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Stenting “Vulnerable” But Fractional Flow Reserve–Negative Lesions: Potential Statistical Limitations of Ongoing and Future Trials

https://doi.org/10.1016/j.jcin.2020.05.036Get rights and content
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Abstract

Can imaging provide sufficient risk stratification to warrant revascularization of a stable plaque with negative fractional flow reserve (FFR)? Prophylactic stenting could at best be applied selectively since the composite group of FFR-negative lesions has a death or myocardial infarction rate of approximately 1%/year or less but modern stents have a rate of 2% to 3.5%/year. Because vulnerable features exist in a minority of lesions, at least 9,000 patients must be screened in order to enroll a cohort with sufficient risk. While several ongoing randomized trials are testing the concept of plaque sealing in FFR-negative lesions, preventive stenting depends on such a small effect that sample sizes to validate or refute its benefit become prohibitive. Since FFR provides a quantitative, straightforward, and reproducible metric of plaque vulnerability and burden without the need for or expense of additional catheter devices, intracoronary imaging cannot meaningfully guide prophylactic stenting when faced with a negative FFR.

Key Words

fractional flow reserve
percutaneous coronary intervention
vulnerable plaque

Abbreviations and Acronyms

FFR
fractional flow reserve
IVUS
intravascular ultrasound
MI
myocardial infarction
NIRS
near infrared spectroscopy
OCT
optical coherence tomography
PCI
percutaneous coronary intervention
RCT
randomized controlled trial
TVMI
target vessel myocardial infarction

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