Data From SYNTAX III Revolution Trial Presented at EuroPCR
May 23, 2018—Results from the SYNTAX III Revolution trial were presented at EuroPCR 2018, held May 21–25 in Paris, France. The SYNTAX III Revolution trial was designed to provide evidence in decision-making by randomizing two heart teams at 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.
“The SYNTAX III Revolution clinical trial was distinctive among clinical trials in that, 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,” commented Professor Patrick W. Serruys, MD, PhD, in an announcement from EuroPCR. Prof. Serruys is Study Chairman of SYNTAX III Revolution trial.
According to an announcement from EuroPCR, the two heart teams were presented with the same patient and asked to plan a procedure. Then, the primary goal was to assess the treatment decision as to whether surgery or percutaneous coronary intervention (PCI) was chosen.
Heart team A had to make their decision on whether to perform revascularization with either PCI or surgery using information received strictly from noninvasive means, such as multislice coronary CTA from a Revolution multislice CT scan (GE Healthcare) with fractional flow reserve (FFR) CT assessment (HeartFlow Inc.). Heart team B was tasked with making the same decision but only using conventional cineangiography.
Level of agreement between the two groups was evaluated using Cohen’s kappa coefficient statistic.
“We were looking at the concordance of judgment 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,” said Prof. Serruys. “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.”
To ensure patient safety, the initial trial was completed virtually. Then, once each heart team made its decision and planned for either surgery or PCI, the teams were unblinded and given all information gathered from each assessment. All teams were asked if operations to randomized cases could be planned using only the multislice CT scan. Prof. Serruys said the surveyed surgeons had a feeling of feasibility to accomplish this.
“In the next 5 to 10 years, with its increasing accuracy, I think we are going to see the new generation of multislice CT scans replacing conventional cineangiography,” said Prof. Serruys. “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. 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.
“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.
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.