What question did this study set out to answer?

To compare the risks of thromboembolic stroke, intracranial hemorrhage, major bleeding, and mortality in patients treated with dabigatran versus rivaroxaban for atrial fibrillation.

October 3, 2016JAMA Internal Medicine

Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation

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Why the study?

Does rivaroxaban compared to dabigatran reduce thromboembolic stroke, bleeding, or mortality in elderly patients with nonvalvular atrial fibrillation?

Key Points

To compare the risks of thromboembolic stroke, intracranial hemorrhage, major bleeding, and mortality in patients treated with dabigatran versus rivaroxaban for atrial fibrillation.
Retrospective new-user cohort study of 118,891 patients aged 65 and older with nonvalvular AF.
Analysis used propensity score-based stabilized inverse probability of treatment weights to adjust for baseline characteristics.
Data collected from Medicare beneficiaries initiating dabigatran (150 mg twice daily) or rivaroxaban (20 mg once daily) treatment.
Rivaroxaban showed a nonsignificant reduction in thromboembolic stroke (HR 0.81; P = .07), but significant increases in ICH (HR 1.65; P = .002) and major extracranial bleeding (HR 1.48; P < .001).
Rivaroxaban was associated with 3.1 excess cases of mortality per 1000 person-years (HR 1.15; P = .051).
In older patients (≥75 years) or those with high CHADS2 scores, rivaroxaban significantly increased mortality compared to dabigatran.

Structured PICO

Does rivaroxaban compared to dabigatran reduce thromboembolic stroke, bleeding, or mortality in elderly patients with nonvalvular atrial fibrillation?

Population

118,891 patients with nonvalvular atrial fibrillation, aged 65 years or older, enrolled in fee-for-service Medicare, 47% female.

Intervention

Rivaroxaban 20 mg once daily

Comparator

Dabigatran 150 mg twice daily

Outcome

Thromboembolic stroke, intracranial hemorrhage (ICH), major extracranial bleeding including major gastrointestinal bleeding, and mortalityhard clinical

In elderly Medicare beneficiaries with nonvalvular atrial fibrillation, rivaroxaban 20 mg daily was associated with higher risks of intracranial and major extracranial bleeding compared to dabigatran 150 mg twice daily, without a significant reduction in stroke.

Discussion

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Implication

Rivaroxaban was associated with higher bleeding without stroke benefit versus dabigatran in elderly AF; leaves open optimal NOAC choice pending randomized data.

Cite This Study

Graham et al. (2016) studied this question.

synapsesocial.com/papers/6a214be0570f73dd9ac3e786 https://doi.org/10.1001/jamainternmed.2016.5954

Topics

Atrial fibrillation Persistent AF management Valvular heart disease Anticoagulation in AF

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Implication

Rivaroxaban was associated with higher bleeding without stroke benefit versus dabigatran in elderly AF; leaves open optimal NOAC choice pending randomized data.

Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Topics

Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Topics

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