January 1, 2014Circulation Journal31 citationsOpen Access

Long-Term Outcome After Deferral of Revascularization in Patients With Intermediate Coronary Stenosis and Gray-Zone Fractional Flow Reserve

YSYasutsugu Shiono TKTakashi Kubo ATAtsushi Tanaka

Structured PICO

Does deferral of PCI in patients with intermediate coronary stenosis and gray-zone FFR (0.75-0.80) increase the risk of target vessel failure compared to deferral in patients with FFR >0.80?

Population

150 patients with angiographically intermediate stenosis (percent diameter stenosis, 30-70%) who had percutaneous coronary intervention (PCI) deferred based on FFR ≥0.75. Excluded: acute coronary syndrome, left main coronary stenosis, coronary artery bypass graft, and prior PCI to the target vessel.

Intervention

Deferral of percutaneous coronary intervention for coronary lesions with gray-zone fractional flow reserve (FFR 0.75-0.80)

Comparator

Deferral of percutaneous coronary intervention for coronary lesions with FFR >0.80

Outcome

Target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (TVR) during follow-upcomposite

Deferring revascularization in patients with intermediate coronary stenosis and a gray-zone FFR of 0.75-0.80 is associated with a significantly higher risk of target vessel failure, primarily driven by ischemia-driven revascularization, compared to deferral in patients with FFR >0.80.

Limitations

Retrospective observational study with potential selection bias
Follow-up angiography was not performed except when clinically indicated, so clinically silent lesion progression could not be evaluated
Included only patients with stable coronary artery disease, so results cannot be applied to acute coronary syndrome
Small sample size limited statistical power and did not allow multivariate analysis
FFR pull-back data were not available; only absolute FFR was used for analysis

Abstract

BACKGROUND: A strategy of deferred percutaneous coronary intervention for coronary stenosis with fractional flow reserve (FFR) 0.75-0.80, termed the gray zone, remains a matter of debate. The aim of this study was to assess the safety of deferring revascularization for patients with FFR 0.75-0.80 compared with those with FFR >0.80. METHODS AND RESULTS: We assessed 3-year clinical outcome in 150 patients with angiographically intermediate stenosis who had revascularization deferred on the basis of FFR ≥ 0.75 (FFR 0.75-0.80, n=56; FFR >0.80, n=94). Target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (TVR) was evaluated during follow-up. Cardiac death was observed in 1 patient with FFR 0.75-0.80. There was no target vessel-related MI in either group. The incidence of ischemia-driven TVR was higher in patients with FFR 0.75-0.80 than in those with FFR >0.80 (14% vs. 3%, P=0.020). TVF-free survival was significantly worse for the patients with FFR 0.75-0.80 than those with FFR >0.80 (hazard ratio, 5.2; 95% confidence intervals: 1.4-19.5; P=0.015). CONCLUSIONS: Patients with FFR 0.75-0.80 were at higher risk of TVF mainly due to TVR than those with FFR >0.80.

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