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

Abstract

Background: The 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/design: TARGET 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. Discussion: The 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 registration: ClinicalTrials.gov NCT03901326. Registered on 3 April 2019.

On-Site Computed Tomography–Derived Fractional Flow Reserve to Guide Management of Patients With Stable Coronary Artery Disease: The TARGET Randomized Trial

“…The evaluation criteria of stress test examinations are available in the trial protocol. 13 Patients with positive stress tests were recommended to undergo ICA and subsequent coronary revascularization if indicated.…”

“…The trial design and methods have been published previously. 13 The study protocol and other relevant documentation were approved by the institutional human research ethics committee of Chinese People's Liberation Army General Hospital and the relevant national ethics committees and registered on https:// www.clinicaltrials.gov (Unique identifier: NCT03901326). The trial steering committee monitored the progress of all aspects of the trial.…”

The Chinese Experience of Imaging in Cardiac Intervention

“…Combined with the functional assessment of CT-FFR, it can identify physiologically significant flow-limiting lesions and identify target vessels. The TARGET study 27 will provide evidence for the clinical application of CT-FFR. In contrast, based on imaging, intraluminal imaging examinations, IVUS and OCT are the gold standards for identifying plaque tissue components, especially for complex lesions such as the LM, bifurcation lesions, and CTO.…”

“…A retrospective analysis by Qiao et al25showed that CT-FFR could guide diagnosis and treatment decisions, improve the efficiency of invasive coronary angiography (ICA) treatment, and reduce the number of ICA referrals by 54.5% and PCI by 4.4%. As an alternative to ICA, its safety and feasibility in selecting patients requiring PCI were confirmed in the study of Liu et al26 The impact of CT-FFR-guided management on the clinical outcome was being prospectively investigated in a multisite clinical study across China 27. In addition, CT-FFR can also assess ISR,28 showing prognostic value in predicting MACE after stent implantation in low, moderate risk patients (bias-corrected c-index: 0.846).…”

“…As an alternative to ICA, its safety and feasibility in selecting patients requiring PCI were confirmed in the study of Liu et al 26 The impact of CT-FFR-guided management on the clinical outcome was being prospectively investigated in a multisite clinical study across China. 27 In addition, CT-FFR can also assess ISR, 28 showing prognostic value in predicting MACE after stent implantation in low, moderate risk patients (bias-corrected c-index: 0.846). Of note, the above CT-FFR models are machine learning-based that outperform conventional computational fluid dynamics (CFD)-based FFR CT , which possesses limitations of long processing time, high cost, and off-site computation, while preserving diagnostic accuracy compared with invasive fractional flow reserve (FFR).…”