Rationale and design of the pullback pressure gradient (PPG) global registry
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Rationale and design of the pullback pressure gradient (PPG) global registry. / Munhoz, Daniel; Collet, Carlos; Mizukami, Takuya; Yong, Andy; Leone, Antonio Maria; Eftekhari, Ashkan; Ko, Brian; da Costa, Bruno R.; Berry, Colin; Collison, Damien; Perera, Divaka; Christiansen, Evald Høj; Rivero, Fernando; Zimmermann, Frederik M.; Ando, Hirohiko; Matsuo, Hitoshi; Nakayama, Masafumi; Escaned, Javier; Sonck, Jeroen; Sakai, Koshiro; Adjedj, Julien; Desta, Liyew; van Nunen, Lokien X.; West, Nick E. J.; Fournier, Stephane; Storozhenko, Tatyana; Amano, Tetsuya; Engstrøm, Thomas; Johnson, Thomas; Shinke, Toshiro; Biscaglia, Simone; Fearon, William F.; Ali, Ziad; De Bruyne, Bernard; Johnson, Nils P.
I: American Heart Journal, Bind 265, 2023, s. 170-179.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 -
ID: 396945093