"Extended Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients". The New England Journal of Medicine. 2018.
Links to original sources: Wiki Journal Post Full Journal Article
Does extended thromboprophylaxis with rivaroxaban in acutely ill medical patients after hospital discharge reduce the risk of symptomatic venous thromboembolism?
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.
Acutely ill medical patients are at risk for venous thromboembolism following discharge from the hospital, but the benefit of extended thromboprophylaxis remains uncertain due to concerns about bleeding risk. The MARINER trial sought to determine the efficacy and safety of rivaroxaban for 45 days post-discharge in preventing symptomatic venous thromboembolism in this population.
As of the knowledge cutoff date, guidelines had not yet been established reflecting the results of this trial.
MARINER was a multicenter, double-blind, placebo-controlled, randomized trial involving medically ill patients at increased risk for venous thromboembolism.
- 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
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.
- Primary Outcome: Composite of symptomatic venous thromboembolism or death related to venous thromboembolism - Principal Safety Outcome: Major bleeding
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.
This trial was funded by Janssen Research and Development.
Additional details and comprehensive data analysis are available in the full text of the article in The New England Journal of Medicine.