WEDNESDAY, Nov. 22, 2006 (HealthDay News) -- A newer anti-clotting drug called bivalirudin (Angiomax) beats standard combination drug therapy for patients with acute coronary syndromes such as heart attacks, a new study finds.
"We use it at Columbia in the vast majority of cases," said lead researcher Dr. Gregg W. Stone, a professor of medicine and director of cardiovascular research and education at Columbia University. "We find that compared to heparin, it is just as effective and safely allows us to do angioplasty with a major reduction in bleeding episodes."
His team published the results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial in the Nov. 23 issue of the New England Journal of Medicine.
The study was funded by The Medicines Company and Nycomed, which market Angiomax.
The journal report described a trial involving nearly 14,000 patients with heart attack or other acute coronary syndromes. Participants were assigned to one of three drug regimens: a package treatment including heparin; a similar package including bivalirudin; or bivalirudin alone.
On the surface, the numbers coming out of the trial did not seem to favor bivalirudin. The overall incidence of major problems such as a second heart attack, death or the need for a second procedure to reopen a blocked artery were virtually identical between the two groups: 7.7 percent for the combo therapy including heparin vs. 7.3 percent for the bivalirudin package.
The overall incidence of such problems in the patients who got bivalirudin alone was also the same -- 7.3 percent.
However, only 3 percent of those getting bivalirudin alone had major bleeding episodes, compared to 5.7 percent of those getting the heparin package. For patients, that makes all the difference, Stone said.
Bivalrudin also reduced the incidence of artery blockage or major bleeding by about 14 percent compared to a drug package including heparin, the researchers found.
"It makes care of patients in the cath lab much simpler and safer," Stone said. "Cath lab" is medical shorthand for the catheterization facility where doctors perform angioplasty -- threading a tube into an artery so it can be reopened.
"The big difference was the reduction of major bleeding, almost 50 percent," Stone added. "Major bleeding has been associated with higher mortality, so it is important for the outcome."
Like most of the investigators in the ACUITY trial, Stone disclosed prior financial ties to a variety of drug makers, not only The Medicines Company and Nycomed but also companies that market competing brands of blood thinners.
"This report states that bivalirudin can be used for patents with acute coronary syndrome with a lower risk of bleeding than conventional treatment," added Dr. John A. Bittl, an interventional cardiologist at the Munroe Regional Medical Center in Ocala, Fla., who wrote an accompanying editorial.
In principle, bivalirudin could be reserved for patients at increased risk of bleeding episodes, such as those with anemia, Bittl said. "It has recently become apparent that anemia, when detected in the hospital, is a very important prognostic factor," he said. "It is not clear whether it is anemia itself or whether anemia is a marker of general health."
In practice, "We use bivalirudin in more than 90 percent of cases," Bittl said.
There's more on acute coronary syndromes at the American Heart Association.