Siemens-backed Study proves software-guided heart assessments are as effective as invasive wires

GERMANY — Researchers have confirmed that a software-based method for evaluating coronary artery disease performs just as well as the traditional invasive approach, potentially transforming how cardiologists assess and treat patients worldwide.

The FAST III study, co-funded by Siemens Healthineers and Pie Medical Imaging, was presented at the American College of Cardiology Congress and published in The New England Journal of Medicine.

The multicenter, randomized-controlled trial enrolled 2,235 patients across 37 hospitals in seven European countries, randomly assigned to either a software-guided or conventional wire-guided approach.

Results confirmed that Caas vFFR is a safe and effective alternative to conventional pressure wire-based physiology for guiding treatment decisions in patients with intermediate coronary artery stenosis.

Caas vFFR is a tool developed by Pie Medical Imaging that calculates pressure drop and vessel fractional flow reserve from two angiographic images.  

Why it matters

Coronary stenoses lie at the heart of coronary artery disease, the leading cause of death globally.

Fractional flow reserve (FFR) measures how much a narrowed artery restricts blood flow, with evidence showing that blockages causing less than a 20 percent flow reduction generally do not require treatment.

Traditionally, this measurement requires inserting a pressure wire into the coronary artery and administering adenosine to induce hyperemia — a process that frequently causes patients discomfort, including chest pain, restlessness, and shortness of breath.

A less invasive path forward

Caas vFFR eliminates the need for both the pressure wire and hyperemic agents, making the procedure faster, safer, and considerably more comfortable for patients.

Chief investigator Dr. Joost Daemen, a cardiologist at Erasmus University Medical Center in Rotterdam, noted that the technology also enables physiologic assessment in centers that currently perform only diagnostic coronary angiography, broadening access to this critical evaluation.

He believes FAST III could reshape European guidelines for managing chronic coronary syndrome by providing robust evidence for angiography-based physiology as a credible mainstream alternative.

Industry and clinical impact

Doris Pommi, Head of Cardiovascular Care at Siemens Healthineers, described the findings as a significant milestone for cardiovascular care in Europe, crediting the collaboration between scientific, clinical, and industrial expertise.

René Guillaume, recently retired CEO of Pie Medical Imaging, emphasized that unbiased clinical outcome data is essential to establishing the reliability of the Caas vFFR software in real-world settings.

The trial, which represents the culmination of a ten-year evidence-generation journey, was executed through Cardialysis, a cardiovascular research organization based in Rotterdam.

Leading centers involved included Erasmus University Medical Center, John Radcliffe Hospital Oxford, Mater Private Hospital Dublin, University Hospital of Verona, Charité Berlin, and University Hospital Lille.