a randomized trial of early discharge after trans-radial stenting of coronary arteries in acute mi

Conditions: Myocardial Infarction; Ischemia

Summary: hypotheses 1. bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (pai) compared with standard bolus (0.25 mg/kg) administration. 2. total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results. 3. intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results. 4. there is a relationship between pai and angiographic perfusion scores. 5. routine use of sirolimus-eluting stents (cypher, cordis) in primary-pci is associated with a low rate of target vessel revascularization and complications. 6. cardiac mri early and late after primary-pci provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores. 7. after uncomplicated trans-radial pci, patients can be retransferred early to their referring center.

objectives and end-points the objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary pci. the primary platelets end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (max) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (mean). the secondary clinical end-points of the study are: * the composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary pci. * the composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up. the secondary angiographic end-points of the study are: * the proportion of patients having myocardial blush grade 2-3 and timi 3 score at the end of pci in the culprit vessel. * the restenosis rate (diameter stenosis ≥ 50%) and late loss in the culprit vessel at 6-months follow-up. other exploratory end-points are the feasibility and safety of early transfer to the referring hospital after uncomplicated primary pci, the cardiac mri measurements and platelet aggregation inhibition at 6h post-pci.

Eligibility criteria:
inclusion criteria: * patient with acute myocardial infarction eligible for primary pci within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following: * st-segment elevation ≥ 2 mm in 2 or more contiguous precordial ecg leads (anterior infarction) * st-segment depression ≥ 2 mm in v1, v2 or v2, v3 with reciprocal 1 mm st-elevation in ii, augmented unipolar foot (left leg) lead (avf), and v6 (true posterior infarction) * st-segment elevation ≥ 1 mm in 2 or more contiguous limb ecg leads (other infarction) * new or presumably new left bundle branch block (lbbb) * patient must be \> 18 years of age. * patient and treating interventional cardiologist agree for randomization. * patient will be informed of the randomization process and will sign an informed consent. * diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach. * the culprit lesion can be identified on a native coronary vessel, which is suitable for primary pci with stent implantation. exclusion criteria: * patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue pci * concurrent participation in other investigational study * femoral sheath (artery) * intolerance or allergy to asa, clopidogrel or ticlopidine precluding treatment for at least 12 months * any significant blood dyscrasia, diathesis or inr \> 2.0 * any clinical contraindication to abciximab (reopro®) administration i.e. known structural intracranial lesion, thrombocytopenia \< 100,000, active or recent bleeding or hemoglobin level known \< 10 g/dl. * any glycoprotein iib-iiia inhibitors use in the previous 30 days * uncontrolled high blood pressure i.e. systolic blood pressure ≥ 180 mmhg and/or diastolic blood pressure ≥ 100 mmhg. * life expectancy less than 6 months owing to non-cardiac cause * infarction caused by in-stent thrombosis or restenosis * cardiogenic shock evident before randomization

Keywords: coronary artery stenting trans-radial intracoronary