2021
DOI: 10.1056/nejmoa2111016
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Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR

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Cited by 176 publications
(164 citation statements)
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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%
“…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%
“…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%
“…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%