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The Joint Commission


AMMC Uses First FDA-Approved Treatment for Heart Disease Patients Who Also Have Diabetes

Shay Willis April 26, 2012

Arkansas Methodist Medical Center recently became one of the first hospitals in the state of Arkansas to use a newly approved medical device to open narrowed coronary arteries, event in heart disease patients with diabetes. The U.S. Food and Drug Administration (FDA) recently approved this new device-the Resolute Integrity Drug-Eluting Stent (DES) from Medtronic.

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. Remarkably, the new device has been shown in a global series of clinical studies to yield consistently strong performance in CAD patients with and without diabetes. Approximately one-third of all patients-an estimated 300,000 people in the United States alone-who receive a stent each year have diabetes.

Research shows that the nearly 26 million people in the United States who have diabetes are at a greater risk for developing CAD and millions of U.S. patients with both diabetes and CAD face an increased risk of heart attacks and strokes than patients without diabetes.

"The Resolute Integrity Drug-Eluting Stent represents a significant advance in the interventional treatment of coronary artery disease," said Jason Masingale, RN, Cath Lab Director at Arkansas Methodist Medical Center. "The device’s indication for CAD patients with diabetes in particular really distinguishes it from the alternatives."

Caused by a buildup of fatty deposits, or plaque, in coronary arteries, CAD is the most common type of heart disease and the leading cause of death in the United States, killing almost half a million Americans each year. Research shows that people with diabetes have a two-to three-fold increased risk for CAD and two-to-four-fold 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.

A stent is a tiny mesh cylinder designed to prop open a narrowed artery. A drug-eluting stent is coated with medication that is designed to prevent the artery from narrowing again; the drug elutes from the stent and into the arterial wall.

To treat CAD, stents are implanted in a minimally invasive procedure called percutaneous coronary intervention (PCI). Performed by an interventional cardiologist, the procedure involves the insertion of a tiny balloon into the vessel at the site of the narrowing. Crimped tightly on the end of the balloon is the stent. When inflated, the stent expands against the wall of the narrowed artery. With the stent expanded, the balloon is deflated and removed. The stent remains in place, providing a scaffold to keep the artery open and restoring normal blood flow to the heart.