SlideShare a Scribd company logo
1 of 25
TITAX AMI Trial Pasi Karjalainen, MD, PhD Department of Cardiology Satakunta Central Hospital, Pori, Finland Clinical trial registration information www.clinicaltrials.com Unique identifier: NCT00495664
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.
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
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 Finland Sweden Russia *  Pori   *  Turku   *  Oulu   *  Kokkola   *  Kuopio  *  Jyväskylä Norway Estonia
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Inclusion / Exclusion
TITAX AMI trial: Study Design 425  Patients Presenting Acute Myocardial Infarction Requiring PCI Written Informed Consent Randomization 1:1 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
Sample Size Calculation: Karjalainen P, et al.  J Invasive Cardiol 2006;18:462-468 Expected MACE at one year based on PORI stent registry (202 AMI patients) TITANOX 7%  versus  TAXUS-Liberte 16% Two-sided test for differences in independent proportions with 5 % alpha and 80% power    x n=102 n=100
TITAX AMI trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition of Stent Thrombosis  The Academic Research Consortium (ARC) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Baseline Patient Characteristics   0.81 96 (45) 116 (54) GP IIb/IIIa Inhibitors, n (%) 0.14 97 (46) 83 (39) Acute STEMI, n (%) 0.06 40 (19) 26 (12) Thrombolysis, n (%) 0.18 97 (46) 113 (53) History of smoking, n (%) 0.21 151 (72) 141 (66) Hyperlipidemia, n (%) 0.70 13 (6) 16 (7) Previous CABG, n (%) 0.04 10 (5) 22 (10) Previous PCI, n (%) 0.08 33 (16) 48 (22) Diabetes, n (%) 0.82 157 (74) 162 (76) Male sex, n (%) 0.72 64  ±  11 64  ±  11 Age (mean ± SD) P value PES  (211) TITANOX  (214)
Lesion Characteristics   0.16 24 (11) 35 (16) C 0.54 138 (65) 147 (69) B1 / B2 Complex Lesions, n (%) 0.84 9 (4) 10 (5) Bypass Graft (venous) 0.50 1 (0.5) 0 (0) Left Main 0.92 60 (28) 62 (29) RCA 0.48 50 (24) 44 (21) LCX 0.63 91 (43) 98 (46) LAD Infarct-related Vessel, n (%) P value PES (211) TITANOX (214)
Procedural and Lesion Characteristics   0.13 19 (9) 30 (14) Multivessel PCI, n (%) 0.21 207 (98.1) 213 (99.5) Acute Procedural Success, n (%) 0.19 3.11  ±  0.45 3.16  ±  0.42 Stent diameter, (mm) 0.26 19.2  ±  7.2 18.5  ±  6.4 Total stent length, (mm) 0.24 1.1  ±  0.4 1.1  ±  0.3 No of stents per lesion, n (%) 0.48 17.7  ±  5.3 17.4  ±  4.5 Stent length, (mm) 0.47 13.2  ±  6.4 13.6  ±  5.6 Lesion length, (mm) 0.35 3.11  ±  0.50 3.16  ±  0.45 RVD, (mm) P Value PES ( 211)   TITANOX ( 214)
