High-dose tirofiban as effective as abciximab in reducing ST-segment elevation in STEMI patients

Normalization of ST-segment elevation is crucial for managing high-risk patients

PHILADELPHIA, PA, March 30, 2008 — Data from a Phase III, open label, multi-national study of patients undergoing angioplasty for ST-elevation myocardial infarction (STEMI), showed that treatment with tirofiban (AGGRASTAT®) led to non-inferior ST-segment resolution compared to abciximab (ReoPro®). These findings were reported today at the 57th Annual Scientific Session of the American College of Cardiology and released online by the Journal of the American Medical Association (JAMA) to coincide with the conference. The study will be published in the April 16, 2008 issue of JAMA.

At least 50 percent recovery from ST-elevation occurred in 85.3 percent and 83.6 percent of patients in the tirofiban and abciximab groups, respectively (Relative Risk [RR]: 1.020; 97.5 percent confidence Interval [CI], 0.958 to 1.086; P <0.001 for non-inferiority). At 30 days, ischemic and hemorrhagic outcomes were similar in the tirofiban and abciximab groups, with the incidence of thrombocytopenia being significantly more common with abciximab compared to tirofiban (4.0 versus 0.8 percent, P=0.004). At 8 months, the incidence of major adverse cardiac events (MACE) was approximately 20 percent lower in patients treated with tirofiban compared to abciximab (9.8 percent versus 12.4 percent; P=0.30). The study also evaluated sirolimus-stent implantation versus uncoated stent implantation. While there was no interaction between tirofiban or abciximab and stent types (P=0.60), there was a significant reduction in incidence of MACE at 8months in patients treated with sirolimus-stent implantation versus uncoated stent implantation (7.8 percent versus 14.5 percent, P=0.0039), driven primarily by an increase in target vessel revascularization (3.2 percent versus 10.2 percent; P=0.0002).

"The results of MULTISTRATEGY demonstrate that in STEMI patients undergoing primary angioplasty, treatment with tirofiban results in similar clinical outcomes with improved safety, in terms of lower thrombocytopenia, relative to abxicimab," said Marco Valgimigli, MD, PhD, staff cardiologist at the University of Ferrara, Ferrara, Italy and lead study investigator.

AGGRASTAT is not currently approved for use in STEMI patients or as adjunctive therapy in patients undergoing percutaneous coronary intervention (PCI).

In January of 2008, Iroko acquired all non-US commercial rights to AGGRASTAT® (tirofiban HCl) from Merck & Co., Inc.