The risk for major adverse cardiovascular events (MACE) and all-cause mortality was found to be lower in women vs men with symptomatic stable lower extremity peripheral artery disease (PAD), according to a study published in the Journal of the American College of Cardiology.

Patients with vs without PAD are known to be at a greater risk for MACE, but sex differences for cardiovascular (CV) and limb outcomes in this population are less well defined.

This was a post hoc analysis of the Examining Use of Ticagrelor in PAD trial (ClinicalTrials.gov ID NCT01732822), a multicenter,  international, double-blind prospective study in which 13,885 patients with PAD (mean age, 66.6±8.4 years; age ≥50 years) with lower extremity symptoms were treated with ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily In this cohort, 3888 were women (28.0%; mean age, 67.8±8.9 years) and 9997 were men (72.0%; mean age, 66.1±8.2 years). CV outcomes examined were MACE (ie, myocardial infarction, ischemic stroke, or CV death), major adverse limb events (MALE) (ie, acute limb ischemia or major amputation), and all-cause mortality. All endpoints were adjudicated by assessors blinded to treatment group.


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The severity of and medical treatment for PAD were comparable between sexes, but women underwent lower extremity revascularization (LER) procedures less often than men (54.8% vs 57.3%, respectively; P =.006). At baseline, women participants were older compared with men (mean age: 67.8±8.9 years vs 66.1±8.2 years, respectively; P <.001) and more likely to have comorbid hyperlipidemia, hypertension, and chronic kidney disease (P <.001 for all), as well as diabetes mellitus (P =.004).

During the follow-up period (mean, 30 months), women had lower risks for MACE (9.5% vs 11.2%, respectively; adjusted hazard ratio [aHR], 0.77; 95% CI, 0.68-0.88; P <.001) all-cause mortality (7.6% vs 9.7%, respectively; aHR, 0.61; 95% CI, 0.53-0.71; P <.001), MI (4.5% vs 5.1%, respectively; aHR, 0.79; 95% CI, 0.66-0.95; P <.014), and CV death (4.3% vs 5.4%, respectively; aHR, 0.65; 95% CI, 0.54-0.78; P <.001) compared with men. The risks were comparable in women and men for: MALE (2.6% vs 3.0%, respectively; aHR, 0.90; 95% CI, 0.71-1.14; P =.369), acute limb ischemia requiring hospitalization (1.6% vs 1.7%, respectively; aHR, 0.90; 95% CI, 0.66-1.24; P =.536), ischemic stroke (2.0% vs 2.2%, respectively; aHR, 0.88; 95% CI, 0.67-1.16; P =.351), and post-randomization LER (12.6% vs 12.5%, respectively; aHR, 1.02; 95% CI, 0.90-1.14; P =.797).

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Study strengths include comparable PAD severity and therapy between sexes and an excellent retention rate.

Study limitations include possible residual confounders and selection bias, non-matching of groups for all modifiable risk factors, lack of information on cumulative smoking impact, and the fact that EUCLID was not originally designed to assess sex differences.

“Sex is a key variable influencing translation of basic research to clinical trials to inform clinical practice in cardiovascular medicine, and equal inclusion of both sexes is needed to improve understanding of sex-specific differences in clinical outcomes,” noted the authors.

Disclosures:The EUCLID trial was funded by AstraZeneca.

Please see original article for conflict of interest information.

Reference

Haine A, Kavanagh S, Berger JS, et al. Sex-specific risks of major cardiovascular and limb events in patients with symptomatic peripheral artery disease. J Am Coll Cardiol. 2020;75(6):608-617. doi:10.1016/j.jacc.2019.11.057