In an episode of the HCPLive podcast series Heart Trials discussing the VOYAGER PAD findings, Manesh Patel, MD, professor of Medicine and chief of the Division of Clinical Pharmacology and Division of Cardiology at the Duke University School of Medicine, discussed the importance of the trial and the precedent it set for reducing PAD-related adverse outcomes. The May 2020 findings also showed the rate of major bleeding per Thrombolysis in Myocardial Infarction (TIMI) did not significantly differ between patients treated with rivaroxaban or placebo, while a greater incidence of bleeding per International Society on Thrombosis and Haemostasis (ISTH) was observed in patients treated with rivaroxaban. The analysis showed rivaroxaban plus aspirin significantly lowered the composite outcome incidence of composite acute limb ischemia, vascular-related major amputation, myocardial infarction, ischemic stroke, and cardiovascular-related death among treated patients with PAD who had undergone revascularization, versus placebo.
The FDA granted the expanded indication on the basis of findings from the VOYAGER PAD trial.
For this use in post-LER patients, rivaroxaban may help reduce PAD patient risk of amputation-as evidenced by supporting phase 3 data. The indication, granted for 2.5 mg twice-daily rivaroxaban in combination with 100 mg once-daily aspirin, broadens the availability of the anticoagulant therapy for patients in the coronary artery disease (CAD) and PAD spectrum. The US Food and Drug Administration (FDA) has approved an expanded indication for rivaroxaban (XARELTO) vascular dose for the treatment of patients following recent lower-extremity revascularization (LER) due to peripheral artery disease (PAD).
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