Rationale and design of the pullback pressure gradient (PPG) global registry - 11/10/23

Doi : 10.1016/j.ahj.2023.07.016

Daniel Munhoz, MD, PhD ^a,^b, Carlos Collet, MD, PhD ^a, Takuya Mizukami, MD, PhD ^a,^c, Andy Yong, MD, PhD ^d, Antonio Maria Leone, MD, PhD ^e,^f, Ashkan Eftekhari, MD, PhD ^g, Brian Ko, MD, PhD ^h, Bruno R. da Costa, MSc, PhD ^i,^j, Colin Berry, MD, PhD ^k, Damien Collison, MBBCh, MD ^k, Divaka Perera, FRCP, MD ^l, Evald Høj Christiansen, MD, PhD ^m, Fernando Rivero, MD, PhD ⁿ, Frederik M. Zimmermann, MD, PhD ^o, Hirohiko Ando, MD, PhD ^p, Hitoshi Matsuo, MD, PhD ^q, Masafumi Nakayama, MD, PhD ^r, Javier Escaned, MD, PhD ^s, Jeroen Sonck, MD, PhD ^a, Koshiro Sakai, MD, PhD ^a,^t, Julien Adjedj, MD, PhD ^u, Liyew Desta, MD, PhD ^v, Lokien X. van Nunen, MD, PhD ^w, Nick E.J. West, MD ^x, Stephane Fournier, MD, PhD ^y, Tatyana Storozhenko, MD ^a,^z, Tetsuya Amano, MD, PhD ^p, Thomas Engstrøm, MD PhD ^aa, Thomas Johnson, MBBS, MD ^bb, Toshiro Shinke, MD, PhD ^t, Simone Biscaglia, MD, PhD ^cc, William F. Fearon, MD ^dd, Ziad Ali, MD, PhD ^ee, Bernard De Bruyne, MD, PhD ^a,^y, Nils P. Johnson, MD, MS ^ff,^⁎
^a Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
^b Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy
^c Division of Clinical Pharmacology, Department of Pharmacology, Showa University, Tokyo, Japan
^d Concord Repatriation General Hospital, University of Sydney, New South Wales, Australia
^e Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Catholic University School of Medicine, Rome, Italy
^f Center of Excellence in Cardiovascular Diagnostics and Therapeutic, Ospedale Fabenefratelli Isola Tiberina Gemelli Isola, Rome, Italy
^g Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
^h Monash Cardiovascular Research Centre, Monash University and Monash Heart, Monash Health, Clayton, Victoria, Australia
ⁱ Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, England
^j Clinical Epidemiology and Health Care Research, Institute of Health Policy and Management Evaluation (IHPME), University of Toronto, Toronto, Ontorio, Canada
^k School Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK
^l School of Cardiovascular Medicine and Sciences, St Thomas’ Hospital Campus, King's College London, London, UK
^m Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
ⁿ Cardiac Department, Hospital Universitario de La Princesa, Madrid, Spain
^o Department of Cardiology, Catharina Hospital Eindhoven, Eindhoven, The Netherlands
^p Department of Cardiology, Aichi Medical University, Aichi, Japan
^q Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan
^r Department of Cardiology, Tokyo D Tower Hospital, Tokyo, Japan
^s Instituto de Investigacion Sanitaria del Hospital Clinico San Carlos and Complutense University, Madrid, Spain
^t Department of Medicine, Division of Cardiology, Showa University School of Medicine, Tokyo, Japan
^u Department of Cardiology, Arnault Tzanck Institute Saint Laurent du Var, France
^v Department of Cardiology, Karolinska University Hospital, Solna, Stockholm, Sweden
^w Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands
^x Abbott Vascular, Santa Clara, CA
^y Department of Cardiology, University Hospital of Lausanne, Lausanne, Switzerland
^z Department of Prevention and Treatment of Emergency Conditions, L.T. Malaya Therapy National Institute NAMSU, Kharkiv, Ukraine
^aa Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
^bb University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, United Kingdom
^cc Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy
^dd Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine and VA Palo Alto Health Care System, Palo Alto, CA
^ee St Francis Hospital and Heart Center, Roslyn, NY
^ff Weatherhead PET Center, Division of Cardiology, Department of Medicine, McGovern Medical School at UTHealth and Memorial Hermann Hospital, Houston, TX

^⁎Reprint requests: Nils P. Johnson, MD, MS, Weatherhead PET Center, McGovern Medical School at UTHealth, 6431 Fannin Street, Room MSB 4.256, Houston, TX 77030.Weatherhead PET CenterMcGovern Medical School at UTHealth6431 Fannin Street, Room MSB 4.256HoustonTX77030

Résumé

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.

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Graphical Abstract

Image, graphical abstract

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Plan

Methods

Study design

Primary and secondary endpoints

Clinical event definitions

Catheterization laboratory protocol

Calculation of the PPG

The 7 items Seattle angina questionnaire

Clinical decision and treatment

Clinical follow-up

Statistical analysis and sample size

Study limitations

Role of the funding source and study oversight

Results

Discussion

Conclusion

ClinicalTrials.gov Identifier: NCT04789317.

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Vol 265

P. 170-179 - novembre 2023 Retour au numéro

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Rationale and design of the pullback pressure gradient (PPG) global registry - 11/10/23

Résumé

Introduction

Aim

Methods

Results

Conclusion

Graphical Abstract

Plan

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