article101

MARINER

"Extended Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients". The New England Journal of Medicine. 2018.

Clinical Question

Does extended thromboprophylaxis with rivaroxaban in acutely ill medical patients after hospital discharge reduce the risk of symptomatic venous thromboembolism?

Bottom Line

In acutely ill medical patients, extended thromboprophylaxis with rivaroxaban after hospital discharge did not significantly reduce the risk of symptomatic venous thromboembolism when compared with placebo.

Major Points

Guidelines

As of the knowledge cutoff date, guidelines had not yet been established reflecting the results of this trial.

Design

Population

- Inclusion Criteria: Patients aged ≥40 years hospitalized for ≥3 to ≤10 days with acute medical illnesses and additional risk factors for venous thromboembolism
- Exclusion Criteria: Patients with conditions requiring long-term anticoagulant or dual antiplatelet therapy, active cancer, recent significant bleeding, or other contraindications to rivaroxaban
- Baseline Characteristics: Similar across intervention and placebo groups

Interventions

Patients were randomized at hospital discharge to receive either rivaroxaban (10 mg daily or 7.5 mg daily for those with moderate renal impairment) or placebo for 45 days.

Outcomes

- Primary Outcome: Composite of symptomatic venous thromboembolism or death related to venous thromboembolism
- Principal Safety Outcome: Major bleeding

Criticisms

The low incidence of venous thromboembolism–related events in the placebo group (1.10%) and the inclusion of sudden death of unknown cause may have affected the specificity of venous thromboembolism–related death as an outcome.

Funding

This trial was funded by Janssen Research and Development.