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ACC.24: PIONEER AF-PCI Clinical Trial Finds XARELTO (rivaroxaban) Reduces Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization
New exploratory analysis demonstrates consistent results of XARELTO® in treating elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention
XARELTO® is one of the most studied oral anticoagulants, and has been prescribed to more than 10 million patients in the United States
New exploratory analysis demonstrates consistent results of XARELTO® in treating elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention
XARELTO® is one of the most studied oral anticoagulants, and has been prescribed to more than 10 million patients in the United States
NEW BRUNSWICK, N.J.-- Johnson & Johnson announced a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI).1,2 These data were featured in an oral presentation at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia (Abstract #906-04).
"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*, M.D., CEO, of the nonprofit Baim Institute and professor of Medicine, Harvard Medical School. "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."
The PIONEER AF-PCI exploratory trial enrolled 2,124 patients with nonvalvular AF undergoing PCI, of whom 729 (34.3%) were elderly.1,3 Patients were randomized to either rivaroxaban- or warfarin-based antithrombotic regimens.1,3 The data analysis demonstrated a reduced rate of CSB among both elderly (≥75 years) and non-elderly (<75) patients with nonvalvular AF undergoing PCI treated with XARELTO® compared to warfarin.1 Elderly patients treated with XARELTO® had a lower rate of CSB at 12 months compared to those treated with warfarin (21.3% vs 31.4%; hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46-0.88; P=0.005; number needed to treat [NNT]=10).1 The reduction in CSB was consistent among non-elderly patients treated with XARELTO® compared to warfarin (15.3% vs 24.6%; HR, 0.58; 95% CI, 0.45-0.75; P<0.001; NNT=11; interaction P=0.676).1
The analysis also showed XARELTO® treatment was associated with a lower risk of NACE or rehospitalization in both elderly (HR, 0.77; 95% CI, 0.62-0.96) and non-elderly patients (HR, 0.69; 95% CI, 0.58-0.82; interaction P=0.435), primarily driven by a lower risk of CSB.1 In addition, the rates of major bleeding were lower in patients treated with XARELTO® compared to warfarin in both elderly (3.7% vs 5.2%; HR, 0.71; 95% CI, 0.33-1.55) and non-elderly (1.1% vs 2.5%; HR, 0.45; 95% CI, 0.18-1.10) patients.1 Patients treated with XARELTO® also experienced lower rates of minor bleeding compared to warfarin in both elderly (1.4% vs 3.8%; HR, 0.36; 95% CI, 0.12-1.07) and non-elderly (1.0% vs 1.4%; HR, 0.67; 95% CI, 0.23-1.92) patients.1
"At Johnson & Johnson, we are committed to driving innovation that can improve outcomes for all patients," said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Johnson & Johnson. "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."
About PIONEER AF-PCI
PIONEER AF-PCI was an international, multi-center, randomized, open-label clinical trial evaluating the safety of rivaroxaban compared to warfarin for the treatment of patients at least 18 years of age with paroxysmal, persistent, or permanent nonvalvular AF who had undergone PCI with stent placement. In the trial, 2,124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting received, in a 1:1:1 ratio, low-dose rivaroxaban (15 mg once daily) plus a P2Y12 inhibitor for 12 months (group 1), low-dose rivaroxaban (2.5 mg twice daily) plus DAPT for 1, 6, or 12 months (group 2), or standard therapy with a dose-adjusted vitamin K antagonist (once daily) plus DAPT for 1, 6, or 12 months (group 3).
The primary safety endpoint was the occurrence of clinically significant bleeding, a composite of major bleeding or minor bleeding according to Thrombolysis in Myocardial Infarction (TIMI) criteria or bleeding requiring medical attention during the treatment period (which was defined as the time from the first administration of a trial drug to 2 days after the trial drugs were discontinued, through 12 months of therapy). Secondary endpoints included the incidence of each component of the primary safety endpoint, as well as the following efficacy endpoints: the occurrence of a major adverse cardiovascular event (a composite of death from cardiovascular causes, myocardial infarction, or stroke), each component of the major adverse cardiovascular event endpoint, and stent thrombosis.3
About XARELTO® (rivaroxaban)
XARELTO® is a prescription medicine used to:
- reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
FDA approved dosing for patients with nonvalvular AF is 20 mg once daily with an evening meal in patients with CrCl >50 mL/min. For patients with moderate to severe renal impairment (CrCl ≤50 mL/min), the FDA approved dosing is 15 mg once daily with an evening meal.
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