PMID- 25684570 OWN - NLM STAT- MEDLINE DCOM- 20151116 LR - 20181202 IS - 1875-2128 (Electronic) IS - 1875-2128 (Linking) VI - 108 IP - 2 DP - 2015 Feb TI - SAfety of Fondaparinux in transoesophageal echocardiography-guided Electric cardioversion of Atrial Fibrillation (SAFE-AF) study: a pilot study. PG - 122-31 LID - S1875-2136(14)00266-6 [pii] LID - 10.1016/j.acvd.2014.09.009 [doi] AB - BACKGROUND: Current guidelines recommend unfractionated heparin (UFH) or low-molecular-weight heparin plus an oral anticoagulant for the prevention of thromboembolism in patients undergoing electric cardioversion of atrial fibrillation (AF). Selective factor Xa inhibitors, such as fondaparinux, which has a favourable benefit-risk profile in the prevention and treatment of venous thromboembolism and the management of acute coronary syndromes, have not been systematically evaluated in this setting. AIM: To evaluate the efficacy and safety of fondaparinux versus standard treatment in patients undergoing echocardiographically-guided cardioversion of AF. METHODS: In this multicentre, randomized, open-label, controlled, two-parallel-group, phase II pilot study, patients with AF undergoing electric cardioversion following transoesophageal echocardiography (TEE) were randomized to fondaparinux or standard therapy (UFH plus vitamin K antagonist [VKA]). Patients showing an atrial thrombus in the first TEE (clot-positive) were randomized to treatment with fondaparinux or standard care for 4 weeks before cardioversion. RESULTS: The primary endpoint (combined rate of cerebral neurological events, systemic thromboembolism, all-cause death and major bleeding events) occurred in 3 of 174 (1.7%) patients on fondaparinux and 2 of 170 (1.2%) patients on UFH+VKA. The rate of thrombus disappearance among clot-positive patients was higher in the fondaparinux arm (11 of 14; 78.6%) than in the UFH+VKA arm (7 of 14; 50.0%). Incidences of adverse events were similar (45.4% with fondaparinux and 46.5% with UFH+VKA). CONCLUSION: In this pilot study in patients with TEE-guided cardioversion, the use of fondaparinux appeared to be well tolerated, with similar efficacy to UFH+VKA. Furthermore, a trend to greater thrombus resolution was observed. CI - Copyright (c) 2015. Published by Elsevier Masson SAS. FAU - Cohen, Ariel AU - Cohen A AD - Saint-Antoine university and medical school, universite Pierre et Marie Curie, CHU Saint-Antoine, department of cardiology, 184, rue du Faubourg Saint-Antoine, 75571 Paris cedex 12, France. Electronic address: ariel.cohen@sat.aphp.fr. FAU - Stellbrink, Christoph AU - Stellbrink C AD - Hospital Bielefeld centre, department of cardiology and internal intensive care, Bielefeld, Germany. FAU - Le Heuzey, Jean-Yves AU - Le Heuzey JY AD - Rene-Descartes university, Georges-Pompidou European hospital, arrhythmia department, Paris, France. FAU - Faber, Thomas AU - Faber T AD - Heart centre, Freiburg university, cardiology and angiology I, Freiburg, Germany. FAU - Aliot, Etienne AU - Aliot E AD - Institute of heart and vessels Louis-Mathieu, department of cardiology, Vandoeuvre-les-Nancy, France. FAU - Banik, Norbert AU - Banik N AD - Winicker Norimed GmbH, Nuremberg, Germany. FAU - Kropff, Stefan AU - Kropff S AD - GlaxoSmithKline, Germany. FAU - Omran, Heyder AU - Omran H AD - St-Marien hospital Bonn