Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.

<h4>Background</h4>Patients with atrial fibrillation considering use of anticoagulants must balance stroke reduction against bleeding risk. Knowledge of bleeding risk without the use of anticoagulants may help inform this decision.<h4>Purpose</h4>To determine the rate of majo...

Full description

Bibliographic Details
Main Authors: Luciane Cruz Lopes, Frederick A Spencer, Ignacio Neumann, Matthew Ventresca, Shanil Ebrahim, Qi Zhou, Neera Bhatnagar, Sam Schulman, John Eikelboom, Gordon Guyatt
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2014-01-01
Series:PLoS ONE
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24523876/pdf/?tool=EBI
_version_ 1818338189983612928
author Luciane Cruz Lopes
Frederick A Spencer
Ignacio Neumann
Matthew Ventresca
Shanil Ebrahim
Qi Zhou
Neera Bhatnagar
Sam Schulman
John Eikelboom
Gordon Guyatt
author_facet Luciane Cruz Lopes
Frederick A Spencer
Ignacio Neumann
Matthew Ventresca
Shanil Ebrahim
Qi Zhou
Neera Bhatnagar
Sam Schulman
John Eikelboom
Gordon Guyatt
author_sort Luciane Cruz Lopes
collection DOAJ
description <h4>Background</h4>Patients with atrial fibrillation considering use of anticoagulants must balance stroke reduction against bleeding risk. Knowledge of bleeding risk without the use of anticoagulants may help inform this decision.<h4>Purpose</h4>To determine the rate of major bleeding reported in observational studies of atrial fibrillation patients not receiving Vitamin K antagonists (VKA).<h4>Data sources</h4>We searched MEDLINE, EMBASE and CINAHL to October 2011 and examined reference lists of eligible studies and related reviews.<h4>Study selection</h4>All longitudinal cohort studies that included over 100 adult patients with atrial fibrillation not receiving VKA.<h4>Data extraction</h4>Teams of two reviewers independently and in duplicate adjudicated eligibility, assessed risk of bias and abstracted study characteristics and outcomes.<h4>Data synthesis</h4>Twenty-one eligible studies included 96,448 patients. Major bleeding rates varied widely, from 0 to 4.69 events per 100 patient-years. The pooled estimate in 13 studies with 78839 patients was 1.59 with a 99% confidence interval of 1.10 to 2.3 and median 1.42 (interquartile range 0.62-2.70). Pooled estimates for fatal bleeding and non-fatal bleeding from 4 studies that reported these outcomes were, respectively, 0.40 (0.34 to 0.46) and 1.18 (0.30 to 4.56) per 100 patient-years. In 9 randomized controlled trials (RCTs) the median rate of major bleeding in patients not receiving either anticoagulant or antiplatelet therapy was 0.6 (interquartile 0.2 to 0.90), and in 12 RCTs the median rate of major bleeding in patients receiving a single antiplatelet agent was 0.75 (interquartile 0.4 to 1.4).<h4>Conclusion</h4>Results suggest that patients with atrial fibrillation not receiving VKA enrolled in observational studies represent a population on average at higher risk of bleeding.
first_indexed 2024-12-13T15:07:10Z
format Article
id doaj.art-9f58e621c60d4cd19d186560250f1d1c
institution Directory Open Access Journal
issn 1932-6203
language English
last_indexed 2024-12-13T15:07:10Z
publishDate 2014-01-01
publisher Public Library of Science (PLoS)
record_format Article
series PLoS ONE
spelling doaj.art-9f58e621c60d4cd19d186560250f1d1c2022-12-21T23:40:58ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0192e8813110.1371/journal.pone.0088131Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.Luciane Cruz LopesFrederick A SpencerIgnacio NeumannMatthew VentrescaShanil EbrahimQi ZhouNeera BhatnagarSam SchulmanJohn EikelboomGordon Guyatt<h4>Background</h4>Patients with atrial fibrillation considering use of anticoagulants must balance stroke reduction against bleeding risk. Knowledge of bleeding risk without the use of anticoagulants may help inform this decision.<h4>Purpose</h4>To determine the rate of major bleeding reported in observational studies of atrial fibrillation patients not receiving Vitamin K antagonists (VKA).<h4>Data sources</h4>We searched MEDLINE, EMBASE and CINAHL to October 2011 and examined reference lists of eligible studies and related reviews.<h4>Study selection</h4>All longitudinal cohort studies that included over 100 adult patients with atrial fibrillation not receiving VKA.<h4>Data extraction</h4>Teams of two reviewers independently and in duplicate adjudicated eligibility, assessed risk of bias and abstracted study characteristics and outcomes.<h4>Data synthesis</h4>Twenty-one eligible studies included 96,448 patients. Major bleeding rates varied widely, from 0 to 4.69 events per 100 patient-years. The pooled estimate in 13 studies with 78839 patients was 1.59 with a 99% confidence interval of 1.10 to 2.3 and median 1.42 (interquartile range 0.62-2.70). Pooled estimates for fatal bleeding and non-fatal bleeding from 4 studies that reported these outcomes were, respectively, 0.40 (0.34 to 0.46) and 1.18 (0.30 to 4.56) per 100 patient-years. In 9 randomized controlled trials (RCTs) the median rate of major bleeding in patients not receiving either anticoagulant or antiplatelet therapy was 0.6 (interquartile 0.2 to 0.90), and in 12 RCTs the median rate of major bleeding in patients receiving a single antiplatelet agent was 0.75 (interquartile 0.4 to 1.4).<h4>Conclusion</h4>Results suggest that patients with atrial fibrillation not receiving VKA enrolled in observational studies represent a population on average at higher risk of bleeding.https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24523876/pdf/?tool=EBI
spellingShingle Luciane Cruz Lopes
Frederick A Spencer
Ignacio Neumann
Matthew Ventresca
Shanil Ebrahim
Qi Zhou
Neera Bhatnagar
Sam Schulman
John Eikelboom
Gordon Guyatt
Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.
PLoS ONE
title Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.
title_full Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.
title_fullStr Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.
title_full_unstemmed Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.
title_short Systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants.
title_sort systematic review of observational studies assessing bleeding risk in patients with atrial fibrillation not using anticoagulants
url https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24523876/pdf/?tool=EBI
work_keys_str_mv AT lucianecruzlopes systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT frederickaspencer systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT ignacioneumann systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT matthewventresca systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT shanilebrahim systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT qizhou systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT neerabhatnagar systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT samschulman systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT johneikelboom systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants
AT gordonguyatt systematicreviewofobservationalstudiesassessingbleedingriskinpatientswithatrialfibrillationnotusinganticoagulants