Frequency and outcomes of reduced dose Non-Vitamin K antagonist anticoagulants: Results from ORBIT-AF II (The outcomes registry for better informed treatment of atrial fibrillation II)

on behalf of The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) II Investigators

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Background--Non-vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice. Methods and Results--We analyzed data from the ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients. Among 7925 AF patients receiving NOACs, we assessed patterns of use of reduced NOAC doses and associated cardiovascular and bleeding outcomes at median follow-up of 1 year. Overall, 6636 patients (84%) received a NOAC at standard dose, which was consistent with US Food and Drug Administration labeling in 6376 (96%). Reduced NOAC dose was prescribed to 1289 (16% overall), which was consistent with Food and Drug Administration labelingin only555patients (43%).Compared with thosewhoseNOACdosewasappropriately reduced, patients receiving inappropriate dose reductions were younger (median age 79 versus 84, P < 0.0001) and had lower ORBIT bleeding risk scores (26% =4 versus 45%, P < 0.0001). Compared with those appropriately receiving standard dosing, patients receiving inappropriately reduced-doseNOACs had higher unadjusted rates of thromboembolic events (2.11 versus 1.35 events per 100 patient years, hazard ratio 1.56, 95% confidence interval 0.92-2.67) and death (6.77 versus 2.60, hazard ratio 2.61, 95% confidence interval 1.86-3.67). After adjustment, outcomes were not significantly different but tended to favor patients dosed appropriately. Conclusions--The majority of dose reductions of NOACs in AF are inconsistent with US Food and Drug Administration recommendations. There appear to be opportunities to improve current NOAC dosing in community practice.

Original languageEnglish (US)
Article numbere007633
JournalJournal of the American Heart Association
Volume7
Issue number4
DOIs
StatePublished - Feb 1 2018

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Anticoagulants
Atrial Fibrillation
Registries
United States Food and Drug Administration
Drug Labeling
Therapeutics
Confidence Intervals
Hemorrhage
Stroke
Food

Keywords

  • Atrial fibrillation
  • Dosing
  • Non-vitamin K antagonist oral anticoagulant
  • Outcome

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Frequency and outcomes of reduced dose Non-Vitamin K antagonist anticoagulants : Results from ORBIT-AF II (The outcomes registry for better informed treatment of atrial fibrillation II). / on behalf of The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) II Investigators.

In: Journal of the American Heart Association, Vol. 7, No. 4, e007633, 01.02.2018.

Research output: Contribution to journalArticle

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title = "Frequency and outcomes of reduced dose Non-Vitamin K antagonist anticoagulants: Results from ORBIT-AF II (The outcomes registry for better informed treatment of atrial fibrillation II)",
abstract = "Background--Non-vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice. Methods and Results--We analyzed data from the ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients. Among 7925 AF patients receiving NOACs, we assessed patterns of use of reduced NOAC doses and associated cardiovascular and bleeding outcomes at median follow-up of 1 year. Overall, 6636 patients (84{\%}) received a NOAC at standard dose, which was consistent with US Food and Drug Administration labeling in 6376 (96{\%}). Reduced NOAC dose was prescribed to 1289 (16{\%} overall), which was consistent with Food and Drug Administration labelingin only555patients (43{\%}).Compared with thosewhoseNOACdosewasappropriately reduced, patients receiving inappropriate dose reductions were younger (median age 79 versus 84, P < 0.0001) and had lower ORBIT bleeding risk scores (26{\%} =4 versus 45{\%}, P < 0.0001). Compared with those appropriately receiving standard dosing, patients receiving inappropriately reduced-doseNOACs had higher unadjusted rates of thromboembolic events (2.11 versus 1.35 events per 100 patient years, hazard ratio 1.56, 95{\%} confidence interval 0.92-2.67) and death (6.77 versus 2.60, hazard ratio 2.61, 95{\%} confidence interval 1.86-3.67). After adjustment, outcomes were not significantly different but tended to favor patients dosed appropriately. Conclusions--The majority of dose reductions of NOACs in AF are inconsistent with US Food and Drug Administration recommendations. There appear to be opportunities to improve current NOAC dosing in community practice.",
keywords = "Atrial fibrillation, Dosing, Non-vitamin K antagonist oral anticoagulant, Outcome",
author = "{on behalf of The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) II Investigators} and Steinberg, {Benjamin A.} and Peter Shrader and Karen Pieper and Laine Thomas and Allen, {Larry A.} and Jack Ansell and Chan, {Paul S.} and Ezekowitz, {Michael D.} and Fonarow, {Gregg C.} and Freeman, {James V.} and Gersh, {Bernard J.} and Kowey, {Peter R.} and Mahaffey, {Kenneth W.} and Naccarelli, {Gerald V.} and Reiffel, {James A.} and Singer, {Daniel E.} and Peterson, {Eric D.} and Piccini, {Jonathan P.} and Sanjiv Sobti and Anthony Alfieri and James Bacon and Noel Bedwell and John Berry and Ravi Bhagwat and Stephen Bloom and Fernando Boccalandro and Leonard Parilak and James Capo and Shaival Kapadia and {Edwin Morriss}, J. and Basharat Muneer and Harinder Gogia and William Herzog and David Hotchkiss and John Ip and Naseem Jaffrani and Alan Jones and John Kazmierski and Waqar Khan and Kneller, {G. Larsen} and Ajay Labroo and Brian Jaffe and Mark Lebenthal and Daniel Lee and Ahmadian, {Homayoun Reza} and Paul Maccaro and Nolan Mayer and Paul McLaughlin and Robert Mendelson and Nilsson, {Kent R}",
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TY - JOUR

T1 - Frequency and outcomes of reduced dose Non-Vitamin K antagonist anticoagulants

T2 - Results from ORBIT-AF II (The outcomes registry for better informed treatment of atrial fibrillation II)

AU - on behalf of The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) II Investigators

AU - Steinberg, Benjamin A.

