GUSTO II Casts Doubt On Revasc Future

With results of clinical trials for the thrombin inhibitor Revasc (recombinant hirudin) coming in below expectations, Ciba-Geigy is reconsidering whether to continue development of the product for acute coronary syndrome, a life-threatening condition which affects patients with myocardial infarction and unstable angina.

On March 26, Eric Topol of the Cleveland Clinic in the USA presented the results of the GUSTO II (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndrome) study, which compared the effectiveness of Revasc to standard, unfractionated heparin in 12,141 patients with myocardial infarction or unstable angina, at the American College of Cardiology meeting in Florida.

The primary endpoint of the study was the rate of death and myocardial infarction at 30 days. Ciba said in a statement that Revasc was able to demonstrate a "modest, although not statistically significant advantage over heparin, currently the standard treatment." The firm went on to say that it would review the data in more detail and make a decision later on whether or not it was going to pursue cardiovascular indications for the drug.