Acute Myocardial Infarction
Conditions
Keywords
titanium, paclitaxel, stent, myocardial infarction, angioplasty, PCI
Brief summary
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
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.
Interventions
DEVICETitan stent and Taxus-Liberte stent
Sponsors
The Hospital District of Satakunta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| The secondary end points of the trial included all-cause mortality, composite of cardiac death or reinfarction and stent thrombosis. | One year |
Countries
Finland
Outcome results
None listed