The use of the oral anticoagulant rivaroxaban in medically ill patients for 45 days following hospital discharge showed there was no significant difference between rivaroxaban and placebo for the primary efficacy end point: a composite of symptomatic venous thromboembolism (VTE) and VTE-related death in the MARINER (Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness) study.
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The principal safety outcome of major bleeding also showed no significant difference between the rivaroxaban and placebo groups. Rivaroxaban, however, did reduce the rate of symptomatic VTE only, and symptomatic VTE and all-cause mortality, compared to placebo.
On leaving hospital, the rate of symptomatic VTE more than doubles over the first 21 days and is associated with a five-fold increased risk of fatal pulmonary embolism (PE) within 30 days post-discharge. The MARINER trial investigated whether continuing thromboprophylaxis with an oral anticoagulant after discharge could reduce the risk of symptomatic VTE and VTE-related death in medically ill patients at risk for VTE.
The trial enrolled 12,024 patients from 671 centres in 36 countries. Patients were ≥ 40 years of age, had been hospitalised for an acute medical illness, and had other risk factors for VTE. Patients, average age 69.7 years (48% female), were randomly allocated to a 45-day course of either once daily oral rivaroxaban 10 mg (7.5 mg in patients with reduced kidney function) or placebo at the time of hospital discharge.
The final analysis included 12,019 patients, of whom 11,962 (99.5%) had taken at least one dose of study drug. 40% patients had been admitted to hospital for heart failure, 27% for respiratory insufficiency, 17% for infectious disease, 14% for ischaemic stroke, and 2% for inflammatory disease.
During the 45-days post-discharge, there was no significant difference in the primary composite end point: 50 (0.83%) patients taking rivaroxaban had symptomatic VTE or died from VTE-related causes compared to 66 (1.1%) taking placebo (p=0.136), or in major bleeding, which occurred in 17 (0.28%) patients in the rivaroxaban group compared to 66 (1.1%) in the placebo group (p=0.124). There were very few critical and fatal bleeds.
When examining symptomatic VTE only, which included lower extremity DVT and non-fatal pulmonary embolism, there were significantly fewer events with rivaroxaban (0.18%) compared to placebo (0.42%; hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.22–0.89, p=0.023).
Professor Alex Spyropoulos, study author, (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, US), said:“ This study has potential to reduce the public healthcare burden of non-fatal blood clots in a large proportion of medically ill patients.”
Results from the MARINER study were also published simultaneously in The New England Journal of Medicine (DOI: 10.1056/NEJMoa1805090).
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