Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F16%3A00066132" target="_blank" >RIV/65269705:_____/16:00066132 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/16:00091576

Result on the web

<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31474-X/abstract" target="_blank" >http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31474-X/abstract</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(16)31474-X" target="_blank" >10.1016/S0140-6736(16)31474-X</a>

Result language

angličtina

Original language name

Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial

Original language description

Background Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled warfarin therapy. Few safety data about edoxaban in patients undergoing electrical cardioversion are available. Methods We did a multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin-warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. The dose of edoxaban was reduced to 30 mg per day if one or more factors (creatinine clearance 15-50 mL/min, low bodyweight [{= 60 kg], or concomitant use of P-glycoprotein inhibitors) were present. Block randomisation (block size four)-stratified by cardioversion approach (transoesophageal echocardiography [TEE] or not), anticoagulant experience, selected edoxaban dose, and region-was done through a voice-web system. The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality, analysed by intention to treat. The primary safety endpoint was major and clinically relevant non-major (CRNM) bleeding in patients who received at least one dose of study drug. Follow-up was 28 days on study drug after cardioversion plus 30 days to assess safety. This trial is registered with ClinicalTrials.gov, number NCT02072434. Findings Between March 25, 2014, and Oct 28, 2015, 2199 patients were enrolled and randomly assigned to receive edoxaban (n= 1095) or enoxaparin-warfarin (n= 1104). The mean age was 64 years (SD 10 . 54) and mean CHA(2)DS(2)-VASc score was 2.6 (SD 1.4). Mean time in therapeutic range on warfarin was 70.8% (SD 27.4). The primary efficacy endpoint occurred in five (<1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio [OR] 0.46, 95% CI 0.12-1.43).

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FA - Cardiovascular diseases including cardio-surgery

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2016

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Lancet

ISSN

0140-6736

e-ISSN

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Volume of the periodical

388

Issue of the periodical within the volume

10055

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

1995-2003

UT code for WoS article

000385954800029

EID of the result in the Scopus database

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