Clinical trial NCT00986050: Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: STEMI
DES
BMS
abciximab
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Compusense Oegstgeest ( electronic randomization and CRF)
name: CATHREINE ( data monitoring)
First posted: 2009-09-29
Enrollment: 907
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: target vessel failure
timeFrame: 30 days and one year
Secondary outcomes:
measure: Major adverse cardiac and cerebral adverse events ( MACCE)
timeFrame: 30 days and one year
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
state: Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Rolf Michels
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Inge Wijnbergen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
citation: Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansieri M, Choussat R, Pinton P; ADMIRAL Investigators. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001 Jun 21;344(25):1895-903. doi: 10.1056/NEJM200106213442503.
citation: Schomig A, Schmitt C, Dibra A, Mehilli J, Volmer C, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Berger PB, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel. Eur Heart J. 2005 Jul;26(14):1379-84. doi: 10.1093/eurheartj/ehi174. Epub 2005 Feb 25.
citation: Wijnbergen I, Helmes H, Tijssen J, Brueren G, Peels K, van Dantzig JM, Van' t Veer M, Koolen JJ, Pijls NH, Michels R. Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study. JACC Cardiovasc Interv. 2012 Mar;5(3):313-22. doi: 10.1016/j.jcin.2011.11.009.