30-days Follow-up 0.019 10 (4.7) 2 (0.9) Recurrent MI or cardiac death, n (%) 0.99 3 (1.4) 3 (1.4) Death from any cause, n (%) 0.06 0.10 0.31 6 (2.8) 5 (2.4) 1 (0.5) 1 (0.5) 1 (0.5) 0 (0) Stent thrombosis, n (%) Definite, n (%) Probable, n (%) 0.018 12 (5.7) 3 (1.4) MACE, n (%) 0.15 2 (0.9) 0 (0) Death from cardiac causes, n (%) 0.31 6 (2.8) 3 (1.4) TLR, n (%) 0.031 9 (4.3) 2 (0.9) Myocardial infarction, n (%) P value PES (211)   TITANOX (214)
6-months Follow-up 0.27 13 (6.2) 8 (3.7) Recurrent MI or cardiac death, n (%) 0.72 3 (1.4) 4 (1.9) Death from any cause, n (%) 0.031 0.06 0.31 7 (3.3) 6 (2.8) 1 (0.5) 1 (0.5) 1 (0.5) 0 (0) Stent thrombosis, n (%) Definite, n (%) Probable, n (%) 1.0 15 (7.1) 16 (7.5) MACE, n (%) 0.15 2 (0.9) 0 (0) Death from cardiac causes, n (%) 0.12 7 (3.3) 15 (7.0) TLR, n (%) 0.37 12 (5.7) 8 (3.7) Myocardial infarction, n (%) 211 (100) 214 (100) Complete data available, n (%) P value PES (211)   TITANOX (214)
12-months FU: Primary Endpoints % p = 0.1   p = 0.5   p = 0.2   p = 0.5 Complete data available:  TITANOX  97.7 % vs.  PES  98.1 %
12-months FU: Secondary Endpoints % p = 0.08   p = 0.8   p = 0.031
12-months FU: Stent Thrombosis % p = 0.031   p = NS   p = NS
Characteristics of ST cases   16 3.0 12 + 0 STEMI PES 8 NSTEMI STEMI STEMI STEMI NSTEMI STEMI NSTEMI NSTEMI STEMI NSTEMI Indication of index PCI 0 + + + 0 + 0 0 0 0 Thrombolysis therapy + + + + 0 0 0 + + + GP IIb/IIIa 20 3.0 12 PES 6 28 3.0 12 PES 7 16 2.25 12 PES 2 24 2.5 12 PES 3 24 3.5 12 PES 9 16 3.0 12 PES 5 20 2.5 12 PES 4 24 2.5 12 PES 1 16 3.0 6  TITANOX 2 19 mm 3.0 mm 3 months TITANOX 1 Stent length Stent diameter Clopidogrel prescription
Characteristics of ST cases   16 3.0 12 Alive STEMI PES 8 NSTEMI STEMI STEMI STEMI NSTEMI STEMI NSTEMI NSTEMI STEMI NSTEMI Indication of index PCI DIED DIED Alive DIED Alive Alive Alive Alive Alive DIED OUTCOME 20 3.0 12 PES 6 28 3.0 12 PES 7 16 2.25 12 PES 2 24 2.5 12 PES 3 24 3.5 12 PES 9 16 3.0 12 PES 5 20 2.5 12 PES 4 24 2.5 12  PES 1 16 3.0 6 TITANOX 2 19 mm 3.0 mm 3 months TITANOX 1 Stent length Stent diameter Clopidogrel prescription
Antiplatelet Therapy During ST   0 0 0 Discontinuation of aspirin 1 1 1 Discontinuation of clopidogrel 2 0 6 Dual antiplatelet therapy >180 days n = 3 30-180 days n = 1  0-30 days n = 7
12-months FU: NSTEMI vs. STEMI % p = NS p = NS   p = NS p = NS p = NS
12-months Follow-up Multivariable Predictors: The variables significantly ( P  < 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 < 0.05 was required for statistical significance   •  Primary Endpoint No predictors   •  TLR  No predictors •   Stent Thrombosis   No predictors
TITAX AMI trial: Conclusions ,[object Object],[object Object],[object Object]
TITAX AMI trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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!

