RARITAN - The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event.
The primary results of VOYAGER PAD showed that XARELTO plus aspirin reduced first events by 15 percent among patients with PAD after LER. This analysis showed a very high burden of subsequent events and a consistent 14 percent reduction in both primary endpoint events and total vascular events over a median of 2.5 years. These data were presented as a late-breaking presentation during the virtual American College of Cardiology's 70th Annual Scientific Session (ACC.21) and simultaneously published in the Journal of the American College of Cardiology.
PAD is a chronic circulatory condition which causes blood vessels to narrow, thereby reducing blood flow to the limbs, most often the legs.1 An estimated 20 million Americans are living with PAD, but only 8.5 million are currently diagnosed.2 While usually starting as asymptomatic, PAD symptoms can progress to severe and require revascularization to avoid amputation.
'Even years after revascularization, patients with PAD continue to have a markedly high-risk for future thrombotic events due to excessive thrombin generation and platelet aggregation,' said Marc P. Bonaca, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. 'This analysis from VOYAGER PAD looked beyond the first event and found subsequent thrombotic event reduction with rivaroxaban plus aspirin, underscoring the importance of long-term prevention in these high-risk patients.'
In addition to evaluating the time to first event, this sub-analysis from VOYAGER PAD also evaluated thrombotic events that occurred after the first event. Specifically, it showed XARELTO plus aspirin significantly reduced total primary endpoint events (acute limb ischemia, major amputation for vascular causes, non-fatal myocardial infarction, non-fatal ischemic stroke, or death from vascular causes) compared to aspirin alone (Hazard Ratio (HR)=0.86, 95% Confidence Internal (CI) 0.75 to 0.98; p=0.02). The XARELTO plus aspirin regimen also significantly reduced total vascular events (all primary endpoints plus subsequent peripheral revascularizations of both index and contralateral leg and venous thromboembolic events) compared to aspirin alone (HR 0.86, 95% CI 0.79 to 0.95; p=0.003). No significant increase in Thrombolysis in Myocardial Infarction (TIMI) major bleeding was observed in the VOYAGER PAD study in patients treated with XARELTO plus aspirin compared to aspirin alone (2.65% vs. 1.87% respectively; HR=1.43, 95% CI, 0.97-2.10; p=0.07).
'The VOYAGER PAD trial is the first and only study of antithrombotic therapy in the past 20 years to demonstrate a significant benefit in patients with peripheral artery disease after lower-extremity revascularization,' said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. 'With these new data, we now have a full picture of evidence demonstrating the potential of XARELTO in treating patients through various stages of peripheral artery disease - chronic, symptomatic, those requiring revascularization and beyond.'
On October 26, 2020, Janssen announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration to expand the use of XARELTO in patients with PAD to include reducing the risk of major thrombotic vascular events, such as heart attack and amputation, in symptomatic patients after recent LER. XARELTO is currently approved in combination with aspirin to reduce the risk of major cardiovascular (CV) events (CV death, myocardial infarction and stroke) in patients with chronic coronary artery disease (CAD) or PAD.
About VOYAGER PAD
The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomized in a 1:1 ratio and received either XARELTO (2.5 mg twice daily) plus aspirin (100 mg once daily) (n=3,286) or aspirin alone (100 mg once daily) (n=3,278). Patients were stratified by revascularization procedure type (endovascular vs. surgical) and use of clopidogrel, which was administered at the treating physician's discretion. Patients were followed for a median of 28 months.
The primary efficacy endpoint was a composite of major adverse limb and cardiovascular (CV) events, including acute limb ischemia, major amputation for vascular causes, heart attack (myocardial infarction), ischemic stroke, or death from CV causes. Additional prespecified categories of vascular events included subsequent peripheral revascularizations of both index and contralateral leg and venous thromboembolic events. The principal safety endpoint was major bleeding according to the TIMI classification.
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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