Intravenous Versus Intracoronary Use of Abciximab
Intravenous Versus Intracoronary Use of Abciximab
The aim of this study is to investigate wether intracoronary use of bolus Abciximab is
 superior to intravenous bolus in patients undergoing percutaneous coronary intervention.
STEMI patients with indication for adjuvant therapy with GPI during pPCI, and who gave
 informed consent, were randomized, using sealed, opaque envelopes, to either IC or IV bolus
 (0.25 mg/kg body weight) followed by a 12-hour IV infusion of abciximab (0.125 μg/kg body
 weight per minute). IC bolus of abciximab was delivered via the PCI guiding catheter directly
 into the culprit artery, whereas IV bolus was given in a peripheral vein, both after
 filtering of the drug. The drug of use in our centre is Reo-Pro® manufactured by Eli Lilly,
 Denmark, who had no involvement, economically or scientifically, in the trial.

 Inclusion criteria in the present analysis were STEMI (onset of chest pain ≤ 12 hours and
 ST-segment elevation in two contiguous leads of ≥ 2 mm in V1-V3 or ≥ 1 mm in other leads),
 age ≥ 18 years and indication for adjuvant therapy with abciximab (e.g. as bail-out in case
 of no-reflow, high thrombus burden, dissection, or type B2/C lesions) on the operator's
 discretion.

 Exclusion criteria were known allergy to abciximab, ongoing bleeding, recent stroke, major
 surgery within 2 months, known bleeding disorder, or pregnancy.

 All patients were pre-treated with oral Aspirin (300-500 mg) and Clopidogrel (300-600 mg) and
 10,000 IU of unfractionated heparin given IV as a single-dose according to national
 guidelines for STEMI patients referred for pPCI. Patients were discharged with life-long
 Aspirin in a dose of 75 mg/day and Clopidogrel for 12 months in a dose of 75 mg/day.

 In relation to PCI the following data were recorded: infarct localization on ECG and coronary
 angiography, number of diseased vessels, TIMI flow before and after PCI, lesion type (A, B,
 C), and type and number of stents implanted.

 Furthermore, the following baseline data were registered: age, gender, hypertension (defined
 as being treated with blood pressure lowering medication, or being diagnosed as having
 hypertension during hospital stay, i.e. systolic blood pressure > 140 mmHg, or diastolic
 blood pressure > 90 mmHg), hypercholesterolemia (defined as being treated with lipid lowering
 medication, or having an in-hospital fasting total cholesterol of ≥ 5 mmol/L (192 mg/dL), or
 LDL ≥ 3 mmol/L (116 mg/dL)), smoking status, family history of coronary heart disease,
 diabetes (defined as being treated with an anti-diabetic agent, or having an in-hospital
 fasting plasma glucose ≥ 6.1 mmol/L, or a non-fasting plasma glucose ≥ 11.1 mmol/L), prior
 coronary vessel disease, and height and weight. Medication status was recorded at admission,
 at discharge, and at the 30-day follow up. Left ventricular ejection fraction (LVEF) was
 assessed during hospital stay by echocardiography using the 16 standard segments model (28).

 Primary end-points were defined as death and target vessel revascularization (TVR).

 Furthermore recurrent myocardial infarction (MI) and stroke within the first 30 days were
 recorded. Bleeding complications were recorded during hospital stay. Minor bleeding
 complications were defined as bleedings from the vascular access site, not requiring blood
 transfusion, but leading to premature (< 12 hours) cessation of the abciximab IV infusion.

 Major bleeding complications were defined as bleedings that required cessation of abciximab
 infusion and subsequent blood transfusion and/or vascular surgery.

 After 30 days patients were contacted by telephone, subsidiary by letter. All possible events
 within this period were confirmed by checking hospital source data. All end-points were
 evaluated by an independent committee that was unaware of study-group assignment. No patients
 were lost to follow up.

 All patients gave written informed consent. The study was approved by the local ethics
 committee and the Danish Medicines Agency and carried out in concordance with the Helsinki-II
 Declaration and the GCP requirements.
Inclusion Criteria:

 -  Usually inclusion criteria for Abciximab, that is:

 -  Adjunct to PCI for the prevention of cardiac ischemic complications:

 -  In patients undergoing PCI

 -  In patients with UA not responding to conventional medical therapy when PCI is
 planned within 24 hours

 Exclusion Criteria:

 Usually exclusion criteria for Abciximab, that is:

 -  Active internal bleeding, recent (within 6 weeks) gastrointestinal (GI) or
 genitourinary (GU) bleeding of clinical significance

 -  History of cerebrovascular accident (CVA) within 2 years, or CVA with a significant
 residual neurological deficit

 -  Bleeding diathesis

 -  Administration of oral anticoagulants within 7 days unless prothrombin time is less
 than or equal to 1.2 times control, thrombocytopenia (<100,000 cells/µL)

 -  Recent (within 6 weeks) major surgery or trauma

 -  Intracranial neoplasm

 -  Arteriovenous malformation, or aneurysm

 -  Severe uncontrolled hypertension

 -  Presumed or documented history of vasculitis

 -  Use of intravenous dextran before percutaneous coronary intervention, or intent to use
 it during intervention

 -  Known hypersensitivity to any component of this product or to murine proteins.