Medically Ill Patient Assessment of Rivaroxaban versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk - MARINER

Sep 20, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Janssen Research and Development
Date Presented:
08/26/2018
Date Published:
08/26/2018
Date Updated:
09/20/2018
Original Posted Date:
08/26/2018
References

Contribution To Literature:

The MARINER trial failed to show that rivaroxaban prevented thromboembolic events after hospitalization for a medical illness.

Description:

The goal of the trial was to evaluate short-term rivaroxaban compared with placebo among patients discharged after a medical illness.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Stratified

Patients discharged after a medical illness were randomized to rivaroxaban 10 mg daily (n = 6,007) versus placebo (n = 6,012) for 45 days.

  • Total number of enrollees: 12,019
  • Duration of follow-up: 45 days
  • Mean patient age: 70 years
  • Percentage female: 48%

Inclusion criteria:

  • Patients ≥40 years of age hospitalized 3-10 days for one of the following conditions: congestive heart failure, acute respiratory failure, ischemic stroke, infectious or inflammatory disease
  • Additional risk for thromboembolism

Exclusion criteria:

  • Condition treated with anticoagulation or dual antiplatelet therapy
  • Active cancer

Principal Findings:

The primary outcome, death from thromboembolism or symptomatic venous thromboembolism, occurred in 0.83% of the rivaroxaban group compared with 1.10% of the placebo group (p = 0.14).

Secondary outcomes:

  • Symptomatic venous thromboembolism: 0.18% for rivaroxaban vs. 0.42% for placebo (p < 0.05)
  • Major bleeding: 0.28% for rivaroxaban vs. 0.15% for placebo (p = not significant)

Interpretation:

Among patients discharged after hospitalization for a medical illness, rivaroxaban was not beneficial. Rivaroxaban failed to reduce the incidence of the primary outcome of death or recurrent thromboembolism. However, rivaroxaban compared with placebo had a reduction in the individual component of symptomatic venous thromboembolism. An important limitation of the trial was a low event rate.

References:

Spyropoulos AC, Ageno W, Albers GW, et al., on behalf of the MARINER Investigators. Rivaroxaban for Thromboprophylaxis After Hospitalization for Medical Illness. N Engl J Med 2018;379:1118-27.

Presented by Dr. Alex Spyropoulos at the European Society of Cardiology Congress, Munich, Germany, August 26, 2018.

Keywords: ESC Congress, ESC18, Anticoagulants, Brain Ischemia, Heart Failure, Hemorrhage, Patient Discharge, Primary Prevention, Respiratory Insufficiency, Risk, Stroke, Thromboembolism, Vascular Diseases, Venous Thromboembolism


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