Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves

Ajay Yadlapati*, Christopher Groh, S Chris Malaisrie, Mark Gajjar, Jane Kruse, Sheridan Norman Meyers, Rod S Passman

*Corresponding author for this work

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Purpose: Prosthetic valve replacement is performed in several hundred thousand patients worldwide annually, and many of these patients have or will ultimately develop atrial fibrillation or flutter (AF). Novel oral anticoagulants (NOACs) are not recommended in patients with AF and mechanical valves but have not been evaluated in patients with bioprosthetic valves. This study sought to evaluate the efficacy and safety of NOACs in patients with AF and bioprosthetic valves. Methods: A retrospective single-center cohort study was performed on all patients with bioprosthetic valve implantation, for whom a NOAC was prescribed for the indication of AF. Patients were evaluated for thromboembolic events including imaging confirmed ischemic stroke, clinically suspected transient ischemic attack, and major bleeding events (according to International Society on Thrombosis and Hemostasis definition). Results: In total, 73 patients (26 female, 35.6 %) were identified. NOAC therapy began, on average, 990.0 ± 1029.1 days after bioprosthetic valve implantation for an average duration of 511.8 ± 400.8 days. Aspirin was used concomitantly in a majority of patients (72.6 %). There were no ischemic strokes identified (0.0 %) and one possible TIA (1.4 %). There were 6 (8.2 %) minor and 5 (6.9 %) major bleeding events. Conclusion: The use of NOAC therapy for AF in patients with bioprosthetic valves appears safe and effective in the occurrence of thromboembolic events, however, at the expense of increased bleeding. Larger studies are necessary to confirm these findings.

Original languageEnglish (US)
Pages (from-to)268-272
Number of pages5
JournalClinical Research in Cardiology
Volume105
Issue number3
DOIs
StatePublished - Mar 1 2016

Fingerprint

Anticoagulants
Safety
Hemorrhage
Stroke
Atrial Flutter
Transient Ischemic Attack
Hemostasis
Atrial Fibrillation
Aspirin
Thrombosis
Cohort Studies
Therapeutics

Keywords

  • Anticoagulation
  • Atrial fibrillation
  • Atrial flutter
  • Bioprosthetic
  • Novel anticoagulants
  • Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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title = "Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves",
abstract = "Purpose: Prosthetic valve replacement is performed in several hundred thousand patients worldwide annually, and many of these patients have or will ultimately develop atrial fibrillation or flutter (AF). Novel oral anticoagulants (NOACs) are not recommended in patients with AF and mechanical valves but have not been evaluated in patients with bioprosthetic valves. This study sought to evaluate the efficacy and safety of NOACs in patients with AF and bioprosthetic valves. Methods: A retrospective single-center cohort study was performed on all patients with bioprosthetic valve implantation, for whom a NOAC was prescribed for the indication of AF. Patients were evaluated for thromboembolic events including imaging confirmed ischemic stroke, clinically suspected transient ischemic attack, and major bleeding events (according to International Society on Thrombosis and Hemostasis definition). Results: In total, 73 patients (26 female, 35.6 {\%}) were identified. NOAC therapy began, on average, 990.0 ± 1029.1 days after bioprosthetic valve implantation for an average duration of 511.8 ± 400.8 days. Aspirin was used concomitantly in a majority of patients (72.6 {\%}). There were no ischemic strokes identified (0.0 {\%}) and one possible TIA (1.4 {\%}). There were 6 (8.2 {\%}) minor and 5 (6.9 {\%}) major bleeding events. Conclusion: The use of NOAC therapy for AF in patients with bioprosthetic valves appears safe and effective in the occurrence of thromboembolic events, however, at the expense of increased bleeding. Larger studies are necessary to confirm these findings.",
keywords = "Anticoagulation, Atrial fibrillation, Atrial flutter, Bioprosthetic, Novel anticoagulants, Safety",
author = "Ajay Yadlapati and Christopher Groh and Malaisrie, {S Chris} and Mark Gajjar and Jane Kruse and Meyers, {Sheridan Norman} and Passman, {Rod S}",
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Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves. / Yadlapati, Ajay; Groh, Christopher; Malaisrie, S Chris; Gajjar, Mark; Kruse, Jane; Meyers, Sheridan Norman; Passman, Rod S.

In: Clinical Research in Cardiology, Vol. 105, No. 3, 01.03.2016, p. 268-272.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves

AU - Yadlapati, Ajay

AU - Groh, Christopher

AU - Malaisrie, S Chris

AU - Gajjar, Mark

AU - Kruse, Jane

AU - Meyers, Sheridan Norman

AU - Passman, Rod S

PY - 2016/3/1

Y1 - 2016/3/1

N2 - Purpose: Prosthetic valve replacement is performed in several hundred thousand patients worldwide annually, and many of these patients have or will ultimately develop atrial fibrillation or flutter (AF). Novel oral anticoagulants (NOACs) are not recommended in patients with AF and mechanical valves but have not been evaluated in patients with bioprosthetic valves. This study sought to evaluate the efficacy and safety of NOACs in patients with AF and bioprosthetic valves. Methods: A retrospective single-center cohort study was performed on all patients with bioprosthetic valve implantation, for whom a NOAC was prescribed for the indication of AF. Patients were evaluated for thromboembolic events including imaging confirmed ischemic stroke, clinically suspected transient ischemic attack, and major bleeding events (according to International Society on Thrombosis and Hemostasis definition). Results: In total, 73 patients (26 female, 35.6 %) were identified. NOAC therapy began, on average, 990.0 ± 1029.1 days after bioprosthetic valve implantation for an average duration of 511.8 ± 400.8 days. Aspirin was used concomitantly in a majority of patients (72.6 %). There were no ischemic strokes identified (0.0 %) and one possible TIA (1.4 %). There were 6 (8.2 %) minor and 5 (6.9 %) major bleeding events. Conclusion: The use of NOAC therapy for AF in patients with bioprosthetic valves appears safe and effective in the occurrence of thromboembolic events, however, at the expense of increased bleeding. Larger studies are necessary to confirm these findings.

AB - Purpose: Prosthetic valve replacement is performed in several hundred thousand patients worldwide annually, and many of these patients have or will ultimately develop atrial fibrillation or flutter (AF). Novel oral anticoagulants (NOACs) are not recommended in patients with AF and mechanical valves but have not been evaluated in patients with bioprosthetic valves. This study sought to evaluate the efficacy and safety of NOACs in patients with AF and bioprosthetic valves. Methods: A retrospective single-center cohort study was performed on all patients with bioprosthetic valve implantation, for whom a NOAC was prescribed for the indication of AF. Patients were evaluated for thromboembolic events including imaging confirmed ischemic stroke, clinically suspected transient ischemic attack, and major bleeding events (according to International Society on Thrombosis and Hemostasis definition). Results: In total, 73 patients (26 female, 35.6 %) were identified. NOAC therapy began, on average, 990.0 ± 1029.1 days after bioprosthetic valve implantation for an average duration of 511.8 ± 400.8 days. Aspirin was used concomitantly in a majority of patients (72.6 %). There were no ischemic strokes identified (0.0 %) and one possible TIA (1.4 %). There were 6 (8.2 %) minor and 5 (6.9 %) major bleeding events. Conclusion: The use of NOAC therapy for AF in patients with bioprosthetic valves appears safe and effective in the occurrence of thromboembolic events, however, at the expense of increased bleeding. Larger studies are necessary to confirm these findings.

KW - Anticoagulation

KW - Atrial fibrillation

KW - Atrial flutter

KW - Bioprosthetic

KW - Novel anticoagulants

KW - Safety

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