Oct 30 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
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
"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
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.