What is the clinical evidence from this study?

Study design: Cohort. Population: Venous thromboembolism in patients with obesity (n=787). Intervention: Direct oral anticoagulants (DOACs) vs. Warfarin. Primary outcome: Occurrence of a thromboembolic event (DVT, PE, or ischemic stroke) within 12 months (HR 0.6, 95% CI 0.32-1.1, p=.082).

What does this research mean for the field?

Direct oral anticoagulants show no significant difference compared with warfarin for cumulative thromboembolic events or bleeding at 12 months in patients with obesity, though they are associated with a lower risk of deep vein thrombosis. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

January 1, 2024Texas Heart Institute JournalOpen Access

Safety and Efficacy of Direct Oral Anticoagulants vs Warfarin in Patients With Obesity and Venous Thromboembolism: A Retrospective Analysis

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Key result

DOACs show no significant difference in thromboembolic events versus warfarin in patients with obesity.

HR 0.6
95% CI 0.32-1.1
P=.082
n=787

Why the study?

Venous thromboembolism guidelines recommend DOACs over warfarin regardless of obesity status, but evidence remains limited regarding the safety and efficacy of DOAC use in patients with obesity.

Do DOACs compared to warfarin reduce thromboembolic or bleeding events in patients with severe obesity (BMI >40 or weight >120 kg) and VTE?

Study Design

Type

Cohort (n=787)

Multicenter

Yes

Structured PICO

Do DOACs compared to warfarin reduce thromboembolic or bleeding events in patients with severe obesity (BMI >40 or weight >120 kg) and VTE?

Population

787 adults with acute venous thromboembolism and a BMI of at least 40 or weight of at least 120 kg, followed for 12 months after discharge on an oral anticoagulant.

Exposure

Direct oral anticoagulants (DOACs: apixaban, rivaroxaban, dabigatran, or edoxaban) prescribed at discharge.

Comparator

Warfarin prescribed at discharge.

Outcome

Occurrence of a thromboembolic event (composite of DVT, PE, or ischemic stroke) within 12 months of index hospitalization (primary efficacy); bleeding event requiring hospitalization within 12 months (primary safety).composite

Main Result

Hazard Ratio: 0.6 (95% CI 0.32–1.1)

Absolute Event Rate: 4.23% vs 7.12%

p-value: p=.082

In patients with severe obesity and VTE, DOACs demonstrated similar safety and efficacy to warfarin at 12 months, supporting their use in this population.

Limitations

Retrospective observational design limits inference to association, not causality
Single regional health system limits generalizability
Active cancer or history of hypercoagulopathy were not included as regression variables
Unclear whether confounding demographic factors favored the selection of a DOAC over warfarin
Did not differentiate between major bleeding and clinically significant nonmajor bleeding
Data collection limited to a single health system, potentially missing events if patients sought care elsewhere
Adherence to or alteration of anticoagulation therapy after discharge was not assessed
Observational design cannot infer causality
Active cancer or history of hypercoagulopathy not included as regression variables
Did not investigate reasons for prescribing specific agents (potential selection bias)
Did not differentiate major vs nonmajor clinically significant bleeding
Data collection limited to a single health system
Adherence and duration of therapy not assessed

Discussion

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Implication

DOACs were associated with similar thromboembolic and bleeding risks versus warfarin in obese VTE; extends low-certainty evidence but leaves open randomized confirmation.

Cite This Study

Tu et al. (2024) conducted a cohort in Venous thromboembolism in patients with obesity (n=787). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on Occurrence of a thromboembolic event (DVT, PE, or ischemic stroke) within 12 months (HR 0.6, 95% CI 0.32-1.1, p=.082). Direct oral anticoagulants showed no statistically significant difference in the risk of composite thromboembolic events compared with warfarin in patients with obesity and VTE (HR 0.6, p=0.082).

synapsesocial.com/papers/6a194453f2eb401dc788d960 https://doi.org/10.14503/thij-23-8260

Topics

Anticoagulation in AF

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Implication

DOACs were associated with similar thromboembolic and bleeding risks versus warfarin in obese VTE; extends low-certainty evidence but leaves open randomized confirmation.

Safety and Efficacy of Direct Oral Anticoagulants vs Warfarin in Patients With Obesity and Venous Thromboembolism: A Retrospective Analysis

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

Safety and Efficacy of Direct Oral Anticoagulants vs Warfarin in Patients With Obesity and Venous Thromboembolism: A Retrospective Analysis

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider