Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspiration.
BACKGROUND
Administration of abciximab during primary percutaneous coronary intervention is an effective adjunctive therapy in the treatment of patients with ST-segment elevation myocardial infarction. Recent small-scaled studies have suggested that intracoronary administration of abciximab during primary percutaneous coronary intervention is superior to conventional intravenous administration. This study has been designed to investigate whether intracoronary bolus administration of abciximab is more effective than intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration.


METHODS
The Comparison of IntraCoronary versus intravenous abciximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction (CICERO) trial is a single-center, prospective, randomized open-label trial with blinded evaluation of endpoints. A total of 530 patients with STEMI undergoing primary percutaneous coronary intervention are randomly assigned to either an intracoronary or intravenous bolus of weight-adjusted abciximab. The primary end point is the incidence of >70% ST-segment elevation resolution. Secondary end points consist of post-procedural residual ST-segment deviation, myocardial blush grade, distal embolization, enzymatic infarct size, in-hospital bleeding, and clinical outcome at 30 days and 1 year.


CONCLUSIONS
The CICERO trial is the first clinical trial to date to verify the effect of intracoronary versus intravenous administration of abciximab on myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration.
Department of Cardiology, Thorax Center, University Medical Center Groningen, University of Groningen, Hanzeplein 1 PO Box 30001, 9700 RB Groningen, the Netherlands. y.l.gu@thorax.umcg.nl
Youlan L
YL
Gu
Marieke L
ML
Fokkema
Marthe A
MA
Kampinga
Bart J G L
BJ
de Smet
Eng S
ES
Tan
Ad F M
AF
van den Heuvel
Felix
F
Zijlstra
D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000925:Anticoagulants / Q000008:administration & dosage*; D017023:Coronary Angiography; D004562:Electrocardiography; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D009203:Myocardial Infarction / Q000188:drug therapy*; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size; D013927:Thrombosis / Q000188:drug therapy
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab