Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR

Mieghem, Nicolás M. Van; Unverdorben, Martin; Hengstenberg, Christian; Möllmann, Helge; Mehran, Roxana; López-Otero, Diego; Nombela‐Franco, Luis; Moreno, Raúl; Nordbeck, Peter; Thiele, Holger; Lang, Irene; Zamorano, José Luís; Shawl, Fayaz A.; Yamamoto, Masanori; Watanabe, Yusuke; Hayashida, Kentaro; Hambrecht, Rainer; Meincke, Felix; Vranckx, Pascal; Jin, James; Boersma, Eric; Rodés‐Cabau, Josep; Ohlmann, Patrick; Capranzano, Piera; Kim, Hyo–Soo; Pilgrim, Thomas; Anderson, Richard; Baber, Usman; Duggal, Anil; Laeis, Petra; Lanz, Hans; Chen, Cathy; Valgimigli, Marco; Veltkamp, Roland; Saïto, Shigeru; Dangas, George

doi:10.1056/nejmoa2111016

Cited by 178 publications

(164 citation statements)

References 23 publications

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“…Recently, results of the ATLANTIS trial have shown that in patients with an indication for oral anticoagulation, the use of apixaban after TAVR compared favorably with VKA on all endpoints ( 34 ). Moreover, in the ENVISAGE-TAVI AF trial, edoxaban was non-inferior to VKA for the primary composite endpoint of adverse clinical events, including all-cause death, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) definition ( 35 ).…”

Section: Discussionmentioning

confidence: 99%

Real-World Anticoagulatory Treatment After Transcatheter Aortic Valve Replacement: A Retrospective, Observational Study on 4,800 Patients

Hohmann

Ludwig

Walker

et al. 2021

Front. Cardiovasc. Med.

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Background: Transcatheter aortic valve replacement (TAVR) has developed to the therapy of choice for patients with symptomatic severe aortic stenosis who are unsuitable for surgical aortic valve replacement and elderly patients with intermediate or high operative risk. However, the optimal anticoagulant therapy post-TAVR still remains a matter of debate.Aims: This study sought to investigate current anticoagulant treatment patterns and clinical outcome in patients undergoing TAVR.Methods: In a retrospective study based on anonymized health claims data of approximately seven million Germans with statutory health insurance (InGef database), anticoagulant treatment regimens were assessed using any drug prescription post discharge within the first 90 days after TAVR procedure. Clinical events between 30 days and 6 months were examined by treatment regime.Results: The study population comprised 4,812 patients with TAVR between 2014 and 2018: 29.4% received antiplatelet monotherapy, 17.8% dual antiplatelet therapy, 17.4% oral anticoagulation (OAC) plus antiplatelet therapy, 12.9% OAC monotherapy, 2.2% triple therapy and 19.2% did not receive any anticoagulatory drugs. Sixty-four percentage of patients with OAC received direct oral anticoagulants (DOAC). Hence, 68% of all patients were treated non-adherent to current guidelines. Forty percentage of patients with OAC prior to TAVR did not have any OAC after TAVR. The adjusted risk of all-cause mortality was significantly increased in patients with OAC (HR 1.40, 95% CI 1.03–1.90, p = 0.03) and no anticoagulatory treatment (HR 3.95, 95% CI 2.95–5.27, p < 0.0001) when compared to antiplatelet monotherapy.Conclusions: This large real-world data analysis demonstrates substantial deviations from guideline recommendations and treatment after TAVR. Considering relevant differences in clinical outcome across treatment groups, major effort is warranted to examine underlying causes and improve guideline adherence.

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Section: Discussionmentioning

confidence: 99%

Real-World Anticoagulatory Treatment After Transcatheter Aortic Valve Replacement: A Retrospective, Observational Study on 4,800 Patients

Hohmann

Ludwig

Walker

et al. 2021

Front. Cardiovasc. Med.

