SAN FRANCISCO—Research presented Oct. 30 at the Transcatheter Cardiovascular Therapeutics (TCT) scientific session in San Francisco showed that administering bivalirudin to STEMI patients in an ambulance reduces the risk of death and major bleeding complications compared to heparin. But don’t expect quick adoption of the strategy in the U.S.
Philippe Gabriel Steg, MD, director of the Coronary Care Unit at the Hopital Bichat at Assistance Publique-Hôpitaux de Paris in France, shared results from EUROMAX trial, a study that looked at the administration of anticoagulant therapy in a pre-hospital setting. It compared heparin strategy, with or without glycoprotein IIb/IIIa receptor inhibitors, to a bivalirudin (Angiomax, The Medicines Company) strategy.
Patients with STEMI presenting in an ambulance or non-PCI center who were intended for primary PCI were randomized to either the heparin-based strategy (1,109 patients) or the bivalirudin strategy (1,088 patients). The primary endpoint, a composite of death or major bleeding at 30 days, was 5.1 percent in the bivalirudin group and 8.4 percent in the heparin group.
“There were, however, more acute stent thrombosis in the bivalirudin arm,” Steg pointed out.
Discussants praised the study, saying the results could change clinical practice.
“It will interesting to see how this very large difference in major bleeding translates to mortality down the road,” said James B. Hermiller Jr., MD, of St. Vincent Heart Center of Indiana in Carmel, Ind. “We’ve seen over and over again the costs of major bleeding.”
They lamented that in the U.S. it will be difficult to implement the prehospital strategy in competitive markets. “We’re the losers,” said Bernard J. Gersh, MD, ChB, DPhil, of the Mayo Clinic in Rochester, Minn. “I have never seen anything that suggests that prehospital administration … is not beneficial. But how we achieve that in the United States is unknown.”
Hermiller agreed. “The barrier is great but we need to get there because it is very important.”
The trial was funded by The Medicines Company.