Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction

Study Overview
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Brief Summary
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The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

Detailed Description
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In patients with acute myocardial infarction primary PCI without prior thrombolytic therapy, is the treatment of choice. The recommendation for routine stenting in PCI is based on 4 studies that have demonstrated the usefulness of bare metal stents in patients with STEMI. However this recommendation cannot be extrapolated (yet) to the use of drug eluting stents. Although DES have been used widely in unstable angina and in acute myocardial infarction, to date there are no evidence-based recommendations to support the routine use of DES in STEMI. GPI have been studied extensively in patients with non-STsegment elevation myocardial infarctions (NSTEMI) with planned or performed PCI. In STEMI tirofiban and and eptifibatide are less well investigated, and only abciximab is recommended in primary PCI, but the long term benefits require more investigation. In PCI randomized controlled clinical trials (RCT's) abciximab consistently showed a significant reduction in the rate of myocardial infarction and the need for urgent revascularization. Abciximab has been evaluated in 5 RCT's in association with primary PCI. The pooled analysis for the clinical outcome at 30 days, demonstrate a significant reduction of death, re- infarction and target vessel revascularization (TVR), mainly due to a reduction of repeat intervention. The long-term benefits require more investigation. The DEBATER trial is designed to answer the questions about the need for abciximab and about the use of DES in primary PCI.

Official Title
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A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Abciximab
* Device: bare metal stent prokinetic, chrono, skylor or bluemedical
* Device: drug eluting stent (sirolimus eluting) - CYPHER stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI ≤ 12 hours (or STEMI equivalent). No contra - indications for primary PCI. No contra - indications for abciximab. Informed consent from the patient. Exclusion Criteria: Contra - indication for primary PCI: History of peripheral/coronary artery disease that is inaccessible for angiography or PCI. Contra - indications for GPI: Ongoing bleeding, bleeding diathesis, cerebrovascular accident < 6 months, major surgery/trauma < 6 months, platelet count < 100.000 mm3 , intracranial arteriovenous malformation or neoplasm, malignant hypertension, INR >1.5, severe hepatic dysfunction Contra - indications for clopidogrel: Severe liver dysfunction, pathological bleeding disorders such as peptic ulcer or intracranial bleeding. Thrombolytic therapy < 24 hours. Therapy with GPI < 24 hours. Anticoagulation therapy. Co - morbid conditions with a predictable fatal outcome in the short run. No informed consent: refusal, coma, artificial respiration, impaired mentation.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bare metal stent (BMS)<br> | Device: bare metal stent prokinetic, chrono, skylor or bluemedical<br>* bare metal stent in culprit artery in acute myocardial infarction<br>* Other names: operator-dependent: prokinetic, chrono, skylor, bluemedical;|
| Active Comparator: Drug eluting stent (DES)<br> | Device: drug eluting stent (sirolimus eluting) - CYPHER stent<br>* stent implantation in culprit artery in acute myocardial infarction<br>* Other names: CYPHER stent;|
| Active Comparator: Abciximab<br> | Drug: Abciximab<br>* Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.<br>* Other names: reopro;|
| No Intervention: No abciximab<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target vessel failure |  | 30 days and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebral adverse events ( MACCE) |  | 30 days and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, DES, BMS, abciximab