J&J’s Xarelto Evokes Fewer Blood Clots in Patients Than Aspirin

Johnson & Johnson recently announced that Xarelto elicited fewer blood clots and clinical events strongly associated with blood clots in pediatric patients compared to treatment with aspirin.

The two-part, randomized Phase 3 Universe study examined the use of Xarelto in children two to eight years of age with single ventricle physiology who had the Fontan procedure within four months before enrollment. 

During the first part of the study, researchers collected pharmacokinetic (PK) and pharmacodynamic (PD) blood samples on days one and four to determine if the patient could continue receiving the study drug for one year. 

The second part of the study randomized patients to receive either body weight-adjusted Xarelto twice daily or aspirin once daily. 

The primary safety outcome of the trial focused on major bleeding events. And the secondary safety outcomes were clinically relevant non-major bleeding and minimal bleeding events. 

The findings, published in the Journal of the American Heart Association, found that patients treated with Xarelto had a slightly lower prevalence of non-major clinically relevant bleeding and minimal bleeding than aspirin. 

And researchers also noted fewer thrombotic events with Xarelto. But the safety profile for the drugs was similar. 

“We’re optimistic these findings will generate greater understanding and help to inform guidance for physicians managing thrombotic complications in these vulnerable and high-risk pediatric patients,” James List, MD, PhD, global therapeutic area head of cardiovascular, metabolism, & retina at Janssen, said in the announcement. 

Children with congenital heart disease who have a single functioning ventricle undergo the Fontan procedure. The surgery helps to redirect blood flow to the lungs to evoke reoxygenation.  

Children who undergo the Fontan procedure generally face substantial morbidity and mortality from thrombotic events, especially during the three to 12-month period following the procedure. 

“For years, health care providers have had limited options to help reduce potentially fatal thrombotic events that often occur in young children following the Fontan procedure,” said Brian W. McCrindle, MD, MPH, pediatric cardiologist at the Hospital for Sick Children in Toronto. 

“We now not only have data suggesting that Xarelto has a similar positive effect and safety as aspirin, but we also have identified an age-appropriate formulation with precise weight-based dosing to help manage our young patients during a critical time,” McCrindle concluded.