TUESDAY, Aug. 10, 2004 (HealthDayNews) -- A new anti-clotting drug for people having artery-opening procedures lowers the rate of complications, gets patients out of the hospital faster, and probably saves lives, a study finds.
And it saves money to boot, says Dr. A. Michael Lincoff, a professor of medicine at the Cleveland Clinic and lead author of a report on the trial, which appears in the Aug. 11 issue of the Journal of the American Medical Association.
That report described how heart patients who underwent procedures such as angioplasty did in the year after they were given either the new drug, bivalirudin, or conventional drug treatment to prevent the clots that are a major problem in the artery-opening game.
A year after the 6,010 patients in the trial were treated, the incidence of heart attacks among those who got bivalirudin was 7.4 percent, compared to 8.4 percent for those who got the clot-preventing treatment, consisting of heparin and a drug whose complicated name is abbreviated Gp IIb/IIIa, the report said. The incidence of complications caused by excess bleeding was 40 percent lower in the bivalirudin group.
Repeat artery-opening operations were necessary for 11.4 percent of the bivalirudin patients and 12.1 percent of the heparin-Gp IIb/IIIa patients. And 2.46 percent of the patients getting the combined therapy died, compared to 1.89 percent of those getting bivalirudin -- a difference that did not quite reach statistical significance but is regarded as significant by cardiologists who took part in the study.
"The mortality part of the trial was extraordinarily impressive," said Dr. Frederick Feit, director of interventional cardiology at the New York University School of Medicine. "Every single subset of patients you look at, the result in terms of mortality are better for bivalirudin."
One major advantage of the new treatment, Lincoff said, is that it can be given much quicker than the standard treatment. The heparin-Gp IIb/IIIa combination must be infused for 12 to 18 hours, while bivalirudin treatment takes just 44 minutes, he said.
"The infusion time is so short that you can get out of bed sooner and out of the hospital sooner," Lincoff said. That often means a patient need not stay in the hospital overnight, he noted.
And unlike most new drugs, bivalirudin is a money-saver, Lincoff and Feit said. One reason is that it costs much less than Gp IIb/IIIa. Another is that it reduces incidence of bleeding complications, which are costly to treat. A third is that hospital costs are lowered by getting patients home sooner.
The current estimate is that bivalirudin saves about $374 per patient, Feit said.
"We now use it in probably 99 percent of our patients," he said. The one group that is more likely to get the old clot-preventing therapy consists of high-risk patients those with complicating conditions such as diabetes.
Lincoff is being more cautious. "I use it 60 to 70 percent of the time," he said. He said he is waiting for the results of an ongoing trial with high-risk patients before expanding its use to them.
Nationwide, Lincoff said, "no one knows the exact numbers, but its use is up to about 30 percent of patients and is growing."
Get a primer on angioplasty from the American Heart Association.