The HORIZONS AMI trial showed the usefulness of bivalirudin in reducing mortality and bleeding compared with the use of heparin plus glycoprotein IIBIIIA. However, some questions remained unanswered: What is the utility of starting the infusion during the ambulance journey? Is it possible to reduce the risk of acute thrombosis by extending bivalirudin infusion or administering new ADP receptor blockers? Are new anti-aggregators safe combined with bivalirudin? 2,200 randomized patients will be enrolled in a myocardial infarction ST segment elevation course with the onset of symptoms between 20 minutes and 12 hours with the intention of performing primary angioplasty.
All will receive aspirin and an ADP receptor blocker. A group will be assigned to heparin plus glycoprotein inhibitors IIBIIIA to medical criteria and another group to prolonged infusion of bivalirudin monotherapy. The primary endpoint is a combination of death and bleeding at 30 days. The study is expected to be completed by June 2013 since, so far, 2,120 patients have been randomized out of the ultimate target of 2,200. The final results will be available for TCT 2013 (San Francisco).
Ph. Gabriel Steg
2013-05-21
Original title: EUROMAX a randomised trial of bivalirrudina in the ambulance for patients transferred for primary PCI.