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| |  Use Of ReoPro With Stents Cuts Death Or Heart Attack Risk In Half MALVERN, PA -- Aug. 24, 1998 -- In the six-month follow-up of the largest coronary stent trial ever conducted, the combined use of Centocor, Inc.’s ReoPro(R) (abciximab), a monoclonal antibody platelet glycoprotein IIb/IIIa inhibitor, with stents in patients undergoing coronary interventions reduces the risk of death or heart attack. This benefit was sustained with a 51 percent reduction at six months compared with stents alone. A sustained benefit at six months was also demonstrated in patients receiving ReoPro and angioplasty (31 percent reduction) compared with stents alone. These data were released during the 20th congress of the European Society of Cardiology. The six-month results from the EPISTENT (Evaluation of IIb/IIIa Platelet Inhibitor for Stenting) trial confirmed earlier 30-day results, which were published in the July 11, 1998 issue of The Lancet. This is the only clinical trial to demonstrate that the use of a pharmacologic agent and device (stents) offers sustained cardiac benefits at six months. The reduction in death or heart attack at six months was particularly prominent in patients presenting with unstable angina within 48 hours of randomisation. The reduction in this population from 14.5 percent in patients treated with stents alone to 4.5 percent in those treated with ReoPro and stents (69 percent reduction) suggests that one death or heart attack was prevented for every ten unstable angina patients treated. One of the difficulties for all types of catheter-based revascularisation strategies has been the need for repeat revascularisation procedures in the vessel treated, or target vessel, within six months. The endpoint of death, heart attack, or target vessel revascularisation (TVR) within six months was significantly reduced from 18.3 percent in the placebo and stent group to 13.0 percent in the ReoPro and stent group. Each component of the endpoint was also lower in the ReoPro and stent group compared to the placebo and stent group (death 0.5 percent versus 1.2 percent; heart attack 5.2 percent versus 10.3 percent; TVR 8.7 percent versus 10.6 percent). In patients with diabetes, who tend to have worse outcomes after coronary revascularisation procedures, the composite endpoint of death, heart attack, or TVR was reduced by 48 percent (25.2 percent to 13.0 percent), while TVR alone was reduced by more than 50 percent (16.6 percent to 8.1 percent). This suggests that the combined use of ReoPro and stents can substantially mitigate the higher risk and poorer long term outcomes of coronary intervention in patients with diabetes and is a major step in the treatment of ischemic heart disease in this patient population. The most common side effect of ReoPro is bleeding. However, the EPILOG study showed that bleeding events can be reduced to a level similar to placebo by the use of low-dose, weight-adjusted heparin regimens, early sheath removal and meticulous care of the site of catheter insertion. The randomised, controlled, multicentre (63 sites in the United States and Canada) trial involving 2,399 patients with ischemic heart disease tested whether stents or balloon angioplasty plus ReoPro would be superior to stenting alone. Patients were assigned to one of the three following groups: stent plus placebo (809 patients); stent plus ReoPro (794 patients); or balloon angioplasty plus ReoPro (796 patients). All patients received the standard blood thinners aspirin and heparin. The primary endpoint of the trial -- a composite of death, heart attack, or need for urgent revascularisation at 30 days -- was significantly reduced in both the ReoPro treated groups. Related Links: ReoPro, Centocor Inc.
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