Angio-based Final Functional Effect of PCI (AFFE-PCI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Chronic Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Angiography-based vessel fractional flow reserve (vFFR) calculation

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.

• Study Type: Observational
• Enrollment (Estimated): 2005

Contacts and Locations

• Study Contact: Name: Mariusz Tomaniak, MD PhD; Phone Number: +48 22 5991951; Email: mariusz.tomaniak@wum.edu.pl
• Study Contact Backup: Name: Karol Sadowski; Email: karol.sadowski@wum.edu.pl

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Recruiting
    • Medical University of Warsaw
    • Contact: Mariusz Tomaniak, MD, PhD; Email: mariusz.tomaniak@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Angiography-based vessel fractional flow reserve (vFFR) calculation; vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).	24 months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; vFFR; ACS; NST-ACS; Angiography-based FFR; Residual angina
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: AFFE-PCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No