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“…In patients with indications for OAC, no significant differences were found between apixaban and VKAs in the primary and secondary outcomes. However, in patients without indications for OAC, apixaban was associated with a higher incidence of combined endpoint consisting of all-cause mortality, all stroke/TIA, and systemic embolism [apixaban 9.5% versus APT 6.3%, 52 They concluded that edoxaban was noninferior to VKAs for the incidence of net adverse clinical events, with a higher incidence of major bleeding with edoxaban than that with VKAs. This study was not added to the nine cohort studies because of the heterogeneity caused by the difference between cohort studies and RCTs.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of antithrombotic therapy with non-vitamin K antagonist oral anticoagulants after transcatheter aortic valve replacement: a systematic review and meta-analysis

et al. 2021

Therapeutic Advances in Chronic Disease

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Objective: A meta-analysis was performed to compare the efficacy and safety of antithrombotic therapy with non-vitamin K antagonist oral anticoagulants (NOACs) versus standard care in patients after successful transcatheter aortic valve replacement (TAVR). Methods: A systematic search of PubMed, Cochrane Central Register of Controlled Trials, and EMBASE databases and ClinicalTrials.gov website (through 21 October 2020) was performed. Risk ratios (RRs) with 95% confidence intervals (CIs) for all outcomes were calculated using random-effects models. Results: Twelve studies (two studies were randomized controlled trials) comprising 6943 patients were included (5299 had indications for oral anticoagulation (OAC) and 1644 had none). No significant differences were found between NOACs and the standard care in the incidences of all stroke, a composite endpoint, and major/life-threatening bleeding. NOACs were associated with lower all-cause mortality than vitamin K antagonists (VKAs) in post-TAVR patients with indications for OAC after more than 1 year of follow-up [RR = 0.64; 95% CI, (0.42, 0.96); p = 0.03], whereas NOACs exhibited poor outcomes than antiplatelet therapy (APT) in patients without indications for OAC [RR = 1.66; 95% CI, (1.12, 2.45); p = 0.01]. In the prevention of valve thrombosis, NOACs and VKAs were not significantly different in patients with indications for OAC [RR = 0.66; 95% CI, (0.24, 1.84); p = 0.43], whereas NOACs were better than APT in patients without indications for OAC [RR = 0.19; 95% CI, (0.04, 0.83); p = 0.03]. Conclusions: In patients with indications for OAC, post-TAVR antithrombotic therapy with NOACs was more favorable due to its lower all-cause mortality after more than 1 year of follow-up. In those without indications for OAC, NOACs presented poorer outcomes due to its higher all-cause mortality.

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“…Non-efficacy benefits were most commonly (n = 23, 39%) related to anticoagulation strategies or comparing interventions that require different downstream anticoagulation strategies. Associated non-efficacy benefits included having to use less anticoagulants (with accompanying lower bleeding risk) or convenience to use anticoagulants without the need for therapeutic monitoring [ 5 – 8 , 14 , 17 , 21 , 22 , 24 , 28 , 32 , 33 , 36 , 40 , 41 , 44 , 48 , 58 , 62 , 63 ]. Another common non-efficacy benefit was the use of less invasive techniques to diagnose or treat a variety of cardiac conditions (n = 9, 15%) [ 19 , 21 , 23 , 25 – 27 , 42 , 45 , 54 ].…”

Section: Findings On Non-efficacy Benefits and Non-inferiority Marginsmentioning

confidence: 99%

“…For example, in a theoretical trial comparing two drug regimens where all participants stop taking the study drugs shortly after enrollment, it will be impossible to demonstrate superiority of one drug over the other, whereas both drugs will likely be declared non-inferior to each other. In our literature review, we encountered studies with disproportional larger number of crossovers towards usual care (up to 20-fold [ 52 ]) and trials with up to 40% of the participants discontinuing the study treatment [ 63 ], often reflecting real life clinical care. The interpretation of such non-inferiority trials is challenging and complementary adjusted per-protocol analyses are advisable to explore whether these results are congruent with the standard intention-to-treat analyses [ 3 , 65 ].…”

Section: Specific Considerations Related To Non-efficacy Benefits and Non-inferiority Marginsmentioning

confidence: 99%

Non-efficacy benefits and non-inferiority margins: a scoping review of contemporary high-impact non-inferiority trials in clinical cardiology

Leening

Mahmoud

2021

Eur J Epidemiol

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Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR

Cited by 178 publications

References 23 publications

Real-World Anticoagulatory Treatment After Transcatheter Aortic Valve Replacement: A Retrospective, Observational Study on 4,800 Patients

Real-World Anticoagulatory Treatment After Transcatheter Aortic Valve Replacement: A Retrospective, Observational Study on 4,800 Patients

Efficacy and safety of antithrombotic therapy with non-vitamin K antagonist oral anticoagulants after transcatheter aortic valve replacement: a systematic review and meta-analysis

Non-efficacy benefits and non-inferiority margins: a scoping review of contemporary high-impact non-inferiority trials in clinical cardiology

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