MARINER
Trial question
What is the effect of rivaroxaban in medically ill patients who were at an increased risk for VTE on the basis of a modified International Medical Prevention Registry on VTE score of ≥ 4?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 12019
12019 patients (5735 female, 6284 male).
Inclusion criteria: medically ill patients who were at an increased risk of VTE on the basis of a modified International Medical Prevention Registry on VTE score of ≥ 4 or a score of 2 or 3 plus a plasma D-dimer level of > 2 times the upper limit of the normal range assigned at hospital discharge.
Key exclusion criteria: anticoagulant or dual antiplatelet therapy, active cancer, history of recent bleeding (within 3 months), or a high risk of bleeding, or other contraindications to rivaroxaban.
Interventions
N=6007 rivaroxaban (a dose of 10 mg, with the dose adjusted for renal insufficiency for 45 days).
N=6012 placebo (for 45 days).
Primary outcome
Symptomatic venous thromboembolism or death due to venous thromboembolism
0.83%
1.1%
1.1 %
0.8 %
0.6 %
0.3 %
0.0 %
Rivaroxaban
Placebo
No significant
difference ↔
No significant difference in symptomatic VTE or death due to VTE (0.83% vs. 1.1%; HR 0.76, 95% CI 0.52 to 1.09).
Secondary outcomes
Significant decrease in symptomatic nonfatal VTE (0.18% vs. 0.42%; HR 0.44, 95% CI 0.22 to 0.89).
Safety outcomes
No significant difference in adverse events.
Significant differences in major bleeding (0.28% vs. 0.15%; HR 1.88, 95% CI 0.84-4.23).
Conclusion
In medically ill patients who were at an increased risk of VTE on the basis of a modified International Medical Prevention Registry on VTE score of ≥ 4 or a score of 2 or 3 plus a plasma D-dimer level of > 2 times the upper limit of the normal range assigned at hospital discharge, rivaroxaban was not superior to placebo with respect to symptomatic VTE or death due to VTE.
Reference
Spyropoulos AC, Ageno W, Albers GW et al. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127.
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