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| |  ACC SCIENTIFIC SESSIONS: ReoPro Reduces Heart Attack Risk In Patients Undergoing Coronary Intervention NEW ORLEANS, LA -- March 8, 1999 -- A presentation yesterday at the American College of Cardiology meeting, New Orleans, of preliminary 30 day data from the ADMIRAL trial, further supports the significance of Centocor, Inc.’s and Eli Lilly and Co.’s ReoPro(TM) (abciximab) in reducing risk for patients undergoing coronary intervention. The trial found that patients with acute myocardial infarction (AMI) undergoing percutaneous transluminal coronary angioplasty (PTCA) and stent placement who were treated with abciximab had nearly a 47 percent reduced risk of death, repeat AMI or urgent revascularisation at 30 days compared to patients given PTCA and stents alone. "Preliminary data from the ADMIRAL trial clearly show that abciximab improves clinical outcomes at 30 days for AMI patients undergoing PTCA and stent placement," said professor Gilles Montalescot, Pitie Salpetriere, Paris, France, who presented the results at the American College of Cardiology. The ADMIRAL (Abciximab Before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up) trial is a double-blind, placebo-controlled, multi-centre trial of 299 heart-attack patients, being conducted in France, to examine if stenting plus abciximab during PTCA has superior outcome to PTCA and stenting alone. At 30 days following treatment, less than 11 percent of patients administered abciximab plus PTCA and stents had died, suffered a second AMI, or needed urgent intervention. For patients who underwent PTCA with stenting alone, this figure was 20 percent. Preliminary angiographic data from the study also showed that 21 percent of the patients randomised to receive abciximab before coronary intervention achieved high-level blood flow (TIMI 3) through the affected coronary artery, compared with 10 percent of those who were randomised to standard therapy. There was no significant difference in major hemorrhage, including intracranial hemorrhage or severe bleeding, between the abciximab and coronary intervention groups. In Europe, abciximab is currently approved as adjunctive therapy to prevent cardiac ischemic complications in a broad range of patients undergoing percutaneous coronary intervention (including balloon angioplasty, atherectomy and bailout stent). Data from the EPISTENT trial has been submitted to the European regulatory authority for inclusion in the prescribing information for abciximab. If approved the new data would allow the use of abciximab with routine stent placement. Abciximab -- a unique dual receptor glycoprotein (GP) IIb/IIIa – reduces complications associated with PCI by preventing the formation of blood clots that commonly intensify during the procedure. When blood platelets encounter an injured site, such as one produced by PTCA, they adhere to it, forming a thin, protective layer. Platelets then become activated, exposing certain binding sites on their surface known as glycoprotein receptors. A circulating protein, fibrinogen, latches on to the glycoprotein receptors causing platelets to link together and aggregate into a blood clot. Abciximab takes a unique approach to preventing blood clots by targeting the GP IIb/IIIa receptors and binding to them, inhibiting platelet aggregation. In the ADMIRAL trial, treatment consisted of either a placebo bolus followed by a 12-hour placebo infusion in combination with PTCA and stenting, or a 0.25 milligram/kilogram (mg/kg) bolus of abciximab followed by a 12-hour infusion of abciximab (0.125 microgram/kg every minute) with the coronary interventions. All patients received weight-adjusted heparin prior to and during PTCA and stent placement. Most patients were treated in the catheterisation laboratory, with about one-fourth cared for in the emergency department or in a pre-hospital setting. The most common side effect of ReoPro is bleeding at the site of the catheter insertion. However, bleeding events can be reduced to a similar level to placebo by the use of low-dose, weight-adjusted heparin regimens, early sheath removal, and meticulous care of the site of catheter insertion. Related Links: ReoPro, Centocor, Inc., Eli Lilly and Co.
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