Replacing warfarin with a novel oral anticoagulant: Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study)

Mohit K. Turagam, Valay Parikh, Muhammad R. Afzal, Rakesh Gopinathannair, Madhav Lavu, Arun Kanmanthareddy, Jayasree Pillarisetti, Madhu Reddy, Donita Atkins, Sudharani Bommana, Melissa Jaeger, Courtney Jeffery, Sanghamitra Mohanty, Pasquale Santangeli, Jie Cheng, Luigi Di Biase, Calambur Narasimhan, Andrea Natale, Dhanunjaya Lakkireddy

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of direct oral antagonists (DOACs) in these WI patients. Methods: We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs. Results: Note that 63% (166 of 263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5% vs. 30%, P < 0.0001). Five percent (12 of 263) developed repeat STE. Higher mean CHA2DS2VASC (6.5 ± 1.7 vs. 3.3 ± 1.6 = 0.001) score was associated with repeat STE. About 34% (57 of 166) of patients had an intervention to manage repeat MBE. LAAO devices were successfully used in 67% (12 of 18) high-risk patients who underwent major interventions to manage MBE. Conclusion: In WI patients rechallenged with DOACs, a significant proportion developed repeat MBE. LAAO devices seem reasonable in those patients who undergo major interventions to manage MBE with cautious and temporary continuation of DOAC.

Original languageEnglish (US)
JournalJournal of Cardiovascular Electrophysiology
DOIs
StateAccepted/In press - 2017

Fingerprint

Warfarin
Anticoagulants
Atrial Fibrillation
Stroke
Hemorrhage
Thromboembolism
Equipment and Supplies

Keywords

  • Direct oral anticoagulant
  • Left atrial appendage
  • Major bleeding
  • Systemic thromboembolism
  • Thrombus
  • Warfarin intolerance

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Replacing warfarin with a novel oral anticoagulant : Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study). / Turagam, Mohit K.; Parikh, Valay; Afzal, Muhammad R.; Gopinathannair, Rakesh; Lavu, Madhav; Kanmanthareddy, Arun; Pillarisetti, Jayasree; Reddy, Madhu; Atkins, Donita; Bommana, Sudharani; Jaeger, Melissa; Jeffery, Courtney; Mohanty, Sanghamitra; Santangeli, Pasquale; Cheng, Jie; Di Biase, Luigi; Narasimhan, Calambur; Natale, Andrea; Lakkireddy, Dhanunjaya.

In: Journal of Cardiovascular Electrophysiology, 2017.

