vFFR-Guided Strategy Noninferior to Standard FFR in Coronary Lesions: NEJM
Netherlands: A study in the New England Journal of Medicine has revealed that angiography-derived fractional flow reserve (vFFR) is an effective alternative for assessing intermediate coronary lesions. vFFR-guided revascularization was noninferior to standard FFR-guided treatment in terms of death, myocardial infarction, or repeat revascularization at 1 year.
The findings are from an international, open-label randomized trial led by Joost Daemen and colleagues, conducted across 37 centers in Europe. The study addressed an important clinical question, as current guidelines recommend physiological assessment of intermediate coronary artery lesions, but conventional fractional flow reserve (FFR) requires a pressure wire and pharmacological agents to induce hyperemia, which can increase procedural complexity.
In contrast, vessel fractional flow reserve (vFFR) is derived from three-dimensional quantitative coronary angiography and does not require additional instrumentation or hyperemic drugs. This makes it a potentially simpler and less invasive option for guiding revascularization decisions in routine practice.
The trial enrolled patients with intermediate coronary artery stenosis, defined as 30% to 80% narrowing, who presented with either chronic coronary syndromes or acute coronary syndromes. Participants were randomly assigned to undergo revascularization guided by either vFFR or standard pressure wire–based FFR.
A total of over 2,200 patients were included in the analysis, with 1,116 in the vFFR group and 1,095 in the FFR group. The average age of participants was 67 years, with women accounting for nearly one-quarter of the cohort. Additionally, a significant proportion had comorbid conditions, including diabetes, and close to one-fifth presented with acute coronary syndromes.
Key Findings:
- At 1-year follow-up, the primary composite endpoint—comprising death from any cause, myocardial infarction, or repeat revascularization—occurred at identical rates of 7.5% in both the vFFR-guided and FFR-guided groups.
- These comparable event rates demonstrate that vFFR-guided revascularization successfully met the predefined criteria for noninferiority when compared with the standard pressure wire–based FFR-guided approach.
- The overall safety profile of vFFR-guided treatment was found to be similar to that of the conventional FFR-guided strategy.
- Rates of serious adverse events were comparable between the two groups, indicating no additional safety concerns with the use of vFFR.
- These findings suggest that vFFR provides a less invasive, more streamlined alternative for guiding revascularization decisions without compromising clinical outcomes or patient safety.
The results indicate that vFFR can serve as a reliable alternative to traditional FFR in guiding coronary revascularization decisions. By eliminating the need for pressure wires and hyperemic agents, vFFR has the potential to streamline procedures and improve patient comfort without sacrificing clinical outcomes.
Overall, the study supports the integration of angiography-based physiological assessment into clinical practice, particularly for patients with intermediate coronary lesions, where accurate evaluation is essential for optimal treatment planning.
Reference:
DOI: 10.1056/NEJMoa2601841
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