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. 2022 Aug 18:9:983003.
doi: 10.3389/fcvm.2022.983003. eCollection 2022.

Safety and effectiveness of post percutaneous coronary intervention physiological assessment: Retrospective data from the post-revascularization optimization and physiological evaluation of intermediate lesions using fractional flow reserve registry

Antonio Maria Leone  1 , Stefano Migliaro  2 , Giuseppe Zimbardo  3 , Pio Cialdella  3 , Eloisa Basile  2 , Domenico Galante  2 , Federico Di Giusto  2 , Gianluca Anastasia  2 , Andrea Vicere  2 , Edoardo Petrolati  2 , Antonio Di Stefano  2 , Giorgia Campaniello  2 , Domenico D'Amario  1 , Rocco Vergallo  1 , Rocco Antonio Montone  1 , Antonino Buffon  1   2 , Enrico Romagnoli  1 , Cristina Aurigemma  1 , Francesco Burzotta  1   2 , Carlo Trani  1   2 , Filippo Crea  1   2
Affiliations

Safety and effectiveness of post percutaneous coronary intervention physiological assessment: Retrospective data from the post-revascularization optimization and physiological evaluation of intermediate lesions using fractional flow reserve registry

Antonio Maria Leone et al. Front Cardiovasc Med. .

Abstract

Background: While the importance of invasive physiological assessment (IPA) to choose coronary lesions to be treated is ascertained, its role after PCI is less established. We evaluated feasibility and efficacy of Physiology-guided PCI in the everyday practice in a retrospective registry performed in a single high-volume and "physiology-believer" center.

Materials and methods: The PROPHET-FFR study (NCT05056662) patients undergoing an IPA in 2015-2020 were retrospectively enrolled in three groups: Control group comprising patients for whom PCI was deferred based on a IPA; Angiography-Guided PCI group comprising patients undergoing PCI based on an IPA but without a post-PCI IPA; Physiology-guided PCI group comprising patients undergoing PCI based on an IPA and an IPA after PCI, followed by a physiology-guided optimization, if indicated. Optimal result was defined by an FFR value ≥ 0.90.

Results: A total of 1,322 patients with 1,591 lesions were available for the analysis. 893 patients (67.5%) in Control Group, 249 patients (18.8%) in Angiography-guided PCI Group and 180 patients (13.6%) in Physiology-guided PCI group. In 89 patients a suboptimal functional result was achieved that was optimized in 22 cases leading to a "Final FFR" value of 0.90 ± 0.04 in Angiography-Guided PCI group. Procedural time, costs, and rate of complications were similar. At follow up the rate of MACEs for the Physiology-guided PCI group was similar to the Control Group (7.2% vs. 8.2%, p = 0.765) and significantly lower than the Angiography-guided PCI Group (14.9%, p < 0.001), mainly driven by a reduction in TVRs.

Conclusion: "Physiology-guided PCI" is a feasible strategy with a favorable impact on mid-term prognosis. Prospective studies using a standardized IPA are warrant to confirm these data.

Keywords: FFR; PCI; function based management CCS (chronic coronary syndrome); physiology-guided optimization; post-PCI evaluation.

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Conflict of interest statement

FB and CT disclose having been involved in advisory board meetings or having received speaker’s fees from Abbott, Abiomed, Medtronic, and Biotronic. CA has been involved in advisory board activities by Abbott, Abiomed, Medtronic, and Biotronic. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Study flow chart: group 1 comprised patients for whom percutaneous coronary intervention (PCI) was deferred based on an invasive physiological assessment [Fractional flow reserve (FFR) > 0.80 and/or non-hyperemic pressure ratio (NHPR) > 0.89 and/or contrast FFR (cFFR) > 0.87] (Control Group); group 2 comprised patients who underwent PCI based on an invasive physiological assessment but without any subsequent invasive physiological assessment after PCI (Angiography-Guided PCI); group 3 comprised patients who underwent PCI based on an invasive physiological assessment and with a subsequent invasive physiological assessment after PCI (Physiology-guided PCI) followed by a physiology-guided optimization, if indicated.
FIGURE 2
FIGURE 2
(A) Baseline and post-PCI fractional flow reserve (FFR) values in group 3 (Physiology-guided PCI). (B) Baseline, post PCI and final FFR values in the 22 patients undergoing “Physiology-guided Optimization.”
FIGURE 3
FIGURE 3
Kaplan Meier curves for out-of-hospital outcomes comparing group 1 (Control Group), group 2 [Angiography-Guided percutaneous coronary intervention (PCI)] and group 3 (Physiology-guided PCI).
FIGURE 4
FIGURE 4
Kaplan Meier curves patients with chronic coronary syndromes only at pairwise log rank comparison [Physiology-guided percutaneous coronary intervention (PCI) vs. Angiography-guided PCI p = 0.007, Physiology-guided PCI vs. Control Group p = 0.89].
FIGURE 5
FIGURE 5
ROC curves for the ability of final fractional flow reserve (FFR) value to predict major adverse cardiovascular events (MACE)-free survival.
See this image and copyright information in PMC

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