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Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD
Connie N Hess1,2, Iris Baumgartner3, Sonia S Anand4
1Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO.
Journal of the American Heart Association
|June 14, 2022
Summary
Women with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) had similar primary outcomes as men, but a trend for higher revascularization risk. Rivaroxaban effects were consistent across sexes, though women were more likely to stop treatment.
Area of Science:
- Vascular Surgery
- Cardiology
- Pharmacology
Background:
- Peripheral artery disease (PAD) disproportionately affects women, yet sex-based outcomes post-lower extremity revascularization (LER) remain understudied.
- The efficacy and safety of rivaroxaban in relation to sex following LER require further investigation.
Purpose of the Study:
- To analyze sex-based differences in outcomes after LER for symptomatic PAD.
- To evaluate the consistent effects of rivaroxaban across sexes in patients undergoing LER.
Main Methods:
- Analysis of data from the VOYAGER PAD trial, including 6564 patients undergoing LER.
- Cox proportional hazards models were used to assess outcomes and treatment effects by sex.
- Primary efficacy outcome: composite of cardiovascular and limb events. Primary safety outcome: Thrombolysis in Myocardial Infarction major bleeding.
Main Results:
- Women (26%) had similar risk for the primary efficacy outcome compared to men but showed a trend towards higher risk of unplanned index limb revascularization (HR 1.18).
- Rivaroxaban demonstrated consistent effects on efficacy, limb revascularization, and bleeding outcomes irrespective of sex (P-interaction > 0.20 for all).
- Women were more likely to discontinue study treatment compared to men (HR 1.13).
Conclusions:
- While women and men had similar primary efficacy outcomes post-LER, women exhibited a trend for increased risk of unplanned revascularization.
- Rivaroxaban's therapeutic benefits were consistent across sexes, but adherence may be a concern for female patients.
- Further research is needed to understand sex-based outcomes and improve treatment adherence in PAD patients undergoing LER.
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