Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial

Mieghem, Nicolas Van; Unverdorben, Martin; Valgimigli, Marco; Mehran, Roxana; Boersma, Eric; Baber, Usinan; Hengstenberg, Christian; Shi, Minggao; Chen, Cathy; Saïto, Shigeru; Veltkamp, Roland; Vranckx, Pascal; Dangas, George

doi:10.1016/j.ahj.2018.07.006

Cited by 64 publications

(29 citation statements)

References 26 publications

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“…The ENVISAGE-TAVI (Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) in Atrial Fibrillation) trial is a multicentre open-label randomised trial comparing edoxaban to VKA-based therapy in patients with an indication for OAC after TAVI for up to 36 months [77]. The primary outcome evaluated is net adverse events and major bleeding.…”

Section: Ongoing Trialsmentioning

confidence: 99%

“…OAC: oral anticoagulation; DAPT: dual antiplatelet therapy; VARC: valve academic research consortium; BARC: bleeding academic research consortium; INR: international normalised ratio; MI: Myocardial infarction; PE: pulmonary embolism; DVT: deep vein thrombosis; MRI: Magnetic resonance imaging [75,76,77,78,79,80]. a age >80years, body weight <60 kg, serum creatinine >1.5 mg/dL/; b all-cause death, MI, ischaemic stroke, valve thrombosis, and major bleeding.…”

Section: Figurementioning

confidence: 99%

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Thromboembolic and Bleeding Complications in Transcatheter Aortic Valve Implantation: Insights on Mechanisms, Prophylaxis and Therapy

Ranasinghe

Peter

McFadyen

2019

JCM

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Transcatheter aortic valve implantation (TAVI) has emerged as an important alternative to surgical aortic valve repair (SAVR) for patients with severe aortic stenosis. This rapidly advancing field has produced new-generation devices being delivered with small delivery sheaths, embolic protection devices and improved retrieval features. Despite efforts to reduce the rate of thrombotic complications associated with TAVI, valve thrombosis and cerebral ischaemic events post-TAVI continue to be a significant issue. However, the antithrombotic treatments utilised to prevent these dreaded complications are based on weak evidence and are associated with high rates of bleeding, which in itself is associated with adverse clinical outcomes. Recently, experimental data has shed light on the unique mechanisms, particularly the complex haemodynamic changes at sites of TAVI, that underpin the development of post-TAVI thrombosis. These new insights regarding the drivers of TAVI-associated thrombosis, coupled with the ongoing development of novel antithrombotics which do not cause bleeding, hold the potential to deliver newer, safer therapeutic paradigms to prevent post-TAVI thrombotic and bleeding complications. This review highlights the major challenge of post-TAVI thrombosis and bleeding, and the significant issues surrounding current antithrombotic approaches. Moreover, a detailed discussion regarding the mechanisms of post-TAVI thrombosis is provided, in addition to an appraisal of current antithrombotic guidelines, past and ongoing clinical trials, and how novel therapeutics offer the hope of optimizing antithrombotic strategies and ultimately improving patient outcomes.

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Section: Ongoing Trialsmentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

Thromboembolic and Bleeding Complications in Transcatheter Aortic Valve Implantation: Insights on Mechanisms, Prophylaxis and Therapy

Ranasinghe

Peter

McFadyen

2019

JCM

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“…Other observational studies, however, do not ( 8 ). Large randomized controlled trials are ongoing to further evaluate whether DOAC effectively presents an increased risk of thromboembolic events in patients undergoing TAVR with concomitant OAC indication ( 9 , 10 ).…”

Section: Discussionmentioning

confidence: 99%

Late Clinical Valve Thrombosis After Transcatheter Aortic Valve Replacement Despite Non-Vitamin K Anticoagulant

Carmeliet¹,

Vermeersch

Prihadi

2021

JACC: Case Reports

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This study presents the case of a late clinical leaflet thrombosis 1.5 years after percutaneous aortic valve replacement, despite adequate non-vitamin K anticoagulant therapy. Optimal antithrombotic therapy after transcatheter aortic valve replacement remains undetermined. After switching to vitamin K antagonist therapy, complete resolution occurred at 3 months follow-up. ( Level of Difficulty: Intermediate. )

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“…49 Further studies like ATLANTIS and ENVISAGE-AF trials are ongoing, investigating apixaban and edoxaban in patients with AF and TAVI. 50 Thus, the type of NOAC and dose regimen seems to be crucial. 51 None the less in patients with bioprosthetic valves and AF, a full-dose NOAC treatment seems to be as efficient and safe as VKA.…”

Section: Factor Xa Inhibitorsmentioning

confidence: 99%

Noncanonical Effects of Oral Thrombin and Factor Xa Inhibitors in Platelet Activation and Arterial Thrombosis

et al. 2020

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Nonvitamin K oral anticoagulants (NOACs) or direct oral anticoagulants comprise inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or factor IIa (dabigatran). Both classes efficiently interfere with the final or penultimate step of the coagulation cascade and showed superior net clinical benefit compared with vitamin K antagonists for prevention of thromboembolic events in patients with AF and for prevention and therapy of deep vein thrombosis and pulmonary embolism. None the less, accumulating data suggested, that there may be differences regarding the frequency of atherothrombotic cardiovascular events between NOACs. Thus, the optimal individualized NOAC for each patient remains a matter of debate. Against this background, some basic and translational analyses emphasized NOAC effects that impact on platelet activity and arterial thrombus formation beyond inhibition of plasmatic coagulation. In this review, we will provide an overview of the available clinical and translational evidence for so-called noncanonical NOAC effects on platelet activation and arterial thrombosis.

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Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial

Cited by 64 publications

References 26 publications

Thromboembolic and Bleeding Complications in Transcatheter Aortic Valve Implantation: Insights on Mechanisms, Prophylaxis and Therapy

Thromboembolic and Bleeding Complications in Transcatheter Aortic Valve Implantation: Insights on Mechanisms, Prophylaxis and Therapy

Late Clinical Valve Thrombosis After Transcatheter Aortic Valve Replacement Despite Non-Vitamin K Anticoagulant

Noncanonical Effects of Oral Thrombin and Factor Xa Inhibitors in Platelet Activation and Arterial Thrombosis

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