XARELTO® (rivaroxaban) Plus Aspirin Significantly Reduces Total Ischemic Events in PAD Patients Following Lower-Extremity Revascularization

May 16, 2021 /BioonBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced new data from the Phase 3 VOYAGER PAD study for the anticoagulant Xarelto (rivaroxaban). The study showed that, compared with aspirin (100 mg once daily),The combination of Xarelto (2.5 mg twice daily) and aspirin consistently reduces serious vascular events following lower extremity revascularization (LER) in patients with peripheral artery disease (PAD), whether first, second, third, or subsequent events.The primary endpoint results of the VOYAGER PAD trial demonstrated that the Xarelto plus aspirin regimen reduced the first event following LER in patients with PAD by 15%. The analysis released today indicates that the burden of subsequent events is very high,Over a median follow-up of 2.5 years, primary endpoint events and total vascular events showed a sustained reduction of 14%.

It is worth noting that,The VOYAGER PAD study is the first in 20 years to demonstrate the benefits of long-term treatment for these high-risk patients. These data add to the growing body of evidence.，indicating the effect of dual-pathway inhibition targeting thrombin generation and platelet activation. Relevant data was presented at the recently convened 70th Annual Scientific Session of the American College of CardiologyMeetingpresented at (ACC.21) and simultaneously published in the Journal of the American College of Cardiology.

Peripheral artery disease (PAD) is a chronic circulatory disease that causes blood vessels to narrow, thereby reducing blood flow to the extremities (most commonly the legs). It is estimated that 20 million people in the United States alone have PAD, but currently only 8.5 million have beenDiagnosisPatients diagnosed with this disease. Although initially asymptomatic, PAD symptoms can progress to severe stages, requiring revascularization to prevent amputation.

Dr. Marc P. Bonaca, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, stated: "Even years after revascularization, patients with PAD remain at a significantly elevated risk of thrombotic events due to excessive thrombin generation and platelet aggregation. This analysis from the VOYAGER PAD trial extends beyond the first event and demonstrates that combination therapy with rivaroxaban and aspirin reduces subsequent thrombotic events, underscoring the importance of long-term prevention in these high-risk patients."

Vascular Event Data

In addition to evaluating the time to first event, a subanalysis of the VOYAGER PAD trial also evaluated thrombotic events occurring after the first event. Specifically, the analysis showed that, compared with aspirin,The Xarelto + aspirin regimen significantly reduced composite primary endpoint events (acute limb ischemia, major amputation due to vascular causes, nonfatal myocardial infarction, nonfatal ischemic stroke, or death from vascular causes) (hazard ratio [HR] = 0.86, 95% CI: 0.75–0.98; p = 0.02).

In addition, compared with aspirin,The Xarelto plus aspirin regimen also significantly reduced total vascular events.(all primary endpoints + subsequent peripheral revascularization of the index leg [index leg] and contralateral leg [contralateral leg], and venous thromboembolism events;HR=0.86，95%CI:0.79-0.95；p=0.003). In the VOYAGER PAD study, patients treated with the Xarelto plus aspirin regimen, compared with patients treated with aspirin,No significant increase in Thrombolysis in Myocardial Infarction (TIMI) major bleeding was observed.（2.65% vs 1.87%；HR=1.43，95%CI:0.97-2.10；p=0.07）。

Primary Endpoint Events & Total Vascular Events Data

Dr. James List, Head of Global Therapeutic Area, Cardiovascular & Metabolism, Janssen Research & Development, stated: “The VOYAGER PAD study is the first and only antithrombotic therapy study in the past 20 years to demonstrate significant benefit in patients with peripheral artery disease (PAD) following lower extremity revascularization (LER). With these new data, we now have a complete body of evidence demonstrating the potential of Xarelto in treating patients with PAD across different disease stages (chronic, symptomatic, requiring revascularization, or beyond).”

On October 26, 2020, Janssen announced to the United StatesFDAA supplemental New Drug Application (sNDA) has been submitted to expand the use of Xarelto in patients with PAD, including reducing the risk of major thrombotic vascular events (such as heart attack and amputation) in symptomatic patients following recent lower extremity revascularization (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.

Xarelto is an oral factor Xa inhibitor,This drug is the most widely used non-vitamin K antagonist oral anticoagulant (NOAC) globally.，currently approved for multiple therapeutic indications, with specific indications varying by country. Compared with other NOACs, Xarelto benefits a broad patient population in the prevention of various venous thromboembolism (VTE) and arterial thromboembolism (VAT) conditions.

Xarelto is manufactured byBayerCo-developed with Johnson & Johnson, the drug has been approved in more than 100 countries worldwide. Johnson & Johnson is responsible for sales in the U.S. market, while Bayer handles markets outside the U.S. According to financial reports from both companies, global sales of Xarelto reached $7.5 billion in 2020. (Bioon.com)

Source: Late-Breaking Data at ACC.21 Show XARELTO® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization