2010-09-01 23:26:25 -

Iroko Cardio International Sàrl announces long-term, three-year, mortality data from the Phase III, open label, multi-national study comparing high-dose bolus (HDB) dosing of AGGRASTAT® (tirofiban) (25mcg/kg bolus followed by a 0.15mcg/kg/min infusion for 18-24 hours) vs. ReoPro® (abciximab) in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), presented at the 2010 European Society of Cardiology Meeting in Stockholm, Sweden.

At three years, all but nine patients were available for clinical follow-up (N=745). Patients receiving HDB dosing of tirofiban had comparable rates of all-cause (6.7% versus 7.8%; P=0.56) and adjudicated cardiac-related (4.8% versus 6.5%, P=0.33) mortality when compared to abciximab treated patients. All-cause death or myocardial infarction was similar in both treatment groups (12.9% versus 12.9%).

As previously

published in JAMA (Apr. 2008; 299:1788-1799) at least 50 percent recovery from ST-elevation occurred in 85.3 percent and 83.6 percent of patients in the HDB 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 HDB tirofiban and abciximab groups, with the incidence of thrombocytopenia being significantly more common with abciximab compared to HDB 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 HDB tirofiban compared to abciximab (9.8 percent versus 12.4 percent; P=0.30).

A resource utilisation analysis of the MULTISTRATEGY study, presented at the 12 th European Congress of the International Society of Pharmacoeconomics and Health Outcomes Research in Paris, showed that there was no difference in resources used to treat patients in either arm of MULTISTRATEGY, however there was a significant cost-savings of PCI-dosing of HDB tirofiban compared to abciximab therapy (€876.83 vs.
€348.20; P<0.000) with an overall cost-savings on therapy of over €195,000 for the study. (ISPOR Outcomes Research Digest; Oct. 2009; Abstract PCV115)

One-year follow-up data was presented at the 59 th Annual Scientific Session of the American College of Cardiology. All but four patients were available for one-year follow-up. At one-year, the incidence of death or myocardial infarction was 7.3% in the HDB tirofiban arm versus 8.1% in the abciximab arm (p=0.78) and the incidence of all cause mortality was 3.8% in the HDB tirofiban arm versus 4.6% in the abciximab arm (P=0.71). Patients treated with HDB tirofiban had a nearly significant lower rate of mortality at one-year compared to those treated with abciximab (3.2% versus 7.9%; P=0.09) (JACC; March 2010, 55:10A, 1100-277).

"The three-year results of the MULTISTRATEGY study, combined with the previous efficacy, safety and cost-effectiveness data, demonstrate that in STEMI patients undergoing primary PCI, treatment with tirofiban results in similar clinical outcomes with improved safety, in terms of lower thrombocytopenia, and lower-costs relative to abciximab," said Marco Valgimigli, MD, PhD, Director of the Cardiac Catheterisation Lab at the University of Ferrara, Ferrara, Italy and lead study investigator.

"These data underscore the importance of efficacious, safe and cost-effective therapies, like AGGRASTAT®, in interventional cardiology," said Juergen Raths, newly-appointed President and Chief Executive Officer of Iroko Cardio International Sàrl. "We look forward to working with the global cardiology community to further discuss the utility of AGGRASTAT® in treating patients with acute coronary syndrome."


About 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, at 1 year, 3 years and 5 years. 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).

Important Information about AGGRASTAT® Injection.

AGGRASTAT® is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes.
Patients most likely to benefit from AGGRASTAT® treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA.


About Iroko Cardio International Sàrl

IROKO Cardio has been founded to organize and support the commercial effort for Aggrastat. In close cooperation with our worldwide distribution partners, we aim to provide state of the art customer services to the clinical community we serve.

For more information, please visit www.irokocardio.info : .



Iroko Cardio International SàrlJuergen Raths+41 (0) 22 907

79 70 J.Raths@irokocardio.com : mailto:J.Raths@irokocardio.com