New Data Reaffirm Positive Benefit-Risk Balance of Bayer’s Xarelto® in Patients with Atrial Fibrillation in Daily Clinical Practice

Bayer AG and its development partner Janssen Pharmaceuticals, Inc announced results from a new real-world study, REVISIT-US. 

In REVISIT-US reduced rates of ischemic stroke accompanied by reduced rates of intracranial haemorrhage (ICH) were seen with Xarelto® (rivaroxaban) versus warfarin in patients with non-valvular atrial fibrillation (AF).

These results complement and reaffirm findings from the Phase III ROCKET AF clinical trial as well as the non-interventional XANTUS study. Results from REVISIT-US, which analysed nearly 23,000 real-world patients in the United States, were presented at the 12th Annual Congress of the European Cardiac Arrhythmia Society.

REVISIT-US was a retrospective claims analysis performed using US MarketScan claims data evaluating the real-world occurrence of ischemic stroke and intracranial haemorrhage (ICH) in patients with non-valvular AF taking either rivaroxaban or warfarin. In this real-world setting rivaroxaban (n=11,411) was seen to be associated with a non-significant 29% decrease in ischemic stroke accompanied by a significant 47% reduction in ICH vs. warfarin (n=11,411). Looking at the combined endpoint of ICH and ischemic stroke, rivaroxaban resulted in a significant 39% reduction vs. warfarin in REVISIT-US. These results confirm the positive benefit-risk-profile of Xarelto as determined in the Phase III ROCKET AF clinical trial as well as the non-interventional XANTUS study.

“In the management of patients with AF, ischemic stroke and intracranial haemorrhage are the two events both physicians and patients fear most,” said Professor Craig Coleman, Professor of Pharmacy Practice at the University of Connecticut, U.S. who presented the REVISIT-US results at ECAS. “Finding the appropriate balance of benefit and risk is always the goal. It is therefore highly reassuring to see that results from the real world continue to confirm that rivaroxaban is striking the appropriate balance of reducing stroke whilst at the same time also reducing the risk of intracranial haemorrhage in patients with non-valvular AF.”

“Although pivotal Phase III studies like ROCKET AF remain the gold standard to evaluate the efficacy and safety of a drug, real-world evidence plays an important role in complementing the knowledge about the use and impact of our medicines in everyday clinical practice,” said Dr Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Bayer Chief Medical Officer. “We are pleased that study after study evaluating Xarelto in the real world across the spectrum of approved indications continues to confirm the positive benefit-risk profile of Xarelto.”