ReoPro Shows Significant Mortality Benefit in Ischemic Heart Disease Patients
In a significant breakthrough in the treatment of ischemic heart disease, the combination of the antiplatelet monoclonal antibody drug ReoPro (abciximab) with stent placement has been shown to reduce the risk of death by 57 percent in patients with ischemic heart disease, compared to those undergoing stenting alone. The results, presented at the 71st Scientific Sessions of the American Heart Association, demonstrate a mortality benefit at one year and highlight the potential of this combination therapy in reducing long-term mortality in patients with ischemic heart disease.
Key Takeaways:
- The combination of ReoPro and stents reduced the risk of death by 57 percent in patients with ischemic heart disease, compared to those undergoing stenting alone.
- The mortality benefit was observed at one year, with 8 deaths (1.0 percent) in the ReoPro plus stent group, compared to 19 deaths (2.4 percent) in the stent plus placebo group.
- The analysis of patients who actually received study treatment showed a 68 percent reduction in mortality among patients in the ReoPro plus stent group, compared to patients in the stent plus placebo group.
- The EPISTENT trial, a randomized, controlled, multicenter trial involving 2,399 patients with ischemic heart disease, tested the combination of ReoPro and stenting versus stenting alone.
- The trial showed a statistically significant benefit in patients with diabetes, with a greater than 50 percent reduction in the need for repeat revascularization procedures.
- The anti-restenosis benefit of ReoPro was more pronounced in patients with diabetes, with a 16.6 percent to 8.1 percent reduction in the need for repeat revascularization procedures.
Statistics:
- 57% reduction in risk of death amongst patients receiving ReoPro and stents compared to stenting alone at one year (p=0.037)
- 68% reduction in mortality amongst patients in the ReoPro plus stent group, compared to patients in the stent plus placebo group, based on the analysis of patients who actually received study treatment (p=0.01)
- 8 deaths (1.0 percent) amongst patients in the ReoPro plus stent group, compared to 19 deaths (2.4 percent) in the stent plus placebo group.
- 16.6 percent to 8.1 percent reduction in the need for repeat revascularization procedures amongst patients with diabetes receiving ReoPro and stents.
- 40,000 patients were required in previous mortality trials, such as GUSTO I (tPA vs. streptokinase), to show comparable results.
Sources:
- "ReoPro Also Shows Restenosis Benefit" PRNewswire, November 9, 1998
- The Lancet, 352, 87-92 (1998)
- EPISTENT (Evaluation of IIb/IIIa Platelet Inhibitor for Stenting) trial