Background: Elderly patients (≥80 years) with coronary artery disease (CAD) remain underrepresented in clinical trials, despite high frailty, multimorbidity, and elevated risk of adverse events. Evidence on how diabetes mellitus influences frailty, clinical outcomes and patient-reported outcome measures (PROMs) such as quality of life or symptom burden is limited. The prospective, multicenter Cruz Senior Study evaluates geriatric parameters and their association with both clinical outcomes and PROMs in an all-comer cohort of octo- and nonagenarian patients undergoing PCI with Supraflex Cruz sirolimus-eluting stent. The impact of diabetes in this very high-risk population remains unclear.
Aims: This study sought to investigate the impact of diabetes on clinical outcomes and PROMs in octo- and nonagenerians after PCI with biodegradable polymer sirolimus-eluting stent.
Methods: The Cruz Senior trial is a prospective, multicentre, single-arm observational study including 1993 patients aged ≥80 years across 37 European centers. All-comer NSTE-ACS and CCS patients treated with at least one Supraflex Cruz stent were enrolled. Frailty was assessed using validated tools as Barthel index, Mini Mental Status Test (MMST) and Timed Up and Go (TUG) test. Follow-up at 6 and 12 months recorded clinical outcomes and PROMs. The primary endpoint was the 12-month device-oriented composite endpoint (DOCE) comprising cardiovascular death, non-target vessel myocardial infarction (TVMI) and target lesion revascularization (TLR). Secondary endpoints included its components and PROMs (SAQ, PROMIS-29).
Results: The study cohort of 1,993 patients included 575 patients with diabetes and 1,418 without diabetes. Mean age was 84.3±3.1 years and 61.8% were male. Diabetic patients more often had hypertension (91.0% vs. 84.3%, p<0.001), peripheral vascular diseases (19.3% vs. 11.8%, p<0.001), COPD (10.1% vs. 6.8%, p<0.05) and revealed higher bleeding risk (80.2% vs. 72.3%, p<0.001). Frailty was high in both groups, with poorer mobility in diabetics (TUG 14.9±9.8 vs. 13.4 ± 9.5, p<0.01) and lower Barthel scores (93.4±12.8 vs. 95.7±10.6, p<0.001), while cognitive status was comparable (MMST 23.0±9.7 vs. 23.4±9.7, p=0.06). DOCE rates at 12 months were similar (9.6% vs. 7.7%, p=n.s.) with no differences in individual components. Diabetic patients reported lower baseline QoL (SAQ QoL 56.6±25.6 vs. 59.2±25.0, p=0.05) and higher symptom burden (summary score 62.8±21.2 vs. 67.0±20.0, p<0.001). At 6 months, both groups improved, with diabetic patients approaching non-diabetic levels (QoL 68.4±22.8 vs. 71.2±21.9; summary score: 69.1±19.3 vs. 74.1±18.9).
Conclusions: The present substudy showed within this vulnerable cohort of octo- and nonagenerians undergoing PCI, diabetes was associated with higher frailty levels, a greater comorbidity burden, and lower quality of life. DOCE rates did not differ between groups, and both achieved meaningful symptomatic improvement. These findings support the symptomaitc benefit of PCI in frail, high-risk elderly patients with diabetes.
