NCT00986050

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 907 (actual)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Abciximab	Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.
DEVICE	bare metal stent prokinetic, chrono, skylor or bluemedical	bare metal stent in culprit artery in acute myocardial infarction
DEVICE	drug eluting stent (sirolimus eluting) - CYPHER stent	stent implantation in culprit artery in acute myocardial infarction

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-05-01
• Completion: 2009-07-01
• First posted: 2009-09-29
• Last updated: 2011-07-26

Locations

1 site across 1 country: Netherlands