Methods
Download a PDF of the Research Summary. We randomized 1682 patients being evaluated for PCI to treat interstitial stenosis (40 to 70% occlusion by visual assessment on coronary angiography) in a 1:1 ratio to undergo either an FFR-guided or an IVUS-guided procedure. FFR or IVUS was to be used to determine whether to perform PCI and to assess the success of PCI. In the FFR group, PCI had to be performed if the FFR was 0.80 or less. In the IVUS group, criteria for PCI were a minimal luminal area measuring either 3 mm2 or less or measuring 3 to 4 mm2 with plaque burden greater than 70%. The primary outcome was a composite of death, myocardial infarction, or revascularization 24 months after randomization. We tested the non-inferiority of the FFR group compared with the IVUS group (non-inferiority margin, 2.5 percentage points).
Results
The incidence 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 patients in the FFR group and 8.5% of those in the IVUS group (absolute difference, -0.4 percentage points, 97.5% one-sided confidence upper limit interval, 2.2 percentage points; P=0.01 for non-inferiority). Patient-reported outcomes as reported on the Seattle Angina Questionnaire were similar in the two groups.
conclusions
In patients with interstitial stenosis being evaluated for PCI, FFR guidance was noninferior to IVUS guidance for the composite primary outcome of death, myocardial infarction, or revascularization at 24 months. (Funded by Boston Scientific, FLAVOR ClinicalTrials.gov number, NCT02673424.) QUICK TAKE VIDEO SUMMARY Adjunctive Tools to Guide PCI 02:09
title: “Fractional Flow Reserve Or Endovascular Ultrasound For Pci Guidance Klmat” ShowToc: true date: “2022-11-29” author: “Margaret Labarge”
Methods
Download a PDF of the Research Summary. We randomized 1682 patients being evaluated for PCI to treat interstitial stenosis (40 to 70% occlusion by visual assessment on coronary angiography) in a 1:1 ratio to undergo either an FFR-guided or an IVUS-guided procedure. FFR or IVUS was to be used to determine whether to perform PCI and to assess the success of PCI. In the FFR group, PCI had to be performed if the FFR was 0.80 or less. In the IVUS group, criteria for PCI were a minimal luminal area measuring either 3 mm2 or less or measuring 3 to 4 mm2 with plaque burden greater than 70%. The primary outcome was a composite of death, myocardial infarction, or revascularization 24 months after randomization. We tested the non-inferiority of the FFR group compared with the IVUS group (non-inferiority margin, 2.5 percentage points).
Results
The incidence 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 patients in the FFR group and 8.5% of those in the IVUS group (absolute difference, -0.4 percentage points, 97.5% one-sided confidence upper limit interval, 2.2 percentage points; P=0.01 for non-inferiority). Patient-reported outcomes as reported on the Seattle Angina Questionnaire were similar in the two groups.
conclusions
In patients with interstitial stenosis being evaluated for PCI, FFR guidance was noninferior to IVUS guidance for the composite primary outcome of death, myocardial infarction, or revascularization at 24 months. (Funded by Boston Scientific, FLAVOR ClinicalTrials.gov number, NCT02673424.) QUICK TAKE VIDEO SUMMARY Adjunctive Tools to Guide PCI 02:09