Research output: Contribution to journalArticle

Turagam, MK, Parikh, V, Afzal, MR, Gopinathannair, R, Lavu, M, Kanmanthareddy, A, Pillarisetti, J, Reddy, M, Atkins, D, Bommana, S, Jaeger, M, Jeffery, C, Mohanty, S, Santangeli, P, Cheng, J, Di Biase, L, Narasimhan, C, Natale, A & Lakkireddy, D 2017, 'Replacing warfarin with a novel oral anticoagulant: Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study)', Journal of Cardiovascular Electrophysiology. https://doi.org/10.1111/jce.13254
Turagam, Mohit K. ; Parikh, Valay ; Afzal, Muhammad R. ; Gopinathannair, Rakesh ; Lavu, Madhav ; Kanmanthareddy, Arun ; Pillarisetti, Jayasree ; Reddy, Madhu ; Atkins, Donita ; Bommana, Sudharani ; Jaeger, Melissa ; Jeffery, Courtney ; Mohanty, Sanghamitra ; Santangeli, Pasquale ; Cheng, Jie ; Di Biase, Luigi ; Narasimhan, Calambur ; Natale, Andrea ; Lakkireddy, Dhanunjaya. / Replacing warfarin with a novel oral anticoagulant : Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study). In: Journal of Cardiovascular Electrophysiology. 2017.
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abstract = "Background: A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of direct oral antagonists (DOACs) in these WI patients. Methods: We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs. Results: Note that 63{\%} (166 of 263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5{\%} vs. 30{\%}, P < 0.0001). Five percent (12 of 263) developed repeat STE. Higher mean CHA2DS2VASC (6.5 ± 1.7 vs. 3.3 ± 1.6 = 0.001) score was associated with repeat STE. About 34{\%} (57 of 166) of patients had an intervention to manage repeat MBE. LAAO devices were successfully used in 67{\%} (12 of 18) high-risk patients who underwent major interventions to manage MBE. Conclusion: In WI patients rechallenged with DOACs, a significant proportion developed repeat MBE. LAAO devices seem reasonable in those patients who undergo major interventions to manage MBE with cautious and temporary continuation of DOAC.",
keywords = "Direct oral anticoagulant, Left atrial appendage, Major bleeding, Systemic thromboembolism, Thrombus, Warfarin intolerance",
author = "Turagam, {Mohit K.} and Valay Parikh and Afzal, {Muhammad R.} and Rakesh Gopinathannair and Madhav Lavu and Arun Kanmanthareddy and Jayasree Pillarisetti and Madhu Reddy and Donita Atkins and Sudharani Bommana and Melissa Jaeger and Courtney Jeffery and Sanghamitra Mohanty and Pasquale Santangeli and Jie Cheng and {Di Biase}, Luigi and Calambur Narasimhan and Andrea Natale and Dhanunjaya Lakkireddy",
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T1 - Replacing warfarin with a novel oral anticoagulant

T2 - Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study)

AU - Turagam, Mohit K.

AU - Parikh, Valay

AU - Afzal, Muhammad R.

AU - Gopinathannair, Rakesh

AU - Lavu, Madhav

AU - Kanmanthareddy, Arun

AU - Pillarisetti, Jayasree

AU - Reddy, Madhu

AU - Atkins, Donita

AU - Bommana, Sudharani

AU - Jaeger, Melissa

AU - Jeffery, Courtney

AU - Mohanty, Sanghamitra

AU - Santangeli, Pasquale

AU - Cheng, Jie

AU - Di Biase, Luigi

AU - Narasimhan, Calambur

AU - Natale, Andrea

AU - Lakkireddy, Dhanunjaya

PY - 2017

Y1 - 2017

N2 - Background: A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of direct oral antagonists (DOACs) in these WI patients. Methods: We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs. Results: Note that 63% (166 of 263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5% vs. 30%, P < 0.0001). Five percent (12 of 263) developed repeat STE. Higher mean CHA2DS2VASC (6.5 ± 1.7 vs. 3.3 ± 1.6 = 0.001) score was associated with repeat STE. About 34% (57 of 166) of patients had an intervention to manage repeat MBE. LAAO devices were successfully used in 67% (12 of 18) high-risk patients who underwent major interventions to manage MBE. Conclusion: In WI patients rechallenged with DOACs, a significant proportion developed repeat MBE. LAAO devices seem reasonable in those patients who undergo major interventions to manage MBE with cautious and temporary continuation of DOAC.

AB - Background: A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of direct oral antagonists (DOACs) in these WI patients. Methods: We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs. Results: Note that 63% (166 of 263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5% vs. 30%, P < 0.0001). Five percent (12 of 263) developed repeat STE. Higher mean CHA2DS2VASC (6.5 ± 1.7 vs. 3.3 ± 1.6 = 0.001) score was associated with repeat STE. About 34% (57 of 166) of patients had an intervention to manage repeat MBE. LAAO devices were successfully used in 67% (12 of 18) high-risk patients who underwent major interventions to manage MBE. Conclusion: In WI patients rechallenged with DOACs, a significant proportion developed repeat MBE. LAAO devices seem reasonable in those patients who undergo major interventions to manage MBE with cautious and temporary continuation of DOAC.

KW - Direct oral anticoagulant

KW - Left atrial appendage

KW - Major bleeding

KW - Systemic thromboembolism

KW - Thrombus

KW - Warfarin intolerance

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DO - 10.1111/jce.13254

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