4e27c25193cf662d125818a7fafc7067c4f687e9a37b619d19a3612332fe4833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.amjmed.2019.04.013$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,782,786,3552,27931,27932,46002</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31054829$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Coleman, Craig I.</creatorcontrib><creatorcontrib>Kreutz, Reinhold</creatorcontrib><creatorcontrib>Sood, Nitesh A.</creatorcontrib><creatorcontrib>Bunz, Thomas J.</creatorcontrib><creatorcontrib>Eriksson, Daniel</creatorcontrib><creatorcontrib>Meinecke, Anna-Katharina</creatorcontrib><creatorcontrib>Baker, William L.</creatorcontrib><title>Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation and Severe Kidney Disease or Undergoing Hemodialysis</title><title>The American journal of medicine</title><addtitle>Am J Med</addtitle><description>Patients with nonvalvular atrial fibrillation with stage 4 or 5 chronic kidney disease or undergoing hemodialysis were excluded from phase III randomized trials of nonvitamin K antagonist oral anticoagulants (NOACs). We sought to evaluate the effectiveness and safety of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis in routine practice.
Using MarketScan data from January 2012 to December 2017, we identified patients on oral anticoagulant (OAC) with naïve nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis and with ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between the rivaroxaban and warfarin cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores calculated using generalized boosted models and 10,000 regression trees (absolute standardized differences <0.1 achieved for all covariates after adjustment). Patients were followed until a stroke/systemic embolism or major bleeding event, OAC discontinuation/switch, insurance disenrollment, or end of data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the OAC cohorts were calculated using Cox regression.
We identified 1896 rivaroxaban (38.7% received a dose <20 mg/d) and 4848 warfarin users. Eighty-eight percent of included patients had stage 5 chronic kidney disease or were undergoing hemodialysis. Rivaroxaban did not significantly reduce stroke or systemic embolism (HR = 0.55, 95% CI = 0.27-1.10) or ischemic stroke (HR = 0.67, 95% CI = 0.30-1.50) alone, but it was associated with a significant 32% (95% CI = 1-53%) reduction in major bleeding risk compared with warfarin.
Among patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis, rivaroxaban appears associated with significantly less major bleeding compared to warfarin.</description><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants - therapeutic use</subject><subject>Atrial fibrillation</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - epidemiology</subject><subject>Databases, Factual</subject><subject>Embolism - epidemiology</subject><subject>End-stage kidney disease</subject><subject>Factor Xa Inhibitors - therapeutic use</subject><subject>Female</subject><subject>Hemodialysis</subject><subject>Hemorrhage - epidemiology</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Oral anticoagulation</subject><subject>Renal Dialysis</subject><subject>Renal Insufficiency, Chronic - epidemiology</subject><subject>Renal Insufficiency, Chronic - therapy</subject><subject>Retrospective Studies</subject><subject>Rivaroxaban</subject><subject>Rivaroxaban - therapeutic use</subject><subject>Stroke - epidemiology</subject><subject>United States - epidemiology</subject><subject>Warfarin</subject><subject>Warfarin - therapeutic use</subject><subject>Young Adult</subject><issn>0002-9343</issn><issn>1555-7162</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtv1DAURi1ERYe2_wAhL9kk-JE4yQapKpSiVoDog6V1x74pHiV2aycRs-Sf16Npt0iW_DrfvfYh5B1nJWdcfdyUMG5GtKVgvCtZVTIuX5EVr-u6aLgSr8mKMSaKTlbykLxNaZO3rKvVG3IoOaurVnQr8u-XWyCGv7AGT-8wpjnR3xB7iM7TPH7C5NBP-dBNf-j34BcYlnmASE-n6GCg524d3TBkLHgK3tJrXDAivXTW45Z-dgkhIQ2R3nqL8T44f08vcAw2p7fJpWNy0MOQ8OR5PiK3519uzi6Kqx9fv52dXhVGinYqbIWiMaLmnTS9UsJyUbe8haaH3jRMNabqVdtgB7JZK95ZnleKCylFj1Ur5RH5sK_7EMPjjGnSo0sG89M9hjlpIaTgrOWdymi1R00MKUXs9UN0I8St5kzv5OuN3svXO_maVTrLz7H3zx3m9e7uJfRiOwOf9gDmfy4Oo04m2zVoXUQzaRvc_zs8Aa3BmME</recordid><startdate>201909</startdate><enddate>201909</enddate><creator>Coleman, Craig I.</creator><creator>Kreutz, Reinhold</creator><creator>Sood, Nitesh A.</creator><creator>Bunz, Thomas J.</creator><creator>Eriksson, Daniel</creator><creator>Meinecke, Anna-Katharina</creator><creator>Baker, William L.