Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

Abstract

BACKGROUND:

Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown.

OBJECTIVES:

The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge.

METHODS:

MARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance ≥50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events.

RESULTS:

In total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398).

CONCLUSIONS:

Extended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564).

• Authors: Alex C Spyropoulos, Walter Ageno, Gregory W Albers, C Gregory Elliott, Jonathan L Halperin, William R Hiatt, Gregory A Maynard, P Gabriel Steg, Jeffrey I Weitz, Wentao Lu, Theodore E Spiro, Elliot S Barnathan, Gary E Raskob
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 75 Issue 25 Pg. 3140-3147 (06 30 2020) ISSN: 1558-3597 [Electronic] United States
• PMID: 32586587 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Factor Xa Inhibitors
• Rivaroxaban

Topics

• Acute Disease (therapy)
• Aftercare (methods)
• Aged
• Chemoprevention (adverse effects, methods)
• Double-Blind Method
• Factor Xa Inhibitors (administration & dosage, adverse effects)
• Female
• Hemorrhage (chemically induced, diagnosis, prevention & control)
• Hospitalization (statistics & numerical data)
• Humans
• Male
• Middle Aged
• Patient Discharge
• Rivaroxaban (administration & dosage, adverse effects)
• Treatment Outcome
• Venous Thromboembolism (etiology, prevention & control)