Diabetics Undergoing Angioplasty Benefit From Antiplatelet Drug Reopro (Abciximab)

TORONTO, ON — October 10, 2000 — Findings from the EPISTENT study show that people with diabetes undergoing angioplasty for ischemic heart disease significantly benefited from the combination of the antiplatelet drug abciximab (ReoPro®) and stenting.



Among this patient group, the risk of death or large, non-fatal heart attack (myocardial infarction) was reduced by 65 percent (14 percent to 4.9 percent). As well, the rate of reduction of heart attacks in patients with diabetes was reduced by more than 60 percent (11.1 percent to 4.3 percent). Diabetic patients also had a reduction in death regardless of whether they had balloon angioplasty or stent implantation.



Ischemic heart disease is often treated with angioplasty among non-diabetic patients. People with diabetes, who are often difficult to treat because of a greater risk of restenosis and revascularization of the treated vessel after coronary intervention, were more likely referred to CABG (coronary artery bypass graft) surgery. The results of the EPISTENT study show that people with diabetes can also significantly benefit from angioplasty when abciximab is used with stents.



“Data from this trial showed that the combination of abciximab and stenting provided a long-term benefit in reduction of mortality for all patients enrolled,” said Dr. Eric Cohen, Associate Professor, Faculty of Medicine at University of Toronto, Director of the Cardiac Catheterization Laboratory at Sunnybrook & Women’s College Health Sciences Centre and EPISTENT clinical investigator. “This survival data has not been shown to date by any other drug and represents a major advance in interventional cardiac medicine.”



The results of the one-year follow-up from the EPISTENT study were published in The Lancet.

Overall, EPISTENT showed the combination of abciximab and stents significantly reduces the risk of death by more than 50 percent in all patients. Among patients with diabetes there was a trend towards a reduction in death from 4.1 percent for patients treated with stents alone to 1.2 percent for patients treated with stents plus abciximab.



EPISTENT – a randomized, controlled, multicentre (63 medical centres in Canada and the United States) trial involving 2,399 patients, 960 of which were Canadian, with ischemic heart disease – tested whether stent plus abciximab, or balloon angioplasty plus abciximab is superior to stenting alone. People with diabetes comprised nearly 500 of the 2,399 patients in the study.



Patients were assigned to one of three treatment groups: stent plus placebo (809 patients); stent plus abciximab (794 patients); or balloon angioplasty plus abciximab (796 patients). All patients received Aspirin® and a standard dosage of the blood thinner heparin.



For patients treated with stent and abciximab, mortality was significantly reduced, compared with patients treated with stent alone. Among all patients in the stent plus placebo group, 19 (2.4 percent) died at one year versus eight (1.0 percent) in the stent plus abciximab group, representing a 57 percent reduction in mortality.



While patients treated with abciximab and angioplasty experienced sustained benefits after six months (51 percent reduction, compared with stents alone), these benefits were reduced at one year and are attributed to the lack of stent placement (9 percent reduction in death after one year, compared with patients treated with stent alone).



These results are further supported in a study published in the Journal of the American College of Cardiology where data from three noteworthy trials were pooled. Among diabetic patients who underwent multivessel intervention, the mortality rate was reduced by 88.3 percent. Treatment with abciximab essentially equalized outcomes of diabetic patients to those of placebo-treated non-diabetics.



“Abciximab is the only agent to date to have shown this robust effect in diabetic patients. Further studies will provide us with specific information regarding the benefits of angioplasty with stents and abciximab versus CABG surgery for diabetic patients,” said Dr. Cohen. “What is important is that we now have more options in the treatment of these patients.”

Abciximab is currently being studied in combination with thrombolytic agents in order to find an optimal regimen that would assist with thrombolysis (the break-up of a blood clot). The TIMI 14 (Thrombolysis In Myocardial Infarction) trial is studying abciximab with alteplase and a third-generation thrombolytic, reteplase. Abciximab and reteplase are also being studied in the GUSTO IV Pilot trial (Strategies for Patency Enhancement in the Emergency Department or SPEED).

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Cardiovascular disease (CVD) is the leading cause of death among Canadians, responsible for 44,000 deaths each year. At least half (22,000) of the deaths are caused by heart attacks. Diabetes, smoking, elevated blood cholesterol and high blood pressure are major risk factors for CVD. Two-thirds of Canadians have one or more of these major risk factors. CVD costs the Canadian economy approximately $7.8 billion annually. As well, approximately 25,000 angioplasty procedures are performed in Canada each year.



Abciximab – the first of a new class of drugs called glycoprotein (GP) IIb/IIIa inhibitors – reduces the complications associated with angioplasty, a common procedure used to treat patients with cardiovascular disease, by preventing the formation of blood clots that commonly intensify during the procedure. Abciximab, derived from the 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.



Abciximab is approved for use in more than 40 countries worldwide including Canada, the United States, the United Kingdom, Italy, Spain, France, Germany, Brazil, Austria, Australia, Singapore, Switzerland, India and South Africa.