Feature | Computed Tomography (CT) | May 29, 2018

SYNTAX III Revolution Trial Shows CT-FFR Could Replace Cine-angiography in Coming Years

SYNTAX III Revolution data showed noninvasive FFR-CT assessment of multivessel coronary disease aids decision making and may dawn a new era in noninvasive decision making

FFR-CT may soon replace invasive angiography for coronary lesion assessment. #EuroPCR 

Anexample of a clinical case of CT-FFR, which can derive the FFR numbers for their entire coronary tree using a noninvasive CT scan.

FFR-CT may soon replace invasive angiography for coronary lesion assessment. #EuroPCR 

An illustration of CT-FFR, which can derive the FFR numbers for their entire coronary tree using a noninvasive CT scan.

May 29, 2018 — Results from the innovative SYNTAX III Revolution Trial [1] underline the effectiveness of evolving noninvasive algorithms for fractional flow reserve assessed through computed tomography (FFR-CT) imaging. The data suggests heart teams should use this imaging-based technology for decision making. The data was presented as a late-breaking study at EuroPCR 2018.   

“Designed to better understand the heart team decision-making process itself, the SYNTAX III Revolution clinical Trial was distinctive among clinical trials," said Study Chairman Professor Patrick W. Serruys, M.D. "Rather than randomizing the patient, it was the doctors themselves who were randomized — in this case the heart team – in order to understand more completely the present and future role of noninvasive assessments in deciding and planning revascularization strategies.”

Watch a VIDEO interview with Serruys "Will CT-FFR Replace Diagnostic Angiograms?" regarding the SYNTAX III results.

The SYNTAX III Revolution trial was specifically designed to provide evidence in decision making by randomizing two heart teams in six participating international centers. These teams, composed of a surgeon, an interventional cardiologist and a radiologist, considered the treatment of 223 patients over an 18-month period.

Each of the two heart teams was presented with the same patient and asked to plan a procedure, answering several questions. These include: Which vessels need to be revascularized? How many bypasses are needed? How many stents should be used? The primary goal was to assess the treatment decision, whether it was decided based on the information received, to go with either surgery (CABG) or PCI.

Heart Team A had to make its decision on whether to perform revascularization with either PCI or surgery using information received strictly from noninvasive means using multi-slice coronary computed tomography angiography (MSCT) from a GE Revolution scanner that included CT-FFR assessment using HeartFlow software.

Heart Team B needed to make the same decision but using only conventional, invasive, cine-angiography.

The Cohen’s kappa statistic was employed to indicate the level of agreement between the two heart teams in terms of their treatment decision — in this case to use either CABG or PCI – based on the CT-first assessment or angiography-first evaluation.

“We were looking at the concordance of judgement and the concordance of opinion in the planning of the procedure and discovered that the Cohen’s kappa statistic was very high – 0.82 – which can be called an almost perfect assessment/agreement," Serruys said. He said it showed good agreement as well in terms of the number of bypasses, how many stents should be used and the location in the coronary circulation.

“We were amazed to hear participating surgeons telling us that they could see more things on the GE Revolution multi-slice scan than using conventional angiography,” Serruys continued. “Cine-angiography could be dispensed with completely and only the noninvasive multislice scans used.” 

In the initial trial, in order to ensure patient safety, the actual procedure remained “virtual”. After each blinded heart team made its decision and planned for surgery or PCI – and before the actual intervention took place. The different teams were unblinded and provided with all the information acquired by both the MSCT-first assessment and angiography-first examination before actually continuing with the procedure. 

In January 2018, preparing for the next step, a meeting was organized with the surgeons of the six centers where they were presented with randomized cases and asked if they could plan an operation using the GE multislice scan alone. “To our surprise,” Serruys said, “there was a very high feeling of feasibility among the surgeons.” The next phase, planned for 2018-2019, will be a first-in-man trial asking surgeons to treat 100 patients based on multislice CT scan alone without looking at coronary angiography.

“In the next five to 10 years, with its increasing accuracy, I think we are going to see the new generation of multislice CT scans replacing conventional cine-angiography," Serruys explained. "For interventional cardiologists this is a bonus, allowing them to have the image before bringing the patient to the cath lab and being able to make a decision concerning whether it is a one-vessel or multivessel disease. If it is clearly one-vessel disease, there is no reason to consider surgery, but, when you know in advance that it is a multivessel disease, you can immediately discuss with the surgeon based on the non-invasive imaging alone and go immediately to the operating room or the interventional suite to perform the intervention, So, this can be seen as promising a real change in our practice. It will take time and it will take multiple trials, but the impetus is there to go in this direction. It is clearly the beginning of a trend we will see in the next few years."