More Related Content

What's hot

What's hot (20)

Ikari Y - AIMRADIAL 2014 - Radial and IABP
Ikari Y - AIMRADIAL 2014 - Radial and IABPIkari Y - AIMRADIAL 2014 - Radial and IABP
Ikari Y - AIMRADIAL 2014 - Radial and IABP
 
Kalpak O - AIMRADIAL 2014 - Total wrist access for STEMI
Kalpak O - AIMRADIAL 2014 - Total wrist access for STEMIKalpak O - AIMRADIAL 2014 - Total wrist access for STEMI
Kalpak O - AIMRADIAL 2014 - Total wrist access for STEMI
 
Cardiopatía Estructural. - Dr. José María Hernández
Cardiopatía Estructural. - Dr. José María HernándezCardiopatía Estructural. - Dr. José María Hernández
Cardiopatía Estructural. - Dr. José María Hernández
 
Scalone G - AIMRADIAL 2015 - Radial in heart transplant patients
Scalone G - AIMRADIAL 2015 - Radial in heart transplant patientsScalone G - AIMRADIAL 2015 - Radial in heart transplant patients
Scalone G - AIMRADIAL 2015 - Radial in heart transplant patients
 
Spaulding C - AIMRADIAL 2013 - Heparin and radial
Spaulding C - AIMRADIAL 2013 - Heparin and radialSpaulding C - AIMRADIAL 2013 - Heparin and radial
Spaulding C - AIMRADIAL 2013 - Heparin and radial
 
Rigattieri S - AIMRADIAL 2015 - Transradial and primary PCI
Rigattieri S - AIMRADIAL 2015 - Transradial and primary PCIRigattieri S - AIMRADIAL 2015 - Transradial and primary PCI
Rigattieri S - AIMRADIAL 2015 - Transradial and primary PCI
 
Montalescot G - AIMRADIAL 2013 - Prasugrel and radial
Montalescot G - AIMRADIAL 2013 - Prasugrel and radialMontalescot G - AIMRADIAL 2013 - Prasugrel and radial
Montalescot G - AIMRADIAL 2013 - Prasugrel and radial
 
Hamon M_2 201111
Hamon M_2 201111Hamon M_2 201111
Hamon M_2 201111
 
Euro CTO Club – The Euro CTO trial
Euro CTO Club – The Euro CTO trialEuro CTO Club – The Euro CTO trial
Euro CTO Club – The Euro CTO trial
 
Bienert I - AIMRADIAL 2015 - Exposure
Bienert I - AIMRADIAL 2015 - ExposureBienert I - AIMRADIAL 2015 - Exposure
Bienert I - AIMRADIAL 2015 - Exposure
 
Update de los estudios de ABSORB hasta 2014 - Dr. Flavio Ribichini
Update de los estudios de ABSORB hasta 2014 - Dr.  Flavio RibichiniUpdate de los estudios de ABSORB hasta 2014 - Dr.  Flavio Ribichini
Update de los estudios de ABSORB hasta 2014 - Dr. Flavio Ribichini
 
Long-term outcome for patients with CTOs
Long-term outcome for patients with CTOsLong-term outcome for patients with CTOs
Long-term outcome for patients with CTOs
 
Лечение пациентов с поражением ствола ЛКА, преимущества коронарной хирургии. ...
Лечение пациентов с поражением ствола ЛКА, преимущества коронарной хирургии. ...Лечение пациентов с поражением ствола ЛКА, преимущества коронарной хирургии. ...
Лечение пациентов с поражением ствола ЛКА, преимущества коронарной хирургии. ...
 
Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer...
Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer...Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer...
Reunion Anual Madeira 2015 A randomised comparison of reservoir-based polymer...
 
Friday 08:13 – Joner - Drug-eluting stent thrombosis in the treatment of CTOs
Friday 08:13 – Joner - Drug-eluting stent thrombosis in the treatment of CTOsFriday 08:13 – Joner - Drug-eluting stent thrombosis in the treatment of CTOs
Friday 08:13 – Joner - Drug-eluting stent thrombosis in the treatment of CTOs
 
PCI & AimRadial 2018 | Experience with Left Main PCI by Radial Access - Zsolt...
PCI & AimRadial 2018 | Experience with Left Main PCI by Radial Access - Zsolt...PCI & AimRadial 2018 | Experience with Left Main PCI by Radial Access - Zsolt...
PCI & AimRadial 2018 | Experience with Left Main PCI by Radial Access - Zsolt...
 
Intraluminal coronary thrombus aspiration in patients with STEMI. Prof. Andre...
Intraluminal coronary thrombus aspiration in patients with STEMI. Prof. Andre...Intraluminal coronary thrombus aspiration in patients with STEMI. Prof. Andre...
Intraluminal coronary thrombus aspiration in patients with STEMI. Prof. Andre...
 
