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.

N1 - Publisher Copyright: © 2023 Elsevier Inc.

PY - 2023

Y1 - 2023

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 - Journal article

C2 - 37611857

AN - SCOPUS:85171162678

VL - 265

SP - 170

EP - 179

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -