Rivaroxaban can reduce the risk of cardiovascular death and stroke
The anticoagulant drug rivaroxaban (Xarelto) can significantly reduce the risk of cardiovascular death and stroke when used in combination with aspirin as the secondary prevention after a coronary event, according to new trial data announced at the European Society of Cardiology Congress, and published in The New England Journal of Medicine.
Dr Derek Connolly, Consultant Interventional Cardiologist at Birmingham City Hospital and trial investigator, said: “This was the biggest study of rivaroxaban to date, and when licensed for these conditions, it will provide cardiologists with a new option for treating coronary artery disease and peripheral artery disease.”
Even with current secondary prevention strategies, 5-10% of people with cardiovascular disease still have recurrent events each year – and the trial was halted early due to highly significant efficacy and clinical benefit of the drug. As an anticoagulant, rivaroxaban is a direct inhibitor of activated factor X (factor Xa), and is at the moment prescribed to prevent venous thromboembolism, stroke or systemic embolism in atrial fibrillation.
The Phase II COMPASS trial enrolled 25000 patients in 33 countries that met the criteria for coronary artery disease and peripheral arterial disease. From March 2013 to May 2016, participants were randomly assigned to treatment with rivaroxaban (2.5mg twice daily) plus aspirin (100mg once daily), rivaroxaban (5mg twice daily), or aspirin (100mg once daily). The results showed that in those patients prescribed rivaroxaban and aspirin there was a 22% relative risk reduction (absolute risk reduction 0.47%) in cardiovascular death compared with aspirin 100mg once daily alone, which is the current standard of treatment, whilst there was a 42% relative risk reduction in the risk of stroke. Rivaroxaban and aspirin combined also reduced the risk of heart attack by 14%, though this was not deemed statistically significant.
Dr Connolly said: “The results of the COMPASS trial exceeded all expectations, demonstrating efficacy in reducing serious cardiovascular events that was so compelling we offered the treatment to study participants in an open-label extension trial. This study further builds on rivaroxaban’s role in a wide range of complex conditions.”
However, the trial also revealed that in those participants treated with rivaroxaban, at either of the doses, the risk of major bleeding as a side-effect was highly increased when compared with placebo. Major bleeding events (any bleeding event that required hospitilisation) also occurred in more patients in the group treated with both rivaroxaban and aspirin than in those treated with just aspirin (7.9% of patients compared 7.3% of patients, respectively, P<0.001).