Intravenous Versus Intracoronary Use of Abciximab
Condition: Atherosclerosis; Ischemic Heart Disease
MeSH terms: Heart Diseases; Atherosclerosis; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Abciximab; Abciximab
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous.; Intracoronary
Intervention MeSH terms: Abciximab
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abciximab; Reo-Pro; Intracoronary; PCI