Myocardial Infarction
Conditions
Keywords
inflammation, thrombosis, platelets, adhesion molecules, endothelium
Brief summary
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
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.
Interventions
DRUGIntracoronary administration of an abciximab bolus during primary PCI
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
DRUGIntravenous administration of an abciximab bolus during primary PCI
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in C-reactive protein levels from baseline after PCI | 48h | C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mortality | 1year | Mortality for all causes at 1year after primary PCI |
| Target vessel revascularization | 1 year | Target vessel revascularization at 1 year after primary PCI |
| Myocardial infarction | 1 year | Recurrent Myocardial infarction 1 year after PCI |
Countries
Italy
Outcome results
None listed