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@article{1359727,
author = {Goette, Andreas and Merino, Jose L. and Ezekowitz, Michael D. and Zamoryakhin, Dmitry and Melino, Michael and Jin, James and Mercury, Michele F. and Grosso, Michael A. and Fernandez, Victor and Al Saady, Natalya and Pelekh, Natalya and Merkely, Bela and Zenin, Sergey and Kushnir, Mykola and Špinar, Jindřich and Batushkin, Valeriy and Groot, Joris R. de and Lip, Gregory I.H.},
article_location = {New York},
article_number = {10055},
doi = {http://dx.doi.org/10.1016/S0140-6736(16)31474-X},
keywords = {HEART RHYTHM ASSOCIATION; ORAL ANTICOAGULANTS; EFFICACY; SAFETY; GUIDELINES},
language = {eng},
issn = {0140-6736},
journal = {Lancet},
title = {Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fi brillation (ENSURE-AF): a randomised, open-label, phase 3b trial},
volume = {388},
year = {2016}
}
TY - JOUR
ID - 1359727
AU - Goette, Andreas - Merino, Jose L. - Ezekowitz, Michael D. - Zamoryakhin, Dmitry - Melino, Michael - Jin, James - Mercury, Michele F. - Grosso, Michael A. - Fernandez, Victor - Al Saady, Natalya - Pelekh, Natalya - Merkely, Bela - Zenin, Sergey - Kushnir, Mykola - Špinar, Jindřich - Batushkin, Valeriy - Groot, Joris R. de - Lip, Gregory I.H.
PY - 2016
TI - Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fi brillation (ENSURE-AF): a randomised, open-label, phase 3b trial
JF - Lancet
VL - 388
IS - 10055
SP - 1995-2003
EP - 1995-2003
PB - Elsevier Science Inc.
SN - 01406736
KW - HEART RHYTHM ASSOCIATION
KW - ORAL ANTICOAGULANTS
KW - EFFICACY
KW - SAFETY
KW - GUIDELINES
N2 - 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). The primary safety endpoint occurred in 16 (1%) of 1067 patients given edoxaban versus 11 (1%) of 1082 patients given enoxaparin-warfarin (OR 1.48, 95% CI 0.64-3.55). The results were independent of the TEE-guided strategy and anticoagulation status. Interpretation ENSURE-AF is the largest prospective randomised clinical trial of anticoagulation for cardioversion of patients with non-valvular atrial fibrillation. Rates of major and CRNM bleeding and thromboembolism were low in the two treatment groups.
ER -
GOETTE, Andreas, Jose L. MERINO, Michael D. EZEKOWITZ, Dmitry ZAMORYAKHIN, Michael MELINO, James JIN, Michele F. MERCURY, Michael A. GROSSO, Victor FERNANDEZ, Natalya AL SAADY, Natalya PELEKH, Bela MERKELY, Sergey ZENIN, Mykola KUSHNIR, Jindřich ŠPINAR, Valeriy BATUSHKIN, Joris R. de GROOT a Gregory I.H. LIP. Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fi brillation (ENSURE-AF): a randomised, open-label, phase 3b trial. \textit{Lancet}. New York: Elsevier Science Inc., 2016, roč.~388, č.~10055, s.~1995-2003. ISSN~0140-6736. Dostupné z: https://dx.doi.org/10.1016/S0140-6736(16)31474-X.
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