Venusberg, department of internal medicine, Bonn, Germany. Electronic address: heyder.omran@marien-hospital-bonn.de. CN - SAFE-AF investigators LA - eng SI - EudraCT/2008-000789-22 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20141106 PL - Netherlands TA - Arch Cardiovasc Dis JT - Archives of cardiovascular diseases JID - 101465655 RN - 0 (Anticoagulants) RN - 0 (Polysaccharides) RN - 9001-29-0 (Factor X) RN - J177FOW5JL (Fondaparinux) SB - IM CIN - Arch Cardiovasc Dis. 2015 Feb;108(2):85-7. PMID: 25599831 MH - Aged MH - Anticoagulants/*therapeutic use MH - Atrial Fibrillation/*therapy MH - Echocardiography, Transesophageal MH - *Electric Countershock MH - Factor X/*antagonists & inhibitors MH - Female MH - Fondaparinux MH - Humans MH - Male MH - Middle Aged MH - Pilot Projects MH - Polysaccharides/*therapeutic use MH - Surgery, Computer-Assisted MH - Thromboembolism/*prevention & control OTO - NOTNLM OT - Anticoagulant OT - Atrial fibrillation OT - Cardioversion OT - Cardioversion electrique OT - Fibrillation atriale OT - Fondaparinux OT - Thrombosis OT - Echocardiographie transoesophagienne FIR - Cohen, Ariel IR - Cohen A FIR - Isnard, Richard IR - Isnard R FIR - Doll, Gerard IR - Doll G FIR - Barboteu, Michel IR - Barboteu M FIR - Villemant, Didier IR - Villemant D FIR - Galley, Daniel IR - Galley D FIR - Fondard, Olivier IR - Fondard O FIR - Galinier, Michel IR - Galinier M FIR - Roudaut, Raymond IR - Roudaut R FIR - Leclercq, Christophe IR - Leclercq C FIR - Lellouche, Nicolas IR - Lellouche N FIR - Mansourati, Jacques IR - Mansourati J FIR - Davy, Jean-Marc IR - Davy JM FIR - Delarche, Nicolas IR - Delarche N FIR - Degand, Bruno IR - Degand B FIR - Axthelm, Christoph IR - Axthelm C FIR - Faber, Thomas IR - Faber T FIR - Said, Samir IR - Said S FIR - Lickfett, Lars IR - Lickfett L FIR - Omran, Heyder IR - Omran H FIR - Moeckel, Martin IR - Moeckel M FIR - Herold, Philipp IR - Herold P FIR - Hoffmann, Stefan IR - Hoffmann S FIR - Neuzner, Joerg IR - Neuzner J FIR - Appel, Karl-Friedrich IR - Appel KF FIR - Tiefenbacher, Christiane IR - Tiefenbacher C FIR - Vossbeck, Gisbert IR - Vossbeck G FIR - Cieslinski, Gerhard IR - Cieslinski G FIR - Zimmermann, Ralph IR - Zimmermann R FIR - Kandil, Mehmet IR - Kandil M FIR - Stellbrink, Christoph IR - Stellbrink C FIR - Auer, Johann IR - Auer J FIR - Ruttloff, Andreas IR - Ruttloff A FIR - Kreider-Stempfle, Hans-Ulrich IR - Kreider-Stempfle HU FIR - Cohen, Ariel IR - Cohen A FIR - Omran, Heyder IR - Omran H FIR - Aliot, Etienne IR - Aliot E FIR - Faber, Thomas IR - Faber T FIR - Stellbrink, Christoph IR - Stellbrink C FIR - Le-Heuzey, Jean-Yves IR - Le-Heuzey JY FIR - Montalescot, Gilles IR - Montalescot G FIR - Hanrath, Peter IR - Hanrath P FIR - Stutzer, Hartmut IR - Stutzer H FIR - Diener, Hans Christoph IR - Diener HC FIR - Deharo, Jean-Claude IR - Deharo JC FIR - Hagendorff, Andreas IR - Hagendorff A EDAT- 2015/02/17 06:00 MHDA- 2015/11/17 06:00 CRDT- 2015/02/17 06:00 PHST- 2014/05/05 00:00 [received] PHST- 2014/08/13 00:00 [revised] PHST- 2014/09/30 00:00 [accepted] PHST- 2015/02/17 06:00 [entrez] PHST- 2015/02/17 06:00 [pubmed] PHST- 2015/11/17 06:00 [medline] AID - S1875-2136(14)00266-6 [pii] AID - 10.1016/j.acvd.2014.09.009 [doi] PST - ppublish SO - Arch Cardiovasc Dis. 2015 Feb;108(2):122-31. doi: 10.1016/j.acvd.2014.09.009. Epub 2014 Nov 6.