Key result
There is no significant relationship between DOAC assay concentrations and a patient's risk of bleeding or systemic embolism (e.g., bleeding cases increased by 0.03 per 10ng/ml trough increase, P=0.84).
Why the study?
Current guidelines recommend preoperative DOAC levels of <30-50ng/ml based on limited evidence, prompting this review to determine whether DOAC assay concentrations are associated with bleeding or systemic embolic events.
Are direct oral anticoagulant assay plasma concentrations associated with bleeding or systemic embolic events in patients with atrial fibrillation or venous thromboembolism?
Meta-Analysis
Are direct oral anticoagulant assay plasma concentrations associated with bleeding or systemic embolic events in patients with atrial fibrillation or venous thromboembolism?
Mean Difference: 0.03 (95% CI -0.32–0.38)
p-value: p=0.84
This meta-regression found no significant independent relationship between DOAC assay concentrations and clinical outcomes, suggesting that current guideline-recommended preoperative DOAC levels (<30-50ng/ml) may lack strong evidence.
Preoperative DOAC assays may not predict bleeding or embolic events; leaves open the value of level-guided perioperative strategies.
Current guidelines suggest preoperative direct oral anticoagulant levels of <30-50ng/ml. However, there is limited evidence to guide this expert consensus. Reviewing assay titres and clinical outcomes may be able to inform perioperative care of the anticoagulated patient. This review aimed to determine whether DOAC assay plasma concentrations are associated with bleeding or systemic embolic events to better appreciate a possible therapeutic or hazardous reference range. The systematic search, performed by an information specialist using a peer-reviewed search. Main search concepts were direct oral anticoagulant therapy for atrial fibrillation or venous thromboembolism. Data synthesised in narrative and tabular format whilst data that could be pooled was subjected to meta-analysis, using a random effects model. Meta regression was conducted for DOAC peak levels and clinical events. PRISMA guidelines were adhered to. Of 6717 retrieved publications, a total of 17 studies were included in the systematic review and 14 in the meta-analysis/regression. Studies report clinical outcome follow up ranging from 28-128 weeks. For every 10ng/ml increase in DOAC assay trough and peak titre, the mean number of bleeding cases increases by 0.03(95%CI: -0.32-0.38, P=0.84) and 0.09(95%CI: -3.4-5.3, P=0.55) respectively, the mean number of major bleed cases increases by 0.01(95%CI: -0.05-0.07, P=0.62) and 0.011(95%CI: -0.32-0.34, P=0.74) respectively and the mean number of systemic embolic event cases decreases by 0.00039(95%CI: -0.06-0.0054, P=0.88) and 0.04(95%CI: -0.56-0.48, P=0.77) respectively. There exists no significant, independent relationship, as determined by a univariate meta regression, between DOAC assay concentrations and a patient's risk of bleeding or systemic embolic embolism. This review also highlights the possibility of an absolute, patient specific DOAC assay concentration that may indicate adequate anticoagulation, above which further titre increases do not confer an increased risk of bleeding. However, further research to characterise this and its’ utility in the perioperative setting is urgently required.
No takes yet. Share an insight, caveat, or question.
Stretton et al. (2023) conducted a meta-analysis in Atrial fibrillation or venous thromboembolism. DOAC assay plasma concentrations was evaluated on Mean number of bleeding cases per 10ng/ml increase in DOAC assay trough titre (MD 0.03, 95% CI -0.32-0.38, p=0.84). There is no significant relationship between DOAC assay concentrations and a patient's risk of bleeding or systemic embolism (e.g., bleeding cases increased by 0.03 per 10ng/ml trough increase, P=0.84).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: