Angina Pectoris, Chest Pain, Coronary Artery Disease, Coronary Restenosis, Ischemic Heart Disease
Conditions
Keywords
Coronary Artery Disease, Fractional Flow Reserve (FFR), Coronary physiology, Repeat intervention, diastolic pressure ratio (dPR)
Brief summary
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
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.
Interventions
None listed
Sponsors
Quebec Heart Institute
Laval University
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful uncomplicated PCI as per coronary physiology ratios | Transprocedural, initial and final values | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and types of further interventions or imaging techniques | Historical and immediately after the procedure, up to 36 months | Record the incidence by type of intervention and diagnostic or imaging techniques |
| Residual symptoms and quality of life after repeat angiography | up to 30 days | Identify residual symptoms after intervention, and overall immediate quality of life. |
| Rates of repeat interventions | Historical and immediately after the procedure | on previously intervened lesions versus PCI on new lesions |
| Incidence of successful distal positioning of pressurewire | Transprocedural | — |
Countries
Canada
Contacts
Primary ContactOlivier F. Bertrand, MD, PhD
Outcome results
None listed