Physiology and Residual Ischemia After Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).

Detailed Description
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Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia. Assessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia. Hypothesis: Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in > 20% of cases despite optimal stent implantation and angiographic result. The use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.

Official Title
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Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)

Conditions
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Ischemic Heart Disease, Angina Pectoris, Chest Pain, Coronary Artery Disease, Coronary Restenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation. Exclusion Criteria: Unable to understand study design or objectives of study. Unable to sign informed consent. Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization) Inability to comply with the study follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful uncomplicated PCI as per coronary physiology ratios | Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios . | Transprocedural, initial and final values | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and types of further interventions or imaging techniques | Record the incidence by type of intervention and diagnostic or imaging techniques | Historical and immediately after the procedure, up to 36 months | 
| Residual symptoms and quality of life after repeat angiography | Identify residual symptoms after intervention, and overall immediate quality of life. | up to 30 days | 
| Rates of repeat interventions | on previously intervened lesions versus PCI on new lesions | Historical and immediately after the procedure | 
| Incidence of successful distal positioning of pressurewire |  | Transprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repeat intervention, diastolic pressure ratio (dPR), Coronary Artery Disease, Fractional Flow Reserve (FFR), Coronary physiology