Dec. 22, 1999 DALLAS, Dec. 21 - In the first study of its kind, researchers report that giving diabetics with heart disease the so-called "super-aspirin" greatly reduces complications and death rates following a procedure called stenting, according to a report in today's Circulation: Journal of the American Heart Association.
A stent is a small metal cylinder placed permanently inside a heart artery that has been weakened or clogged with fatty deposits called plaque. Such arteries are frequently opened with balloon angioplasty, but stents are widely used in addition to angioplasty to help hold the vessel open and to prevent re-blockage.
The "super aspirin" drug called abciximab keeps platelets from clumping and forming blood clots that can obstruct blood flow and trigger a heart attack.
The multicenter study called EPISTENT (Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial) involved 491 diabetic patients who were divided into three groups. One group received both a stent and the super-aspirin therapy. A second group underwent balloon angioplasty and also received the drug. The third group had a stent implanted, but received no drug, only a placebo.
One of the most surprising findings was that the re-blockage rate was cut in half in the patients who received both the stent and the drug. Those patients had an 8.1 percent re-blockage rate in the six months following the procedure, which is about half that of the other two groups.
"The stent-abciximab combination brought the re-blockage rate in the diabetic heart patients to about the same levels as heart patients without diabetes. It's the first time this has been demonstrated," says Steven P. Marso, M.D., lead author of the study and a fellow at the MidAmerica Heart Institute of St. Luke's Hospital, Kansas City, Mo.
"Previous studies have shown that abciximab reduces the heart attack and death rate in a variety of heart patients following balloon angioplasty. However, this latest study is the first to demonstrate that the drug combined with stent implantation reduces re-blockage of arteries specifically in diabetics," says Marso.
Two thirds of people with diabetes have some form of heart or blood vessel disease. They also tend to experience re-blockage of heart arteries following balloon angioplasty more often than patients who don't have diabetes.
Heart patients with diabetes are also more likely to have a heart attack in the six to 18 months following angioplasty, and they have higher death rate following the procedure, Marso says.
"I feel we proved that stenting combined with abciximab offers huge benefits to heart patients with diabetes," says co-author Eric J. Topol, M.D., chairman of cardiology at the Cleveland Clinic Foundation, Cleveland, Ohio.
Patients who received the drug, regardless of whether they underwent angioplasty, or received a stent, had a lower rate of heart attack or death in the six months following the procedure when compared to the patients in the stent-placebo group. However, the lowest rate - 6.2 percent - was seen in the stent-abciximab group. The combined death or heart attack rate in the six months following the procedure was 7.8 percent in the angioplasty-abciximab group and 12.7 percent in the stent-placebo group.
The abciximab was delivered intravenously around the time of the procedure and then for 12 hours afterward.
Marso says fewer than 2 percent of the patients in the study had side effects from abciximab such as bleeding or a low platelet count.
In an accompanying editorial, Spencer B. King III, M.D., director of interventional cardiology at Emory University in Atlanta, says the study's findings, if corroborated, will have a significant impact on the medical care of diabetic patients.
Co-authors are A. Michael Lincoff, M.D.; Stephen G. Ellis, M.D.; Deepak L. Bhatt, M.D.; Jean-Francois Tanguay, M.D.; Neal S. Kleiman, M.D.; Talal Hammoud, M.D.; Joan E. Booth, R.N.; and Shelly K. Sapp, M.S. Co-author of the editorial is Ehtisham Mahmud, M.D.
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