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Mosseri Titan Presentation For Tct 2005
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Mosseri Titan Presentation For Tct 2005 Mosseri Titan Presentation For Tct 2005 Presentation Transcript

  • Morris Mosseri, MD Director of Interventional Cardiology Hadassah-Hebrew University Medical Center The Israeli Working Group of Interventional Cardiology The Titan Stent in Real Life Results from a Multi-Center Registry
  • Stainless steel and Cobalt-Chromium stents contain considerable amounts of Nickel , Chromium and Molybdenum : Nickel Chromium Molybdenum 316L SS 12-15% 17-19% 2-3% Co-CR Vision 9-11% 19-21% ___ Co-Cr Driver 33-37% 19-21% 9-10% Background
  • Allergy 5-15 % of the population are allergic to Nickel. Nickel allergy Background
    • All patients with positive allergic patch-test reactions had a restenosis at 6 months post stenting.
    Koster R et al Lancet 2000:356; 1895-7. Nickel and Molybdenum contact allergies in patients with coronary in-stent restenosis. P=0.03 131 42 89 121 42 79 Negative patch test 10 0 10 Positive patch test Restenosis (-) Restenosis (+)
  • The Inflammatory Equilibrium Inflammatory factors Systemic (vulnerable patient) Local (vulnerable plaque) Procedural (trauma) Stent (“foreign” material) Anti-inflammatory therapy DES Systemic therapy
  • TiNOX The Titan stent (Hexacath, France) is a balloon expandable stent made of stainless steel and coated with Titanium-Nitride-Oxide (TiNOX) which completely prevents discharge of nickel, chromium and molybdenum . Background
  • Purpose
    • To assess the short and long term characteristics of the Titan stent in a multi-center registry.
  • The Titan Israeli Registry (296 patients) List of centers and investigators: Hadassah - Mosseri M. Ichilov - Miller H. Barzilai - Jefferey J. Hillel-Jaffe - Friemerman A. Naharia - Brizines M, Poriah - Hasin Y. Shiba - Guetta V Wolfson - Tamari I. Ziv - Plich M, ISRAEL
  • Methods
    • Inclusion criteria
    • This real life registry included all patients candidate for stent implantation. Choosing of Titan stent was at the operator discretion.
    • Exclusion criterion
    • Cardiogenic shock
  • Methods
    • Lesions : De novo and restenotic lesions of native coronary arteries and SVG’s.
    • 30 day and 6 months follow-up was performed by an independent research nurse.
    Methods
    • Outcome data included immediate technical and clinical success and complications, and MACE (sub-acute thrombosis, MI, TLR and death) at 30 days and 6 months.
    Methods
  • Demographics
    • Patients - 296
    • Age 68.8±11.8
    • (33-87)
    • Lesions - 333
    Results %
  • Risk factors %
  • Cardiac history prior to PCI %
  • Indications for PCI %
  • Distribution of patients per number of narrowed coronary arteries
  • Blood vessels treated
  • Lesion location
  • Lesion type
  • Lesion characteristics Length <15 mm Length 15-20 mm Length >20 mm
  • Indications for stenting % Acute MI Prevention of restenosis >30% Residual stenosis In-stent restenosis Dissection
  • Stent diameter (mm)
  • Stent Length (mm) Number of stents
  • Delivery Data % %
  • Delivery data 0 0 No Flow 0 0 Distal dissection 0 0 Proximal dissection 0.6 2/296 Balloon rupture 0.3 1/296 Unsuccessful delivery % No Type
  • Early Complications 0 0 Death 0 0 CABG 0 0 Side branch acute occlusion 0.6 2/296 Sub-acute stent thrombosis 0 0 Acute occlusion / Q wave MI % No Type
  • Adverse Events at 12 months Another 39 patients who underwent coronary angiography during follow up had patent Titan stent. 10.9% (32)   Total pts with TVF 10.9% (32)   Total pts with MACE 12.1% (36)   TVF - Target Vessel Failure (Cardiac death, MI, TVR) 12.5% (37)   MACE (Death, MI, TLR) 0.3% (1)   NQWMI 0.3% (1)   QWMI 9.6% (28) / 1% (3)   PCI / CABG 10.6% (31)   TVR 9.6% (28) / 0.6% (2)   PCI / CABG 10.1% (30)   TLR 1.7% (5) 1% (3) 0.7% (2)   Death Cardiac Non-cardiac 12 months - % (no)   Type
  • MACE at 30 days and 6 months follow up * Another 24 patients who underwent coronary angiography during follow up had patent Titan stent. 6.3 (19) 1.0 (3) Total Patients with MACE 7.0 (21) 1.2 (5) Total MACE       0.3 (1) 0.3 (1) NQWMI 0.3 (1) 0.3 (1) QWMI 0.6 (2) 0 CABG 5.1 (15) 0.6 (2) PCI 5.7 (17) 0.6 (2) TVR (=TLR)* 0.7 (2) 0.3 (1) Death 6 months - % (no) 30 days - % (no) Type
  • MACE at 30 days and 6 months follow up See notes page for report on the 2 patients who died
  • Functional class at 6 months 1 Class IV 1 Class III 15 Class II 83 Class I 6 months (%) Type
  • Results of 17 stent registries in Israel 6 months follow-up %
  • Discussion
    • TLR rate in randomized trials tends to be higher than registries because patients may undergo follow-up angiographic driven revascularization. Therefore, comparison of studies of the same kind (registries, randomized studies) is preferable.
  • Discussion
    • Restenosis reaches plateau at different terms: 6 months after BMS, 9-12 months after DES implantation.
    • Therefore, it is more appropriate to compare restenosis rate, MACE and TLR of various stents at their plateau of restenosis rather than after fixed period of time.
  • Discussion
    • Since death is an ultimate and irreversible complication, its clinical importance exceeds that of other MACE such as TLR and hospital admissions.
  • Discussion
    • In the Israeli registries Cypher’s MACE and TLR rates were slightly lower than Titan’s whereas death rate was somewhat higher, possibly due to sub-acute and late thrombosis
    • The Titan stent has
    • a remarkable safety profile
    • and can be used in complex coronary lesions
    Conclusions
    • After adjusting for the significance of different MACE, current studies suggest that Titan is clinically comparable to DES
    Conclusions
  • Thank you !