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

Yadlapati, Ajay; Groh, Christopher A.; Malaisrie, S. Chris; Gajjar, Mark; Kruse, Jane; Meyers, Sheridan N.; Passman, Rod

doi:10.1007/s00392-015-0919-z

Cited by 57 publications

(26 citation statements)

References 24 publications

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“…5 According to the practice guidelines of the European Heart Rhythm Association, patients with bioprosthetic heart valve or surgical valve repair are eligible to receive NOACs, expectedly for the first 3 to 6 months postoperatively. 6 Few clinical practice data are available in literature about the efficacy and safety of NOACs in AF patients with bioprosthetic heart valves or surgical valve repair, 11,12 and these patients were relatively underrepresented in trials performed to date. The RELY (Randomized Evaluation of Long-term Anticoagulant Therapy) trial excluded AF patients with prosthetic heart valve (biological or mechanical) and valvular disease requiring an intervention before study.…”

Section: Discussionmentioning

confidence: 99%

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience

Russo

Attena²,

Mazzone

et al. 2018

Semin Thromb Hemost

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This is an observational study to investigate the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with bioprosthetic valves or prior surgical valve repair in clinical practice. A total of 122 patients (mean age: 74.1 ± 13.2; 54 females) with bioprosthetic heart valve or surgical valve repair and AF treated with NOACs were included in the analysis. The mean CHADS-VASc (Congestive heart failure, Hypertension, Age >75 years, Diabetes mellitus, prior Stroke or transient ischemic attack, Vascular disease) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR [international normalized ratio], Elderly, Drugs or alcohol) score values were 3.6 ± 1.2 and 2.6 ± 1.4, respectively. Of the total study population, 28.6% was taking apixaban 5 mg twice daily (BID), 24.5% apixaban 2.5 mg BID, 18% dabigatran 150 mg BID, 13% dabigatran 110 mg BID, 9.8% rivaroxaban 20 mg daily (QD), and 5.7% rivaroxaban 15 mg QD. Also, 92% of the study population previously had warfarin replaced with NOACs due to lack compliance and labile INR control (time in therapeutic range < 60%). NOAC therapy for AF was started on average 934 ± 567 days after bioprosthetic heart valve implantation or surgical repair for an average duration of 835 ± 203 days. The study population included 24 (19.6%) patients with bioprosthetic mitral valve, 52 (43%) patients with bioprosthetic aortic valve, 41 (33.6%) patients with previous surgical mitral repair, 5 (4%) patients with previous surgical aortic repair, and concomitant use of NOACs. All patients were evaluated for thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism) as well as major bleeding events during the follow-up period. In our study population, we recorded a low mean annual incidence of thromboembolism (0.8%) and major bleeding (1.3%). According to our data, anticoagulation therapy with NOACs seems to be an effective and a safe treatment strategy for nonvalvular AF patients with bioprosthetic valves or prior surgical valve repair.

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Section: Discussionmentioning

confidence: 99%

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience

Russo

Attena²,

Mazzone

et al. 2018

Semin Thromb Hemost

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“…A sixty-seven-year-old male was initially admitted to our hospital with shortness of breath and severe aortic valve regurgitation ( Figure 1A atrial fibrillation with or without bioprosthetic valve due to the convenience and the potential reduction in the length of hospital stay. 1,6 However, GALILEO (Global Study Comparing a Rivaroxaban-based Antithrombotic Strategy to an Antiplatelet-based Strategy after TAVR to Optimize Clinical Outcomes) trial showed that rivaroxaban was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy after successful transcatheter aortic valve replacement. 7 In addition, rebound thrombosis upon discontinuation of rivaroxaban was reported.…”

Section: A S Ementioning

confidence: 99%

Anticoagulation for coexisting bioprosthetic aortic valve thrombosis and anticoagulant‐related bleeding: “A double edge sword”

Lata

Zhou

et al. 2020

Echocardiography

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The choice of anticoagulant agents for newly implanted bioprosthetic valve varies significantly, particularly in the presence of postoperative atrial fibrillation with increasing use of nonvitamin K oral anticoagulation (NOACs) in recent years. We reported a challenging case with a coexisting bioprosthetic aortic valve thrombosis and significant anticoagulant-related bleeding. Clinical management strategy and brief literature review were presented.

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“…31 One small pilot study compared dabigatran versus warfarin after bioprosthesis valve replacement for the management of AF postoperatively (DAWA pilot study), but small numbers preclude definitive conclusions. 32 Recent small studies also suggest that NOACs can be a reasonable alternative to VKA in patients with AF and remote bioprosthetic valve implantation; 22,33 however, larger studies are needed to define the safety and efficacy profile. Data on thromboprophylaxis in patients with AF and TAVI, which is actually the insertion of a bioprosthesis, are preliminary 34 and discussed in section 'Antithrombotic Therapy in Patients with AF Undergoing TAVI or Left Atrial Appendage Occlusion'.…”

Section: Bioprosthesesmentioning

confidence: 99%

Antithrombotic Therapy in Atrial Fibrillation Associated with Valvular Heart Disease: Executive Summary of a Joint Consensus Document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology Working Group on Thrombosis, Endorsed by the ESC Working Group on Valvular Heart Disease, Cardiac Arrhythmia Society of Southern Africa (CASSA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de E

Lip¹,

Collet²,

Caterina³

et al. 2017

Thromb Haemost

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Management strategies for patients with atrial fibrillation (AF) in association with valvular heart disease (VHD) have been less informed by randomized trials, which have largely focused on ‘non-valvular AF’ patients. Thromboembolic risk also varies according to valve lesion and may also be associated with CHA2DS2-VASc score risk factor components, rather than only the valve disease being causal. Given the need to provide expert recommendations for professionals participating in the care of patients presenting with AF and associated VHD, a task force was convened by the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group (WG) on Thrombosis, with representation from the ESC WG on Valvular Heart Disease, Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) with the remit to comprehensively review the published evidence, and to produce a consensus document on the management of patients with AF and associated VHD, with up-to-date consensus statements for clinical practice for different forms of VHD, based on the principles of evidence-based medicine. This is an executive summary of a consensus document which proposes that the term ‘valvular AF’ is outdated and given that any definition ultimately relates to the evaluated practical use of oral anticoagulation (OAC) type, we propose a functional EHRA (Evaluated Heartvalves, Rheumatic or Artificial) categorization in relation to the type of OAC use in patients with AF, as follows: (1) EHRA (Evaluated Heartvalves, Rheumatic or Artificial) type 1 VHD, which refers to AF patients with ‘VHD needing therapy with a vitamin K antagonist (VKA)’ and (2) EHRA (Evaluated Heartvalves, Rheumatic or Artificial) type 2 VHD, which refers to AF patients with ‘VHD needing therapy with a VKA or a non-VKA oral anticoagulant also taking into consideration CHA2DS2-VASc score risk factor components.

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

Abstract: 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.

Cited by 57 publications

References 24 publications

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience

Anticoagulation for coexisting bioprosthetic aortic valve thrombosis and anticoagulant‐related bleeding: “A double edge sword”

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