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Rivaroxaban Reduces Thromboembolic Events in Medically Ill Patients
Quick Takes
- The MARINER study demonstrated efficacy of post-hospital rivaroxaban use for preventing VTE in medically ill patients.
- Use of rivaroxaban 10 mg daily had a number needed to treat of 204 for the reduction of symptomatic VTE, myocardial infarction, stroke, and VTE-related death following acute medical hospitalization.
- In patients with adequate renal function, use of rivaroxaban 10 mg daily for post-hospital discharge did not significantly increase major bleeding compared to placebo.
Study Questions:
How does use of post-discharge prophylaxis with rivaroxaban impact the risk of venous and arterial fatal and major thromboembolic events as well as major bleeding in acutely ill medical patients?
Methods:
An exploratory analysis was performed using data from the MARINER study, where medically ill patients were randomized to rivaroxaban or placebo at hospital discharge for 45 days. Using the intent-to-treat trial population of patients who received rivaroxaban 10 mg daily (creatinine clearance [CrCl] ≥50 ml/min), a time-to-event analysis was performed to assess for the prespecified composite efficacy endpoint of symptomatic venous thromboembolism (VTE), myocardial infarction, nonhemorrhagic stroke, and cardiovascular death. The primary safety outcome was major bleeding, as defined by the International Society on Thrombosis and Haemostasis.
Results:
The study compared 4,909 patients randomized to rivaroxaban 10 mg daily and 4,913 patients randomized to placebo at the time of hospital discharge. The mean age was 67.8 years, 55.5% were men, and the mean baseline CrCl was 87.8 ml/min. Mean duration of hospitalization was 6.7 days. The prespecified efficacy endpoint occurred in 1.28% of patients randomized to rivaroxaban versus 1.77% of patients randomized to placebo (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.52-1.00). Major bleeding occurred in 0.27% of patients randomized to rivaroxaban versus 0.18% of patients randomized to placebo (HR, 1.44; 95% CI, 0.62-3.37).
Conclusions:
The authors concluded that post-discharge use of rivaroxaban for medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding.
Perspective:
This exploratory analysis of the MARINER study focused on use of rivaroxaban 10 mg daily for medically ill patients. The thrombotic event risk was reduced by 28%, with a number needed to treat of 204, while major bleeding was not significantly different between the two groups. This analysis differs slightly from the primary analysis published in N Engl J Med in 2018, as this analysis was limited to patients who had CrCl ≥50 ml/min and were randomized to rivaroxaban 10 mg daily or placebo, not the reduced 7.5 mg dose. Despite not being endorsed by recent guidelines, there has been renewed interest in use of post-hospital VTE prophylaxis given the coronavirus disease 2019 (COVID-19) pandemic and associated VTE risk. This analysis provides some reassurance about the relative efficacy and safety of this regimen for patients at increased risk for VTE. It should be noted that patients in the MARINER study were enriched for VTE risk through use of the IMPROVE (International Medical Prevention Registry on Venous Thromboembolism) VTE risk score and/or elevated D-dimer. Many of these factors are present in patients hospitalized with COVID-19 (e.g., elevated D-dimer, acute respiratory and/or infectious illness, immobilization, intensive care unit stay, and age >60 years).
Clinical Topics: Anticoagulation Management, COVID-19 Hub, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism
Keywords: Anticoagulants, Coronavirus, COVID-19, Creatinine, Hemorrhage, Hemostasis, Myocardial Infarction, Patient Discharge, Secondary Prevention, severe acute respiratory syndrome coronavirus 2, Stroke, Thrombosis, Vascular Diseases, Venous Thromboembolism, Venous Thrombosis
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