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

Lopes LC, Spencer FA, Neumann I, Ventresca M, Ebrahim S, Zhou Q, Bhatnagar N, Schulman S, Eikelboom J, Guyatt G - PLoS ONE (2014)

Bottom Line: 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).

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Affiliation: Pharmaceutical Sciences Postgraduate Course, University of Sorocaba, Sao Paulo, Brazil.

ABSTRACT

Background: 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.

Purpose: To determine the rate of major bleeding reported in observational studies of atrial fibrillation patients not receiving Vitamin K antagonists (VKA).

Data sources: We searched MEDLINE, EMBASE and CINAHL to October 2011 and examined reference lists of eligible studies and related reviews.

Study selection: All longitudinal cohort studies that included over 100 adult patients with atrial fibrillation not receiving VKA.

Data extraction: Teams of two reviewers independently and in duplicate adjudicated eligibility, assessed risk of bias and abstracted study characteristics and outcomes.

Data synthesis: 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).

Conclusion: Results suggest that patients with atrial fibrillation not receiving VKA enrolled in observational studies represent a population on average at higher risk of bleeding.

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Subpopulation taking at least one antiplatelet.
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pone-0088131-g004: Subpopulation taking at least one antiplatelet.

Mentions: Of the 21 studies, 6 reported major bleeding in patients not taking antiplatelet agents with overall bleeding rates from 0.0 to 4.73 per 100 patient-years (median 1.54, interquartile range 1.05 to 2.10) and pooled estimate of bleeds per 100 patient-years 2.18 with 99% confidence interval 1.19 to 3.99 (Table 2, Figure 4).


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

Lopes LC, Spencer FA, Neumann I, Ventresca M, Ebrahim S, Zhou Q, Bhatnagar N, Schulman S, Eikelboom J, Guyatt G - PLoS ONE (2014)

Subpopulation taking at least one antiplatelet.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3921139&req=5

pone-0088131-g004: Subpopulation taking at least one antiplatelet.
Mentions: Of the 21 studies, 6 reported major bleeding in patients not taking antiplatelet agents with overall bleeding rates from 0.0 to 4.73 per 100 patient-years (median 1.54, interquartile range 1.05 to 2.10) and pooled estimate of bleeds per 100 patient-years 2.18 with 99% confidence interval 1.19 to 3.99 (Table 2, Figure 4).

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Pharmaceutical Sciences Postgraduate Course, University of Sorocaba, Sao Paulo, Brazil.

ABSTRACT

Background: 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.

Purpose: To determine the rate of major bleeding reported in observational studies of atrial fibrillation patients not receiving Vitamin K antagonists (VKA).

Data sources: We searched MEDLINE, EMBASE and CINAHL to October 2011 and examined reference lists of eligible studies and related reviews.

Study selection: All longitudinal cohort studies that included over 100 adult patients with atrial fibrillation not receiving VKA.

Data extraction: Teams of two reviewers independently and in duplicate adjudicated eligibility, assessed risk of bias and abstracted study characteristics and outcomes.

Data synthesis: 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).

Conclusion: Results suggest that patients with atrial fibrillation not receiving VKA enrolled in observational studies represent a population on average at higher risk of bleeding.

Show MeSH
Related in: MedlinePlus