Reviewer: Dr. Erdi Babayiğit

Name of the Study: Safety And Efficacy of Post PCI Physiological Assessment: the PROPHET-FFR study.

Published Congress: EuroPCR 2022

Background: Residual ischemia or persistent symptoms remain in approximately 30% of patients after an angiographically successful PCI. Physiological evaluation after PCI may reveal suboptimal results and benefit clinical outcomes.

Objectives: The PROPHET FFR study aimed to evaluate the safety and feasibility, in-hospital outcomes and out-of-hospital outcomes of “full physiology-guided PCI” in contemporary interventional procedures.

Methods: The PROPHET FFR study is a single-center, observational, ambispective study (Only retrospective results are presented at EuroPCR 2022), Between January 2015 and June 2020, 1550 patients with intermediate stenosis who underwent invasive intervention with acute and chronic coronary syndromes were included, and all patients underwent physiological evaluation (FFR/NHPR/cFFR). The patients were divided into 3 groups according to physiological assessment. The first group consisted of patients with negative functional evaluation (control group), the second group consisted of patients who underwent PCI and were not assessed after PCI (angio-guided), and the third group consisted of patients who underwent PCI and subsequently underwent physiological assessment (physio-guided).

Results: In the study, 71.5% of all lesions were in the first group, while this rate was 16.7% and 11.9% in groups 2 and 3, respectively. Approximately 70% of patients in all three groups had chronic coronary syndrome. In the second and third groups, approximately 30% of the patients had 2-vessel disease and 8.5% had 3-vessel disease. In 12% of the lesions in group 3, the baseline mean FFR value was 0.76±0.03, the  intermediate mean FFR value after PCI was 0.82±0.04, and the final mean FFR value was 0.91±0.04. Of the in-hospital outcomes, fluoroscopy time, total contrast dose, and procedure costs were higher in groups 2 and 3 than in the control group (p values between groups 2 and 3 were 0.56, 0.01, and 1, respectively). Total hospital stay was shortest in the third group with 6±4.3 days (p<0.001). There was no statistical difference between the 2nd and 3rd groups in terms of myocardial injury and periprocedural MI (p=0.14, p=1, respectively). MACE and TVR rates were higher at 21 months for out-of-hospital outcomes in the angio-guided group (p=0.015 and p=0.024, respectively). At 36 months, MACE-free survival and TVR-free survival were lower in group 2 (p=0.019 and p=0.0003, respectively). No difference was observed between the control group and the physio-guided group in terms of MACE-free survival, CV death-free survival, spontaneous MI-free survival, and TVR-free survival at 36 months. There was no statistically significant difference between groups in spontaneous MI-free survival and CV-free survival.

Conclusion: This real-world retrospective study demonstrated the feasibility, safety, and potential use of post-PCI physiological assessment to improve outcomes. The physio-guided strategy resulted in lower TVR rates than the angio-guided strategy.

Interpretations: Although there was no difference between the physio-guided strategy and the control group in terms of MACE and TVR, the higher percentage of these events in the angio-guided group may predict that the physio-guided strategy may reduce the event rates compared to the angio-guided strategy. Ongoing prospective study will demonstrate the potential of this strategy by reducing the effects of low optimization rates and heterogeneity combined with systemic physiological evaluation.