AU - Shrader, Peter

AU - Pieper, Karen

AU - Thomas, Laine

AU - Allen, Larry A.

AU - Ansell, Jack

AU - Chan, Paul S.

AU - Ezekowitz, Michael D.

AU - Fonarow, Gregg C.

AU - Freeman, James V.

AU - Gersh, Bernard J.

AU - Kowey, Peter R.

AU - Mahaffey, Kenneth W.

AU - Naccarelli, Gerald V.

AU - Reiffel, James A.

AU - Singer, Daniel E.

AU - Peterson, Eric D.

AU - Piccini, Jonathan P.

AU - Sobti, Sanjiv

AU - Alfieri, Anthony

AU - Bacon, James

AU - Bedwell, Noel

AU - Berry, John

AU - Bhagwat, Ravi

AU - Bloom, Stephen

AU - Boccalandro, Fernando

AU - Parilak, Leonard

AU - Capo, James

AU - Kapadia, Shaival

AU - Edwin Morriss, J.

AU - Muneer, Basharat

AU - Gogia, Harinder

AU - Herzog, William

AU - Hotchkiss, David

AU - Ip, John

AU - Jaffrani, Naseem

AU - Jones, Alan

AU - Kazmierski, John

AU - Khan, Waqar

AU - Kneller, G. Larsen

AU - Labroo, Ajay

AU - Jaffe, Brian

AU - Lebenthal, Mark

AU - Lee, Daniel

AU - Ahmadian, Homayoun Reza

AU - Maccaro, Paul

AU - Mayer, Nolan

AU - McLaughlin, Paul

AU - Mendelson, Robert

AU - Nilsson, Kent R

PY - 2018/2/1

Y1 - 2018/2/1

N2 - Background--Non-vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice. Methods and Results--We analyzed data from the ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients. Among 7925 AF patients receiving NOACs, we assessed patterns of use of reduced NOAC doses and associated cardiovascular and bleeding outcomes at median follow-up of 1 year. Overall, 6636 patients (84%) received a NOAC at standard dose, which was consistent with US Food and Drug Administration labeling in 6376 (96%). Reduced NOAC dose was prescribed to 1289 (16% overall), which was consistent with Food and Drug Administration labelingin only555patients (43%).Compared with thosewhoseNOACdosewasappropriately reduced, patients receiving inappropriate dose reductions were younger (median age 79 versus 84, P < 0.0001) and had lower ORBIT bleeding risk scores (26% =4 versus 45%, P < 0.0001). Compared with those appropriately receiving standard dosing, patients receiving inappropriately reduced-doseNOACs had higher unadjusted rates of thromboembolic events (2.11 versus 1.35 events per 100 patient years, hazard ratio 1.56, 95% confidence interval 0.92-2.67) and death (6.77 versus 2.60, hazard ratio 2.61, 95% confidence interval 1.86-3.67). After adjustment, outcomes were not significantly different but tended to favor patients dosed appropriately. Conclusions--The majority of dose reductions of NOACs in AF are inconsistent with US Food and Drug Administration recommendations. There appear to be opportunities to improve current NOAC dosing in community practice.

AB - Background--Non-vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice. Methods and Results--We analyzed data from the ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients. Among 7925 AF patients receiving NOACs, we assessed patterns of use of reduced NOAC doses and associated cardiovascular and bleeding outcomes at median follow-up of 1 year. Overall, 6636 patients (84%) received a NOAC at standard dose, which was consistent with US Food and Drug Administration labeling in 6376 (96%). Reduced NOAC dose was prescribed to 1289 (16% overall), which was consistent with Food and Drug Administration labelingin only555patients (43%).Compared with thosewhoseNOACdosewasappropriately reduced, patients receiving inappropriate dose reductions were younger (median age 79 versus 84, P < 0.0001) and had lower ORBIT bleeding risk scores (26% =4 versus 45%, P < 0.0001). Compared with those appropriately receiving standard dosing, patients receiving inappropriately reduced-doseNOACs had higher unadjusted rates of thromboembolic events (2.11 versus 1.35 events per 100 patient years, hazard ratio 1.56, 95% confidence interval 0.92-2.67) and death (6.77 versus 2.60, hazard ratio 2.61, 95% confidence interval 1.86-3.67). After adjustment, outcomes were not significantly different but tended to favor patients dosed appropriately. Conclusions--The majority of dose reductions of NOACs in AF are inconsistent with US Food and Drug Administration recommendations. There appear to be opportunities to improve current NOAC dosing in community practice.

KW - Atrial fibrillation

KW - Dosing

KW - Non-vitamin K antagonist oral anticoagulant

KW - Outcome

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U2 - 10.1161/JAHA.117.007633

DO - 10.1161/JAHA.117.007633

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VL - 7

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

SN - 2047-9980

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