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Vanderbilt Heart uses first FDA-approved treatment for heart disease patients who also have diabetes

March 27, 2012

The Resolute Integrity DES implanted in a coronary artery. Photo courtesy of Medtronic.

The Resolute Integrity DES implanted in a coronary artery. Photo courtesy of Medtronic.

Vanderbilt Heart recently used a newly approved medical device to open narrowed coronary arteries, even in heart disease patients who also have diabetes. The U.S. Food and Drug Administration (FDA) recently approved this new device –– the Resolute Integrity Drug-Eluting Stent (DES) from Medtronic –– and Vanderbilt took part in a clinical study that supported its approval.

The Resolute Integrity DES is the first and only heart stent to be FDA-approved for treating patients with coronary artery disease (CAD) who also have diabetes. The new device has been shown to benefit CAD patients with and without diabetes. About one-third of all patients –– an estimated 300,000 people in the United States alone –– who receive a stent each year have diabetes.

“This is a new generation of drug-eluting stents with superior deliverability, and I think it’s going to have good clinical outcomes,” said David Zhao, M.D., director of Interventional Cardiology at Vanderbilt. “I think it’s going to make the procedure easier and safer.”

CAD is caused by a buildup of fatty deposits, or plaque, in coronary arteries. Research shows that people with diabetes have a twofold to threefold increased risk for CAD and twofold to fourfold higher CAD morbidity and mortality rates.

Historically it’s been difficult to treat CAD patients with diabetes because they tend to have smaller coronary arteries and persistently elevated blood-sugar levels, which can increase the rate of procedural complications and long-term safety risks.

The Resolute Integrity drug-eluting stent is a tiny mesh cylinder designed to prop open a narrowed artery. It is coated with medication that is designed to prevent the artery from narrowing again.

The novel heart stent received approval from the FDA in February following the conclusion of the RESOLUTE US clinical study, which enrolled 1,402 patients across 128 U.S.-based clinical trial sites, including Vanderbilt. John McPherson, M.D., associate professor of Medicine, was the principal investigator for Vanderbilt.

“The Resolute Integrity drug-eluting Stent represents a significant advance in the interventional treatment of coronary artery disease,” McPherson said. “The device’s indication for CAD patients with diabetes in particular really distinguishes it from the alternatives.”
 

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