Rivaroxaban (Xarelto, Janssen/ Bayer) was found to significantly reduce the risk of strokes and heart attacks in patients with stable coronary or peripheral artery disease, according to a new study.
The results of the COMPASS study were presented at the ESC Congress 2017 in Barcelona in late August, and simultaneously published in The New England Journal of Medicine. COMPASS, the largest study of rivaroxaban, enrolled more than 27,000 patients with stable coronary artery disease and/or peripheral artery disease (CAD/PAD) and was funded by Bayer.
In the study, 2.5 mg twice daily of rivaroxaban was compared to 2.5 mg twice daily combined with 100 mg of aspirin once daily and to aspirin alone. The combination of rivaroxaban and aspirin reduced the risk of major cardiovascular (CV) events — defined as CV death, myocardial infarction, or stroke — by 24% in patients with stable CAD/PAD, compared to aspirin alone. Researchers found a 42% reduction in any stroke and a 22% reduction in CV death, compared to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better CV outcomes than aspirin alone.
Because of the efficacy of the combination of rivaroxaban and aspirin, the study was halted early.
Despite use of preventive medicines as directed by current guidelines, approximately 5% of people with CAD or PAD will experience a debilitating or fatal CV event each year, according to a statement from Janssen Pharmaceuticals.
"The results of COMPASS represent a true breakthrough in CAD and PAD, as they confirm the combination regimen of Xarelto and aspirin is highly effective and well-tolerated in preventing the devastating and irreversible CV events that often occur in these patients," said COMPASS lead investigator John Eikelboom, MBBS, MSc FRCPC, Associate Professor in the Department of Medicine, McMaster University, Hamilton, Ontario. "In addition to achieving a positive balance of efficacy and safety, we observed a considerable reduction in stroke and CV death, which could have a profound effect on how physicians manage patients with stable CAD and PAD.”
However, the study found that the risk of major bleeding was significantly higher in patients taking the Xarelto/aspirin regimen compared to aspirin alone. “In total, the benefits outweigh the side effect risks by far. You can see it from the clearly lowered mortality rate and that number also takes the cases of fatal bleeding into account,” said Frank Misselwitz, head of cardiovascular drug development at Bayer, Reuters reported.
Notably, the increased bleeding primarily occurred in the gastrointestinal tract. “Importantly, there was no significant difference in fatal bleeds, intracranial bleeds, symptomatic bleeding into a critical organ or bleeding into the surgical site requiring reoperation between the two groups,” Janssen said in the statement.
While Xarelto is already approved for a number of cardiovascular conditions and prevention of strokes caused by atrial fibrillation, the drug could potentially be used on an additional 30 million patients.