Physiological assessment is effective when it comes to decision-making for percutaneous coronary intervention (PCI). However, despite the available evidence, its use remains limited. AngioFFR technology offers a simpler approach, as it allows for direct angiographic analysis without the need for specific wires.
In addition to its diagnostic function, the use of AngioFFR could optimize PCI similarly to IVUS, which is employed for that same purpose.
The objective of this study was to compare the efficacy of AngioFFR-guided vs. IVUS-guided PCI in patients with angiographically significant stenosis.
Researchers designed a non-inferiority study whose primary endpoint (PEP) was a composite of mortality, acute myocardial infarction (AMI), or revascularization over 12 months. Secondary events included the PEP at 24 and 60 months, target vessel failure (TVF), all-cause mortality, and any type of revascularization.
The study included a total of 1872 patients from 22 centers in China. All subjects presented with ≥50% stenosis in a vessel ≥2.5 mm. Exclusion criteria included graft lesions, left main coronary artery (LMCA) lesions, chronic total occlusions (CTO), and lesions that could not be assessed by AngioFFR (such as myocardial bridges, severe tortuosity, severe overlap, or poor image quality).
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PCI was performed on lesions with an AngioFFR ≤0.8 or a minimum lumen area (MLA) ≤3 mm², or between 3-4 mm² with a plaque burden (PB) >70%. PCI was considered optimized when post-procedure AngioFFR was ≥0.88. In the case of IVUS, optimization was defined as a minimum stent area (MSA) ≥5.5 mm² and an edge PB ≤55%.
The average patient age was 66 years, 67.4% of subjects were men, and 59% had acute coronary syndrome. A total of 73.9% of patients underwent AngioFFR-guided PCI, while 83.1% underwent IVUS-guided PCI. The average Syntax score was 9.
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Regarding the PEP, the AngioFFR group had a 6.3-% event rate, while the IVUS group had a 6-% event rate, with a non-inferiority p-value of 0.022. There were no significant differences in the individual events of the primary endpoint or in the pre-specified subgroup analyses.
Conclusion
In patients with non-complex coronary artery disease, PCI guided and optimized by AngioFFR was not inferior to IVUS-guided PCI in the PEP assessed at 12 months.
Presented by Jian’an Wang in Late-Breaking Clinical Trials, ACC 25, March 30, Chicago, EE.UU.
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