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Pori 36 Months Francophone

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  • 1. Clinical Experience with the Bio Active Stent (BAS) in FINLAND 9 e CFCI Hotel Meridien Etoile Paris, France 10 Octobre 2007 Pasi Karjalainen, MD, PhD
  • 2. Presenter Disclosure Information
    • P Karjalainen, MD, PhD
    • No relationships exist related to this presentation
  • 3. Subject Groups of the Presentation
    • PORI stent registries,
    • 3-years follow-up
  • 4. Background Better outcome with the PCI, but in-stent restenosis (ISR) compromises the long-term results PCI is the most frequently used method for revascularization As a consequence, the prevention and treatment of ISR have become priorities in interventional cardiology !
  • 5. Background The use of DES is the most effective way to reduce ISR according to randomized trials in selected patient groups However, there is no evidence that BMS or DES could influence mortality or prevent MI Recently, growing concern has been expressed about the safety of DES most notably with respect to late Stent Thrombosis As a result, some cardiologists have tended to revert to more predictable devices e.g., BMS or stents that are coated with active compounds , such as titanium-nitride-oxide
  • 6. Bio Active Stent (BAS) TITAN ® - stent by Hexacath (France) TITANOX Coating (Titanium-Nitride-Oxide) Nitrogen, Oxygen and Titanium atoms are bounded with electronic and atomic links. (L.Pauling classification) < 1mm Crimped profile 70-90 MICRONS Strut thickness 316L+TITANOX COATING Material HELICOIDAL DESIGN Stent geometry
  • 7. Bio Active Stent in Finland Helistent ® Hexacath, Fra  2002 Titan ® Stent in Finland August 2002 First Treated Patient in PORI May 2003 PORI stent registry May 2003 – Nov 2004 TITAX AMI Nov 2005- Nov 2006 Pori Stent Registry Eurointerv. 2006 J Invasive Cardiol. 2006 TCT2005, TCT2006 TITAX AMI trial EuroPCR2007 Late Breaking Trials TCT2007 Karjalainen P, et al. J Invasive Cardiol 2006;18:462-468
  • 8.
    • Compare clinical outcome of a stainless steel
    • Stent coated with titanium nitride oxide
    • ( TITANOX ), paclitaxel eluting stent ( PES ) and
    • bare metal stent ( BMS ) in routine clinical practice
    Between May 2003 and November 2004, all consecutive patients scheduled for stent implantation were considered for these registries 3 Years Follow up of the PORI Stent Registries PURPOSE OF THE STUDY
  • 9. Baseline Clinical Characteristics * p < 0.05 155 (84) 164 (80) 177 (88) Lipid-lowering agents 37 (20) 36 (18) 33 (16) ACE inhibitor 147 (80) 160 (78) 152 (76) ß-Blockers 175 (95) 190 (93) 189 (94) Acetylsalicylic acid       Medical Treatment, n (%) 107 (58) 110 (54) 133 (66)* Hypertension, n (%) 147 (80) 167 (82) 181 (90)* Hypercholesterolemia, n (%) 44 (24) 53 (26) 58 (29) Current smoking, n (%) 45 (24) 37 (18) 34 (17) Diabetes, n (%) 120 (65) 147 (72) 143 (71) Men, n (%) 68 ± 10 64 ± 10* 67 ± 10 Age (years) BMS (184 ) PES (204) TITANOX (201)
  • 10. Baseline Clinical Characteristics * p < 0.05 15 (8) 20 (10) 20 (10) Unstable angina, n (%) 71 (39)* 49 (24) 52 (26) Acute NSTEMI, n (%) 29 (16) 31 (15) 40 (20) Rescue angioplasty, n (%) 9 (5) 10 (5) 22 (11)* Primary angioplasty, n (%) 39 (21) 41 (20) 62 (31)* Acute STEMI, n (%) 120 (65) 137 (67) 133 (66) Multivessel disease, n (%) 20 (11) 20 (10) 25 (12) Previous CABG, n (%) 13 (7) 49 (24)* 29 (14) Previous PCI, n (%) 58 (32) 65 (32) 89 (44)* Previous myocardial infarction, n (%) BMS (184 ) PES (204) TITANOX (201)
