Long-term Outcomes After Real-World Fractional Flow Reserve Use
Long-term Outcomes After Real-World Fractional Flow Reserve Use
Background. Long-term clinical outcomes of real-world use of fractional flow reserve (FFR), including the decisions against FFR, have not been fully evaluated in the era of drug-eluting stent (DES) implantation.
Methods. A total of 1294 patients who underwent FFR measurement for de novo coronary lesions were included. FFR measured lesions (n = 1628) were divided into FFR-defer or FFR-stent lesions according to the treatment strategy selected after FFR measurement. Clinical outcomes were assessed by patient-related major adverse cardiac event (a composite of all-cause death, myocardial infarction, and any revascularization) and target-lesion related event (target-lesion related myocardial infarction and revascularization).
Results. Mean FFR was 0.80 ± 0.12, and FFR was ≤0.8 in 728 lesions (44.7%). Five-year cumulative all-death rate was 6.3%, myocardial infarction rate was 1.5%, and rate of any revascularization was 12.5%. Among 797 deferred lesions, 105 lesions had FFR ≤0.8 and those lesions had a higher risk of 5-year target-lesion related events than the lesions with FFR >0.8 (21.2% vs 6.6%, respectively; P=.03). By multivariate analyses, the determinant for the 1-year target-lesion related events was the presence of diabetes (hazard ratio, 3.74; 95% confidence interval, 1.45–9.67; P=.01), while the determinant for delayed events at 1–5 years was FFR ≤0.8 (hazard ratio, 4.50; 95% confidence interval, 1.65–12.28; P=.01). Angiographic lesion severity was not an independent predictor for clinical events during follow-up among deferred lesions.
Conclusion. The deferral of stenting according to FFR was associated with favorable long-term outcomes. Presence of diabetes and low FFR (≤0.8) increased the risk of clinical events in deferred lesions.
Fractional flow reserve (FFR) is an invasive physiologic index that can be easily measured in the cardiac catheterization laboratory to assess the presence of myocardial ischemia or the need for revascularization. Recent randomized trials showed that an FFR-guided revascularization strategy was better than angiography-guided drug-eluting stent (DES) implantation, and DES implantation for functionally significant stenosis reduced the need for urgent revascularization compared with medical therapy alone. Therefore, the use of FFR is increasing in daily clinical practice.
In real-world practice, FFR is measured for angiographically intermediate or ambiguous lesions and revascularization is performed without FFR when there is a clinically-indicated culprit lesion. In those cases, the outcome of a patient is determined by both FFR-measured lesions and stented lesions without FFR. Furthermore, the decision to perform revascularization is sometimes made by the clinical and anatomical information as well as FFR value. As residual stenosis after revascularization is reported to be associated with increased risk of future cardiovascular events, some operators believe that the clinical judgment against FFR may improve patient outcomes, especially when second-generation DESs are used. However, long-term clinical outcomes of real-world FFR use, including the decisions against FFR, have not been fully evaluated in the DES era.
We performed this study to comprehensively evaluate the long-term patient-related and target-lesion related clinical outcomes after FFR use in real-world clinical practice in four Korean centers.
Abstract and Introduction
Abstract
Background. Long-term clinical outcomes of real-world use of fractional flow reserve (FFR), including the decisions against FFR, have not been fully evaluated in the era of drug-eluting stent (DES) implantation.
Methods. A total of 1294 patients who underwent FFR measurement for de novo coronary lesions were included. FFR measured lesions (n = 1628) were divided into FFR-defer or FFR-stent lesions according to the treatment strategy selected after FFR measurement. Clinical outcomes were assessed by patient-related major adverse cardiac event (a composite of all-cause death, myocardial infarction, and any revascularization) and target-lesion related event (target-lesion related myocardial infarction and revascularization).
Results. Mean FFR was 0.80 ± 0.12, and FFR was ≤0.8 in 728 lesions (44.7%). Five-year cumulative all-death rate was 6.3%, myocardial infarction rate was 1.5%, and rate of any revascularization was 12.5%. Among 797 deferred lesions, 105 lesions had FFR ≤0.8 and those lesions had a higher risk of 5-year target-lesion related events than the lesions with FFR >0.8 (21.2% vs 6.6%, respectively; P=.03). By multivariate analyses, the determinant for the 1-year target-lesion related events was the presence of diabetes (hazard ratio, 3.74; 95% confidence interval, 1.45–9.67; P=.01), while the determinant for delayed events at 1–5 years was FFR ≤0.8 (hazard ratio, 4.50; 95% confidence interval, 1.65–12.28; P=.01). Angiographic lesion severity was not an independent predictor for clinical events during follow-up among deferred lesions.
Conclusion. The deferral of stenting according to FFR was associated with favorable long-term outcomes. Presence of diabetes and low FFR (≤0.8) increased the risk of clinical events in deferred lesions.
Introduction
Fractional flow reserve (FFR) is an invasive physiologic index that can be easily measured in the cardiac catheterization laboratory to assess the presence of myocardial ischemia or the need for revascularization. Recent randomized trials showed that an FFR-guided revascularization strategy was better than angiography-guided drug-eluting stent (DES) implantation, and DES implantation for functionally significant stenosis reduced the need for urgent revascularization compared with medical therapy alone. Therefore, the use of FFR is increasing in daily clinical practice.
In real-world practice, FFR is measured for angiographically intermediate or ambiguous lesions and revascularization is performed without FFR when there is a clinically-indicated culprit lesion. In those cases, the outcome of a patient is determined by both FFR-measured lesions and stented lesions without FFR. Furthermore, the decision to perform revascularization is sometimes made by the clinical and anatomical information as well as FFR value. As residual stenosis after revascularization is reported to be associated with increased risk of future cardiovascular events, some operators believe that the clinical judgment against FFR may improve patient outcomes, especially when second-generation DESs are used. However, long-term clinical outcomes of real-world FFR use, including the decisions against FFR, have not been fully evaluated in the DES era.
We performed this study to comprehensively evaluate the long-term patient-related and target-lesion related clinical outcomes after FFR use in real-world clinical practice in four Korean centers.
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