6/28/23, 11:16 PM MARINER Pathway Feedback Search Clinical Topics Home Studies MARINER MARINER Disease Disease Deep vein thrombosis Pulmonary embolism 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 N = 12024 52.0% male 12024 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) https://web.pathway.md/studies/recZqQMdD0eW5P1ZU 1/2 6/28/23, 11:16 PM MARINER Pathway Primary outcome Symptomatic venous thromboembolism or death due to venous thromboembolism 1.1 % 1.1 0.8 % 0.83 0.6 % 0.3 % No significant difference 0.0 % Rivaroxaban Placebo 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 Borderline 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. Open reference URL https://web.pathway.md/studies/recZqQMdD0eW5P1ZU 2/2