[Clinical safety using the thrombocyte aggregation inhibitor c7E3 in interventional cardiology in 520 patients].

Klinische Sicherheit der Anwendung des Thrombozytenaggregationshemmers c7E3 in der Interventionellen Kardiologie bei 520 Patienten.

Publisher: Steinkopff Country of Publication: Germany NLM ID: 0360430 Publication Model: Print Cited Medium: Print ISSN: 0300-5860 (Print) Linking ISSN: 03005860 NLM ISO Abbreviation: Z Kardiol Subsets: MEDLINE

Original Publication: Darmstadt, Steinkopff.

Angioplasty, Balloon, Coronary*; Angina, Unstable/*therapy ; Antibodies, Monoclonal/*administration & dosage ; Coronary Circulation/*drug effects ; Coronary Disease/*therapy ; Immunoglobulin Fab Fragments/*administration & dosage ; Myocardial Infarction/*therapy ; Platelet Aggregation Inhibitors/*administration & dosage; Abciximab ; Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/adverse effects ; Aspirin/administration & dosage ; Aspirin/adverse effects ; Drug Therapy, Combination ; Female ; Hemorrhage/chemically induced ; Heparin/administration & dosage ; Heparin/adverse effects ; Humans ; Immunoglobulin Fab Fragments/adverse effects ; Male ; Middle Aged ; Platelet Aggregation Inhibitors/adverse effects ; Prospective Studies

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.

0 (Antibodies, Monoclonal)
0 (Immunoglobulin Fab Fragments)
0 (Platelet Aggregation Inhibitors)
9005-49-6 (Heparin)
R16CO5Y76E (Aspirin)
X85G7936GV (Abciximab)

Date Created: 19980321 Date Completed: 19980422 Latest Revision: 20191024

20240628

10.1007/s003920050139

9499495