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

Azienda Ospedaliero Universitaria Maggiore della Carita89 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myocardial Infarction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 48h

Secondary Outcomes

Overall Mortality

Mortality for all causes at 1year after primary PCI

Time frame: 1year

Target vessel revascularization

Target vessel revascularization at 1 year after primary PCI

Time frame: 1 year

Myocardial infarction

Recurrent Myocardial infarction 1 year after PCI