Rationale and design of the pullback pressure gradient (PPG) global registry

Munhoz D 1 , Collet C 2 , Mizukami T 3 , Yong A 4 , Leone AM 5 , Eftekhari A 6 Show all authors , Ko B 7 , da Costa BR 8 , Berry C 9 , Collison D 9 , Perera D 10 , Christiansen EH 11 , Rivero F 12 , Zimmermann FM 13 , Ando H 14 , Matsuo H 15 , Nakayama M 16 , Escaned J 17 , Sonck J 2 , Sakai K 18 , Adjedj J 19 , Desta L 20 , van Nunen LX 21 , West NEJ 22 , Fournier S 23 , Storozhenko T 24 , Amano T 14 , Engstrøm T 25 , Johnson T 26 , Shinke T 27 , Biscaglia S 28 , Fearon WF 29 , Ali Z 30 , De Bruyne B 31 , Johnson NP 32

Affiliations 

  • 1 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy
  • 2 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
  • 3 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Division of Clinical Pharmacology, Department of Pharmacology, Showa University, Tokyo, Japan
  • 4 Concord Repatriation General Hospital, University of Sydney, New South Wales, Australia
  • 5 Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Catholic University School of Medicine, Rome, Italy; Center of Excellence in Cardiovascular Diagnostics and Therapeutic, Ospedale Fabenefratelli Isola Tiberina Gemelli Isola, Rome, Italy
  • 6 Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
  • 7 Monash Cardiovascular Research Centre, Monash University and Monash Heart, Monash Health, Clayton, Victoria, Australia
  • 8 Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, England; Clinical Epidemiology and Health Care Research, Institute of Health Policy and Management Evaluation (IHPME), University of Toronto, Toronto, Ontorio, Canada
  • 9 School Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK
  • 10 School of Cardiovascular Medicine and Sciences, St Thomas' Hospital Campus, King's College London, London, UK
  • 11 Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
  • 12 Cardiac Department, Hospital Universitario de La Princesa, Madrid, Spain
  • 13 Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands
  • 14 Department of Cardiology, Aichi Medical University, Aichi, Japan
  • 15 Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan
  • 16 Department of Cardiology, Tokyo D Tower Hospital, Tokyo, Japan
  • 17 Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Madrid, Spain
  • 18 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Department of Medicine, Division of Cardiology, Showa University School of Medicine, Tokyo, Japan
  • 19 Department of Cardiology, Arnault Tzanck Institute Saint Laurent du Var, France
  • 20 Department of Cardiology, Karolinska University Hospital, Solna, Stockholm, Sweden
  • 21 Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands
  • 22 Abbott Vascular, Santa Clara, CA
  • 23 Department of Cardiology, University Hospital of Lausanne, Lausanne, Switzerland
  • 24 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Department of Prevention and Treatment of Emergency Conditions, L.T. Malaya Therapy National Institute NAMSU, Kharkiv, Ukraine
  • 25 Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  • 26 University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, United Kingdom
  • 27 Department of Medicine, Division of Cardiology, Showa University School of Medicine, Tokyo, Japan
  • 28 Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy
  • 29 Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine and VA Palo Alto Health Care System, Palo Alto, CA
  • 30 St Francis Hospital and Heart Center, Roslyn, NY
  • 31 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Department of Cardiology, University Hospital of Lausanne, Lausanne, Switzerland
  • 32 Weatherhead PET Center, Division of Cardiology, Department of Medicine, McGovern Medical School at UTHealth and Memorial Hermann Hospital, Houston, TX. Electronic address: nils.johnson@uth.tmc.edu
Am Heart J, 2023 Nov;265:170-179.
PMID: 37611857 DOI: 10.1016/j.ahj.2023.07.016

Abstract

INTRODUCTION: Diffuse disease has been identified as one of the main reasons leading to low post-PCI fractional flow reserve (FFR) and residual angina after PCI. Coronary pressure pullbacks allow for the evaluation of hemodynamic coronary artery disease (CAD) patterns. The pullback pressure gradient (PPG) is a novel metric that quantifies the distribution and magnitude of pressure losses along the coronary artery in a focal-to-diffuse continuum.

AIM: The primary objective is to determine the predictive capacity of the PPG for post-PCI FFR.

METHODS: This prospective, large-scale, controlled, investigator-initiated, multicenter study is enrolling patients with at least 1 lesion in a major epicardial vessel with a distal FFR ≤ 0.80 intended to be treated by PCI. The study will include 982 subjects. A standardized physiological assessment will be performed pre-PCI, including the online calculation of PPG from FFR pullbacks performed manually. PPG quantifies the CAD pattern by combining several parameters from the FFR pullback curve. Post-PCI physiology will be recorded using a standardized protocol with FFR pullbacks. We hypothesize that PPG will predict optimal PCI results (post-PCI FFR ≥ 0.88) with an area under the ROC curve (AUC) ≥ 0.80. Secondary objectives include patient-reported and clinical outcomes in patients with focal vs. diffuse CAD defined by the PPG. Clinical follow-up will be collected for up to 36 months, and an independent clinical event committee will adjudicate events.

RESULTS: Recruitment is ongoing and is expected to be completed in the second half of 2023.

CONCLUSION: This international, large-scale, prospective study with pre-specified powered hypotheses will determine the ability of the preprocedural PPG index to predict optimal revascularization assessed by post-PCI FFR. In addition, it will evaluate the impact of PPG on treatment decisions and the predictive performance of PPG for angina relief and clinical outcomes.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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