</creator><general>Elsevier Inc</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></search><sort><creationdate>201909</creationdate><title>Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation and Severe Kidney Disease or Undergoing Hemodialysis</title><author>Coleman, Craig I. ; Kreutz, Reinhold ; Sood, Nitesh A. ; Bunz, Thomas J. ; Eriksson, Daniel ; Meinecke, Anna-Katharina ; Baker, William L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c328t-d4e27c25193cf662d125818a7fafc7067c4f687e9a37b619d19a3612332fe4833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants - therapeutic use</topic><topic>Atrial fibrillation</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - epidemiology</topic><topic>Databases, Factual</topic><topic>Embolism - epidemiology</topic><topic>End-stage kidney disease</topic><topic>Factor Xa Inhibitors - therapeutic use</topic><topic>Female</topic><topic>Hemodialysis</topic><topic>Hemorrhage - epidemiology</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Oral anticoagulation</topic><topic>Renal Dialysis</topic><topic>Renal Insufficiency, Chronic - epidemiology</topic><topic>Renal Insufficiency, Chronic - therapy</topic><topic>Retrospective Studies</topic><topic>Rivaroxaban</topic><topic>Rivaroxaban - therapeutic use</topic><topic>Stroke - epidemiology</topic><topic>United States - epidemiology</topic><topic>Warfarin</topic><topic>Warfarin - therapeutic use</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Coleman, Craig I.</creatorcontrib><creatorcontrib>Kreutz, Reinhold</creatorcontrib><creatorcontrib>Sood, Nitesh A.</creatorcontrib><creatorcontrib>Bunz, Thomas J.</creatorcontrib><creatorcontrib>Eriksson, Daniel</creatorcontrib><creatorcontrib>Meinecke, Anna-Katharina</creatorcontrib><creatorcontrib>Baker, William L.</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>The American journal of medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Coleman, Craig I.</au><au>Kreutz, Reinhold</au><au>Sood, Nitesh A.</au><au>Bunz, Thomas J.</au><au>Eriksson, Daniel</au><au>Meinecke, Anna-Katharina</au><au>Baker, William L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation and Severe Kidney Disease or Undergoing Hemodialysis</atitle><jtitle>The American journal of medicine</jtitle><addtitle>Am J Med</addtitle><date>2019-09</date><risdate>2019</risdate><volume>132</volume><issue>9</issue><spage>1078</spage><epage>1083</epage><pages>1078-1083</pages><issn>0002-9343</issn><eissn>1555-7162</eissn><abstract>Patients with nonvalvular atrial fibrillation with stage 4 or 5 chronic kidney disease or undergoing hemodialysis were excluded from phase III randomized trials of nonvitamin K antagonist oral anticoagulants (NOACs). We sought to evaluate the effectiveness and safety of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis in routine practice.
Using MarketScan data from January 2012 to December 2017, we identified patients on oral anticoagulant (OAC) with naïve nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis and with ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between the rivaroxaban and warfarin cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores calculated using generalized boosted models and 10,000 regression trees (absolute standardized differences <0.1 achieved for all covariates after adjustment). Patients were followed until a stroke/systemic embolism or major bleeding event, OAC discontinuation/switch, insurance disenrollment, or end of data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the OAC cohorts were calculated using Cox regression.
We identified 1896 rivaroxaban (38.7% received a dose <20 mg/d) and 4848 warfarin users. Eighty-eight percent of included patients had stage 5 chronic kidney disease or were undergoing hemodialysis. Rivaroxaban did not significantly reduce stroke or systemic embolism (HR = 0.55, 95% CI = 0.27-1.10) or ischemic stroke (HR = 0.67, 95% CI = 0.30-1.50) alone, but it was associated with a significant 32% (95% CI = 1-53%) reduction in major bleeding risk compared with warfarin.
Among patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis, rivaroxaban appears associated with significantly less major bleeding compared to warfarin.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31054829</pmid><doi>10.1016/j.amjmed.2019.04.013</doi><tpages>6</tpages></addata></record> |
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| subjects | Administration, Oral Adolescent Adult Aged Aged, 80 and over Anticoagulants - therapeutic use Atrial fibrillation Atrial Fibrillation - drug therapy Atrial Fibrillation - epidemiology Databases, Factual Embolism - epidemiology End-stage kidney disease Factor Xa Inhibitors - therapeutic use Female Hemodialysis Hemorrhage - epidemiology Humans Male Middle Aged Oral anticoagulation Renal Dialysis Renal Insufficiency, Chronic - epidemiology Renal Insufficiency, Chronic - therapy Retrospective Studies Rivaroxaban Rivaroxaban - therapeutic use Stroke - epidemiology United States - epidemiology Warfarin Warfarin - therapeutic use Young Adult |
| title | Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation and Severe Kidney Disease or Undergoing Hemodialysis |
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