What is the clinical evidence from this study?

Study design: Observational. Population: Venous Thromboembolism (n=62431). Intervention: Rivaroxaban vs. Warfarin. Primary outcome: All-cause mortality at 6 months (OR 0.97, 95% CI 0.84, 1.11).

What question did this study set out to answer?

To compare all-cause mortality risk associated with direct oral anticoagulants and warfarin in treating venous thromboembolism.

August 13, 2018Thrombosis and HaemostasisOpen Access

All-Cause Mortality Risk with Direct Oral Anticoagulants and Warfarin in the Primary Treatment of Venous Thromboembolism

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Key result

In patients with venous thromboembolism, the use of rivaroxaban or apixaban was not associated with a significant difference in 6-month all-cause mortality compared to warfarin.

Why the study?

Does rivaroxaban or apixaban reduce all-cause mortality compared to warfarin in patients receiving primary treatment for incident venous thromboembolism?

Key Points

To compare all-cause mortality risk associated with direct oral anticoagulants and warfarin in treating venous thromboembolism.
Analyzed claims data from a large U.S. insurance database (2012-2017) for patients prescribed oral anticoagulants.
Employed marginal structural logistic models to assess mortality risks based on anticoagulant type and other factors.
Included 62,431 enrollees, with different initial prescriptions for warfarin and DOACs.
1,791 deaths occurred within 6 months of initial anticoagulant prescription.
No significant association found between warfarin and DOACs regarding all-cause mortality (p>0.05).
Results align with previous studies, suggesting patient preference and other factors should guide anticoagulant choice.

Study Design

Type

Observational (n=62,431)

Structured PICO

Does rivaroxaban or apixaban reduce all-cause mortality compared to warfarin in patients receiving primary treatment for incident venous thromboembolism?

Population

62,431 adults with venous thromboembolism prescribed an oral anticoagulant, followed for up to 6 months.

Exposure

Direct oral anticoagulants, specifically rivaroxaban (n=21,064) or apixaban (n=5,663), for the primary treatment of venous thromboembolism.

Comparator

Warfarin (n=35,704) or head-to-head DOAC comparisons.

Outcome

All-cause mortality within 3 and 6 months of the initial oral anticoagulant prescription, ascertained via Social Security Administration Death Master File and medical claims.hard clinical

Main Result

Odds Ratio: 0.97 (95% CI 0.84–1.11)

Absolute Event Rate: 2% vs 3.4%

In routine clinical practice, the choice between warfarin, rivaroxaban, and apixaban for the primary treatment of venous thromboembolism is not associated with a significant difference in 6-month all-cause mortality.

Limitations

Possibility of uncontrolled confounding due to lack of data on lifestyle factors and over-the-counter medications.
Limited power for detecting treatment-covariate interactions in specific sub-groups.
Potential misclassification of mortality due to missing deaths in the SSA Death Master File.
Possibility of uncontrolled confounding (e.g., inability to adjust for lifestyle factors like smoking and physical activity, or over-the-counter medications like aspirin)
Limited power for detecting treatment-covariate interactions with respect to the risk of all-cause mortality in specific sub-groups (e.g., renal disease and liver disease)
Reliance on administrative claims data and potential for misclassification

Discussion

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Implication

Supports similar short-term mortality risk with DOACs versus warfarin in VTE; observational data leave open need for randomized confirmation.

Cite This Study

Roetker et al. (2018) conducted an observational in Venous Thromboembolism (n=62,431). Rivaroxaban vs. Warfarin was evaluated on All-cause mortality at 6 months (OR 0.97, 95% CI 0.84, 1.11). In patients with venous thromboembolism, the use of rivaroxaban or apixaban was not associated with a significant difference in 6-month all-cause mortality compared to warfarin.

synapsesocial.com/papers/6a415371901a52dbcb71fee4 https://doi.org/10.1055/s-0038-1668521

Topics

Anticoagulation in AF

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Implication

Supports similar short-term mortality risk with DOACs versus warfarin in VTE; observational data leave open need for randomized confirmation.

All-Cause Mortality Risk with Direct Oral Anticoagulants and Warfarin in the Primary Treatment of Venous Thromboembolism

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

All-Cause Mortality Risk with Direct Oral Anticoagulants and Warfarin in the Primary Treatment of Venous Thromboembolism

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider