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

Catharina Hospital

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Device: drug eluting stent (sirolimus eluting) - CYPHER stent; Device: bare metal stent prokinetic, chrono, skylor or bluemedical; Drug: Abciximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00986050

CATHREINE-DEBATER 2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 907 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

907 participants in 4 patient groups

Bare metal stent (BMS)

Active Comparator group

Treatment:

Device: bare metal stent prokinetic, chrono, skylor or bluemedical

Drug eluting stent (DES)

Active Comparator group

Treatment:

Device: drug eluting stent (sirolimus eluting) - CYPHER stent

Abciximab

Active Comparator group

Treatment:

Drug: Abciximab

No abciximab

No Intervention group