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Rivaroxaban plus aspirin significantly improved walking distance in patients with peripheral artery disease and intermittent claudication. This combination therapy showed a 327% greater improvement compared to aspirin alone, with no increase in major bleeding events.

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Area of Science:

  • Cardiovascular Medicine
  • Pharmacology

Background:

  • Peripheral artery disease (PAD) affects numerous adults, with intermittent claudication being a common symptom.
  • While rivaroxaban plus aspirin is known to benefit high-risk PAD patients, its efficacy in lower-risk patients with intermittent claudication was previously unestablished.

Purpose of the Study:

  • To investigate the effectiveness of combining rivaroxaban with aspirin in improving walking distance for patients suffering from peripheral artery disease and intermittent claudication.
  • To assess the safety profile of this combination therapy, specifically focusing on bleeding events.

Main Methods:

  • A randomized, open-label, multicenter trial involving 88 patients with PAD and intermittent claudication.
  • Participants were assigned to receive either rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily) or aspirin (100 mg once daily) for 24 weeks.
  • The primary efficacy endpoint was the change in total walking distance assessed by the 6-minute walking test; the primary safety endpoint was the incidence of major or clinically relevant nonmajor bleeding.

Main Results:

  • The rivaroxaban-aspirin group demonstrated a significantly greater improvement in the 6-minute walking test distance (89 m) compared to the aspirin-alone group (21 m).
  • This represented an absolute difference of 68 m and a relative improvement of 327% in favor of the combination therapy.
  • No major bleeding events were reported in either treatment arm, indicating a favorable safety profile for the rivaroxaban-aspirin combination.

Conclusions:

  • The combination of rivaroxaban (2.5 mg twice daily) and aspirin (100 mg once daily) significantly enhances walking distance in patients with peripheral artery disease and intermittent claudication.
  • This therapeutic approach offers a promising option for improving functional capacity in this patient population without a discernible increase in major bleeding risk.