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

University Hospital Maggiore della Carità of Novara

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Intravenous administration of an abciximab bolus during primary PCI; Drug: Intracoronary administration of an abciximab bolus during primary PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01757457

0000004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Intracoronary abciximab

Experimental group

Description:

Intracoronary administration of an abciximab bolus during primary PCI

Treatment:

Drug: Intracoronary administration of an abciximab bolus during primary PCI

Intravenous abciximab

Active Comparator group

Description:

Intravenous standard administration of an abciximab bolus during primary PCI

Treatment:

Drug: Intravenous administration of an abciximab bolus during primary PCI