The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications.
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Hospital-associated venous thromboembolism (VTE) is a leading cause of premature death and disability worldwide. Evidence-based guidelines recommend that anticoagulant thromboprophylaxis be given to hospitalised medical patients at risk of VTE, but suggest against routine use of thromboprophylaxis beyond the hospital stay. The MARINER study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of thromboprophylaxis using rivaroxaban, begun at hospital discharge and continued for 45 days, for preventing symptomatic VTE in high-risk medical patients. Eligible patients are identified using the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE VTE) risk score, combined with a laboratory test, D-dimer. The rivaroxaban regimen is 10 mg once daily for patients with CrCl ≥ 50 ml/min, or 7.5 mg once daily for patients with CrCl ≥ 30 ml/min and < 50 ml/min. The primary efficacy outcome is the composite of symptomatic VTE (lower extremity deep-vein thrombosis and non-fatal pulmonary embolism) and VTE-related death. The principal safety outcome is major bleeding. A blinded clinical events committee adjudicates all suspected outcome events. The sample size is event-driven with an estimated total of 8,000 patients to acquire 161 primary outcome events. Study design features that distinguish MARINER from previous and ongoing thromboprophylaxis trials in medically ill patients are: (i) use of a validated risk assessment model (IMPROVE VTE) and D-dimer determination for identifying eligible patients at high risk of VTE, (ii) randomisation at the time of hospital discharge, (iii) a 45-day treatment period and (iv) restriction of the primary efficacy outcome to symptomatic VTE events.
Date Issued
2016-06-02
Date Acceptance
2015-12-16
Citation
Thrombosis and Haemostasis, 2016, 115 (6), pp.1240-1248
ISSN
0340-6245
Publisher
Schattauer
Start Page
1240
End Page
1248
Journal / Book Title
Thrombosis and Haemostasis
Volume
115
Issue
6
Copyright Statement
© Schattauer 2016. This is an open access article freely available at the publisher's website https://dx.doi.org/10.1160/TH15-09-0756
Identifier
PII: 15-09-0756
Subjects
Venous thromboembolism
anticoagulants
deep-vein thrombosis
medical patients
pulmonary embolism
rivaroxaban
thromboprophylaxis
Publication Status
Published