Back to Search Results

Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial.

Seoul National University Hospital, Seoul, Korea. Seoul National University Hospital, Seoul, Korea; Institute on Aging, Seoul National University, Seoul, Korea. Electronic address: bkkoo@snu.ac.kr. 2nd Affiliated Hospital, Zhejiang University, Hangzhou, China. Samsung Medical Center, Seoul, Korea. Ajou University Hospital, Suwon, Korea. Ulsan University Hospital, Seoul, Korea; Division of Cardiology, Dietrich Bonhoeffer Hospital, Academic Teaching Hospital of University of Greifswald, Griefwald, Germany. Keimyung University Dongsan Medical Center, Daegu, Korea. Inje University Ilsan Hospital, Ilsan, Korea. Kangwon National University Hospital, Chuncheon, Korea. Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA. 2nd Affiliated Hospital, Zhejiang University, Hangzhou, China. Electronic address: jian_an_wang@yahoo.com.

American heart journal. 2018;:7-12
Full text from:

Other resources

Abstract

BACKGROUND Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis. TRIAL DESIGN Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) trial is an international, multicenter, prospective, randomized clinical trial. A total of 1,700 consecutive patients with intermediate stenosis (40%-70% by visual estimation) in a major epicardial coronary artery will be randomized 1:1 to receive either FFR-guided or IVUS-guided PCI strategy. Patients will be treated with PCI according to the predefined criteria for revascularization; FFR ≤ 0.80 in the FFR-guided group and Minimal Lumen Area (MLA) ≤3 mm2 (or 3 mm270%) in the IVUS-guided group. The primary end point is the patient-oriented composite outcome, which is a composite of all-cause death, myocardial infarction, and any repeat revascularization at 24months after randomization. We will test noninferiority of current standard FFR-guided PCI strategy compared with IVUS-guided decision for PCI and stent optimization strategy. CONCLUSION The FLAVOUR trial will compare the safety and efficacy of FFR- and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. This study will provide an insight on optimal evaluation and treatment strategy for patients with intermediate coronary stenosis.

Methodological quality

Metadata