SYNTAX III Revolution Trial Evaluates CT as a Decision-Making Tool for Complex Coronary Disease

October 15, 2018—GE Healthcare announced the publication of a study that used the company's imaging system, the Healthcare Revolution CT, to demonstrate that CT can be a useful aid in heart team decision-making for complex coronary disease. The results also suggest that the state-of-the-art imaging technology may offer a noninvasive diagnostic alternative to conventional coronary angiography.

The investigator-driven SYNTAX III Revolution trial was conducted by Cardialysis, the clinical trial management and core laboratory company, on behalf of the European Cardiovascular Research Institute. Prof. Patrick W. Serruys, MD, served as Principal Investigator and Study Chairman. The findings were published online by Carlos Collet, MD, et al in European Heart Journal.

According to GE Healthcare, the international, multicenter trial included 223 patients with diagnosed left main or three-vessel disease. Each patient was diagnosed using conventional, invasive angiography and subsequently received a multislice CT scan on the Healthcare Revolution CT.

Data from each patient was evaluated by two randomized heart teams—each made up of an interventional cardiologist, cardiac surgeon, and radiologist—to make a treatment recommendation of coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention, or either. One heart team made treatment recommendations based only on the coronary CTA imaging, and the other made treatment recommendations using angiography.

The investigators found that the treatment decisions between the two randomized heart teams were in almost perfect agreement (Cohen’s kappa, 0.82), highlighting the potential of CT to not only diagnose coronary disease, but also assist in subsequent heart team decision-making.

After reviewing the trial’s results, 84% of surveyed cardiac surgeons agreed planning and executing surgery based on the multislice CT scan is viable.

Cardialysis will follow up the SYNTAX III Revolution trial with a new study, CABG Revolution, to test the safety of CABG surgery for left main or three-vessel disease using only the anatomy and function described by the multislice CT scan.

In the GE Healthcare announcement, Prof. Serruys commented, “The implications of these trial results for the future are tremendous. 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 play an increasingly important role in diagnosing and treating coronary artery disease. It will take time and it will take multiple trials, but the results of our SYNTAX III trial suggest a promising, real change in our practice.”

Prof. Serruys suggests the CT’s potential as a diagnostic tool for complex coronary disease could enable catheterization labs to transition from diagnostic to interventional suites that concentrate on the significant load of coronary and structural heart disease patients.

He continued, “Technological advancements are drastically improving medical insights and opportunities as well as patient care. The ability to capture an image of the whole heart in one beat with the multislice CT and then see the coronary artery from multiple views is very appealing to interventional cardiologists and surgeons. The images provided by the multislice CT are a bonus that can help surgeons plan and mentally prepare to treat patients in the interventional suite.”