Coronary artery disease may have a new enemy.
Interim results of the FAME II clinical trial sponsored by St. Jude Medical (NYSE:STJ), which treated people with coronary heart disease, were so positive that the company announced Wednesday that an independent board had asked that the trial be stopped immediately.
In an interview with MedCity News following that announcement, Frank Callaghan, president of the cardiovascular division, said the results will help to expand the use of fractional flow reserve technology in percutaneous coronary intervention (PCI), which suffered a setback back in 2007. That’s because a previous trial showed PCI did not always have better results compared to drug therapy alone. But that trial was performed before FFR was available.
The FAME II trial now shows FFR technology in stenting is much more effective in preventing urgent hospital readmission compared with conventional drug therapy alone to treat clogged arteries. That meant that continuing to randomize patients for the trial would be unfair to those patients. Hence the trial is being stopped.
“The penetration of FFR in interventional procedures is really quite low today, and we see opportunity to expand that penetration significantly as we develop the clinical data to support that,” Callaghan said.
St. Jude Medical described FFR technology this way:
It is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries, and is measured using St. Jude Medical’s PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and guides the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Callaghan would not break out FFR revenue or comment on another analyst’s opinion that FFR was a small portion of the company’s overall revenue, but he said that the products have shown “significant growth” year on year.
“We’re pleased with that,” Callaghan said.
But what he is even more excited about given the performance of FFR is its potential down the road.
“I think it has the potential to benefit all of interventional cardiology and not just stenting, and not just the FFR business,” Callaghan said.
