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

Sponsor

Catharina Ziekenhuis Eindhoven (Other)

Overall Status

Completed

CT.gov ID

NCT00986050

Collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), Compusense Oegstgeest ( electronic randomization and CRF) (Other), CATHREINE ( data monitoring) (Other)

907

Enrollment

Location

Arms

Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Drug: Abciximab Device: bare metal stent prokinetic, chrono, skylor or bluemedical Device: drug eluting stent (sirolimus eluting) - CYPHER stent	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

907 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: CYPHER stent
Active Comparator: Abciximab	Drug: Abciximab Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI. Other Names: reopro
No Intervention: No abciximab

Outcome Measures

Primary Outcome Measures

target vessel failure [30 days and one year]

Secondary Outcome Measures

Major adverse cardiac and cerebral adverse events ( MACCE) [30 days and one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.