Sex-based Differences in Outcomes Following Peripheral Artery Revascularization: Insights from VOYAGER PAD

• Low dose rivaroxaban with aspirin has been shown to reduce cardiovascular and limb events in patients with peripheral artery disease (PAD) undergoing lower extremity revascularisation (LER). Despite high female prevalence and women presenting with more severe disease, the effects of rivaroxaban according to sex was not fully reported
• This study aimed to make better understanding of sex-based differences in patient characteristics and clinical outcomes when receiving rivaroxaban for PAD managed with LER
• The effects of rivaroxaban were consistent by sex, however, women discontinued treatment more frequently and had greater risk of unplanned index limb revascularisation (UILR)

This was a secondary analysis of VOYAGER PAD (Vascular Outcomes Study of acetylsalicylic acid [ASA] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) (NCT02504216). Patient sex was a pre-specified subgroup. Comparisons of baseline characteristics grouped by sex were by Wilcoxon rank- sum tests for continuous variables and chi-square or Fisher’s exact tests for categorical variables.

• Acute limb ischemia
• Major amputation
• Myocardial infarction (MI)
• Ischemic stroke
• Cardiovascular death

• Unplanned index limb revascularisation (UILR)
• Hospitalisation for thrombotic event

• ≥50 years
• Had an abnormal ankle-brachial index or toe-brachial index and imaging evidence of PAD distal to the external iliac artery
• Underwent successful infrainguinal LER for claudication or critical limb ischemia via an endovascular (including hybrid) or surgical approach within the previous 10 days

• Of the 6,564 patients in VOYAGER PAD, 1704 were women.
  • Follow up time: median of 28 months
• Male and female sex were at similar risk for the primary composite outcome (17.9% versus 20.6% at 3 years; hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.74–1.09]; P=0.29)
• There was a trend for greater risk for UILR among women than men (25.3% versus 21.5% at 3 years; [HR], 1.18; 95% [CI], 1.00–1.40; p = 0.0499)
• Treatment effects for rivaroxaban regarding efficacy and safety were overall consistent between sexes, females (HR, 0.97; 95% CI, 0.77–1.23), males (HR, 0.82; 95% CI, 0.71–0.94)
• Greater treatment discontinuation was observed among women vs men (HR, 1.13; 95% CI, 1.03–1.25; p = 0.0099). Women more often discontinued treatment because of patient decisions (28.1% versus 23.0%; p = 0.0174)

In patients undergoing LER for symptomatic PAD, both sexes were at similar risk for the primary outcome. Though the effects of rivaroxaban were consistent between sexes, women showed higher risk for UILR and prematurely discontinued treatment more often.

• The choice of medical and device-based therapies was made at the physician’s discretion
• Real life practice patterns and patient characteristics may differ from those observed in VOYAGER PAD
• VOYAGER PAD was not designed to assess the primary outcome of this study