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Rivaroxaban for Patients with Intermittent Claudication. | LitMetric

AI Article Synopsis

  • Rivaroxaban combined with aspirin significantly reduces major cardiovascular and limb risks in high-risk peripheral artery disease patients, but its effects on lower-risk patients with intermittent claudication are unclear.
  • A 24-week clinical trial involved 88 patients with intermittent claudication, comparing a treatment group receiving rivaroxaban plus aspirin to a control group getting aspirin alone, focusing on walking distance improvement.
  • Results showed that the combination treatment increased walking distance by 68 meters more than aspirin alone, with no major bleeding issues reported in either group, indicating a beneficial effect of the combination therapy.

Article Abstract

Background: The combination of rivaroxaban plus aspirin compared with aspirin alone reduces the risk of major adverse cardiovascular and limb events for high-risk patients with peripheral artery disease. It is unknown whether rivaroxaban plus aspirin improves intermittent claudication for adults with lower-risk peripheral arterial disease.

Methods: In this randomized, open-label, multicenter, 24-week clinical trial, we randomly assigned patients with peripheral artery disease and intermittent claudication to receive either 2.5 mg of rivaroxaban twice daily plus 100 mg of aspirin once daily or 100 mg of aspirin once daily. The primary outcome was a 24-week change in total walking distance, measured by the 6-minute walking test. The primary safety outcome was the incidence of major bleeding or clinically relevant nonmajor bleeding.

Results: Eighty-eight patients were randomly assigned to either rivaroxaban plus aspirin (n=46) or aspirin alone (n=42). The mean age was 67 years, and 54% were female. The total walking distance measured by 6-minute walk test improved by 89 ± 18 m (mean±standard error) in the rivaroxaban-plus-aspirin group versus 21 ± 16 m in the aspirin-alone group. This corresponded to an absolute difference of 68 ± 24 m (95% confidence interval [CI], 19 to 116 m; P=0.007) and a relative improvement over the aspirin-alone group of 327% (95% CI, 94 to 560%). No major bleeding events were observed in either group.

Conclusions: In patients with peripheral artery disease and intermittent claudication, 2.5 mg of rivaroxaban twice daily plus 100 mg of aspirin daily improved the total walking distance by a 6-minute walking test compared with 100 mg of aspirin daily alone. (Funded by Bayer S.A.; Clinicaltrials.gov number, NCT04853719.).

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Source
http://dx.doi.org/10.1056/EVIDoa2400021DOI Listing

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