The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design

Junjie Yang,Yundai Chen,Dongkai Shan,Mei Dong,Hesong Zeng,Zhiqiang Wang,Xinyang Hu,Xiang Ma

doi:10.1186/s13063-020-04649-9

Abstract

BackgroundThe diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated. This advanced technology focus on evaluating anatomical stenosis and functional ischemia simultaneously. However, the effect of CT-FFR on the management of decision making has not been fully evaluated in randomized controlled design.Method/designTARGET study is a pragmatic, multicenter, prospective, open-label, and randomized controlled trial evaluating the effect of a CCTA/CT-FFR strategy (group A) versus usual care (group B) on intermediate-to-high risk patients with suspected CAD who undergo clinically indicated diagnostic evaluation. A total sample size of 1216 subjects will be enrolled and followed up for 12 months. This study will be performed in 6 Chinese hospitals, and the primary endpoint is the planned ICA without significant obstructive CAD within 90 days. The secondary endpoints include MACE, quality of life, medical expenditure, and cumulative radiation exposure during 1-year follow-up.DiscussionThe study will provide information to patients, health care providers, and other stakeholders in China about which strategy could be more effective in the management of intermediate-to-high risk patients with suspect CAD.Trial registrationClinicalTrials.gov NCT03901326. Registered on 3 April 2019.

Highlights

The diagnostic accuracy of CT-derived fractional flow reserve (CT-Fractional flow reserve (FFR)) in clinical application has been well validated
Study aim TARGET trial is a multicenter, prospective, open-label, and pragmatic randomized controlled trial evaluating the effect of a Coronary computed tomographic angiography (CCTA)/CT-derived fractional flow reserve (CT-FFR) strategy on management decision making versus usual care in intermediate-to-high risk patients with suspected coronary artery disease (CAD) who undergo clinically indicated diagnostic evaluation
The core goal of TARGET trial is to assess the effect of CT-FFR on clinical decision making to the patients with stable chest pain in comparison of standard of care group (Fig. 3)

Summary

Discussion

The core goal of TARGET trial is to assess the effect of CT-FFR on clinical decision making to the patients with stable chest pain in comparison of standard of care group (Fig. 3). The hypothesis is that CT-FFR-guided clinical management may provide extra benefit in reducing the rate of planned ICA without obstructive CAD, decreasing patients’ medical expenditure, and improving outcomes. This randomized control trial will help physicians to understand deeply the availability of CT-FFR as a non-invasive diagnostic method in the evaluation of myocardial ischemia. The purpose of the TARGET trial is to evaluate whether clinical decisions based on CT-FFR measurements could decrease unnecessary ICA, optimize diagnostic and therapeutic procedures, reduce radiation exposure, save medical expenditure, and improve prognosis in comparison of conventional management for patients with stable chest pain. The 1-year follow-up will be completed in December 2021

Background

Findings