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Rivaroxaban for thromboprophylaxis among patients recently hospitalized for acute infectious diseases: a subgroup
K P Cohoon1, Y De Sanctis2, L Haskell3
1Department of Cardiovascular Diseases and Gonda Vascular Center, Mayo Clinic, Rochester, MN, USA.
Abstract:
Essentials Net benefit of venous thromboprophylaxis (VTE) in patients hospitalized for infections is unknown. MAGELLAN trial subgroup analysis was performed for patients hospitalized for acute infectious diseases. At day 35, prolonged rivaroxaban prophylaxis reduced VTE compared to enoxaparin (4.2% vs. 6.6%). Rivaroxaban prophylaxis reduced VTE in patients hospitalized for active lung infections.
Summary:
Background Despite the well-established association between infection and venous thromboembolism (VTE), there are few data specifically assessing the efficacy and safety of the VTE prophylaxis strategies for patients hospitalized for acute infectious diseases. Objectives To estimate the incidence of VTE and bleeding outcomes, comparing prolonged prophylaxis with rivaroxaban 10 mg daily for 35 days with enoxaparin 40 mg daily for 10 days. Patients/Methods A subgroup analysis of patients hospitalized for acute infectious diseases in the MAGELLAN trial was performed. The primary efficacy outcome was the composite of asymptomatic proximal or symptomatic VTE at days 10 and 35. The principal safety outcome was the composite of major or clinically relevant non-major bleeding. Results Three thousand one hundred and seventy-three patients with acute infectious diseases leading to hospitalization were randomized to either rivaroxaban (n = 1585) or enoxaparin/placebo (n = 1588), and received at least one dose of study medication. At day 10, primary composite efficacy outcomes did not differ between prophylaxis strategies (rivaroxaban, 2.7%; and enoxaparin, 3.7%). At day 35, there were fewer VTE events with rivaroxaban (4.2%) than with enoxaparin (6.6%) (relative risk [RR] 0.64; 95% confidence interval [CI] 0.45-0.92). Patients with pulmonary infections randomized to rivaroxaban had a lower incidence of VTE both at 10 days (RR 0.50, 95% CI 0.28-0.90) and at 35 days (RR 0.54, 95% CI 0.33-0.87). Primary safety outcome events were increased with rivaroxaban (RR 2.42, 95% CI 1.60-3.66). Conclusions Prolonged rivaroxaban prophylaxis reduced the incidence of VTE in patients hospitalized for acute infectious diseases, particularly those involving the lungs. Efficacy benefits were, in part, offset by bleeding outcomes. ClinicalTrials.gov Number: NCT 00571649.
Insights
Prolonged rivaroxaban prophylaxis reduced venous thromboembolism (VTE) in hospitalized patients with infections compared to enoxaparin. This benefit was particularly noted in patients with lung infections, though it was partially offset by increased bleeding risks.
Area of Science:
- Internal Medicine
- Pharmacology
- Critical Care Medicine
Background:
- The association between infection and venous thromboembolism (VTE) is known, but evidence for VTE prophylaxis in infected patients is limited.
- Optimal VTE prophylaxis strategies for patients hospitalized with acute infectious diseases require further investigation.
- The MAGELLAN trial subgroup assessed VTE and bleeding outcomes for prolonged rivaroxaban versus enoxaparin.
Purpose of the Study:
- To compare the efficacy and safety of prolonged rivaroxaban (35 days) versus standard enoxaparin (10 days) for VTE prophylaxis.
- To evaluate VTE incidence and bleeding events in patients hospitalized for acute infectious diseases.
Main Methods:
- Subgroup analysis of the MAGELLAN trial involving 3,173 patients hospitalized for acute infectious diseases.
- Patients were randomized to receive either rivaroxaban 10 mg daily for 35 days or enoxaparin 40 mg daily for 10 days.
- Primary efficacy outcome: composite of asymptomatic proximal or symptomatic VTE at days 10 and 35. Safety outcome: composite of major or clinically relevant non-major bleeding.
Main Results:
- At day 10, VTE incidence did not differ significantly between rivaroxaban (2.7%) and enoxaparin (3.7%).
- At day 35, rivaroxaban showed a significant reduction in VTE events (4.2%) compared to enoxaparin (6.6%).
- Patients with pulmonary infections receiving rivaroxaban had lower VTE incidence at both 10 and 35 days. However, rivaroxaban was associated with an increase in bleeding events (RR 2.42).
Conclusions:
- Prolonged rivaroxaban prophylaxis effectively reduced VTE incidence in patients hospitalized for acute infectious diseases, especially pulmonary infections.
- The efficacy benefits of rivaroxaban were partially counterbalanced by an increased risk of bleeding events.
- Further research may be needed to balance efficacy and safety in this patient population.
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