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 - 12/05/18

Doi : 10.1016/j.ahj.2017.11.001

Jeehoon Kang, MD ^a, Bon-Kwon Koo, MD, PhD ^a,^b,^{^⁎} , Xinyang Hu, MD ^c, Joo Myung Lee, MD ^d, Joo-Yong Hahn, MD ^d, Hyoung-Mo Yang, MD ^e, Eun-Seok Shin, MD ^f,^g, Chang-Wook Nam, MD ^h, Joon-Hyung Doh, MD ⁱ, Bong-Ki Lee, MD ^j, Chul Ahn ^k, JianAn Wang, MD ^c,^{^⁎⁎} , Seung-Jae Tahk, MD ^e
^a Seoul National University Hospital, Seoul, Korea
^b Institute on Aging, Seoul National University, Seoul, Korea
^c 2nd Affiliated Hospital, Zhejiang University, Hangzhou, China
^d Samsung Medical Center, Seoul, Korea
^e Ajou University Hospital, Suwon, Korea
^f Ulsan University Hospital, Seoul, Korea
^g Division of Cardiology, Dietrich Bonhoeffer Hospital, Academic Teaching Hospital of University of Greifswald, Griefwald, Germany
^h Keimyung University Dongsan Medical Center, Daegu, Korea
ⁱ Inje University Ilsan Hospital, Ilsan, Korea
^j Kangwon National University Hospital, Chuncheon, Korea
^k Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA

^⁎Reprint requests: Bon-Kwon Koo, MD, PhD, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 110-744, China. Institute on Aging, Seoul National University, Seoul, Korea.Department of Internal Medicine, Cardiovascular CenterSeoul National University HospitalInstitute on Aging, Seoul National University, Seoul, Korea101 Daehak-ro, Jongro-guSeoul110-744China^⁎⁎Reprint requests: JianAn Wang, Department of Internal Medicine Cardiovascular key lab of Zhejiang Province, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.Department of Internal Medicine Cardiovascular key lab of Zhejiang ProvinceThe Second Affiliated Hospital of Zhejiang UniversityHangzhouChina

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 mm²<MLA ≤4 mm² and plaque burden >70%) 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.

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Plan

Study design and methods

Study objectives and hypotheses

Study organization and funding agencies

Study design

Study population and entry criteria

Research materials, indication for revascularization, and PCI optimization

Study outcomes

Participant follow-up

Data Safeguard and Monitoring Board

Clinical Event Adjudication Committee

Data confidentiality

Treatment of missing values

Statistical considerations

Authors' contributions

RCT# NCT02673424.

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Vol 199

P. 7-12 - mai 2018 Retour au numéro

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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 - 12/05/18

Abstract

Background

Trial design

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Plan

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