Lutheran Uses New FDA-Approved Drug-Eluting Stent for Patients with Coronary Artery Disease, Including Those with Diabetes
New device expands treatment options for complex cases
FORT WAYNE, Ind. (Feb. 23, 2012) – Lutheran Hospital has become one of the first hospitals in Indiana, and the first in Fort Wayne, to use a newly approved medical device to open narrowed coronary arteries, even in heart disease patients with diabetes. The U.S. Food and Drug Administration approved this new device Friday –– the Resolute Integrity Drug-Eluting Stent from Medtronic –– and Lutheran took part in the clinical study that supported its approval.
Matthew Bilodeau, MD, PhD, treated a patient with the new stent Tuesday, one of two individuals to receive the device at Lutheran earlier this week. Bilodeau, a Lutheran Medical Group cardiologist who is experienced in cardiac research and coronary interventions, noted that the new stent is “substantially easier to deliver to the blockages than some of the other stents available today.”
Lutheran Hospital and Lutheran Medical Group cardiologists and research staff participated in the recently completed RESOLUTE US clinical trial that included 12 local patients who received the Resolute Integrity DES in the hospital’s cardiac catheterization laboratory. More than a third of the patients who received stents in the national trial had diabetes. Patients with diabetes who are in need of stents after balloon angioplasty have historically been more difficult to treat for several reasons, including a greater likelihood that their arteries are smaller and more twisted.
The Resolute Integrity DES is the first and only heart stent to be FDA approved for treating patients with coronary artery disease who also have diabetes. 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 rate 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 Bilodeau. “The device’s FDA indication for CAD patients with diabetes in particular 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. 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.
More information about the Resolute Integrity DES is available online at www.medtronicstents.com.