NCT07442526

AGECTO Study: PCI vs. Optimal Medical Therapy for CTO in the Octogenarian Patients

AGECTO Study: A Comparative Study of Percutaneous Coronary Intervention vs. Medical Therapy for Chronic Total Occlusion in Octogenarian Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: San Luigi Gonzaga Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The study compares an interventional strategy (PCI) with optimal medical therapy (OMT) in ultra-octogenarians with chronic total occlusions (CTO). Results suggest that successful PCI leads to significant improvements in symptoms and quality of life compared to OMT alone. While initially carrying higher procedural risks, CTO-PCI is considered feasible and safe in experienced centers. There is also potential for long-term benefits in survival and a reduction in major adverse cardiovascular events (MACE). The choice between treatments depends on an individual risk-benefit assessment, considering the patient's overall condition.

Detailed description

Coronary artery disease (CAD) in the elderly is a growing healthcare concern, with chronic total occlusion (CTO) representing a particularly challenging and complex subset. Despite the increasing prevalence of CTO in older patients, there remains significant controversy and a lack of specific evidence regarding the optimal management strategy for this population. Recent advancements in CTO percutaneous coronary intervention (PCI) techniques have improved success rates and reduced procedural risks. However, older patients (particularly those aged 80 and above) are often underrepresented or excluded from major clinical trials due to perceived higher risks, comorbidities, and potentially reduced life expectancy. This has led to a significant evidence gap regarding the specific benefits and risks of CTO PCI in the very elderly. Consequently, many octogenarian patients with CTO are primarily managed with optimal medical therapy (OMT), not based on robust clinical trial data but often due to physician and institutional bias, age-based exclusion criteria, and a reluctance to pursue invasive procedures in this age group. This often results in a "treatment disparity," where patients are denied access to potentially beneficial interventions based solely on their chronological age, rather than their functional status or individual risk profile. The rationale for the AGECTO study is to address this crucial clinical and ethical gap. By comparing the outcomes of CTO PCI with OMT in a dedicated cohort of octogenarian patients, this study aims to provide initial evidence-based data to guide clinical decision-making. We hypothesize that CTO PCI, when performed successfully in this carefully selected population, offers significant benefits in terms of symptom relief and potentially long-term clinical outcomes compared to OMT alone.

Conditions

• Coronary Artery Disease (CAD)
• Chronic Total Occlusion (CTO)
• Percutaneous Coronary Intervention (PCI)
• Optimal Medical Therapy

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-09-01
• Completion: 2026-12-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Italy