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(Circulation. 2001;104:870.)
© 2001 American Heart Association, Inc.

Clinical Investigation and Reports

Abciximab Readministration

Results of the ReoPro Readministration Registry

James E. Tcheng, MD; Dean J. Kereiakes, MD; A. Michael Lincoff, MD; Barry S. George, MD; Neal S. Kleiman, MD; David C. Sane, MD; Douglas B. Cines, MD; Robert E. Jordan, PhD; Mary Ann Mascelli, PhD; Mary Ann Langrall, BS, MT; Lakshmi Damaraju, PhD; Allen Schantz, MS; Mark B. Effron, MD; Gregory A. Braden, MD; , for the ReoPro Readministration Registry Investigators

From The Duke Clinical Research Institute, Durham, NC (J.E.T.); the Carl and Edyth Lindner Center for Clinical Cardiovascular Research and Ohio Heart Health Center, Cincinnati, Ohio (D.J.K.); the Cleveland Clinic Foundation, Cleveland, Ohio (A.M.L.); the Midwest Cardiology Research Foundation, Columbus, Ohio (B.S.G.); Baylor College of Medicine and the Methodist Hospital, Houston, Tex (N.S.K.); Wake Forest University School of Medicine, Winston-Salem, NC (D.C.S., G.A.B.); University of Pennsylvania, Philadelphia, Pa (D.B.C.); Centocor, Malvern, Pa (R.E.J., M.A.M., M.A.L., L.D., A.S.); and Lilly Research Laboratories, Indianapolis, Ind (M.B.E.).

Correspondence to James E. Tcheng, MD, Box 3275, Duke University Medical Center, Durham, NC 27710. E-mail tchen001{at}mc.duke.edu

Background—— Platelet glycoprotein IIb/IIIa blockade with abciximab (ReoPro) improves the clinical outcomes of percutaneous coronary intervention. This registry was conducted to characterize the effects of repeated administration of abciximab during intervention.

Methods and Results—— We recruited 500 consecutive patients at 22 centers in the United States who were receiving abciximab for at least a second time during percutaneous coronary intervention. Safety was measured as the incidence of hypersensitivity reactions, major bleeding, and thrombocytopenia. Efficacy was assessed as event-free clinical success. Human antichimeric antibody (HACA) responses were also characterized. There were no cases of hypersensitivity (95% upper confidence bound, 0.3%), major bleeding, or death. Clinical success was 94.4%. Thrombocytopenia occurred in 23 patients (4.6%; 95% CI, 2.8% to 6.4%), including 12 (2.4%; 95% CI, 1.1% to 3.7%) who developed profound thrombocytopenia (<20x10⁹ cells/L). In 2 patients (0.4%), profound thrombocytopenia did not develop until after hospital discharge; in 4 (0.8%), profound thrombocytopenia recurred despite platelet transfusion. Before a first readministration, a positive HACA titer was present in 22 of 454 patients (4.8%); after a first readministration, an additional 82 of 432 (19.0%) became HACA-positive. HACA did not neutralize the in vitro inhibition of platelet aggregation by abciximab or correlate with clinical events.

Conclusions—— The results, including overall rates of thrombocytopenia, were consistent with randomized clinical trials of first abciximab treatment. However, there was a shift from mild to profound thrombocytopenia, and cases of delayed presentation and of recurrent thrombocytopenia were seen. These findings suggest that indications and guidelines for first-time use apply to retreatment, particularly the systematic monitoring for thrombocytopenia.

Key Words: angioplasty • platelet aggregation inhibitors • pharmacodynamics • thrombocytopenia

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