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Previous Volume 341:319-327 July 29, 1999 Number 5 Next

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ABSTRACT

Background Inhibition of the platelet glycoprotein IIb/IIIa receptor with the monoclonal-antibody fragment abciximab reduces the acute ischemic complications associated with percutaneous coronary revascularization, whereas coronary-stent implantation reduces restenosis. We conducted a trial to determine the efficacy of abciximab and stent implantation in improving long-term outcome.

Methods A total of 2399 patients were randomly assigned to stent implantation and placebo, stent implantation and abciximab, or balloon angioplasty and abciximab. The patients were followed for six months.

Results At six months, the incidence of the composite end point of death or myocardial infarction was 11.4 percent in the group that received a stent and placebo, as compared with 5.6 percent in the group that received a stent and abciximab (hazard ratio, 0.47; 95 percent confidence interval, 0.33 to 0.68; P<0.001) and 7.8 percent in the group assigned to balloon angioplasty and abciximab (hazard ratio, 0.67; 95 percent confidence interval, 0.49 to 0.92; P=0.01). The hazard ratio for stenting plus abciximab as compared with angioplasty plus abciximab was 0.70 (95 percent confidence interval, 0.48 to 1.04; P=0.07). The rate of repeated revascularization of the target vessel was 10.6 percent in the stent-plus-placebo group, as compared with 8.7 percent in the stent-plus-abciximab group (hazard ratio, 0.82; 95 percent confidence interval, 0.59 to 1.13; P=0.22) and 15.4 percent in the angioplasty-plus-abciximab group (hazard ratio, 1.49; 95 percent confidence interval, 1.13 to 1.97; P=0.005). The hazard ratio for stenting plus abciximab as compared with angioplasty plus abciximab was 0.55 (95 percent confidence interval, 0.41 to 0.74; P<0.001). Among patients with diabetes, the combination of abciximab and stenting was associated with a lower rate of repeated target-vessel revascularization (8.1 percent) than was stenting and placebo (16.6 percent, P=0.02) or angioplasty and abciximab (18.4 percent, P=0.008).

Conclusions For coronary revascularization, abciximab and stent implantation confer complementary long-term clinical benefits.

Source Information

From the Departments of Cardiology (A.M.L., D.J.M., S.G.E., J.E.B., E.J.T.) and Biostatistics and Epidemiology (S.K.S.), Cleveland Clinic Foundation, Cleveland; the Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, N.C. (R.M.C.); the University of Manitoba, Winnipeg, Man., Canada (J.D.); Our Lady of Lourdes Medical Center, Cherry Hill, N.J. (J.H.K.); Baylor College of Medicine, Houston (N.S.K.); Sunnybrook Health Science Centre, Toronto (E.A.C.); and Centocor, Malvern, Pa. (C.F.C.). Other authors were James E. Tcheng, M.D. (Duke Clinical Research Institute), J. David Talley, M.D. (University of Arkansas, Little Rock), Paul O. Caramori, M.D. (Toronto Hospital, Toronto), Jeffrey R. Burton, M.D. (University of Alberta Hospital, Edmonton, Alta., Canada), Thomas A. Kelly, M.D. (Moses Cone Memorial Hospital, Greensboro, N.C.), and Tom B. Ivanc, M.S. (Cleveland Clinic Foundation).

Address reprint requests to Dr. Lincoff at the Department of Cardiology, Desk F25, Cleveland Clinic Foundation, Cleveland, OH 44195.

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