TCT 2010: COMPARE Trial
TCT 2010: COMPARE TrialTCT 2010: COMPARE Trial
TCT 2010: COMPARE Trial
 
Cortese B - AIMRADIAL 2014 - Acute kidney injury
Cortese B - AIMRADIAL 2014 - Acute kidney injuryCortese B - AIMRADIAL 2014 - Acute kidney injury
Cortese B - AIMRADIAL 2014 - Acute kidney injury
 
07 FFR Kawase Y aimradial2016 - potential of pressure wire use
07 FFR Kawase Y aimradial2016 - potential of pressure wire use07 FFR Kawase Y aimradial2016 - potential of pressure wire use
07 FFR Kawase Y aimradial2016 - potential of pressure wire use
 

Similar to Titax Tct 2007

Pori 36 Months Francophone
Pori 36 Months FrancophonePori 36 Months Francophone
Pori 36 Months Francophone
benklinger
 
Lecture Pr Windecker
Lecture Pr WindeckerLecture Pr Windecker
Lecture Pr Windecker
benklinger
 
STEMI – My Approach 2010
STEMI – My Approach 2010STEMI – My Approach 2010
STEMI – My Approach 2010
ishakansari
 
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
MedicineAndFamily
 

Similar to Titax Tct 2007 (20)

Pori 36 Months Francophone
Pori 36 Months FrancophonePori 36 Months Francophone
Pori 36 Months Francophone
 
Lecture Pr Windecker
Lecture Pr WindeckerLecture Pr Windecker
Lecture Pr Windecker
 
Wivon
WivonWivon
Wivon
 
CTO and low ejection fraction
CTO and low ejection fraction CTO and low ejection fraction
CTO and low ejection fraction
 
09 Cohen aimradial20170922 Ventricular support
09 Cohen aimradial20170922 Ventricular support09 Cohen aimradial20170922 Ventricular support
09 Cohen aimradial20170922 Ventricular support
 
Fundación EPIC _ Is valve durability an issue?
Fundación EPIC _ Is valve durability an issue?Fundación EPIC _ Is valve durability an issue?
Fundación EPIC _ Is valve durability an issue?
 
Carlo Di Mario - Recent Publications & Research in CTO: 2015-16
Carlo Di Mario - Recent Publications & Research in CTO: 2015-16Carlo Di Mario - Recent Publications & Research in CTO: 2015-16
Carlo Di Mario - Recent Publications & Research in CTO: 2015-16
 
Future of site stable to unstable
Future of site stable to unstableFuture of site stable to unstable
Future of site stable to unstable
 
What do we need to indicate CTO PCI?
What do we need to indicate CTO PCI?What do we need to indicate CTO PCI?
What do we need to indicate CTO PCI?
 
Benefits of RCA CTO-PCI Based on Clinical Data.pptx
Benefits of RCA CTO-PCI Based on Clinical Data.pptxBenefits of RCA CTO-PCI Based on Clinical Data.pptx
Benefits of RCA CTO-PCI Based on Clinical Data.pptx
 
STEMI – My Approach 2010
STEMI – My Approach 2010STEMI – My Approach 2010
STEMI – My Approach 2010
 
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
 
Zest Park
Zest ParkZest Park
Zest Park
 
Friday 1653 – karmpalotis – stent patency post cto pci
Friday 1653 – karmpalotis – stent patency post cto pciFriday 1653 – karmpalotis – stent patency post cto pci
Friday 1653 – karmpalotis – stent patency post cto pci
 
TCT 2006 highlight
TCT 2006 highlightTCT 2006 highlight
TCT 2006 highlight
 
Foro Epic _ Oclusión Crónica Total (CTO): Intervención Coronaria Percutánea (...
Foro Epic _ Oclusión Crónica Total (CTO): Intervención Coronaria Percutánea (...Foro Epic _ Oclusión Crónica Total (CTO): Intervención Coronaria Percutánea (...
Foro Epic _ Oclusión Crónica Total (CTO): Intervención Coronaria Percutánea (...
 
