Patients undergoing angioplasty for STEMI showed that treatment with tirofiban (Aggrastat) led to non-inferior ST-segment resolution compared to abciximab (ReoPro), according to study results reported at the 2008 American College of Cardiology (ACC) Scientific Session.
"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 lead study investigator Marco Valgimigli, MD, PhD, staff cardiologist at the University of Ferrara in Ferrara, Italy.
He reported on the open-label trial of 745 patients presenting with STEMI or new left bundle-branch block, which was conducted in 16 referral centers in Italy, Spain and Argentina from October 2004 to April 2007. The patients were randomly assigned to one of four interventional strategies: abciximab with an uncoated-stent, abciximab with a sirolimus-eluting stent (SES), tirofiban with an uncoated-stent, or tirofiban with a SES.
Valgimigli reported that 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.
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 percent vs. 0.8 percent), the investigators reported. At eight months, Valgimigli and colleagues found the incidence of major adverse cardiac events (MACE) was approximately 20 percent lower in patients treated with tirofiban compared to abciximab (9.8 percent vs. 12.4 percent).
The study also evaluated SES implantation versus uncoated stent implantation. While there was no interaction between tirofiban or abciximab and stent types. Valgimigli said that there was a significant reduction in the incidence of MACE at eight months in patients treated with SES implantation versus uncoated stent implantation (7.8 percent vs. 14.5 percent), driven primarily by an increase in target vessel revascularization (3.2 percent vs. 10.2 percent).
Tirofiban is not currently approved by the FDA for use in STEMI patients or as adjunctive therapy in patients undergoing PCI. In January, the Philadelphia-based Iroko Pharmaceuticals acquired all non-U.S. commercial rights to Aggrastat from Merck.
The Indianapolis-based Eli Lilly owns the rights to abciximab , which the FDA has indicated as an adjunct to PCI for the prevention of cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24 hours.
The MULTISTRATEGY (Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs. Abciximab with Sirolimus Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study) randomized trial was published online on March 30 in the Journal of the American Medical Association.