  • 11. Procedural and Lesion Characteristics * TITANOX vs. PES / BMS, p < 0.05 24 (12) 34 (14) 35 (16) Thrombus present, n (%) 8 (4) 19 (8) 55 (25)* C 145 (72) 171 (70) 137 (63) B1 / B2 49 (24) 54 (22) 26 (12) A       Lesion Type, n (%) 12 (6) 8 (3) 9 (4) Bypass graft (venous) 8 (4) 7 (3) 7 (3) Left Main 57 (28) 68 (28) 54 (25) RCA 57 (28) 37 (15) 48 (22) LCX 68 (34) 124 (51) 100 (46) LAD   Target Vessel, n (%) BMS (202 lesions/ 218 stents) PES (244 lesions/ 247 stents) TITANOX (218 lesions/ 221 stents )
  • 12. Procedural and Lesion Characteristics * PES vs. TITANOX / BMS, p < 0.05 8.3 ± 3.6 8.2 ± 3.0 7.7 ± 3.3 Clopidogrel, (months) 37 (20) 49 (24) 54 (27) Gp IIb/IIIa inhib. n (%) 46 (23) 46 (19) 48 (22) Direct stenting, n (%) 16.4 ± 5.2 21.2 ± 6.7 * 15.6 ± 3.5 Stent length used 3.04 ± 0.5 2.97 ± 0.34 2.98 ± 0.34 Stent diameter 13.4 ± 4.5 13.5 ± 4.2 13.1 ± 3.4 Lesion length, (mm) 3.00 ± 0.48 2.97 ± 0.35 2.95 ± 0.34 RVD, (mm) BMS (202 lesions/ 218 stents) PES (244 lesions/ 247 stents) TITANOX (218 lesions/ 221 stents)
  • 13. 30 Days MACE Composition % p = 0.02 p = 0.04 p = 0.02 p = 0.004
  • 14. 12 Months MACE Composition % Control Angiography TITANOX 20% PES 19% BMS 22% p = 0.03
  • 15. Late Follow up: End points > 12 months 0.001 42 ± 5 (41) 43 ± 5 (43) 40 ± 5 (39) FU, months ± SD, (median) 0.002 25 (13.6) 21 (10.3) 7 (3.5) MACE, n (%) 0.007 2 (1.1) 8 (3.9) 0 (0) Stent thrombosis, n (%) 0.1 2 (1.1) 0 (0) 0 (0) TVR (non-TLR), n (%) 0.03 9 (4.9) 9 (4.4) 1 (0.5) TLR, n (%) 0.01 11 (6.0) 9 (3.9) 1 (0.5) TVR, n (%) 0.03 10 (5.4) 19 (9.3) 6 (3.0) Myocardial infarction, n (%) 0.2 5 (2.7) 2 (1.0) 1 (0.5) Death from cardiac causes, n (%) 0.6 8 (4.3) 5 (2.5) 6 (3.0) Death, n (%) P value BMS (184) PES (204) TITANOX (201)
  • 16. 36 Months MACE Composition % p < 0.001 p = 0.003 [ 0.002 ] [ <0.001 ]
  • 17. 36 Months MACE Composition % p < 0.001 [ <0.001 ]
  • 18. Cumulative Rate of Events October 2007: FU 36 – 52 months 0.001 42 ± 5 (41) 43 ± 5 (43) 40 ± 5 (39) FU, months ± SD, (median) <0.001 58 (31.5) 49 (24.0) 29 (14.4) MACE, n (%) <0.001 5 (2.7) 15 (7.4) 0 (0) Stent thrombosis, n (%) NS 5 (2.7) 4 (2.0) 6 (3.0) TVR (non-TLR), n (%) 0.08 22 (12.0) 19 (9.3) 11 (5.5) TLR, n (%) 0.2 27 (14.7) 23 (11.3) 17 (8.5) TVR, n (%) 0.002 27 (14.7) 40 (19.6) 15 (7.5) Myocardial infarction, n (%) 0.06 11 (6.0) 7 (3.4) 2 (1.0) Death from cardiac causes, n (%) 0.4 16 (8.7) 13 (6.4) 11 (5,5) Death, n (%) P value BMS (184) PES (204) TITANOX (201)
  • 19.
    • • The 519 patients ( TITANOX 184 , PES 183 , BMS 152 )
    • who were MACE free at the time of the discontinuation
    • of clopidogrel treatment were followed for an
    • additional 12 months after discontinuation.
    • • The goal was to evaluate late thrombotic events
    • related to clopidogrel discontinuation.
    Late Follow up in the Year Following Clopidogrel Discontinuation
  • 20. All Death / Cardiac death % All Death, p = 0.75 Cardiac Death, p = 0.18 Late Follow up in the Year Following Clopidogrel Discontinuation
  • 21. All Death / Cardiac death % Myocardial Infarction (MI), p = 0.004 Target Lesion Revascularization (TLR), p = 0.10 Late Follow up in the Year Following Clopidogrel Discontinuation p = 0.004
  • 22. All Death / Cardiac death % Stent Thrombosis, p = 0.007 MACE, p = 0.10 Late Follow up in the Year Following Clopidogrel Discontinuation p = 0.007
  • 23. PORI Stent Registries Conclusions
    • • Lower rates of recurrent MI and MACE with the use of TITANOX coated stent compared with PES or BMS
    • • Secondly, very low TLR rate with the use of TITANOX coated stent (5.5 %)
    • • PES  higher rates of MI and Stent Thrombosis after the discontinuation of clopidogrel compared with TITANOX coated stent or BMS