Clinical characteristics, prescription patterns and clinical outcomes of patients with extended therapy with direct oral anticoagulants for unprovoked venous thromboembolism.
Insights from the RIETE Registry
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Background: Extended therapy with direct oral anticoagulants (DOACs) is common for managing unprovoked venous thromboembolism (VTE), but real-world data on dosing decisions and their association with outcomes are limited.
Methods: From April 2013 to September 2023, we identified patients with unprovoked VTE in the RIETE registry who survived the first 6 months without recurrent VTE or major bleeding. We examined predictors of reduced- vs. full-dose DOACs (rivaroxaban or apixaban), and the association between dosing and recurrent VTE and major bleeding. Logistic regression was used to identify predictors of dosing, and competing risk regression models to identify predictors of outcomes.
Results: Among 3749 patients undergoing extended DOAC therapy, 921 (25%) received reduced doses. Predictors of reduced-dose use included age >75 years [adjusted odds ratio (aOR): 1.74; 95%CI: 1.48-2.05], body weight <60 kg (aOR: 1.36; 95%CI: 1.08-1.71), renal failure (aOR: 1.78; 95%CI: 1.41-2.24), and apixaban (vs. rivaroxaban) use (aOR: 2.33; 95%CI: 1.80-3.00). Over a median of 240 days, among all 3749 patients, 44 developed VTE recurrence and 15 bled. Apixaban (vs. rivaroxaban) use [adjusted hazard ratio (aHR): 0.42; 95%CI: 0.40-0.45] and antiplatelet therapy (aHR: 1.72; 95%CI: 1.68-1.77) were associated with VTE recurrence. Male sex (aHR: 0.70; 95%CI: 0.65-0.76), weight <60 kg (aHR: 2.02; 95%CI: 1.91-2.14), renal failure (aHR: 2.76; 95%CI: 2.72-2.81), reduced- (vs. full-dose) DOACs (aHR: 0.83; 95%CI: 0.80-0.87), and antiplatelet use (aHR: 8.18; 95%CI: 7.89-8.47) were associated with major bleeding.
Conclusions: We highlight a mismatch between dosing decisions and clinical outcomes, suggesting a need for more outcome-focused strategies in DOAC prescribing.
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Ethics Approval
all enrollees provided written or verbal informed consent according to the lo-cal ethics protocols of enrolling centers. The institutional review board at each enrolling center approves participation in RIETE for the site investigators and allows the entry of de-identified pa-tient information into the RIETE databaseCRediT authorship contribution
All the authors read and approved the final version of the manuscript and agreed to be accountable for all aspects of the work
Supporting Agencies
SANOFI and ROVI supported this Registry with an unrestricted educational grantData Availability Statement
All relevant data are included in the manuscript. Additional original data will be made available by contacting the corresponding author
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
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