Recent publications, key points from this year
Recent publications, key points from this yearRecent publications, key points from this year
Recent publications, key points from this year
 
SCA non-ST+ de la personne âgée - D.U. MUPA 2018
SCA non-ST+ de la personne âgée - D.U. MUPA 2018SCA non-ST+ de la personne âgée - D.U. MUPA 2018
SCA non-ST+ de la personne âgée - D.U. MUPA 2018
 
04 aimradial2016 thu S Bartus
04 aimradial2016 thu S Bartus04 aimradial2016 thu S Bartus
04 aimradial2016 thu S Bartus
 
NOBLE LEFT MAIN BIFURCATION PCI.pptx
NOBLE LEFT MAIN BIFURCATION PCI.pptxNOBLE LEFT MAIN BIFURCATION PCI.pptx
NOBLE LEFT MAIN BIFURCATION PCI.pptx
 

More from benklinger (13)

שחרור אנדוסקופי של העצב האולנרי במרפק
שחרור אנדוסקופי של העצב האולנרי במרפקשחרור אנדוסקופי של העצב האולנרי במרפק
שחרור אנדוסקופי של העצב האולנרי במרפק
 
Mosseri Titan Presentation For Tct 2005
Mosseri Titan Presentation For Tct 2005Mosseri Titan Presentation For Tct 2005
Mosseri Titan Presentation For Tct 2005
 
Titan S.V Final Ici
Titan S.V Final  IciTitan S.V Final  Ici
Titan S.V Final Ici
 
1st
1st1st
1st
 
בטיחות מטופלים מול אחריות נזיקית
בטיחות מטופלים מול אחריות נזיקיתבטיחות מטופלים מול אחריות נזיקית
בטיחות מטופלים מול אחריות נזיקית
 
בטיחות מטופלים מול אחריות נזיקית
בטיחות מטופלים מול אחריות נזיקיתבטיחות מטופלים מול אחריות נזיקית
בטיחות מטופלים מול אחריות נזיקית
 
מצגת טעויות בכירורגיה
מצגת טעויות בכירורגיהמצגת טעויות בכירורגיה
מצגת טעויות בכירורגיה
 
בטיחות מטופלים
בטיחות מטופליםבטיחות מטופלים
בטיחות מטופלים
 
Photoshop
PhotoshopPhotoshop
Photoshop
 
Tomer's Banana
Tomer's BananaTomer's Banana
Tomer's Banana
 
Art
ArtArt
Art
 
Lang
LangLang
Lang
 
Hand
HandHand
Hand
 

Recently uploaded

Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls DelhiRussian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
AlinaDevecerski
 
Call Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service Available
Dipal Arora
 

Recently uploaded (20)

Call Girls Bareilly Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Bareilly Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 8250077686 Top Class Call Girl Service Available
 
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort ServicePremium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
 
Night 7k to 12k Chennai City Center Call Girls 👉👉 7427069034⭐⭐ 100% Genuine E...
Night 7k to 12k Chennai City Center Call Girls 👉👉 7427069034⭐⭐ 100% Genuine E...Night 7k to 12k Chennai City Center Call Girls 👉👉 7427069034⭐⭐ 100% Genuine E...
Night 7k to 12k Chennai City Center Call Girls 👉👉 7427069034⭐⭐ 100% Genuine E...
 
Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Ge...
Top Rated Bangalore Call Girls Richmond Circle ⟟  9332606886 ⟟ Call Me For Ge...Top Rated Bangalore Call Girls Richmond Circle ⟟  9332606886 ⟟ Call Me For Ge...
Top Rated Bangalore Call Girls Richmond Circle ⟟ 9332606886 ⟟ Call Me For Ge...
 
Call Girls Ooty Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Ooty Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Ooty Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Ooty Just Call 8250077686 Top Class Call Girl Service Available
 
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service AvailableCall Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
 
All Time Service Available Call Girls Marine Drive 📳 9820252231 For 18+ VIP C...
All Time Service Available Call Girls Marine Drive 📳 9820252231 For 18+ VIP C...All Time Service Available Call Girls Marine Drive 📳 9820252231 For 18+ VIP C...
All Time Service Available Call Girls Marine Drive 📳 9820252231 For 18+ VIP C...
 
