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Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI
Bon-Kwon Koo1, Xinyang Hu1, Jeehoon Kang1
1From Seoul National University Hospital (B.-K.K., J.K., D.H., H.-S.K.), Samsung Medical Center (J.-Y.H., J.-M.L.), and Kyung Hee University Hospital (W.K.), Seoul, Keimyung University Dongsan Medical Center (C.-W.N.) and Yeungnam University Medical Center (U.K.), Daegu, Inje University Ilsan Paik Hospital, Goyang (J.-H.D.), Kangwon National University Hospital, Chuncheon (B.-K.L.), Wonju Severance Christian Hospital, Wonju (S.-G.A.), Ajou University Hospital, Suwon (M.-H.Y., S.-J.T.), Uijeongbu Eulji Medical Center, Uijeongbu (Y-.J.K.), and Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan (E.-S.S.) - all in South Korea; the Second Affiliated Hospital, Zhejiang University School of Medicine (X.H., J.Z., J.J., J.W.), Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine (J.H.), Hangzhou Normal University Affiliated Hospital (F.J.), and Zhejiang Hospital (L.T.), Hangzhou, the First Affiliated Hospital of Wenzhou Medical University (H.Z.), the Second Affiliated Hospital of Wenzhou Medical University (P.C.), and the Third Clinical Institute Affiliated to Wenzhou Medical University (W.J.), Wenzhou, and Ningbo First Hospital (X.C.) and the Affiliated Hospital of the Medical School of Ningbo University (W.H.), Ningbo - all in China.
Insights
Fractional flow reserve (FFR) guidance is as effective as intravascular ultrasonography (IVUS) guidance for patients undergoing percutaneous coronary intervention (PCI). Both methods showed similar rates of death, heart attack, or revascularization at 24 months.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Imaging
Background:
- Percutaneous coronary intervention (PCI) decisions for coronary artery disease often use fractional flow reserve (FFR) or intravascular ultrasonography (IVUS).
- The comparative clinical outcomes of using only FFR or IVUS for both PCI decision-making and stent assessment remain unclear.
Purpose of the Study:
- To compare the clinical outcomes of FFR-guided versus IVUS-guided PCI in patients with intermediate coronary artery stenosis.
- To determine if FFR guidance is noninferior to IVUS guidance for key adverse cardiovascular events.
Main Methods:
- A randomized trial involving 1682 patients with intermediate coronary stenosis undergoing evaluation for PCI.
- Patients were assigned to either FFR-guided or IVUS-guided procedures, with specific criteria for PCI based on FFR values (≤0.80) or IVUS measurements (minimal lumen area ≤3 mm² or 3-4 mm² with >70% plaque burden).
- The primary outcome was a composite of death, myocardial infarction, or revascularization at 24 months, with noninferiority testing for the FFR group compared to the IVUS group.
Main Results:
- PCI was performed in 44.4% of patients in the FFR group and 65.3% in the IVUS group.
- At 24 months, the primary outcome occurred in 8.1% of the FFR group and 8.5% of the IVUS group, demonstrating noninferiority (absolute difference -0.4%, upper 97.5% CI 2.2%, P=0.01).
- Patient-reported outcomes, assessed by the Seattle Angina Questionnaire, were similar between the two groups.
Conclusions:
- FFR guidance is noninferior to IVUS guidance for managing patients with intermediate coronary stenosis undergoing PCI.
- The study supports the use of FFR as a primary guidance tool for PCI, yielding comparable clinical outcomes to IVUS.
- Both FFR and IVUS are effective in guiding PCI decisions, but FFR resulted in lower rates of the intervention itself.
Background:
In patients with coronary artery disease who are being evaluated for percutaneous coronary intervention (PCI), procedures can be guided by fractional flow reserve (FFR) or intravascular ultrasonography (IVUS) for decision making regarding revascularization and stent implantation. However, the differences in clinical outcomes when only one method is used for both purposes are unclear.
Methods:
We randomly assigned 1682 patients who were being evaluated for PCI for the treatment of intermediate stenosis (40 to 70% occlusion by visual estimation on coronary angiography) in a 1:1 ratio to undergo either an FFR-guided or IVUS-guided procedure. FFR or IVUS was to be used to determine whether to perform PCI and to assess PCI success. In the FFR group, PCI was to be performed if the FFR was 0.80 or less. In the IVUS group, the criteria for PCI were a minimal lumen area measuring either 3 mm2 or less or measuring 3 to 4 mm2 with a plaque burden of more than 70%. The primary outcome was a composite of death, myocardial infarction, or revascularization at 24 months after randomization. We tested the noninferiority of the FFR group as compared with the IVUS group (noninferiority margin, 2.5 percentage points).
Results:
The frequency of PCI was 44.4% among patients in the FFR group and 65.3% among those in the IVUS group. At 24 months, a primary-outcome event had occurred in 8.1% of the patients in the FFR group and in 8.5% of those in the IVUS group (absolute difference, -0.4 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.2 percentage points; P = 0.01 for noninferiority). Patient-reported outcomes as reported on the Seattle Angina Questionnaire were similar in the two groups.
Conclusions:
In patients with intermediate stenosis who were being evaluated for PCI, FFR guidance was noninferior to IVUS guidance with respect to the composite primary outcome of death, myocardial infarction, or revascularization at 24 months. (Funded by Boston Scientific; FLAVOUR ClinicalTrials.gov number, NCT02673424.).
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