PMID- 27349698
OWN - NLM
STAT- MEDLINE
DCOM- 20171109
LR  - 20180209
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 18
IP  - 9
DP  - 2016 Sep
TI  - Efficacy and safety of edoxaban compared with warfarin in patients with atrial 
      fibrillation and heart failure: insights from ENGAGE AF-TIMI 48.
PG  - 1153-61
LID - 10.1002/ejhf.595 [doi]
AB  - AIMS: In the ENGAGE AF-TIMI 48 trial, edoxaban, a factor Xa inhibitor, was not 
      found to be inferior to warfarin for the prevention of stroke or systemic embolic 
      events (SEE) in patients with atrial fibrillation (AF) and was associated with 
      significantly less bleeding. The higher-dose edoxaban regimen (HDER; 60 mg 
      dose-reduced to 30 mg once daily) has been approved in various countries in 
      Europe, the USA, and Japan. Among patients treated with vitamin K antagonists 
      (VKAs), symptomatic heart failure (HF) is an independent risk factor for lower 
      time-in-therapeutic range, which reduces the efficacy and safety of VKA therapy. 
      We evaluated the efficacy and safety of edoxaban compared with warfarin across 
      the spectrum of HF severity in the ENGAGE AF-TIMI 48 trial. METHODS AND RESULTS: 
      Of 14 071 patients randomized to well-controlled warfarin or the HDER, 5926 (42%) 
      had no history of HF, 6344 (45%) were in New York Heart Association (NYHA) class 
      I-II, and 1801 (13%) were in NYHA class III-IV. The efficacy of edoxaban compared 
      with warfarin in preventing stroke/SEE was similar in patients without and with 
      HF regardless of the severity of HF; [HDER vs. warfarin: No-HF: hazard ratio (HR) 
      0.87, 95% confidence interval (CI) 0.69-1.11; NYHA class I-II: HR 0.88, 95% CI 
      0.69-1.12; NYHA class III-IV: HR 0.83, 95% CI 0.55-1.25; Pinteraction = 0.97]. 
      Compared with warfarin, HDER was consistently associated with lower risk of major 
      bleeding (No-HF: HR 0.82, 95% CI 0.68-0.99; NYHA class I-II: HR 0.79, 95% CI 
      0.65-0.96; NYHA class III-IV: HR 0.79, 95% CI 0.54-1.17; Pinteraction = 0.96). 
      CONCLUSION: The relative efficacy and safety of HDER compared with well-managed 
      warfarin in AF patients with HF were similar to those without HF.
CI  - (c) 2016 The Authors. European Journal of Heart Failure (c) 2016 European Society of 
      Cardiology.
FAU - Magnani, Giulia
AU  - Magnani G
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Giugliano, Robert P
AU  - Giugliano RP
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Ruff, Christian T
AU  - Ruff CT
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Murphy, Sabina A
AU  - Murphy SA
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Nordio, Francesco
AU  - Nordio F
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Metra, Marco
AU  - Metra M
AD  - University of Brescia, Brescia, Italy.
FAU - Moccetti, Tiziano
AU  - Moccetti T
AD  - Fondazione Cardiocentro Ticino, Lugano, Switzerland.
FAU - Mitrovic, Veselin
AU  - Mitrovic V
AD  - Kerckhoff-Klinik, Bad Nauheim, Germany.
FAU - Shi, Minggao
AU  - Shi M
AD  - Daiichi Sankyo, Parsippany, NJ, USA.
FAU - Mercuri, Michele
AU  - Mercuri M
AD  - Daiichi Sankyo, Edison, NJ, USA.
FAU - Antman, Elliott M
AU  - Antman EM
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
FAU - Braunwald, Eugene
AU  - Braunwald E
AD  - TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and 
      Harvard Medical School, 350 Longwood Avenue, Boston, MA, 02115, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160628
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Anticoagulants)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Pyridines)
RN  - 0 (Thiazoles)
RN  - 5Q7ZVV76EI (Warfarin)
RN  - NDU3J18APO (edoxaban)
SB  - IM
MH  - Aged
MH  - Anticoagulants/therapeutic use
MH  - Atrial Fibrillation/complications/*drug therapy
MH  - Double-Blind Method
MH  - Factor Xa Inhibitors/*therapeutic use
MH  - Female
MH  - Heart Failure/*complications
MH  - Hemorrhage/*chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Pyridines/*therapeutic use
MH  - Stroke/etiology/*prevention & control
MH  - Thiazoles/*therapeutic use
MH  - Treatment Outcome
MH  - Warfarin/*therapeutic use
OTO - NOTNLM
OT  - Anticoagulation management
OT  - Atrial fibrillation
OT  - Edoxaban
OT  - Heart failure
OT  - New oral anticoagulants
OT  - Thromboembolic risk prevention
EDAT- 2016/06/29 06:00
MHDA- 2017/11/10 06:00
CRDT- 2016/06/29 06:00
PHST- 2016/01/26 00:00 [received]
PHST- 2016/04/28 00:00 [revised]
PHST- 2016/05/15 00:00 [accepted]
PHST- 2016/06/29 06:00 [entrez]
PHST- 2016/06/29 06:00 [pubmed]
PHST- 2017/11/10 06:00 [medline]
AID - 10.1002/ejhf.595 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2016 Sep;18(9):1153-61. doi: 10.1002/ejhf.595. Epub 2016 Jun 
      28.