Syracuse, N.Y. -- Syracuse hospitals are using a new medical device to treat heart disease in diabetic patients that may spare some of them from open heart surgery.
The stent, a small metal wire tube used to prop open blocked arteries, is the first approved by the U.S. Food and Drug Administration for treating heart disease patients who have diabetes.
Research shows people with diabetes have a two- to three-fold increased risk for heart disease and much higher rates of mortality and complications. Diabetes is a lifelong disease in which there are high levels of sugar in the blood.
St. Joseph’s Hospital Health Center participated in a worldwide study of the device, known as the Resolute Integrity stent made by Medtronic. St. Joe’s put the stents in 60 patients three years ago. They were among the more than 5,000 patients who participated in clinical trials.
The FDA approved the device in February.
Dr. Ron Caputo, a St. Joe’s cardiologist who was involved in the study, said diabetics with blocked arteries are challenging to treat because they tend to have smaller arteries, more blockages and their arteries are more likely to close up again after receiving balloon angioplasty to open them up.
“If you have a patient with diabetes, you are more apt to send them for bypass surgery,” Caputo said. “Has this device allowed us to spare some patients from bypass surgery? Absolutely.”
The new stent is thinner and more flexible than other stents, which makes it easier to put the device in smaller arteries, Caputo said.
During an angioplasty procedure, a doctor guides a long, thin tube through the arteries to the heart. A small balloon at the end of the tube is inflated to open the clogged artery.
The stent, a tiny mesh cylinder coated with a drug designed to prevent the vessel from renarrowing, is at the end of the balloon. When the balloon inflates, the stent expands in the narrowed artery and the drug is released over time into the wall of the artery. After the balloon is deflated and removed, the stent remains in place, providing a scaffold to keep the artery open and restore normal blood flow to the heart.
After getting stents, diabetics have traditionally experienced higher rates of artery renarrowing than non-diabetic patients, Caputo said.
In the clinical trial, less than 5 percent of diabetic patients experienced renarrowing, about the same rate as non-diabetic patients, he said.
Stents are not appropriate for every patient, Caputo said. People who get them have to take aspirin and the drug Plavix for up to a year to prevent blood clots from forming on the stent. A patient who cannot afford Plavix or remember to take the pills every day is not a good candidate for stenting, he said.
Caputo said while the new stent is a great treatment option, people should concentrate on eating well, exercising and taking other steps to prevent diabetes and heart disease.
After installing a stent, Caputo said he routinely tells patients, “I fixed the pothole, now you better take care of the rest of the highway.”