Study backs St. Jude technology

  • Article by: JAMES WALSH
  • Star Tribune
  • August 28, 2012 - 8:37 PM

Patients who received blood-flow measurements in the coronary arteries to guide the placement of stents were significantly less likely to be readmitted to the hospital, according to the results of a St. Jude Medical Inc. study released Tuesday

Called the FAME II Trial, the study showed that patients with stable coronary artery disease who received stents guided by fractional flow reserve (FFR) measurements using St. Jude's PressureWire technology showed an 86 percent reduction in unplanned readmission to the hospital than patients treated with medical therapy alone.

The results were presented Tuesday at the European Society of Cardiology conference in Munich, Germany. They were also published in the New England Journal of Medicine.

The technology could bolster St. Jude's footprint in devices that treat heart disease. Senior analyst Larry Biegelsen of Wells Fargo said in a letter to investors Tuesday that he projects St. Jude's sales of FFR technology for 2012 to hit $138 million, up 28 percent, and to grow to $298 million in 2016. He said the FAME II results will drive continued growth in fractional flow reserve-guided technology, of which St. Jude is the global market leader.

"We expect the FAME II data to drive continued strong growth for FFR over the next several years," Biegelsen wrote.

Coronary artery disease is the most common type of heart disease and affects millions worldwide. It is caused by a narrowing or blocking of the arteries from plaque, which restricts blood flow and reduces the amount of oxygen to the heart.

Doctors use several tools to treat the disease, including an X-ray examination of the blood vessels of the heart and FFR, which gives a more detailed analysis of blood flow blockages. FFR helps determine which blockages in the coronary arteries are responsible for restricting blood flow to the heart, also known as ischemia.

Doctors then use that information to guide percutaneous coronary intervention (PCI) -- often using balloon angioplasty to open the blockage and placing a stent to inhibit blockages from reoccurring.

"Though there have been questions in the past about whether a patient should have a stent or is better off with medical treatment, we now know that if a lesion is significant as determined by FFR guidance, the stenting procedure will provide a better outcome," said Dr. Bernard De Bruyne of the OLV Clinic in Aalst, Belgium, the coordinating clinical investigator of the FAME II Trial.

"With this new knowledge, I believe that FFR should become the standard of care for treating patients with stable coronary artery disease and significant coronary narrowings."

St. Jude officials said their PressureWire FFR measurement technology helps doctors make a measurable difference in the health of patients. It can also help determine which patients will benefit from medical treatment alone. Where FFR showed no evidence of ischemia-producing blockages, patients were treated solely with medical therapy and had few complications later.

"Publication of this groundbreaking research in the New England Journal of Medicine coinciding with a Hot Line session during ESC [the European cardiology conference] demonstrates that the role of FFR in guiding medical care has moved to broader and more mainstream acceptance within the cardiology community," said Frank Callaghan, president of St. Jude Medical's cardiovascular division.

Other important developments from the study:

• The FAME II Trial showed that death, heart attack or urgent revascularization was significantly lower in patients who had PCI plus medical therapy than in patients with medical therapy alone -- 4.3 percent versus 12.7 percent.

• Instances of hospital readmission leading to urgent revascularization were reduced by 86 percent for patients in the FFR-guided arm of the trial. There was no significant difference in mortality or heart attack between patients with PCI plus medical therapy and those with medical therapy alone.

The FAME II Trial began enrolling patients in May 2010. At the time enrollment was stopped in January 2012, 1,220 patients with stable coronary artery disease were enrolled at 28 centers across Europe, the United States and Canada.

Enrollment was halted after an independent Data Safety Monitoring Board found a highly statistically significant reduction in unplanned hospitalizations and urgent revascularizations in patients enrolled in the PCI plus medical therapy arm of the trial. The board deemed it unethical to continue to randomize patients into the arm of the trial receiving medical therapy alone. As a result, patients already enrolled in the trial continue to be followed, but no additional patients were added.

James Walsh • 612-673-7428

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