Clinical trial NCT06255678: Angio-based Final Functional Effect of PCI
Official title: Angio-based Final Functional Effect of PCI (AFFE PCI): a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Non ST Segment Elevation Acute Coronary Syndrome
Chronic Coronary Syndrome
Keywords: vFFR
ACS
NST-ACS
Angiography-based FFR
Quality of life
Residual angina
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 2005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)

Brief summary: 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.

Detailed description: 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:

* Diabetes/non-diabetes
* Glomerular filtration rate (GFR)≥60/GFR\<60 \[ml/min./1,73m2\]
* Focal/diffuse atherosclerosis
* Multivessel/single-vessel disease
* CCS/NST-ACS/STEMI
* CCS/ACS

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.

Eligibility criteria: Inclusion Criteria:

* Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
* Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation/angulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification)
* Age \>18 years
* The patient's written informed consent has been obtained before the procedure

Exclusion Criteria:

* Cardiogenic shock, pulmonary oedema
* Severe hemodynamical instability
* Prior coronary artery bypass grafting (CABG)
* Active bleeding
* Acute and chronic inflammatory conditions
* Acute mechanical complications of myocardial infarction
* Congenital heart disease
* Heart transplantation
* Non-cardiac comorbidities with a life expectancy of less than 1 year

Primary outcomes:
measure: Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
timeFrame: 24 months
Secondary outcomes:
measure: Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
timeFrame: 6 months, 12 months
measure: Rate of all-cause death
timeFrame: 6 months, 12 months, 24 months
measure: Rate of target-vessel myocardial infarction (TVMI)
timeFrame: 6 months, 12 months, 24 months
measure: Rate of target-vessel target vessel revascularization (TVR)
timeFrame: 6 months, 12 months, 24 months
measure: Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L)
timeFrame: 6 months, 12 months, 24 months
measure: Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ)
timeFrame: 6 months, 12 months, 24 months
measure: Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ).
timeFrame: 6 months, 12 months, 24 months
measure: Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ).
timeFrame: 6 months, 12 months, 24 months
measure: Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
timeFrame: 6 months, 12 months, 24 months
measure: Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
timeFrame: 6 months, 12 months, 24 months
measure: AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE
timeFrame: 6 months, 12 months, 24 months
measure: AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE
timeFrame: 6 months, 12 months, 24 months
measure: 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.
timeFrame: 6 months, 12 months, 24 months
measure: 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.
timeFrame: 6 months, 12 months, 24 months
measure: AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median SAQ score.
timeFrame: 6 months, 12 months, 24 months
measure: AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median EQ-5D-5L score.
timeFrame: 6 months, 12 months, 24 months
measure: Rate of revascularization of any vessel due to exacerbation of angina symptoms.
timeFrame: 6 months, 12 months, 24 months
measure: Rate of definite and probable stent thrombosis.
timeFrame: 6 months, 12 months, 24 months
measure: Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms.
timeFrame: 6 months, 12 months, 24 months
measure: AUC for the value of in-stent vFFR gradient in predicting the rate of MACE
timeFrame: 6 months, 12 months, 24 months
measure: 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
timeFrame: 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
References: