CLINICAL SAFETY OF THE PLATELET-AGGREGATI ON INHIBITOR C7E3 IN 520 PATIENTS UNDERGOING CORONARY INTERVENTIONS

The monoclonal antibody c7E3 (ReoPro((TM))) is a highly selective inhi bitor of platelet aggregation that binds to the fibrinogen receptor (G P IIb/IIIa) on the surface of platelets and leads to a dose-dependent, nearly complete inhibition of platelet aggregation. The clinical valu e of c7E3 to reduce ischemic events after PTCA in addition to heparin and aspirin has been demonstrated in the EPIC-, EPILOG-, and CAPTURE-t rial. In these studies, c7E3 was associated with an increased bleeding risk after the coronary intervention. The DTREO-Trial (German trial w ith c7E3) was designed as a prospective study to investigate the clini cal 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 cla ssification type B and C lesion in 84 % of the study group). In 51 % o f the interventions a stent was implanted (25 % in bailout-situations and in 26 % as an elective intervention) and c7E3 was used as an adjun ctive to prevent subacute 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 pro file of c7E3 in patients undergoing high-risk percutaneous revasculari zation procedures.