By Bill Berkrot
(Reuters) - Medicines Co's blood thinner Angiomax, when administered en route to the hospital to patients suffering a serious heart attack, significantly reduced the risk of major bleeding and death compared with commonly used heparin, according to data from a large clinical trial.
However, those who got Angiomax in the 2,198-patient study had a far higher risk of suffering acute stent thrombosis, or blood clots forming within 24 hours at the site of devices used to prop open previously clogged arteries, researchers found.
The primary goal of the open label trial measured the combined rate of death and major bleeding 30 days after receiving the drug. The rate was 5.1 percent in the Angiomax group versus 8.4 percent for those who got heparin, which researchers said was highly statistically significant. That translates into a 40 percent reduction in combined risk of death and major bleeding.
"The benefit was early and sustained at 30 days," said Dr. Philippe Steg, lead investigator of the Euromax study, who presented the findings on Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting in San Francisco.
A secondary goal, added second heart attacks to the composite of death and major bleeding. By that measure, Angiomax reduced risk by 28 percent at 30 days - 6.7 percent compared to 9.1 percent of those who got heparin.
The results favoring Angiomax were largely driven by about a 60 percent reduction in major bleeding not related to coronary bypass surgery, Steg said.
Even with the much lower rate of bleeding complications seen with the Medicines Co drug, the incidence of acute stent thrombosis was significantly higher with Angiomax at 1.1 percent versus 0.2 percent for heparin, despite the additional pre-hospital use of aspirin and other powerful anticoagulants, such as AstraZeneca's Brilinta or Eli Lilly's Effient.
"This did not translate into a statistically significant increase in new heart attacks or need for revascularization," Steg said of the increased stent thrombosis.
Researchers plan to follow patients in the study for one year to see if the lower death rate holds up for those who received Angiomax prior to reaching the hospital.
Angiomax, known chemically as bivalirudin, was approved based on clinical trials done in the hospital setting. The Euromax study, conducted in nine European countries, was the first to test the drug when administered in the ambulance en route to the hospital for emergency interventional treatments, such as coronary bypass surgery or angioplasty and stenting, in patients suffering a heart attack.
"In Europe, (the results) will definitely lead to a widespread embrace of bivalirudin in the ambulance," Steg predicted.
Such adoption is less likely to happen anytime soon in the United States, Steg said, due to much the more fragmented healthcare system and ambulance services that are often not connected to hospitals.
Angiomax is by far the most important product for The Medicines Co. It reported Angiomax sales of $152 million in the third quarter out of total revenue of $174.3 million.
Results of the study were also published in the New England Journal of Medicine.
(Reporting by Bill Berkrot; Editing by Bernard Orr)