title: Safety and tolerability of abciximab in patients with acute myocardial infarction and failed thrombolysis.
abstract: OBJECTIVE
  The aim of this study was to evaluate glycoprotein IIb/IIIa receptor inhibitor effectiveness in AMI patients with unsuccessful thrombolysis.
  
  
  METHODS
  Eighty-four patients hospitalised within 4 h of symptom onset were randomised (single blind) into two groups. Regardless of the group, placebo or GP IIb/IIIa inhibitors were administered to patients who did not present with reperfusion signs 30 min after starting thrombolysis and 30-60 min after the end of full thrombolysis in patients with pain recurrence and ST-segment elevation. Reperfusion was assessed by the creatine kinase peak occurring within 12 h, by the observation of rapid ST-segment reduction (50-70% within 1 h) in 12-lead ECG continuous monitoring, by the rapid regression of pain and by the development of early ventricular arrhythmias. Group 1 (GP IIb/IIIa) (42 patients) received treatment with GP IIb/IIIa inhibitors i.v., heparin according to TIMI-14 trial and aspirin during failed thrombolysis or after 30-60 min effective thrombolysis because of pain recurrence and ST segment elevation. Group 2 (placebo) (42 patients) received a full dose of rtpA (100 mg) and placebo either during failed thrombolysis or after 30-60 min effective thrombolysis because of pain recurrence and ST segment elevation and standard heparin treatment and aspirin.
  
  
  RESULTS
  Thirty-nine group 1 (GP IIb/IIIa) patients showed rapid reperfusion (6 +/- 4 min) after abciximab treatment; 22 patients received rtpA 65 mg and 20 patients received rtpA 100 mg and subsequent GP IIb/IIIa inhibitor treatment. Coronarography, performed after 3-12 h, showed patency of infarct related artery (IRA) in 39 patients whose clinical picture was suggestive of rapid reperfusion during administration of a bolus of GP IIb/IIIa inhibitors. No group 2 (placebo) patients showed reperfusion and they were submitted to rescue PTCA.
  
  
  RESULTS
  Four cases in the GP IIb/IIIa group and two cases in placebo group (major bleeding). Patients receiving GIIb/IIIa inhibitors showed a reduced incidence of stent treatment (ns) and a significant reduction of events (angina) within 30 days of treatment.
  
  
  CONCLUSIONS
  Our data suggest the possibility of using IIb/IIIa glycoprotein receptor inhibitors in patients with AMI and failed thrombolysis. The increased risk of bleeding was acceptable. The most important results were the safety of this combination.
authors.affiliation: Division of Cardiology, Paolo Borsellino, GF Ingrassia Hospital, Via Val Platani 3, 90144 Palermo, Italy. lehdi@tin.it
authors.forename: Pietro
authors.initials: P
authors.lastname: Di Pasquale
authors.forename: Sergio
authors.initials: S
authors.lastname: Cannizzaro
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Scalzo
authors.forename: Giorgio
authors.initials: G
authors.lastname: Maringhini
authors.forename: Gabriella M
authors.initials: GM
authors.lastname: Vitrano
authors.forename: Alfonso
authors.initials: A
authors.lastname: Giubilato
authors.forename: Francesco
authors.initials: F
authors.lastname: Giambanco
authors.forename: Filippo M
authors.initials: FM
authors.lastname: Sarullo
authors.forename: Salvatore
authors.initials: S
authors.lastname: Paterna
mesh_terms: D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D017023:Coronary Angiography; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D015425:Myocardial Reperfusion; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D012107:Research Design; D012449:Safety; D016037:Single-Blind Method; D015912:Thrombolytic Therapy; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D017211:Treatment Failure
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D010959:Tissue Plasminogen Activator; D000077284:Abciximab