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Data from new VOYAGER PAD analyses at ACC.22 reinforce benefit of Xarelto + aspirin in patients with peripheral artery disease and co-morbid conditions.-Janssen Pharma companies.

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Published:2nd Apr 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced data from new analyses from the Phase III VOYAGER PAD clinical trial reinforcing the benefit of the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs.


Data from the two analyses demonstrate the role that the Xarelto vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy. Results will be featured at the American College of Cardiology's 71st Annual Scientific Session (ACC.22), hosted in Washington, D.C. and virtually from April 2-4, 2022.

Role of the Xarelto vascular dose in reducing hospitalizations due to thrombotic events in PAD patients with and without CKD: Some co-morbid conditions put patients at a higher risk of PAD; in fact, patients with CKD have a higher prevalence of PAD, at 24-32 percent, with associated higher six-month rehospitalization rates compared to those without renal impairment. In the VOYAGER PAD trial, the Xarelto vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) significantly reduced hospitalizations due to thrombotic events in patients who underwent LER, compared to patients who took aspirin alone (Kaplan-Meier estimate at 3 years: 8.7% vs. 12.1%). The results of a VOYAGER PAD subgroup analysis of patients with and without CKD, to be presented as an oral presentation on April 3 (Abstract #906-06), show a consistent 4.7 percent absolute risk reduction (ARR) in the subgroup with CKD with Xarelto plus aspirin compared to aspirin alone (Kaplan-Meier estimate at 3 years: 7.9% vs. 12.6%).

Effect of the Xarelto vascular dose and statin therapy in high-risk patients : High cholesterol is another co-morbid condition that can harm a person's arteries, and raises the risk of PAD. If high cholesterol isn't controlled, a patient is more likely to have PAD and other blood vessel problems. An additional VOYAGER PAD analysis to be presented in a moderated poster presentation on April 2 (Abstract #1024-11) at ACC.22 evaluated PAD patients with and without a history of statin use, a therapy commonly prescribed to lower cholesterol levels and reduce the risk of heart attack and stroke. Consistent with the overall VOYAGER PAD clinical trial results, the analysis showed that patients with PAD post-LER who received the Xarelto vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) and statin therapy had a 19 percent reduction in the primary endpoint composite of acute limb ischemia (ALI), major amputation for vascular cause, myocardial infarction, ischemic stroke or cardiovascular death; a 26 percent reduction of major adverse limb events (MALE); and a 32 percent reduction of acute limb injury versus placebo and statin therapy. Overall, it was found that with or without statin therapy, the Xarelto vascular dose consistently reduced the composite of major adverse cardiovascular events (MACE) or MALE after revascularization for PAD.

Both analyses showed a numerical but not statistically significant increase in thrombolysis in myocardial infarction (TIMI) major bleeding in patients treated with Xarelto plus aspirin versus aspirin alone, consistent with the primary results of VOYAGER PAD, regardless of CKD at baseline or statin history. There was no increased intracerebral hemorrhage (ICH) or fatal bleeding with Xarelto plus aspirin in PAD patients with or without CKD.

Condition: Peripheral Artery Disease
Type: drug

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