Background: Elderly patients ≥80 years with coronary artery disease remain underrepresented in trials, despite substantial frailty, multimorbidity and elevated risk of adverse events. Evidence on how high bleeding risk (HBR) and frailty shape clinical and patient-reported outcome measures (PROM) is limited. The Cruz Senior study evaluates geriatric parameters and their relationship to outcomes and PROMs in an all-comer elderly PCI cohort.
Aims: This study aims to compare frailty, clinical outcome and PROMs in octo- and nonagenerians undergoing PCI stratified by HBR status.
Methods: The Cruz Senior trial is a prospective, multicenter observational trial enrolling 1993 all-comer NSTE-ACS and CCS patients aged ≥80 years and undergoing PCI with Supraflex Cruz stent across 37 European sites. A comprehensive geriatric assessment was conducted to assess frailty using validated tools (Barthel index, Timed Up and Go (TUG)). Quality of life (QoL) and angina symptom burden were assessed by Seattle Anigna Questionnaire (SAQ). The primary endpoint at 12 months was a device-oriented composite endpoint (DOCE) comprising cardiovascular death, myocardial infarction not attributable to a non-target vessel, and target lesion revascularization. Secondary endpoints included individual DOCE components and PROMs. In this substudy, patients were stratified by HBR status using ARC-HBR criteria, defined as a predicted BARC 3 or 5 bleeding risk of ≥4% at 1 year or an intracranial hemorrhage of ≥1%.
Results: The total study cohort of 1993 patients comprised 1486 patients with HBR and 507 patients with non-HBR. Patients in the HBR group were significantly older (84.5±3.1 vs. 83.9 ± 2.8 years, p<0.001) and displayed more comorbidities as previous PCI (44.1% vs. 37.1%, p<0.01), peripheral artery disease (15.6% vs. 9.3%, p<0.001) and diabetes (31.0% vs. 22.5%, p<0.001). Geriatric assessment revealed high frailty in both groups, with even greater impairment observed in the HBR-group inlcuding poorer mobility (TUG: 14.3±9.4 vs. 12.7±10.1, p<0.001) and lower Barthel scores (94.2±12.3 vs. 97.4±7.4, p<0.001). The primary endpoint DOCE was significantly higher in the HBR-group (9.4% vs. 4.7%, p<0.0001) mainly driven by cardiovascular death (6.3% vs. 1.8%, p<0.0001). Patients in the HBR-group reported lower QoL (57.4±25.3 vs. 61.4±24.7, p<0.01), and more frequently angina symptoms (76.0±25.5 vs. 79.7±21.7, p<0.05) at baseline. The greatest benefit in PROMs could be seen in the HBR-group with significant improvements.
Conclusions: This study provides the first detailed analysis in elderly PCI patients, showing how frailty and HBR jointly influence clinical outcomes and PROMs. HBR patients had higher DOCE rates but experienced the greatest symptomatic improvement after PCI. PCI decisions in frail older adults require careful, patient-centered evaluation to balance risks and benefits.
