For patients hospitalized with an acute illness, prescribing rivaroxaban for 45 days after discharge doesn’t significantly reduce the risk of venous thromboembolism (VTE) or VTE-related death, according to research presented at the European Society of Cardiology Congress and published online in the New England Journal of Medicine.
More than 12,000 patients were randomized to rivaroxaban or placebo treatment following hospitalization with an acute condition such as heart failure. The patients were 69.7 years old on average, 52 percent men, hospitalized for between three and 10 days and were deemed to be at increased risk of VTE based on the IMPROVE risk score.
The primary endpoint of symptomatic VTE or death due to VTE occurred in 0.83 percent of patients in the rivaroxaban group and 1.1 percent of those taking placebo medication. Major bleeding occurred in less than 0.3 percent of individuals in each group, although the relative risk was 88 percent higher with rivaroxaban.
However, lead author Alex C. Spyropoulos, MD, said he was encouraged by the lower rate of nonfatal blood clots observed in the rivaroxaban arm—0.18 percent versus 0.42 percent, a 56 percent relative difference.
“Our results suggest we may be able to offer further protection to patients at risk from non-fatal blood clots, with no increase in major bleeding, by prescribing an oral anticoagulant for use after discharge,” Spyropoulos said in a press release. “This study has potential to reduce the public healthcare burden of non-fatal blood clots in a large proportion of medically ill patients.”
The researchers calculated 430 patients with the characteristics of those in the study would need to be treated with rivaroxaban to prevent one case of symptomatic VTE. On the other hand, 856 would need to be treated to cause one additional major bleeding event compared to placebo.
“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,” the authors wrote. “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.”
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.