[Clinical safety using the thrombocyte aggregation inhibitor c7E3 in interventional cardiology in 520 patients].
The monoclonal antibody c7E3 (ReoPro) is a highly selective inhibitor of platelet aggregation that binds to the fibrinogen receptor (GP IIb/IIIa) on the surface of platelets and leads to a dose-dependent, nearly complete inhibition of platelet aggregation. The clinical value of c7E3 to reduce ischemic events after PTCA in addition to heparin and aspirin has been demonstrated in the EPIC-, EPILOG-, and CAPTURE-trial. In these studies, c7E3 was associated with an increased bleeding risk after the coronary intervention. The DTREO-Trial (German trial with c7E3) was designed as a prospective study to investigate the clinical safety of c7E3 in the daily routine of a cath lab. From April 1995 through September 1996 520 patients were enrolled at 30 German sites. c7E3 was mainly used in patients with acute coronary syndromes (55% unstable angina Braunwald Class I-III and C; 28% in acute myocardial infarction) and in patients with complex coronary lesions (AHA/ACC classification type B and C lesion in 84% of the study group). In 51% of the interventions a stent was implanted (25% in bailout-situations and in 26% as an elective intervention) and c7E3 was used as an adjunctive to prevent sub-acute stent thrombosis. The incidence of "major" bleeding events (TIMI-classification) was less frequent in this study as in the EPIC-trial and comparable to the results of the EPILOG- and CAPTURE trial. In conclusion this study confirms the positive risk profile of c7E3 in patients undergoing high-risk percutaneous revascularization procedures.
Machnig
T
T
II. Medizinische Klinik, Universität Lübeck.
Zahn
R
R
Rustige
J
J
Gödicke
J
J
Marsalek
P
P
Gulba
D
D
D000077284:Abciximab; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D003326:Coronary Circulation / Q000187:drug effects*; D003327:Coronary Disease / Q000628:therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D001241:Aspirin; D000077284:Abciximab
Klinische Sicherheit der Anwendung des Thrombozytenaggregationshemmers c7E3 in der Interventionellen Kardiologie bei 520 Patienten.