Rivaroxaban prevents thrombotic events after Fontan procedure similar to aspirin
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In pediatric patients undergoing the Fontan procedure, those assigned rivaroxaban had numerically lower but statistically similar rates of thrombotic events compared with those assigned aspirin, according to results of the UNIVERSE trial.
“Anticoagulation in the pediatric population is somewhat challenging, mainly because the primary agent that we have available is warfarin, which is associated with a lot of drug-drug and drug-food interactions,” Brian W. McCrindle, MD, MPH, pediatric cardiologist at The Hospital for Sick Children (SickKids) in Toronto, told Healio. “It’s hard to keep a young patient within a narrow therapeutic target, and patients have to have frequent blood monitoring. The promise of an agent where none of that is applicable was attractive for us to study.”
For the two-part UNIVERSE study, 12 children who underwent the Fontan procedure were enrolled in a single-arm analysis of the pharmacokinetics, pharmacodynamics and safety of rivaroxaban (Xarelto, Janssen/Bayer), and then 100 children who had the procedure were randomly assigned to rivaroxaban or aspirin on a 2:1 basis.
“The Fontan procedure is done for patients who have functional single-ventricle heart disease, which is one of the most severe forms of congenital heart disease,” McCrindle told Healio. “These patients are at risk for clots and need clot prevention.”
The primary safety outcome of major bleeding occurred in one patient from the rivaroxaban group, who had epistaxis requiring transfusion. The rates of clinically relevant nonmajor bleeding were 6% in the rivaroxaban group and 9% in the aspirin group, whereas the rates of trivial bleeding were 33% in the rivaroxaban group and 35% in the aspirin group, according to the researchers.
The rate of thrombotic events in the rivaroxaban group during the randomized phase was 2%, with one patient having a pulmonary embolism, compared with 9% in the aspirin group, with one patient having an ischemic stroke and two patients having venous thrombosis (post hoc log-rank P = .095), McCrindle and colleagues wrote, noting one patient taking rivaroxaban in the single-arm phase had venous thrombosis, for a combined event rate in both phases of 3%.
“Compared to aspirin, rivaroxaban had similar rates of adverse effects, mainly bleeding, and perhaps a trend toward better prevention of thrombosis,” McCrindle told Healio. “This disease is very rare and clot formation is an infrequent event, so in order to definitively answer the question, we would need thousands of patients, which is not feasible. However, this study does give some very useful information, which will allow us to consider starting to put it into practice. For patients who require anticoagulation, rivaroxaban now can be considered as part of the clinical armamentarium.”
Reference:
- New phase 3 data suggest positive effect and show similar safety with Xarelto (rivaroxaban) compared to aspirin in pediatric Fontan procedure patients at risk for blood clots and blood clot-related events. www.prnewswire.com/news-releases/new-phase-3-data-suggest-positive-effect-and-show-similar-safety-with-xarelto-rivaroxaban-compared-to-aspirin-in-pediatric-fontan-procedure-patients-at-risk-for-blood-clots-and-blood-clot-related-events-301385198.html. Published Sept. 27, 20201. Accessed Oct. 13, 2021.
For more information:
Brian W. McCrindle, MD, can be reached at brian.mccrindle@sickkids.ca.
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