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

"These positive data add to the growing body of evidence illustrating AGGRASTAT’s potential role in the management of high-risk patients," said John Vavricka, President and Chief Executive Officer of Iroko Pharmaceuticals. "We look forward to further data which will reinforce the utility of AGGRASTAT in this patient type."

Multicentre Evaluation of Single High-Dose Bolus Tirofiban versus Abciximab with Sirolimus Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY)

The open-label trial of 745 patients presenting with STEMI or new left bundle-branch block was conducted in 16 referral centers in Italy, Spain and Argentina from October 2004 to April 2007. Patients were randomly assigned with the use of a 2-by-2 factorial design to one of four interventional strategies: abciximab with an uncoated-stent, abciximab with a sirolimus-eluting stent, tirofiban with an uncoated-stent, or tirofiban with a sirolimus-eluting stent.

The study’s primary end points included evaluating tirofiban’s noninferiority to abciximab for cumulative ST-segment resolution, expressed as the proportion of patients that achieve at least 50 percent recovery within 90 minutes after intervention, as well as whether the sirolimus-stent is superior to uncoated-stent in terms of the composite of death from any cause, reinfarction and clinically-driven target vessel revascularization within the first 8 months. Secondary endpoints included each component of the composite end point, stent thrombosis and bleedings according to the criteria of the Thrombolysis in Myocardial Infarction (TIMI) trials.

Either tirofiban or abciximab was administered at first medical contact, before arterial sheath insertion. Tirofiban was given as a bolus of 25 µg/kg, followed by an 18-24 hour infusion at 0.15 µg/kg/min. Abciximab was administered as a bolus of 0.25 mg/kg, followed by a 12-hour infusion at 0.125 µg/kg/min. Stenting, either sirolimus-eluting or any uncoated-stent, was the default strategy in patients with a reference vessel diameter 2.5 mm at visual estimation. Crossover from a sirolimus-eluting stent to other stent types was allowed only after failure of a sirolimus-stent implantation attempt, or when there were no available stent sizes that matched the coronary reference diameter.

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

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