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

Daniel Munhoz, Carlos Collet, Takuya Mizukami, Andy Yong, Antonio Maria Leone, Ashkan Eftekhari, Brian Ko, Bruno R. da Costa, Colin Berry, Damien Collison, Divaka Perera, Evald Høj Christiansen, Fernando Rivero, Frederik M. Zimmermann, Hirohiko Ando, Hitoshi Matsuo, Masafumi Nakayama, Javier Escaned, Jeroen Sonck, Koshiro SakaiJulien Adjedj, Liyew Desta, Lokien X. van Nunen, Nick E. J. West, Stephane Fournier, Tatyana Storozhenko, Tetsuya Amano, Thomas Engstrøm, Thomas Johnson, Toshiro Shinke, Simone Biscaglia, William F. Fearon, Ziad Ali, Bernard De Bruyne, Nils P. Johnson*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)170-179
Number of pages10
JournalAmerican Heart Journal
Volume265
DOIs
Publication statusPublished - Nov 2023
Externally publishedYes

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