TITAX AMI Trial Y. Giraud-Sauveur on behalf of P.Karjalainen, MD, PhD : Principal Investigator BCIS 2009 London, UK A Prospective, Randomized Trial Comparing.

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Presentation transcript:

TITAX AMI Trial Y. Giraud-Sauveur on behalf of P.Karjalainen, MD, PhD : Principal Investigator BCIS 2009 London, UK A Prospective, Randomized Trial Comparing TITAN-2 ® Stent and TAXUS-Liberte ® Stent in Acute Myocardial Infarction 24-months Clinical Follow-Up

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

Titanium-NO Mechanisms of Action Inhibits Platelet Aggregation Minimizes Fibrin Growth Reduces Inflammation Promotes Healing Multifunctional Anti-restenotic Effect - Stabilizes microtubules to inhibit smooth muscle cell migration and proliferation - Stable and durable Translute Polymer * Vascular compatible, biocompatible * Controlled and consistent dose release of paclitaxel

Background: TITAX AMI at 1-Year Eurointerv 2008;4: TCT 2007, Late Breaking Trial Comparison of titanium-nitride-oxide-coated TITAN-2 ® Stent to the paclitaxel-eluting TAXUS-Liberte ® stent resulted in: Comparable clinical outcome at 1-Year although the overall risk of stent thrombosis was low, it concentrated on the use of TAXUS-Liberte ® stent Secondly, although the overall risk of stent thrombosis was low, it concentrated on the use of TAXUS-Liberte ® stent In addition, stent thrombosis occurred in 3 patients after premature discontinuation of clopidogrel.

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 SwedenRussia * Pori * * Turku * Oulu * Kokkola * Kuopio * Jyväskylä Norway Estonia

Inclusion Criteria: Written informed consent Age > 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 < 12 months Stent length needed > 28 mm Inclusion / Exclusion

TITAX AMI trial: Study Design 425 Patients Presenting Acute Myocardial Infarction Requiring PCI Written Informed Consent Randomization 1:1 TITAN-2 ® 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

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

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

Baseline Patient Characteristics TITAN-2 ® (N=214) TAXUS-L* ® (N=211) P value Age (mean ± SD)64 ± Male sex, n (%)162 (76)157 (74)0.82 Diabetes, n (%)48 (22)33 (16)0.08 History of smoking, n (%)113 (53)97 (46)0.18 Hyperlipidemia, n (%)141 (66)151 (72)0.21 Previous PCI, n (%)22 (10)10 (5)0.04 Previous CABG, n (%)16 (7)13 (6)0.70 Acute STEMI, n (%)83 (39)97 (46)0.14 Thrombolysis, n (%)26 (12)40 (19)0.06 GP IIb/IIIa Inhibitors, n (%)116 (54)96 (45)0.81 * L= Liberte

Lesion Characteristics TITAN-2 ® (N=214) TAXUS-L* ® (N=211) P value Infarct-related Vessel, n (%) LAD98 (46)91 (43)0.63 LCX44 (21)50 (24)0.48 RCA62 (29)60 (28)0.92 Left Main0 (0)1 (0.5)0.50 Bypass Graft (venous)10 (5)9 (4)0.84 Complex Lesions, n (%) B1 / B2147 (69)138 (65)0.54 C35 (16)24 (11)0.16 * L= Liberte

Procedural and Lesion Characteristics TITAN-2 ® (N=214) TAXUS-L* ® (N=211) P Value RVD, (mm)3.16 ± ± Lesion length, (mm)13.6 ± ± Stent diameter, (mm)3.16 ± ± Stent length, (mm)17.4 ± ± Total stent length, (mm)18.5 ± ± No of stents per lesion, n (%)1.1 ± ± Acute Procedural Success, n (%)213 (99.5)207 (98.1)0.21 Multivessel PCI, n (%)30 (14)19 (9)0.13 * L= Liberte

Antiplatelet Agent Utilization TITAN-2 ® (N=214) TAXUS-L* ® (N=211) P value Aspirin - At 6 months 100%98.6%ns - At 12 months 100%98.6%ns Clopidogrel - At 6 months 89.3%98.1%< At 12 months 31.3%65.4%< Mean duration, (months) < * L= Liberte Extended clopidogrel treatments beyond 12 months were discouraged

Patient Flow - Clinical Randomized (N=425) TITAN-2 ® stent (N=214/214) TAXUS-Liberte ® stent (N=211/211) 1-Year follow-up (N=425/425; 100%) TITAN-2 ® stent (N=214/214) 24 months follow-up (N=424/425; 99.8%) TAXUS-Liberte ® stent (N=210/211) 1 = Lost to f/u Lost to f/u = 0

TITAX AMI trial MACE at 12, 18 and 24 months % p = 0.5

TITAX AMI trial MACE at 12, 18 and 24 months % p = 0.04 p = 0.5

TITAX AMI trial MACE at 12, 18 and 24 months % p = 0.04 p = 0.5 p = 0.006

TITAX AMI trial MI at 12, 18 and 24 months % p = NS p < 0.001

TITAX AMI trial Cardiac Death at 12, 18 and 24 months % p = 0.02 NS p = 0.02

TITAX AMI trial TLR at 12, 18 and 24 months % NS

TITAX AMI trial Definite Stent Thrombosis at 12, 18 and 24 months % p = p = 0.03 p = 0.001

TITAX AMI trial MI or Cardiac Death at 12, 18 and 24 months % p = p = 0.08 p < 0.001

TITAX AMI trial: Conclusions (24 months follow-up) Late follow up (12 to 24 months) after the clopidogrel discontinuation showed higher rates of: - Myocardial Infarction - Cardiac Death - MACE with the use of TAXUS-Liberte ® stent Secondly, the incidence of Stent Thrombosis (ARC definition) was significantly higher in the TAXUS- Liberte ® stent group TITAN-2 ® stent: non-inferior 24-months rate of TLR

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

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!