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

Area of Science:

• Cardiology
• Pharmacology
• Internal Medicine

Background:

• Hospitalized acutely ill medical patients face significant risks of fatal and major thromboembolic events.
• The efficacy of extended-duration primary thromboprophylaxis in preventing these events remains under investigation.

Purpose of the Study:

• To assess if extended-duration rivaroxaban reduces venous and arterial fatal/major thromboembolic events.
• To determine if rivaroxaban increases major bleeding in acutely ill medical patients post-discharge.

Main Methods:

• The MARINER study randomized 4,909 acutely ill medical patients with VTE risk factors to receive rivaroxaban 10 mg or placebo daily for 45 days post-discharge.
• Patients had a baseline creatinine clearance ≥50 ml/min; outcomes were adjudicated by an independent committee.
• Intent-to-treat analysis included data through day 45, with time-to-event curves calculated using the Kaplan-Meier method.

Main Results:

• The composite efficacy endpoint occurred in 1.28% of the rivaroxaban group versus 1.77% in the placebo group (HR: 0.72; 95% CI: 0.52-1.00; p=0.049).
• Major bleeding occurred in 0.27% of the rivaroxaban group compared to 0.18% in the placebo group (HR: 1.44; 95% CI: 0.62-3.37; p=0.398).

Conclusions:

• Extended-duration rivaroxaban demonstrated a 28% reduction in fatal and major thromboembolic events in hospitalized medically ill patients.
• The study found no significant increase in major bleeding events with rivaroxaban use.