Rivoli Hospital
Rivoli, 10098, Italy
NCT Number: NCT07442526
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.
This study is active but is not currently recruiting participants.
All sexes
Observational
Rivoli, 10098, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to 1-year
MACE is defined as a composite of all-cause mortality, non-fatal myocardial infarction, and repeat revascularization.
Time frame: From the enrollment to 1-year
Quality of life will be assess in the long-term impact of treatment strategy on symptoms, functional capacity and re-hospitalization for cardiac causes.
San Luigi Gonzaga Hospital
Other
AGECTO Study: A Comparative Study of Percutaneous Coronary Intervention vs. Medical Therapy for Chronic Total Occlusion in Octogenarian Patients
Acronym: AGECTO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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