Background: Sex-specific differences in coronary artery disease (CAD) are well documented. However, these differences have not been specifically investigated in very elderly patients, who are often underrepresented in clinical trials. Therefore, this substudy of the Cruz Senior trial assesses sex-specific differences in clinical as well as patient reported outcome among octo- and nonagenarian all-comer patients with CAD undergoing PCI.
Methods: This prospective, multicentre, observational study enrolled patients of age ≥80 years, across 37 sites in Europe. All-comer patients with acute coronary syndrome, stable angina, or silent ischemia undergoing PCI were included. Follow-up was performed over 12 months and assessed clinical outcomes, quality of life and frailty markers. The primary endpoint at 12 months was a device-oriented composite (DOCE) comprising cardiovascular death, myocardial infarction not attributable to a non-target vessel, and clinically driven target lesion revascularization. Secondary endpoints included individual components of the primary endpoint and quality of life measures (Seattle Angina Questionnaire - SAQ, PROMIS-29).
Results: A total of 1993 octo- and nonagenarian patients with CAD were included, with a mean age of 84.3 years and 38.2 % (n =762) being female. Women were slightly older than men (84.5 ± 3.1 vs. 84.2 ± 3.0 years; p<0.01). Women were frailer across all assessments: Timed Up & Go test (15.8 vs. 12.8 s; p<0.0001), Mini-Mental State Test (22.6 vs. 23.8; p<0.001), Barthel Index (93.6 vs. 95.9; p<0.0001), and G8 score (12.4 vs. 12.9; p<0.0001). With regards to the primary endpoint, no relevant differences were observed between females and males (DOCE 8.2% vs. 9.2%; p = n.s.). However, women reported a higher symptomatic burden in nearly all domains of the SAQ, including summary score (62.5 vs. 67.8; p < 0.0001), physical limitation (55.1 vs. 63.1; p < 0.0001), angina stability (45.1 vs. 48.1; p < 0.05), angina frequency (75.9 vs. 78.2; p < 0.01), and quality of life (55.1 vs. 60.6; p < 0.0001). According to PROMIS-29 assessments, women had worse scores across all domains, including physical function (12.9 vs. 14.9; p<0.0001), anxiety (7.7 vs. 6.6; p<0.0001), depression (7.0 vs. 6.0; p<0.0001), fatigue (10.7 vs. 9.4; p<0.0001), sleep disturbance (11.4 vs. 9.9;p< 0.0001), social participation (13.6 vs. 14.7; p<0.0001), and pain interference (10.2 vs. 8.6; p<0.0001).
Conclusion: Female patients showed similar event rates compared with male patients. However, despite only a minor age difference, elderly women exhibited a higher symptomatic burden, lower quality of life, and greater geriatric dependency. These findings may have implications for future patient management and individualized treatment strategies.
