Johnson & Johnson Reports Promising Findings for Xarelto for Reducing the Risk of Clinically Significant Bleeding

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Johnson & Johnson has announced positive new findings from the PIONEER AF-PCI trial for Xarelto (rivaroxaban) at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24). In the trial, Xarelto displayed efficacy in minimizing the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) or rehospitalization for both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). As part of the study, participants of both cohorts were either treated with Xarelto or warfarin. Results indicated that elderly participants treated with Xarelto had a lower rate of CSB at 12 months compared to those treated with warfarin, while non-elderly patients stayed consistent with warfarin.¹

“Despite advances in cardiovascular care, patients with nonvalvular AF continue to be at risk of potentially life-threatening cardiovascular events, especially older patients considered difficult to treat due to multiple factors, including age and co-morbidities,” said C. Michael Gibson, MD, CEO, Baim Institute, professor of Medicine, Harvard Medical School, in a press release. “A significant challenge in managing nonvalvular AF in older individuals undergoing PCI is determining a treatment that balances the prevention of stroke with the risk for bleeding. Results from the PIONEER AF-PCI trial reinforce the need to continue to research this complex and fragile elderly patient population.”

Additionally, Xarelto contributed to a lower risk of NACE or rehospitalization in both age cohorts, primarily driven by the reduced risk of CSB.¹

“At Johnson & Johnson, we are committed to driving innovation that can improve outcomes for all patients,” said Avery Ince, MD, PhD, VP, medical affairs, cardiovascular & metabolism, Johnson & Johnson, in the press release. “With this new exploratory analysis at ACC.24, we’re pleased to bring the latest research to healthcare providers that adds to the growing body of clinical evidence in older adults.”

Back in November, Johnson & Johnson released results stemming from the Phase III VOYAGER PAD clinical trial of Xarelto in combination with aspirin for the treatment of peripheral artery disease (PAD). This study found that the medication has the potential to reduce vascular events in fragile patients over time, with findings showing 82.1 events per 100 patients at three years compared to 99.3 events per 100 patients in those treated with placebo at three years. For non-fragile patients, data showed that there were 70.4 events per 100 patients at three years in those treated with Xarelto plus aspirin compared to 81.6 events per 100 patients in those treated with placebo at three years.²

“These analyses reinforce the consistency of the favorable benefit-risk profile of Xarelto plus aspirin for patients with vascular disease, regardless of comorbidity. For example, patients categorized as ‘fragile’ are often undertreated due to concerns about benefit-risk, particularly with antithrombotic treatments,” said Marc P. Bonaca*, MD, department of medicine, division of cardiovascular medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, in a press release. “We hope the ongoing wealth of data coming from VOYAGER PAD presented at AHA offers clinicians the information they need to support shared decision-making in prescribing Xarelto plus aspirin as the standard of care for their PAD patients, including those who are high-risk or complex.”

Xarelto was first approved in July 2011 to help prevent deep vein thrombosis which may lead to a pulmonary embolism in patients undergoing knee or hip replacement surgery.³

References

1. Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization. Johnson & Johnson. April 8, 2024. Accessed April 8, 2024. https://www.jnj.com/media-center/press-releases/findings-presented-at-acc-24-showed-xarelto-rivaroxaban-reduced-the-risk-of-clinically-significant-bleeding-and-net-adverse-clinical-events-or-rehospitalization

2. New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations with Peripheral Artery Disease (PAD). Johnson & Johnson. November 14, 2023. Accessed April 8, 2024. https://www.jnj.com/media-center/press-releases/new-voyager-pad-analyses-reinforce-benefit-of-xarelto-rivaroxaban-plus-aspirin-across-high-risk-and-complex-patient-populations-with-peripheral-artery-disease-pad

3. FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery. Johnson & Johnson. July 1, 2011. Accessed April 8, 2024. https://www.jnj.com/media-center/press-releases/fda-approves-xarelto-rivaroxaban-tablets-to-help-prevent-deep-vein-thrombosis-in-patients-undergoing-knee-or-hip-replacement-surgery