Clinical trial NCT04789317: Pullback Pressure Gradient (PPG) Global Registry
Official title: Pullback Pressure Gradient (PPG) Global Registry: Prospective Evaluation of the Impact of the PPG Index on Clinical Decision Making and Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Coronary Insufficiency
Non ST Elevation Myocardial Infarction
Keywords: FFR
PPG
PCI
Lead sponsor: VZW Cardiovascular Research Center Aalst
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 982
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and indication for hemodynamic assessment by FFR and subsequent confirmation of significant epicardial CAD assessed by an invasive FFR measurement ≤0.80.

Brief summary: The purpose of this study is to determine the predictive capacity of the Pullback Pressure Gradient (PPG) index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.

Detailed description: A Fractional Flow Reserve (FFR) evaluation comprises measurement of a distal single value and a pullback maneuver during hyperemic conditions. The PPGindex is a novel metric derived from the FFR pullback curve.3 This metric complements the distal FFR value by informing the spatial distribution of epicardial resistance (i.e. focal or diffuse) along the coronary vessel. The PPGindex relies on two components: first, the magnitude of pressure drop determined as a maximal pressure gradient over 20 millimeters relative to the total vessel gradient; and second, the length of functional disease relative to total vessel length. These two parameters are weighted equally to provide a metric that ranges from 0 to 1. PPGindex values approaching 1 represent functional focal coronary artery disease (CAD) whereas values close to 0 represent diffuse functional CAD. Until now, the interpretation of the FFR pullback relied on visual assessment. The PPGindex quantifies the pattern of functional CAD and has been shown to predict functionally complete revascularization. Percutaneous revascularization in vessels with high PPGindex is associated with high post-PCI FFR and vast improvement in epicardial conductance whilst PCI in vessels with low PPGindex results in low post-PCI FFR. An curvilinear relationship is observed between PPGindex and functional gain (i.e. FFR post-PCI minus FFR pre-PCI). The PPGindex, therefore, aims to predict the response to PCI in physiological terms.

Calculation of the PPGindex is indicated in cases with an FFR≤0.80. FFR pullbacks are performed under hyperemic conditions at a steady pace during manual pullback. A calculation of the PPGindex using the Coroflow console (Coroventis Research Ab, Uppsala, Sweden) is available for online use and computes the PPG value immediately after the pullback maneuver. This software also includes an automated drift correction. The pullback curve is depicted on an dedicated pullback display screen and the pressure gradients are shown per millimeter, allowing correlation between the location of pressure step-ups and the anatomical target for PCI. In summary, we can distinguish three points where FFR influences the clinical decision-making process. First, an FFR ≤0.80 indicates potential benefit of revascularization. Second, the pullback curve assesses disease pattern and PPG index value quantifies it, helping de physician in the decision about treatment options (e.g. PCI, CABG or OMT). And, third, the location of pressure step-ups along the vessels helps plan the PCI strategy with respect to coverage of functional disease. A combined FFR and PPG-guided PCI strategy has the potential to improve patient selection and enhance procedural planning.

The purpose of this study is to determine the predictive capacity of the PPG index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with stable coronary artery disease or stabilized acute coronary syndrome and invasive FFR measurement ≤0.80.

Exclusion Criteria:

* Angiographic exclusion criteria

  1. Ostial lesions.
  2. Severe vessel tortuosity.
  3. Vessel rewiring deemed 'difficult' by the operator.
  4. Bifurcation with planned two-stent strategy.
  5. NSTEMI culprit vessel.
  6. STEMI
  7. Uncontrolled or recurrent ventricular tachycardia.
  8. Hemodynamic instability
  9. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2

Primary outcomes:
measure: Predictive capacity of the PPG index for post-PCI FFR.
timeFrame: 1 year
Secondary outcomes:
measure: To assess the relationship between baseline PPG index and major adverse cardiovascular events (cardiac death, peri-procedural and spontaneous myocardial infarction and target vessel revascularization) at one, two and three years.
timeFrame: 3 years after completion of inclusion
measure: Difference between baseline and 12 month follow-up in the Seattle Angina Questionnaire (SAQ) stratified by PPG index.
timeFrame: 1 years after completion of inclusion
Other outcomes:
measure: Rate of patients with intended PCI but deferred after PPG calculation.
timeFrame: 1 year
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: New York
country: United States
facility: St Francis Hospital and Heart Center
state: New York
city: Texas City
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Melbourne
country: Australia
facility: Monash Medical Center
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital
city: Aalst
country: Belgium
facility: OLV Aalst
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Righospitalet
city: Nice
country: France
facility: Institut Arnault Tzanck
city: Ferrara
country: Italy
facility: Ferrara University
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Aichi
country: Japan
facility: Aichi University
city: Gifu
country: Japan
facility: Gifu Heart Center
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: Tokyo D Tower Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Lausanne
country: Switzerland
facility: CHUV
city: London
country: United Kingdom
facility: Guy and St Thomas NHS Foundation Trust
Study officials:
affiliation: OLV Hospital
name: Carlos Collet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072.