Study Heralds Ticagrelor Use in 911 Care

AstraZeneca's beleaguered anti-platelet drug ticagrelor (Brilinta) may get a boost from a French study published online Sept. 3 in the New England Journal of Medicine. In findings also reported at the European Society of Cardiology Congress in Barcelona, Spain, Gilles Montalescot, MD, found that in a group of 1862 patients, the drug appeared to offer greater protection from stent thrombosis when administered by ambulance personnel than when given later in a cardiac cath lab.

AstraZeneca’s beleaguered anti-platelet drug ticagrelor (Brilinta) may get a boost from a French study published online Sept. 3 in the New England Journal of Medicine.

In findings also reported at the European Society of Cardiology Congress in Barcelona, Spain, Gilles Montalescot, MD, found that in a group of 1862 patients, the drug appeared to offer greater protection from stent thrombosis when administered by ambulance personnel than when given later in a cardiac cath lab.

The patients were all in the throes of having acute ST-segment elevation myocardial infarctions (STEMI) and were candidates for percutaneous coronary intervention (PCI).All patients also got aspirin and standard care.

The two groups showed no significant differences in rates of adverse events, Montalescot wrote.

Known as the ATLANTIC study, and funded by AstraZeneca, the investigation involved researchers and patients in 13 countries. Montalescot is based at Pitie-Saltpetriere Hospital in Paris.

The team found that prehospital administration of the drug was safe, but when it came to coronary reperfusion, the group that got it in the ambulance had about the same results as those who received it in the hospital.

The main benefit of administering the drug before arriving at the hospital was a reduction in clots forming in stents later, Montalescot reported in the journal. “In this study all the stent thrombosis events within the first 23 hours occurred in the in-hospital group, and the difference remained significant in favor of prehospital administration of ticagrelor for up to 30 days,” Montalescot and colleagues wrote.

The study did not attempt to measure the AstraZeneca drug’s pre-hospital effectiveness versus clopidogrel. The researchers noted that ticagrelor works more quickly, taking about an hour to have its anti-clotting effect.

An earlier study known as PLATO found that ticagrelor did a better job than clopidogrel in reducing heart attack, stroke, and cardiovascular death.

But critics went public with accusations that the study design was flawed andquestioned its conclusions.

A US Department of Justice investigation followed, but on Aug. 19 AstraZeneca announced it had been informed that the federal investigation was closed with no finding of impropriety.

“We have always had absolute confidence in the integrity of the PLATO trial,” Pascal Soriot, AstraZeneca’s chief executive said in a statement.

http://www.astrazeneca-us.com/media/press-releases/Article/us-doj-closes-investigation-into-plato-clinical-trial