Titanium Nitride Oxide Coated Stents and Paclitaxel Eluting Stents for Acute Myocardial Infarction

Study Overview
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Brief Summary
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Coronary-stent implantation is commonly performed for treatment of acute myocardial infarction (MI). Drug eluting stents (DES) among selected patients have been shown to reduce target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). However, there is no studies comparing titanium-nitride-oxide (TITANOX) coated stent with paclitaxel-eluting stent (PES) in acute MI.

Detailed Description
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Study Design and Patient Population The TITAX AMI (Titanium-Nitride-Oxide Coated stents versus Paclitaxel-Eluting Stents In Acute Myocardial Infarction) trial is a prospective, randomized and a multicenter trial conducted from December 2005 to November 2006 in six Finnish hospitals. The study was conducted according to the declaration of Helsinki and written informed consent was obtained from all patients. This protocol was approved by the Ethics Committees of the coordinating centre Satakunta Central Hospital and the participating hospitals. Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial. Exclusion criteria included unprotected left main disease, ostial or restenotic lesions, contraindication to aspirin, clopidogrel or heparins, life expectancy of less than 12 months and if a stent longer than 28 mm was needed. According to the trial protocol, randomization was performed after visualization of the culprit lesion or a totally occluded infarct-related vessel during coronary angiography. Using sealed envelopes, patients were randomly assigned to the groups in a 1:1 ratio in each participating center.

Official Title
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Titanium Nitride Oxide Coated Stents Versus Paclitaxel Eluting Stents for Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: Titan stent and Taxus-Liberte stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years of age presenting with acute MI (NSTEMI or STEMI) were eligible for this trial. Wtitten informed consent Exclusion Criteria: Restenosis Unprotected left main disease Ostial lesion Contraindication to asa, heparins, thienopyridines life expectancy < 12 months stent length needed > 28 mm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TITANOX<br>Titanium-nitride-oxide coated stent | Device: Titan stent and Taxus-Liberte stent<br> <br> |
| Active Comparator: PES<br>Paclitaxel-eluting stent | Device: Titan stent and Taxus-Liberte stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point was the first occurrence of major adverse cardiac event at 12 months defined as the composite of target lesion revascularization (TLR), recurrent MI, or death from cardiac causes. |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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titanium, paclitaxel, stent, myocardial infarction, angioplasty, PCI