TITAX AMI Trial

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TITAX AMI Trial

• Pasi Karjalainen, MD, PhD

Department of Cardiology Satakunta Central
Hospital, Pori, Finland
Clinical trial registration information www.clinic
altrials.com Unique identifier NCT00495664
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Disclosure Statement of Financial Interest
I, (Pasi Karjalainen) DO NOT have a financial
interest / arrangement or affiliation with one or
more organizations that could be perceived as a
real or apparent conflict of interest in the
context of the subject of this presentation.
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TITAX AMI trial

• P Karjalainen, MD, PhD
• Juhani Airaksinen, Antti Ylitalo, Matti Niemelä,
• Kari Kervinen, Mikko Pietilä, Jussi Sia,
• Kai Nyman, Petri Tuomainen, Timo Mäkikallio
• for the TITAX AMI Investigators

All investigators state that no
relationships exist related to this presentation
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Participating Centers in Finland
Purpose of the TITAX AMI trial Initiated by the
investigators A Prospective, Multi-center,
Randomized Trial that Compares the Implantation
of Titanium-Nitride-Oxide Coated Stents to
Paclitaxel-Eluting Stents for Acute Myocardial
Infarction
Norway
Finland
Sweden
Russia
Oulu
Kokkola
Kuopio
Jyväskylä
Pori
Turku
Estonia
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Inclusion / Exclusion

• Inclusion Criteria
• Written informed consent
• Age gt 18 years
• Patient with symptoms and
• signs of myocardial
• infarction requiring PCI

• Exclusion Criteria
• Prior PCI on target vessel
• (restenosis)
• Unprotected LM disease
• Ostial lesion
• Contraindication to aspirin,
• heparins, clopidogrel,
• (allergy / risk for bleeding)
• Life expectancy lt 12 months
• Stent length needed gt 28 mm

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TITAX AMI trial Study Design
425 Patients Presenting Acute Myocardial
Infarction Requiring PCI
Written Informed Consent
Randomization 11
TITAN stent (Hexacath) Titanium-Nitride-Oxide
Coated Stent (TITANOX) 214 Patients
TAXUS-Liberte stent (Boston) Paclitaxel-Eluting
Stent (PES) 211 Patients
Primary Endpoint MACE at 1 Year
Independent Endpoint Committee
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Sample Size Calculation
Expected MACE at one year based on PORI stent
registry (202 AMI patients) TITANOX 7 versus PES
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? x
n100
n102
Two-sided test for differences in independent
proportions with 5 alpha and 80 power
Karjalainen P, et al. J Invasive Cardiol
200618462-468
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TITAX AMI trial

• Primary Endpoint
• - MACE at 12- months including
• Myocardial infarction
• TLR (PCI or CABG)
• Cardiac death
• Secondary Endpoints
• - Composite of cardiac death or recurrent MI
• - All cause death
• - Stent Thrombosis

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Definition of Stent Thrombosis The Academic
Research Consortium (ARC)

• Definite
• - Acute coronary syndrome and angiographic (or
  autopsy) confirmation of stent thrombosis
• Probable
• - Any unexplained death within the first 30 days
• - Target vessel related AMI
• Possible
• - Any unexplained death from 30 days after PCI

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Baseline Patient Characteristics
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Lesion Characteristics
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Procedural and Lesion Characteristics
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30-days Follow-up
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6-months Follow-up
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12-months FU Primary Endpoints

p 0.5
p 0.5
p 0.1
p 0.2
Complete data available TITANOX 97.7 vs. PES
98.1
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12-months FU Secondary Endpoints

p 0.08
p 0.031
p 0.8
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12-months FU Stent Thrombosis

p 0.031
p NS
p NS
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Characteristics of ST cases
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Characteristics of ST cases
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Antiplatelet Therapy During ST
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12-months FU NSTEMI vs. STEMI

p NS
p NS
p NS
p NS
p NS
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12-months Follow-up
Multivariable Predictors The variables
significantly (P lt 0.05) associated with
dependent variables in univariate analyses were
included in multivariable analyses Results of
the logistic regression are presented using odds
ratios and their 95 confidence intervals. A
two-sided P value lt 0.05 was required for
statistical significance Primary
Endpoint No predictors TLR No
predictors Stent Thrombosis No predictors
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TITAX AMI trial Conclusions

• Both TITANOX coated stent and PES resulted in
  comparable clinical outcome.
• Secondly, although the overall risk of stent
  thrombosis was low, it concentrated on the use of
  PES.
• Stent thrombosis occurred in 3 patients after
  premature discontinuation of clopidogrel.

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TITAX AMI trial

• Possible limitations
• Small sample size (425 patients)
• Thrombolysis therapy not excluded
• Strengths of the study
• Initiated by the investigators, no sponsors
• Prospective, randomized, multicenter study
• Primary clinical end point
• New ARC definition of stent thrombosis

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TITAX AMI trial

• P Karjalainen, MD, PhD
• Juhani Airaksinen, Antti Ylitalo, Matti Niemelä,
• Kari Kervinen, Mikko Pietilä, Jussi Sia,
• Kai Nyman, Petri Tuomainen, Timo Mäkikallio
• for the TITAX AMI Investigators

Thank You! Kiitos!