Combination of INTEGRILIN(R) (Eptifibatide) with rt-PA Is Effective in Opening Clogged Arteries in Heart Attack Patients

BARCELONA, Spain (ots-PRNewswire) - INTEGRILIN Benefit Comparable
to Primary Angioplasty

Results from a phase II study of heart attack patients demonstrate that INTEGRILIN(R) (eptifibatide), a GP IIb/IIIa platelet inhibitor that prevents clot formation, and low-dose rt-PA may be as effective as other therapies, including angioplasty, in opening occluded coronary arteries. The findings are based on results from the INTRO AMI study (INTEGRILIN and Reduced Dose of Thrombolytic in Acute Myocardial Infarction) presented today by Uwe Zeymer, MD, Städtische Kliniken Kassel, INTRO AMI German country coordinator, during the Hot-Line Session at the XXIst Congress of the European Society of Cardiology.

The study showed that 78 percent of patients who received INTEGRILIN plus half the standard dose of rt-PA (recombinant tissue plasminogen activator) had blood flow to their coronary arteries restored in full within 90 minutes. In comparison, 54 percent of patients receiving full dose rt-PA achieved this level of blood flow at 90 minutes (based on findings from the GUSTO-1 study results). These data are on par with other anti-thrombolytic combination research.

"My impression of the INTRO AMI data is that this combination therapy works as quickly as primary angioplasty to reopen occluded coronary arteries," said Dr. Zeymer. "This can be an important discovery considering that not all cardiac centers have the capability to perform this type of intervention. Looking ahead, cardiologists may begin to reserve primary angioplasty for heart attack patients with contraindications for its use or for whom pharmacological therapy fails."

The multinational, multi-centre, phase II study involved 342 heart-attack patients who arrived at the hospital within six hours of experiencing chest pain. The primary objectives of the study are the incidence of patients achieving optimal blood flow (referred to as TIMI 3 flow) through the occluded coronary artery at 60 and 90 minutes after treatment was initiated and the incidence of major bleeding during acute hospitalization. Städtische Kliniken Kassel, a leading cardiac research center in Germany, was a major coordinating center for INTRO AMI.

An improvement in the restoration of normal coronary blood flow (TIMI 3 blood flow) in the infarcted artery was observed using half the standard dose of rt-PA in combination with INTEGRILIN. This strategy was not associated with an increase in major bleeding complications, including intracranial hemorrhage, which was observed in earlier attempts to improve thrombolysis with rt-PA by increasing the dose or combining it with more potent thrombin inhibitors. In addition researchers found a reduced reinfarction rate in patients treated with INTEGRILIN and rt-PA was reduced (less than 5 percent), compared with reinfarction rates seen when rt-PA therapy is used alone (usually 5-10 percent).

"This is very encouraging data and will point us toward how to optimally treat acute MI," Dr. med Zeymer added. "Assuming our preliminary results hold up in the dose confirmation phase of this study, we believe physicians may now have a fast and effective thrombolytic regimen to add to their treatment armamentarium."

Under the direction of Eric J. Topol, MD, Cleveland Clinic, INTRO AMI study chairman, a dose confirmation, angiographic study is planned to confirm the safety and efficacy of using INTEGRILIN in combination with rt-PA in patients with acute myocardial infarction against full dose rt-PA.


INTEGRILIN(R) was approved for marketing in July 1999 by the European Union's (EU) Commission of the European Communities for the prevention of early myocardial infarction in patients with unstable angina (UA) or non-Q-wave myocardial infarction (NQMI), serious heart conditions known collectively as acute coronary syndromes (ACS), who are managed medically and/or with percutaneous coronary intervention (PCI).

ots Original Text Service: Städtische Kliniken Kassel

Contact: Nina Mehta, in Barcelona, +34-609-326-533, or after 1 September, +212-885-0399, or Mary Barrington-Ward, mobile, +44-468-337-513, or after 1 September, +44-171-413-3000, both of Hill & Knowlton