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 Sakai; Julien 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

doi:10.1016/j.ahj.2023.07.016

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 journal › Article (Academic Journal) › peer-review

7 Citations (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 language	English
Pages (from-to)	170-179
Number of pages	10
Journal	American Heart Journal
Volume	265
Early online date	21 Aug 2023
DOIs	https://doi.org/10.1016/j.ahj.2023.07.016
Publication status	Published - 1 Nov 2023

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Munhoz, D., Collet, C., Mizukami, T., Yong, A., Leone, A. M., Eftekhari, A., Ko, B., da Costa, B. R., Berry, C., Collison, D., Perera, D., Christiansen, E. H., Rivero, F., Zimmermann, F. M., Ando, H., Matsuo, H., Nakayama, M., Escaned, J., Sonck, J., ... Johnson, N. P. (2023). Rationale and design of the pullback pressure gradient (PPG) global registry. American Heart Journal, 265, 170-179. https://doi.org/10.1016/j.ahj.2023.07.016

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title = "Rationale and design of the pullback pressure gradient (PPG) global registry",

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.",

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

year = "2023",

month = nov,

day = "1",

doi = "10.1016/j.ahj.2023.07.016",

language = "English",

volume = "265",

pages = "170--179",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby, Inc.",

}

Munhoz, D, Collet, C, Mizukami, T, Yong, A, Leone, AM, Eftekhari, A, Ko, B, da Costa, BR, Berry, C, Collison, D, Perera, D, Christiansen, EH, Rivero, F, Zimmermann, FM, Ando, H, Matsuo, H, Nakayama, M, Escaned, J, Sonck, J, Sakai, K, Adjedj, J, Desta, L, van Nunen, LX, West, NEJ, Fournier, S, Storozhenko, T, Amano, T, Engstrøm, T, Johnson, T, Shinke, T, Biscaglia, S, Fearon, WF, Ali, Z, De Bruyne, B & Johnson, NP 2023, 'Rationale and design of the pullback pressure gradient (PPG) global registry', American Heart Journal, vol. 265, pp. 170-179. https://doi.org/10.1016/j.ahj.2023.07.016

TY - JOUR

T1 - Rationale and design of the pullback pressure gradient (PPG) global registry

AU - Munhoz, Daniel

AU - Collet, Carlos

AU - Mizukami, Takuya

AU - Yong, Andy

AU - Leone, Antonio Maria

AU - Eftekhari, Ashkan

AU - Ko, Brian

AU - da Costa, Bruno R

AU - Berry, Colin

AU - Collison, Damien

AU - Perera, Divaka

AU - Christiansen, Evald Høj

AU - Rivero, Fernando

AU - Zimmermann, Frederik M

AU - Ando, Hirohiko

AU - Matsuo, Hitoshi

AU - Nakayama, Masafumi

AU - Escaned, Javier

AU - Sonck, Jeroen

AU - Sakai, Koshiro

AU - Adjedj, Julien

AU - Desta, Liyew

AU - van Nunen, Lokien X

AU - West, Nick E J

AU - Fournier, Stephane

AU - Storozhenko, Tatyana

AU - Amano, Tetsuya

AU - Engstrøm, Thomas

AU - Johnson, Thomas

AU - Shinke, Toshiro

AU - Biscaglia, Simone

AU - Fearon, William F

AU - Ali, Ziad

AU - De Bruyne, Bernard

AU - Johnson, Nils P

PY - 2023/11/1

Y1 - 2023/11/1

N2 - 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.

AB - 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.

U2 - 10.1016/j.ahj.2023.07.016

DO - 10.1016/j.ahj.2023.07.016

M3 - Article (Academic Journal)

C2 - 37611857

SN - 0002-8703

VL - 265

SP - 170

EP - 179

JO - American Heart Journal

JF - American Heart Journal

ER -

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

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