Chronic Total Occlusion (CTO), Coronary Artery Disease (CAD), Optimal Medical Therapy, Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI), Optimal Medical Therapy (OMT), Octogenarians
Brief 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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥ 80 years. * CTO in at least one major coronary artery. * Complete revascularization or non-critical stenosis in the non-CTO vessels. * Life expectancy \> 1-year
Exclusion criteria
* Severe non-cardiac comorbidities with a life expectancy \< 1 year. * CTOs in the native vessel and patency grafts in CABG patients * CTOs in the minor vessel (Non dominant RCA, small diagonal or obtuse marginal branch) * Lack of any anatomical or clinical details of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE (Major Cardiovascular Events) | From enrollment to 1-year | MACE is defined as a composite of all-cause mortality, non-fatal myocardial infarction, and repeat revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (recurrent angina, dyspnea, re-hospitalization for cardiac causes) | 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. |
Countries
Italy