Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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Intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.

Detailed Description
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BACKGROUND: intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. Besides antiplatelet effects, abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. METHODS: 87 consecutive STEMI patients candidate to pPCI were randomized to receive intracoronary (Group A, 47 patients) or intravenous (Group B, 42 patients) abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.

Official Title
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Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Intracoronary administration of an abciximab bolus during primary PCI
* Drug: Intravenous administration of an abciximab bolus during primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of STEMI according to the universal definition of myocardial infarction (7); hospital admission within 12 hours from symptom onset; successful treatment by primary PCI, defined as a procedure achieving infarct-related artery (IRA) patency with less than 10% residual coronary stenosis based on visual estimation. Exclusion Criteria: age > 90 years; cardiogenic shock at admission; left main as IRA; saphenous vein graft as IRA; previous PCI in the last 6 months; severe renal impairment (eGFR<30ml/min) or dialysis treatment; thrombolytic drug administration in the last 30 days before admission; known malignancy diagnosed less than 5 years before admission; known active infectious, coagulative or systemic inflammatory diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracoronary abciximab<br>Intracoronary administration of an abciximab bolus during primary PCI | Drug: Intracoronary administration of an abciximab bolus during primary PCI<br>* Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI<br>|
| Active Comparator: Intravenous abciximab<br>Intravenous standard administration of an abciximab bolus during primary PCI | Drug: Intravenous administration of an abciximab bolus during primary PCI<br>* Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-reactive protein levels from baseline after PCI | C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction | 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mortality | Mortality for all causes at 1year after primary PCI | 1year | 
| Target vessel revascularization | Target vessel revascularization at 1 year after primary PCI | 1 year | 
| Myocardial infarction | Recurrent Myocardial infarction 1 year after PCI | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, thrombosis, platelets, adhesion molecules, endothelium