Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction (DEBATER)
|Acute Myocardial Infarction||Drug: Abciximab Device: bare metal stent prokinetic, chrono, skylor or bluemedical Device: drug eluting stent (sirolimus eluting) - CYPHER stent||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study|
- target vessel failure [ Time Frame: 30 days and one year ]
- Major adverse cardiac and cerebral adverse events ( MACCE) [ Time Frame: 30 days and one year ]
|Study Start Date:||January 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Bare metal stent (BMS)||
Device: bare metal stent prokinetic, chrono, skylor or bluemedical
bare metal stent in culprit artery in acute myocardial infarction
Other Name: operator-dependent: prokinetic, chrono, skylor, bluemedical
|Active Comparator: Drug eluting stent (DES)||
Device: drug eluting stent (sirolimus eluting) - CYPHER stent
stent implantation in culprit artery in acute myocardial infarction
Other Name: CYPHER stent
|Active Comparator: Abciximab||
Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.
Other Name: reopro
|No Intervention: No abciximab|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986050
|Eindhoven, Brabant, Netherlands|
|Principal Investigator:||Rolf Michels||Catharina Ziekenhuis Eindhoven|
|Principal Investigator:||Inge Wijnbergen||Catharina Ziekenhuis Eindhoven|