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Two large Xarelto studies support effectiveness of dual pathway inhibition in patients with coronary artery disease and/or peripheral artery disease.

Created by Allen Wellings
Read time: 1 mins
Published:25th May 2022

Two studies with Bayer´s Factor Xa inhibitor rivaroxaban (Xarelto), the Long-Term Open Label Extension (LTOLE) of the COMPASS trial and the XATOA registry, provide complementary evidence of the benefits of dual pathway inhibition (DPI), defined as the combination of the vascular dose of Xarelto (2.5 mg twice daily) and aspirin.

The Phase III COMPASS study, published in 2017 in the New England Journal of Medicine and the largest clinical study of Xarelto to date with 27,395 patients, confirmed that Xarelto 2.5 mg twice daily plus aspirin 100 mg once daily reduced the risk of the composite outcome of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) in patients with chronic coronary artery disease and/or peripheral artery disease. The findings of the LTOLE study and the XATOA registry were published in European Heart Journal - Cardiovascular Pharmacotherapy, one of the official journals of the European Society of Cardiology (ESC).

The LTOLE part of the COMPASS study found that continued treatment with Xarelto 2.5 mg twice daily and aspirin 100 mg once daily for up to 3 years was associated with incidence rates for major adverse cardiovascular events (cardiovascular death, stroke, or myocardial infarction) and for bleeding that were similar to or lower than those seen during the randomized treatment phase.

DPI, the combination of the vascular dose of Xarelto (2.5 mg twice daily) and aspirin (75 – 100 mg once daily), is widely approved by healthcare authorities for use in patients with CAD, PAD, or both having increased vascular risk. However outside the context of a randomized trial, clinical characteristics of patients at risk, bleeding rates and clinical event rates in patients receiving DPI were not available. The XATOA study investigated these for the first time in registry, revealing that patients at high risk due to vascular disease are being prioritized for DPI therapy in clinical practice. Rates of major adverse cardiovascular events (MACE) were similar to these in the COMPASS study; rates of major adverse limb events (MALE) were higher, consistent with the greater proportion of patients with PAD in the study.

“The XATOA study was a first of its kind,” said Professor Keith Fox, University of Edinburgh, and lead author of the XATOA registry. “Patient outcomes overall were consistent with the COMPASS study. Major bleeding rates were even lower. The findings give us additional evidence of the benefits of using DPI in patients at increased risk of vascular events and should be considered as treatment option.”

See-"Platelet P2Y12 inhibiting therapy in adjunct to vascular dose of rivaroxaban or aspirin: A pharmacodynamic study of dual pathway inhibition versus dual antiplatelet therapy". Mattia Galli, MD, Francesco Franchi, MD, Fabiana Rollini, MD, Latonya Been, AAS, Patrick Abou Jaoude, MD ... European Heart Journal - Cardiovascular Pharmacotherapy, pvac022, https://doi.org/10.1093/ehjcvp/pvac022. Published: 30 March 2022.

Condition: PAD + CAD
Type: drug

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