Efficacy and Safety of Novel Oral Anticoagulants in Patients With Atrial Fibrillation and Heart Failure: A Meta-Analysis.
This study investigated the efficacy and safety of novel oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) and heart failure (HF) by a meta-analysis.



AF is quite prevalent in patients with HF.



Four phase III clinical trials comparing NOACs to warfarin in patients with AF were included. Each patient was defined as affected by HF according to the criteria of the trial in which the patient was enrolled. Pre-specified outcomes were the composite of stroke/systemic embolism (SSE); major, intracranial, and any bleeding; and cardiovascular (CV) and all-cause death.



A total of 55,011 patients were enrolled, 26,384 (48%) with HF, and 28,627 (52%) without HF; 27,518 receiving NOACs and 27,493 receiving warfarin (median, 70 years of age; 36% females; follow-up: 1.5 to 2.8 years). Rates of SSE (relative risk [RR]: 0.98; 95% confidence interval [CI]: 0.90 to 1.07]; p = 0.68) and major bleeding (RR: 0.95; 95% CI: 0.88 to 1.03; p = 0.21) were comparable in patients with and without HF. HF patients had reduced rates of any (RR: 0.86; 95% CI: 0.81 to 0.91; p < 0.01) and intracranial (RR: 0.74 95% CI: 0.63 to 0.88; p < 0.01) bleeding but increased rates of all-cause (RR: 1.70 95% CI: 1.31 to 2.19; p < 0.01) and CV death (RR: 2.05 95% CI: 1.66 to 2.55; p < 0.01). NOACs, compared with warfarin significantly reduced SSE and major, intracranial, and any bleeding, regardless of the presence or absence of HF (pinteraction> 0.05 for each).



Patients with AF and HF had increased mortality but reduced rates of intracranial and any bleeding compared with the no-HF patients, with no differences in rates of SSE and major bleeding. NOACs significantly reduced SSE, major bleeding, and intracranial hemorrhage in HF patients. No interactions in efficacy and safety of NOACs were observed between AF patients with and without HF.
Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy; Cardiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Gianluigi
G
Savarese
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Robert P
RP
Giugliano
Cardiovascular and Cell Sciences Research Institute, St. George's University, London, United Kingdom; IRCCS San Raffaele Pisana, Rome, Italy.
Giuseppe M C
GM
Rosano
Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
John
J
McMurray
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Giulia
G
Magnani
Athens University Hospital Attikon, Athens, Greece.
Gerasimos
G
Filippatos
Villa dei Fiori, Acerra, Napoli, Italy; Mount Sinai Medical School, New York City, New York.
Santo
S
Dellegrottaglie
Cardiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Lars H
LH
Lund
Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy.
Bruno
B
Trimarco
Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy. Electronic address: fpperron@unina.it.
Pasquale
P
Perrone-Filardi
D000284:Administration, Oral; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D002318:Cardiovascular Diseases / Q000401:mortality; D002423:Cause of Death; D000069604:Dabigatran / Q000627:therapeutic use; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D065427:Factor Xa Inhibitors / Q000627:therapeutic use*; D006333:Heart Failure / Q000150:complications*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced*; D009026:Mortality; D011720:Pyrazoles / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011728:Pyridones / Q000627:therapeutic use; D000069552:Rivaroxaban / Q000627:therapeutic use; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013844:Thiazoles / Q000627:therapeutic use; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use
D000925:Anticoagulants; D000991:Antithrombins; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D011728:Pyridones; D013844:Thiazoles; C522181:apixaban; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran; C552171:edoxaban
atrial fibrillation; heart failure; meta-analysis; novel oral anticoagulants; trials