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
 
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
 
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
 
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
 
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
 
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
 
Call Girls Kochi Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Kochi Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Kochi Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Kochi Just Call 8250077686 Top Class Call Girl Service Available
 
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
 
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls DelhiRussian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
 
Call Girls Tirupati Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Tirupati Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Tirupati Just Call 8250077686 Top Class Call Girl Service Available
 
Call Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Aurangabad Just Call 8250077686 Top Class Call Girl Service Available
 
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Cuttack Just Call 9907093804 Top Class Call Girl Service Available
 
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟   9332606886 ⟟ Call Me For Genuine S...Top Rated Bangalore Call Girls Mg Road ⟟   9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
 

Titax Tct 2007

  • 1. TITAX AMI Trial Pasi Karjalainen, MD, PhD Department of Cardiology Satakunta Central Hospital, Pori, Finland Clinical trial registration information www.clinicaltrials.com Unique identifier: NCT00495664
  • 2. 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.
  • 3. 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
  • 4. 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 Finland Sweden Russia * Pori * Turku * Oulu * Kokkola * Kuopio * Jyväskylä Norway Estonia
  • 5.
  • 6. TITAX AMI trial: Study Design 425 Patients Presenting Acute Myocardial Infarction Requiring PCI Written Informed Consent Randomization 1:1 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
  • 7. Sample Size Calculation: Karjalainen P, et al. J Invasive Cardiol 2006;18:462-468 Expected MACE at one year based on PORI stent registry (202 AMI patients) TITANOX 7% versus TAXUS-Liberte 16% Two-sided test for differences in independent proportions with 5 % alpha and 80% power  x n=102 n=100
  • 8.
  • 9.
  • 10. Baseline Patient Characteristics 0.81 96 (45) 116 (54) GP IIb/IIIa Inhibitors, n (%) 0.14 97 (46) 83 (39) Acute STEMI, n (%) 0.06 40 (19) 26 (12) Thrombolysis, n (%) 0.18 97 (46) 113 (53) History of smoking, n (%) 0.21 151 (72) 141 (66) Hyperlipidemia, n (%) 0.70 13 (6) 16 (7) Previous CABG, n (%) 0.04 10 (5) 22 (10) Previous PCI, n (%) 0.08 33 (16) 48 (22) Diabetes, n (%) 0.82 157 (74) 162 (76) Male sex, n (%) 0.72 64 ± 11 64 ± 11 Age (mean ± SD) P value PES (211) TITANOX (214)
  • 11. Lesion Characteristics 0.16 24 (11) 35 (16) C 0.54 138 (65) 147 (69) B1 / B2 Complex Lesions, n (%) 0.84 9 (4) 10 (5) Bypass Graft (venous) 0.50 1 (0.5) 0 (0) Left Main 0.92 60 (28) 62 (29) RCA 0.48 50 (24) 44 (21) LCX 0.63 91 (43) 98 (46) LAD Infarct-related Vessel, n (%) P value PES (211) TITANOX (214)
