Differences in coronary artery disease and outcomes of percutaneous coronary intervention with drug-eluting stents in women and men

ABSTRACT

Introduction

Despite common perceptions, coronary artery disease (CAD) is not a male-specific condition, and sex-based differences do occur in many aspects, including clinical outcomes after percutaneous coronary intervention (PCI) with stent implantation. New-generation drug-eluting stents (DES) significantly improved post-PCI outcomes. However, no sex-specific guidelines on PCI and the use of DES are available as current evidence was derived from clinical trials enrolling predominantly male patients.

Areas covered

This review aims at exploring sex-based disparities in CAD characteristics and manifestations, and comparing PCI outcomes and the efficacy and safety profiles of DES according to sex. In addition, a critical approach to trials’ interpretation with an analysis of sources of bias is provided to inform future research and clinical practice.

Expert opinion

Sex gap in clinical outcomes after PCI with DES implantation is narrowing due to improved performances of new-generation DES. However, scientific research and biomedical engineering are striving to optimize DES profiles and generate new iterations of devices. At the same time, gender initiatives and sex-specific trials are accruing to overcome current issues in the field. Advances in these areas will foster improvements in early and long-term clinical outcomes of both women and men.

KEYWORDS:

• Coronary artery disease
• drug-eluting stent
• female patients
• gender medicine
• percutaneous coronary intervention
• personalized medicine
• sex
• women

Article highlights

• Coronary artery disease (CAD) patients display high morbidity and mortality rates. Percutaneous coronary intervention (PCI) with stent implantation is the treatment of choice for a large proportion of CAD patients, in both the acute and the chronic settings.

• New-generation drug-eluting stents (DES) consist of a metallic (cobalt-chromium or platinum-chromium) scaffold, a coating polymer (although not always), and an antiproliferative drug. New DES iterations were made available, overcoming limitations of bare-metal stent (BMS) and first-generation DES, and leading to improved post-PCI outcomes, independently of patient or procedural characteristics.

• Differences between female and male patients are evident in several aspects, including coronary anatomy, risk factors and comorbidities, CAD pathophysiology and clinical presentation, diagnostic approach, and response to pharmacotherapy. Sex hormones contribute through several mechanisms, but are not the only determinant of such disparities.

• Compared to men, women affected with CAD were traditionally deemed to be at higher risk for recurrent events and to suffer from worse early and long-term clinical outcomes. However, this detrimental impact of sex almost regularly subsides when adjusting for confounders (e.g., age, risk factors, and comorbidities).

• Regardless of stent type, large-scale trials and pooled analyses consistently showed optimal efficacy and safety in both sexes with regards to post-PCI clinical outcomes, including target lesion revascularization and stent thrombosis rates. These findings were confirmed in all the tested women subgroups, such as acute clinical setting, complex PCI, unprotected left main disease.

• Biomedical engineering and clinical research are relentlessly improving contemporary technologies and testing newer devices. The better outcomes with latest DES iterations are further contributing to narrow the sex gap in post-PCI clinical outcomes.

• Several factors can influence the relationship between sex and clinical outcomes, contributing to the distorted perceptions that have accrued over the years. Identification and critical appraisal of sources of bias in the design and interpretation of clinical trials are of the utmost importance.

• To address sex bias and to promote clinical research and career development, groups and collaborations were started in the fields of medicine and interventional cardiology, fostering the role of women either as patients or health professionals.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Declaration of interest

D Capodanno received speaker honoraria from Biotronik and Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was not funded.