The SYNTAX III trial is an investigator-driven study sponsored by the European Cardiovascular Research Institute (ECRI). For this study, the ECRI received research grants from GE Healthcare and HeartFlow Inc.

Links to other 2018 EuroPCR late-breaking trials

 

Related FFR-CT Content:

What is New in FFR Technology

Clinical Applications of FFR-CT

VIDEO: The Status FFR-CT Adoption in the United States

New Technology Supports CT as Prime Cardiac Imaging Modality

 

 

Reference:

1. Cavalcante R, Onuma Y, Sotomi Y, et al. Non-invasive Heart Team assessment of multivessel coronary disease with coronary computed tomography angiography based on SYNTAX score II treatment recommendations: design and rationale of the randomised SYNTAX III Revolution trial. EuroIntervention. 2017 Mar 20;12(16):2001-2008. doi: 10.4244/EIJ-D-16-00612.

Related Content

The Clear AI software can help with identification coronary plaque features in CT scans that may cause heart attacks. Cleerly Coronary’s noninvasive, AI-driven approach supports the understanding of plaques using FDA-cleared technologies.

The Clear AI software can help with identification coronary plaque features in CT scans that may cause heart attacks. Cleerly Coronary’s noninvasive, AI-driven approach supports the understanding of plaques using FDA-cleared technologies.

News | Computed Tomography (CT) | July 16, 2021
July 16, 2021 — Canon Medical Systems USA is joining forces with Cleerly in a strategic partnership to support simple
The inherent spectral capabilities of Mayo Clinic's new third-generation photon-counting CT research scanner allows clear visualization of the intact portions of the coronary artery lumen (arrowhead) by reducing the bright signal from the dense coronary calcifications (arrows). Spectral CT is able to bin photos on different energies that can be used to enhance or subtract chemical elements based on their spectral signature, such as calcium shown here, and iodine.

The inherent spectral capabilities of Mayo Clinic's new third-generation photon-counting CT research scanner allows clear visualization of the intact portions of the coronary artery lumen (arrowhead) by reducing the bright signal from the dense coronary calcifications (arrows). Spectral CT is able to bin photos on different energies that can be used to enhance or subtract chemical elements based on their spectral signature, such as calcium shown here, and iodine.
 

News | Computed Tomography (CT) | July 14, 2021
July 14, 2021 — Performing the first cardiac scan on their new photon-counting detector...
Illustration of how spectral CT can help confirm findings on a conventional CT scan without requiring follow-up imaging, such as a nuclear scan. The conventional CT on the left, and the dual-energy CT on the right confirms an infarct.

Illustration of how spectral CT can help confirm findings on a conventional CT scan without requiring follow-up imaging, such as a nuclear scan. The conventional CT on the left, and the dual-energy CT on the right confirms an infarct. Image from Philips Healthcare.

Feature | Computed Tomography (CT) | May 27, 2021
May 27, 2021 — Philips Healthcare released a workhorse...
FDA Clears AiCE Image Reconstruction on Canon's Aquilion Precision CT
Technology | Computed Tomography (CT) | October 21, 2019
Canon Medical Systems USA Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance on its Advanced...
FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers
Technology | Computed Tomography (CT) | September 26, 2019
The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT, an intelligent...
Videos | Computed Tomography (CT) | August 07, 2019
This is an example of in-stent restenosis shown using spectral CT imaging.
Achenbach to Receive Inaugural 2019 Stephan Achenbach Pioneer Award in Cardiovascular CT
News | Computed Tomography (CT) | July 10, 2019
The Society of Cardiovascular Computed Tomography (SCCT) will present Stephan Achenbach, M.D., FSCCT with the inaugural...
New Type of Cardiac Care to Cut Imaging Wait Times and Unnecessary Hospital Admissions
News | Computed Tomography (CT) | June 20, 2019
A new type of care for cardiac patients at St. Paul’s Hospital, Vancouver, has the potential to reduce heart imaging...
Canon Medical Receives FDA Clearance for AiCE Reconstruction Technology for CT
Technology | Computed Tomography (CT) | June 18, 2019
Canon Medical Systems USA Inc. has received 510(k) clearance on its new deep convolutional neural network (DCNN) image...