Abstract
BackgroundAdministration 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/DesignThe 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.DiscussionThe 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.Trial registrationClinicalTrials.gov NCT00927615
Highlights
Administration of abciximab during primary percutaneous coronary intervention is an effective adjunctive therapy in the treatment of patients with ST-segment elevation myocardial infarction
Despite optimal reperfusion of the infarct-related coronary artery, impaired myocardial perfusion is still present in a significant proportion of patients following successful percutaneous coronary intervention (PCI), which is associated with larger infarct size and increased long-term cardiac mortality [6,7]
Several trials and meta-analyses have demonstrated that manual thrombus aspiration improved myocardial reperfusion in patients presenting with segment elevation myocardial infarction (STEMI) and was associated with improved survival compared to conventional PCI at clinical follow-up up to 1 year [11,12,16,17,18,19,20]
Summary
The CICERO trial is a single-center, prospective, randomized trial to determine whether IC administration of abciximab during primary PCI is more effective than IV administration in improving myocardial perfusion in STEMI patients undergoing primary PCI with thrombus aspiration. This is the first large clinical trial to date to determine the effect of IC versus IV administration of abciximab in STEMI patients undergoing primary PCI with thrombus aspiration
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