Acute Myocardial Infarction
Conditions
Keywords
STEMI, DES, BMS, abciximab
Brief summary
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
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.
Interventions
DRUGAbciximab
Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.
DEVICEbare metal stent prokinetic, chrono, skylor or bluemedical
bare metal stent in culprit artery in acute myocardial infarction
DEVICEdrug eluting stent (sirolimus eluting) - CYPHER stent
stent implantation in culprit artery in acute myocardial infarction
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Compusense Oegstgeest ( electronic randomization and CRF)
CATHREINE ( data monitoring)
Catharina Ziekenhuis Eindhoven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| target vessel failure | 30 days and one year |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiac and cerebral adverse events ( MACCE) | 30 days and one year |
Countries
Netherlands
Outcome results
None listed