The use of rivaroxaban (Xarelto) in patients for 45 days following their discharge after a hospitalization for a medical illness reduces the rate of nonfatal symptomatic blood clots, according to a new study. However, it did not have any effect on fatal blood clots, according to the study presented at the European Society of Cardiology Congress 2018 in Munich, Germany, in August.
“Anticoagulants help prevent blood clots in medically ill patients while they are under our supervision at the hospital. However, the risk of blood clots extends well beyond this period,” says Alex Spyropoulos, MD, in an ESC Congress statement. “Our results suggest we may be able to offer further protection to patients at risk from nonfatal blood clots, with no increase in major bleeding, by prescribing an oral anticoagulant for use after discharge. Spyropoulos is the study’s lead author and professor at the Center for Health Innovations and Outcomes Research at Norwell Health in New York. “This study has potential to reduce the public healthcare burden of nonfatal blood clots in a large proportion of medically ill patients.”
Around 70% of hospital-acquired fatal pulmonary embolisms occur in medically ill patients—patients who had not undergone surgery—so anticoagulants delivered by intravenous drip or injection are recommended to prevent blood clots in these patients while in the hospital, according to Spyropoulos. However, guidelines do not recommend any use of anticoagulants postdischarge.
“After leaving the hospital the rate of symptomatic venous thromboembolism (VTE) more than doubles over the first 21 days and is associated with a five-fold increased risk of fatal pulmonary embolism within 30 days post-discharge,” the ESC statement says.
The trial included 12,024 patients from 671 centers in 36 countries. Patients involved in the trial had been hospitalized for an acute medical illness and had other risk factors for VTE. Patients were randomly allocated to a 45-day course of either 10 mg once daily oral rivaroxaban (7.5 mg in patients with reduced kidney function) or placebo at the time of hospital discharge.
During the 45-days postdischarge, 0.83% of patients taking rivaroxaban had symptomatic VTE or died from VTE-related causes compared to 1.1% taking placebo.
When examining symptomatic VTE only, which included lower extremity deep venous thrombosis (DVT) and nonfatal pulmonary embolism, there were fewer events with rivaroxaban (0.18%) than placebo (0.42%).
Major bleeding occurred in 0.28% of patients taking rivaroxaban versus 0.15% taking placebo. There were very few critical and fatal bleeds and no significant difference between groups, according to the researchers.
“Our trial did not show a significant benefit of this rivaroxaban regimen started at hospital discharge with regard to the composite outcome of fatal or symptomatic venous thromboembolism in medically ill patients,” Spyropoulos writes. “Given the relatively low incidence of events despite the enrichment strategy and the lack of effect on venous thromboembolism-related death, the usefulness of extended thromboprophylaxis remains uncertain.”
“Future studies should more accurately identify deaths caused by thrombotic mechanisms and focus on the patients who are at highest risk and who may benefit from anticoagulant prophylaxis,” he adds.
The study, published in The New England Journal of Medicine, was funded by Janssen, Xarelto’s manufacturer.