A promising new treatment for keeping narrowed heart vessels open is available at Wake Forest University Baptist Medical Center through its selection for two national research studies.
The Medical Center is evaluating two types of stents - both coated with a drug that has shown significant potential for keeping narrowed heart arteries open after they''ve been treated with angioplasty. The first five Wake Forest patients to enroll in the studies were treated Dec. 5.
"This is perhaps the most profound advance in the care of cardiac patients in decades," said Robert Applegate, M.D., professor of cardiology at Wake Forest. Wake Forest is one of the first 20 centers in the nation selected for one of the studies, called DELIVER, and one of 70 centers selected for the other study, called TAXUS IV. The studies will compare the effectiveness of drug-coated stents versus uncoated stents at preventing the renarrowing of arteries months after they''ve been opened with angioplasty.
Since the early 1980s, balloon angioplasty, a procedure to open narrowed arteries by inflating a balloon-like device inside them, has been an alternative to major surgery to bypass blocked arteries. But, a drawback of angioplasty was that in about 40 percent of cases, the arteries renarrowed within six months. Doctors then began inserting stents - cylinder-shaped metal devices - into the arteries to help keep them open. This procedure reduced the rate of renarrowing to about 20 percent to 25 percent.
Studies in animals and small groups of patients have shown that coating stents with antibiotics and other drugs can dramatically reduce the rates of renarrowing even further. Preliminary studies have shown renarrowing rates of only 0 to 3 percent. The results were reported this year at meetings of the American Heart Association and the European Society of Cardiology.
"Ever since we did the first coronary angioplasty at Wake Forest over 20 years ago, we have been striving to eliminate the renarrowing problem," said Michael A. Kutcher, M.D., director of interventional cardiology. "The use of drug-coated stents is an exciting concept that may well achieve that goal."
The newest studies will evaluate the treatment in larger groups of patients. The studies at Wake Forest will use stents coated with paclitaxel, a variation of the cancer drug taxol. Patients will be tested eight or nine months after stent placement to measure the rate of vessel renarrowing.
"Because of the very small amounts of drug used to coat the stents, no serious toxic side effects have been seen in the animal or patient studies," said Applegate. "We are proud to be able to offer our patients the opportunity to participate in these studies of this exciting new treatment."
Contacts: Karen Richardson, (336) 716-4453