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Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health.
This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.
The primary goal of this prospective multicenter register study is to evaluate the association between the value of vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) at 6 and 24 months following PCI. The primary composite endpoint is defined as a major adverse cardiovascular event (MACE) including all-cause death, target-vessel myocardial infarction (TVMI), and target vessel revascularization (TVR)] at 6, 12 and 24-month follow-ups. Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study. The analyses of the primary endpoint will be stratified according to the following subgroups:
The patients' coronary angiograms will be analyzed using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology, Medical University of Warsaw (Poland) and other centers in Poland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing PCI | Assessment of ΔvFFR and vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) in patients with CCS or ACS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiography-based vessel fractional flow reserve (vFFR) calculation | Diagnostic Test | vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). | 6 months, 12 months | |
| Rate of all-cause death | 6 months, 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariusz Tomaniak, MD PhD | Contact | +48 22 5991951 | mariusz.tomaniak@wum.edu.pl | |
| Karol Sadowski | Contact | karol.sadowski@wum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Recruiting | Warsaw | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38695286 | Derived | Tomaniak M, Sadowski K, Bednarek A, Huczek Z, Gierlotka M, Hawranek M, Grabowski M, Wojakowski W, Milewski K, Kochman J. Study design and rationale of the angio-based final functional effect of PCI (AFFE PCI) study: a prospective multi-center study of post-PCI vFFR impact on clinical outcomes and residual angina. Cardiol J. 2024;31(3):488-495. doi: 10.5603/cj.99332. Epub 2024 May 2. No abstract available. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Rate of target-vessel myocardial infarction (TVMI) | 6 months, 12 months, 24 months |
| Rate of target-vessel target vessel revascularization (TVR) | 6 months, 12 months, 24 months |
| Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) | The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. | 6 months, 12 months, 24 months |
| Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ) | The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. | 6 months, 12 months, 24 months |
| Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ). | The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function. | 6 months, 12 months, 24 months |
| Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ). | The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. | 6 months, 12 months, 24 months |
| Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). | The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function. | 6 months, 12 months, 24 months |
| Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). | The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. | 6 months, 12 months, 24 months |
| AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE | MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). | 6 months, 12 months, 24 months |
| AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE | MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). | 6 months, 12 months, 24 months |
| AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median SAQ score. | The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function. | 6 months, 12 months, 24 months |
| AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median EQ-5D-5L score. | The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function. | 6 months, 12 months, 24 months |
| AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median SAQ score. | The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. | 6 months, 12 months, 24 months |
| AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median EQ-5D-5L score. | The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. | 6 months, 12 months, 24 months |
| Rate of revascularization of any vessel due to exacerbation of angina symptoms. | Decisions on the performance of revascularization will be made by the attending physician according to the clinical features and available methods. | 6 months, 12 months, 24 months |
| Rate of definite and probable stent thrombosis. | 6 months, 12 months, 24 months |
| Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms. | Decisions on the performance of invasive coronary angiography will be made by the attending physician according to the clinical features. | 6 months, 12 months, 24 months |
| AUC for the value of in-stent vFFR gradient in predicting the rate of MACE | vFFR values are within the range 0-1, where higher values indicate better function. | 6 months, 12 months, 24 months |
| AUC for the value of 3-vessel post-PCI vFFR burden (sum of the vFFR estimated in the three main epicardial arteries) in predicting the rate of MACE | 3-vessel post-PCI vFFR will be defined as the sum of the post-PCI vFFR values derived for each vessel (left anterior descending, circumflex, right coronary artery). | 6 months, 12 months, 24 months |