  • 12. Procedural and Lesion Characteristics 0.13 19 (9) 30 (14) Multivessel PCI, n (%) 0.21 207 (98.1) 213 (99.5) Acute Procedural Success, n (%) 0.19 3.11 ± 0.45 3.16 ± 0.42 Stent diameter, (mm) 0.26 19.2 ± 7.2 18.5 ± 6.4 Total stent length, (mm) 0.24 1.1 ± 0.4 1.1 ± 0.3 No of stents per lesion, n (%) 0.48 17.7 ± 5.3 17.4 ± 4.5 Stent length, (mm) 0.47 13.2 ± 6.4 13.6 ± 5.6 Lesion length, (mm) 0.35 3.11 ± 0.50 3.16 ± 0.45 RVD, (mm) P Value PES ( 211) TITANOX ( 214)
  • 13. 30-days Follow-up 0.019 10 (4.7) 2 (0.9) Recurrent MI or cardiac death, n (%) 0.99 3 (1.4) 3 (1.4) Death from any cause, n (%) 0.06 0.10 0.31 6 (2.8) 5 (2.4) 1 (0.5) 1 (0.5) 1 (0.5) 0 (0) Stent thrombosis, n (%) Definite, n (%) Probable, n (%) 0.018 12 (5.7) 3 (1.4) MACE, n (%) 0.15 2 (0.9) 0 (0) Death from cardiac causes, n (%) 0.31 6 (2.8) 3 (1.4) TLR, n (%) 0.031 9 (4.3) 2 (0.9) Myocardial infarction, n (%) P value PES (211) TITANOX (214)
  • 14. 6-months Follow-up 0.27 13 (6.2) 8 (3.7) Recurrent MI or cardiac death, n (%) 0.72 3 (1.4) 4 (1.9) Death from any cause, n (%) 0.031 0.06 0.31 7 (3.3) 6 (2.8) 1 (0.5) 1 (0.5) 1 (0.5) 0 (0) Stent thrombosis, n (%) Definite, n (%) Probable, n (%) 1.0 15 (7.1) 16 (7.5) MACE, n (%) 0.15 2 (0.9) 0 (0) Death from cardiac causes, n (%) 0.12 7 (3.3) 15 (7.0) TLR, n (%) 0.37 12 (5.7) 8 (3.7) Myocardial infarction, n (%) 211 (100) 214 (100) Complete data available, n (%) P value PES (211) TITANOX (214)
  • 15. 12-months FU: Primary Endpoints % p = 0.1 p = 0.5 p = 0.2 p = 0.5 Complete data available: TITANOX 97.7 % vs. PES 98.1 %
  • 16. 12-months FU: Secondary Endpoints % p = 0.08 p = 0.8 p = 0.031
  • 17. 12-months FU: Stent Thrombosis % p = 0.031 p = NS p = NS
  • 18. Characteristics of ST cases 16 3.0 12 + 0 STEMI PES 8 NSTEMI STEMI STEMI STEMI NSTEMI STEMI NSTEMI NSTEMI STEMI NSTEMI Indication of index PCI 0 + + + 0 + 0 0 0 0 Thrombolysis therapy + + + + 0 0 0 + + + GP IIb/IIIa 20 3.0 12 PES 6 28 3.0 12 PES 7 16 2.25 12 PES 2 24 2.5 12 PES 3 24 3.5 12 PES 9 16 3.0 12 PES 5 20 2.5 12 PES 4 24 2.5 12 PES 1 16 3.0 6 TITANOX 2 19 mm 3.0 mm 3 months TITANOX 1 Stent length Stent diameter Clopidogrel prescription
  • 19. Characteristics of ST cases 16 3.0 12 Alive STEMI PES 8 NSTEMI STEMI STEMI STEMI NSTEMI STEMI NSTEMI NSTEMI STEMI NSTEMI Indication of index PCI DIED DIED Alive DIED Alive Alive Alive Alive Alive DIED OUTCOME 20 3.0 12 PES 6 28 3.0 12 PES 7 16 2.25 12 PES 2 24 2.5 12 PES 3 24 3.5 12 PES 9 16 3.0 12 PES 5 20 2.5 12 PES 4 24 2.5 12 PES 1 16 3.0 6 TITANOX 2 19 mm 3.0 mm 3 months TITANOX 1 Stent length Stent diameter Clopidogrel prescription
  • 20. Antiplatelet Therapy During ST 0 0 0 Discontinuation of aspirin 1 1 1 Discontinuation of clopidogrel 2 0 6 Dual antiplatelet therapy >180 days n = 3 30-180 days n = 1 0-30 days n = 7
  • 21. 12-months FU: NSTEMI vs. STEMI % p = NS p = NS p = NS p = NS p = NS
  • 22. 12-months Follow-up Multivariable Predictors: The variables significantly ( P < 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 < 0.05 was required for statistical significance • Primary Endpoint No predictors • TLR No predictors • Stent Thrombosis No predictors
  • 23.
  • 24.
  • 25. 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!