Stanford researcher leads international trial to compare heart-disease treatments

Researchers are recruiting patients for a clinical trial that will compare bypass surgery with a stenting procedure for the treatment of coronary artery disease.

- By Tracie White

William Fearon

Researchers have announced the enrollment of the first patient in an international, multicenter clinical trial comparing the effectiveness of two different treatments for multivessel coronary artery disease.

Coronary artery disease is the most common type of heart disease, affecting millions of people worldwide. The condition is caused by a narrowing or blockage of the arteries due to plaque, which restricts blood flow and reduces the amount of oxygen to the heart.

The trial, called FAME 3, is sponsored and coordinated by the Stanford University School of Medicine. It will compare traditional bypass surgery with a minimally invasive stenting procedure for the treatment of multivessel coronary artery disease. Patients who undergo the stenting procedure will first have the blood pressure and flow in their narrowed arteries measured using a catheter-based sensor.

The first patient was enrolled by researchers at the Catharina Hospital in the Netherlands, said William Fearon, MD, associate professor of cardiovascular medicine at Stanford and principal investigator for the trial.

A total of 1,500 patients are being recruited at 50 sites in the United States and around the world. Stanford is recruiting 50 patients for its portion of the trial. Participants will be randomly assigned to either surgery or the stenting procedure.

“We hope the trial will provide important information to guide our management of patients with multivessel coronary artery disease who require revascularization,” said Fearon, who was an investigator for the previous two FAME trials.

Subjective vs. objective assessments

The traditional method for diagnosing coronary artery disease and deciding among the various treatments — stenting, bypass surgery or medical management — is to perform a coronary angiogram. An angiogram involves injecting contrast agent into the coronary arteries and performing an X-ray. When multiple coronary narrowings are detected, coronary artery bypass surgery is generally recommended to restore blood flow to the heart. It’s one of the most commonly performed surgeries in the United States.

Previous studies have found that patients with multivessel coronary disease who undergo stenting procedures based on an angiogram have poorer outcomes than those who have bypass surgery, Fearon said. One reason for this is that angiography yields a subjective visual assessment rather than an objective physiological measurement of blockage severity, he said. But such a measurement can be obtained by using a coronary pressure guidewire.

“This new trial will go beyond the traditional stenting method of relying solely on the angiogram to determine which arteries should be stented,” Fearon said. “It will involve inserting a pressure guidewire into the coronary artery to provide a more in-depth measurement of blood flow in the vessels to the heart.”

In addition, the FAME 3 trial will test the latest generation of drug-eluting stents, which have been shown to perform better than earlier versions.

Results from the previous two FAME trials indicated that relying on an angiogram alone may not be sufficient to accurately determine vessel narrowing or blockage and that adding the use of the pressure guidewire can improve diagnoses.

The study is supported by Medtronic Inc., which makes the drug-eluting stents that will be used in the trial, and by St. Jude Medical Inc., which owns Radi Medical Systems Inc., based in Sweden, one of two companies that make the pressure wires used in the study.

For more information, visit http://clinicaltrials.gov/ct2/show/NCT02100722?term=FAME+3&rank=1.

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