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Center for Global Research Data

Performance of the AF-adapted VTE-BLEED score for predicting major bleeding in patients with atrial fibrillation a post-hoc analysis of the ENGAGE-AF TIMI-48 Study

Lead Investigator: Frederikus Klok, Leiden University Medical Center
Title of Research Proposal: Performance of the AF-adapted VTE-BLEED score for predicting major bleeding in patients with atrial fibrillation a post-hoc analysis of the ENGAGE-AF TIMI-48 Study
Vivli Data Request: 4121
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
It has been projected that by 2060, 17.9 million people in the European Union (3.5% of the total population), will have atrial fibrillation (AF). AF is the most commonest heart rhythm disorder, but is associated with a most devastating complication: stroke. One of the cornerstones in the management of AF is oral anticoagulation, which prevents the majority of strokes and improves survival. However, such treatment is accompanied by the risk of bleeding. Therefore, anticoagulant management of AF patients requires weighing the benefit of stroke risk reduction against the risk of bleeding.
Over the past decade, bleeding risk scores, such as HAS-BLED (Hypertension, Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage), ORBIT (Outcomes Registry for Better Informed Treatment of atrial fibrillation) and ATRIA (AnticoagulaTion and Risk factors in Atrial fibrillation), have been developed to evaluate bleeding risk in AF patients under anticoagulation therapy. Similar efforts have been made in patients with venous thromboembolisms (VTE), who often require chronic anticoagulation therapy as well. One such score is VTE-BLEED (actiVe cancer, male with uncontrolled hyperTension, anaEmia, history of Bleeding, agE, rEnal Dysfunction), which predicts major bleeding in VTE patients under chronic anticoagulation therapy. This score has been validated for VTE patients receiving Factor Xa inhibitors, thrombin inhibitors and vitamin K antagonists.(8-11) In a prior analysis we have optimized VTE-BLEED to fit the AF population (AF-adapted VTE-BLEED; unpublished data).
In this post-hoc analysis of the ENGAGE-AF TIMI-48 study, we aim to evaluate the predictive performance of AF-adapted VTE-BLEED for major bleeding. Moreover, we aim to evaluate whether AF-adapted VTE-BLEED could potentially aid in decision making regarding the optimal dose of edoxaban in patients at high risk of bleeding. Similar analyses have been performed by our study group in the RE-LY study, which randomized AF patients to dabigatran or warfarin (unpublished data).
By validating VTE-BLEED for the AF population receiving both Factor Xa inhibitors and thrombin inhibitors, we hope to propose a score that could be applied uniformly to patients receiving any kind of chronic anticoagulation therapy, irrespective of their indication (VTE or AF), and introduce a tool for dose optimization to improve treatment outcomes.
Requested Studies:
Update: This data request was withdrawn on 17 September 2020 by the researcher.