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| |  ACC SCIENTIFIC SESSIONS: Use Of ReoPro With Stents Beneficial For Patients With Diabetes NEW ORLEANS, LA -- March 8, 1999 -- New findings from the EPISTENT (Evaluation of IIb/IIIa Platelet Inhibitor for Stenting) study show that patients with diabetes may benefit from treatment with Centocor, Inc.’s and Eli Lilly and Co.’s ReoPro(R) (abciximab) while undergoing stent placement. The results of this study -- the largest coronary stent trial ever conducted -- were presented yesterday (March 7) at the 48th annual scientific sessions of the American College of Cardiology. The six-month analysis of these results indicate that in patients with diabetes, the use of stents plus ReoPro significantly reduced the risk of death and myocardial infarction (MI) by 51 percent compared to stents alone. Additionally, the study showed that ReoPro and stents lowered the risk of restenosis (recurrent vessel narrowing) by 51 percent up to six months after treatment, compared with patients who received stents alone. The new data come from EPISTENT, a randomised, controlled, multicentre (63 medical centres in the United States and Canada) trial involving 2,399 patients with ischemic heart disease, 21 percent of whom had diabetes. The trial tested whether using a stent plus ReoPro or percutaneous transluminal coronary angioplasty (PTCA) plus ReoPro would be superior to stenting alone. The EPISTENT trial demonstrated significant long-term mortality benefits in patients who received ReoPro with stenting (57 percent lower risk of death after one-year, compared with patients undergoing stenting alone). The most common side effect of ReoPro is bleeding at the site of catheter insertion. However, bleeding events can be, reduced to a level similar to placebo by the use of lowdose, weight-adjusted heparin regiments, early sheath removal and meticulous care of the site of catheter insertion. In women aged 65 and older -- a patient population for which coronary interventions have traditionally not been as successful -- ReoPro also seems to offer a benefit. In another sub-analysis from the EPISTENT trial presented at the ACC conference, the use of ReoPro plus PTCA reduced the risk of death, MI and urgent revascularisation in older women by 83 percent at 30 days, compared with those given stents alone. Nearly seven million American women today have coronary heart disease and a history of MI, chest pain, or both. ReoPro -- a unique dual receptor glycoprotein (GP) IIb/IIIa and (alpha V beta 3) antagonist -- reduces the 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 angioplasty, they adhere to it and form a thin, protective layer. These and other 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 and causes platelets to link together and aggregate into a blood clot. ReoPro, derived from a monoclonal antibody, c7E3 Fab, takes a unique approach to preventing blood clots by targeting the GP IIb/IIIa receptors and binding to them inhibiting platelet aggregation. It also acts to inhibit (alpha V beta 3), which is believed to be implicated in smooth-muscle cell migration after vascular injury. Related Links: ReoPro, Centocor, Inc., Eli Lilly and Co.
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