Abstract
The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction) compared higher-dose edoxaban regimen (HD-ER) and lower-dose edoxaban regimen with well-managed warfarin in 21 105 patients with atrial fibrillation. The risk factors and clinical impact of gastrointestinal bleeding (GIB) in this trial have not been described in detail. This analysis was undertaken to identify risk factors for major GIB (MGIB) and compare the severity and outcomes of GIB with edoxaban and warfarin. During 2.8 years mean follow-up, there were 579 MGIB (1.22% per year), of which 63 were life-threatening or fatal (0.13% per year). Male sex, increased age, prior GIB, concomitant aspirin, lower baseline hemoglobin, renal dysfunction, and higher HAS-BLED and CHADS2 scores were independently associated with the risk of MGIB. Whereas the annual rate of MGIB was higher with HD-ER than with warfarin (1.53% and 1.25%, respectively; hazard ratio, 1.23; 95% confidence interval, 1.02-1.48; P=0.033), the annual rates of life-threatening or fatal GIB were similar (0.15% and 0.18%, respectively). Several indicators of more severe GIB, including hemodynamic instability, hospitalizati...Continue Reading
References
Jun 13, 2001·JAMA : the Journal of the American Medical Association·B F GageM J Radford
Apr 22, 2005·Journal of Thrombosis and Haemostasis : JTH·S SchulmanUNKNOWN Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on T
Jul 24, 2008·Chest·Clive KearonAnthony J Comerota
Oct 4, 2008·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Nirmala RaghavanDonglu Zhang
Apr 1, 2009·Circulation·Sumeet SubherwalKaren P Alexander
Sep 1, 2009·The New England Journal of Medicine·Stuart J ConnollyUNKNOWN RE-LY Steering Committee and Investigators
Oct 12, 2010·American Heart Journal·Christian T RuffEugene Braunwald
May 18, 2011·Circulation·John W EikelboomSalim Yusuf
Aug 13, 2011·The New England Journal of Medicine·Manesh R PatelUNKNOWN ROCKET AF Investigators
Aug 30, 2011·The New England Journal of Medicine·Christopher B GrangerUNKNOWN ARISTOTLE Committees and Investigators
Mar 9, 2012·Thrombosis and Haemostasis·Daniel E SalazarShashank Rohatagi
Sep 1, 2012·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Mohinder S BathalaJeanne Mendell
Dec 29, 2012·Circulation·Antonio L DansSalim Yusuf
May 25, 2013·Thrombosis and Haemostasis·Jay DesaiJames Aisenberg
Oct 1, 2013·Journal of the American College of Cardiology·Paul A ReillyUNKNOWN RE-LY Investigators
Nov 21, 2013·The New England Journal of Medicine·Robert P GiuglianoUNKNOWN ENGAGE AF-TIMI 48 Investigators
Dec 10, 2013·Lancet·Christian T RuffElliott M Antman
Mar 25, 2014·Journal of the American College of Cardiology·Elaine M HylekChristopher B Granger
Apr 1, 2014·Circulation·Craig T JanuaryUNKNOWN ACC/AHA Task Force Members
Apr 16, 2014·JAMA Internal Medicine·Bruce L DavidsonMartin H Prins
Mar 15, 2015·Lancet·Christian T RuffElliott M Antman
Oct 16, 2015·Circulation Journal : Official Journal of the Japanese Circulation Society·Yuichi J ShimadaRobert P Giugliano
Nov 28, 2015·Journal of the American College of Cardiology·Matthew W SherwoodManesh R Patel
Feb 26, 2016·Journal of the American Heart Association·Haiyan XuEugene Braunwald
Jul 1, 2016·Circulation·Erin A BohulaEugene Braunwald
May 2, 2017·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Corey S MillerAlan N Barkun
Citations
Oct 11, 2019·Circulation·Brian A BergmarkRobert P Giugliano
Nov 28, 2019·European Heart Journal. Cardiovascular Pharmacotherapy·Peter Brønnum NielsenGregory Y H Lip
Oct 3, 2018·American Journal of Therapeutics·Wilbert S Aronow, Tatyana A Shamliyan
Jan 8, 2019·Open Heart·Ole-Christian Walter RutherfordSigrun Halvorsen
Dec 27, 2019·Journal of Medical Case Reports·Hideya Itagaki, Suzuki Katuhiko
Jun 22, 2020·Herz·Martina-Elisabeth SpehlmannOliver J Müller
Jul 12, 2019·Journal of Clinical Pharmacy and Therapeutics·Bo Min JangSandy Jeong Rhie
Nov 20, 2019·European Heart Journal. Cardiovascular Pharmacotherapy·Anne-Marie Schjerning OlsenMorten Lamberts
Jun 7, 2020·Drugs·Alberto CorsiniGiuseppe Boriani
Nov 6, 2020·Circulation. Cardiovascular Quality and Outcomes·Katherine VilainUNKNOWN ENGAGE AF-TIMI 48 Trial Investigators
Aug 28, 2020·European Heart Journal. Cardiovascular Pharmacotherapy·Mario BoGaetano Maria De Ferrari
Jan 13, 2021·Journal of the American Geriatrics Society·Melissa BendayanJonathan Afilalo
Jan 22, 2021·Expert Review of Cardiovascular Therapy·N AlShoaibiA Al Fagih
Jun 19, 2021·Cardiovascular Drugs and Therapy·Robert BenamouzigLaurent Fauchier
Jul 18, 2021·Journal of Thrombosis and Haemostasis : JTH·Yan Xu, Deborah M Siegal
Jan 8, 2022·Thrombosis and Haemostasis·Alexander P BenzUNKNOWN ANNEXA-4 Investigators