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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.

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Presentation on theme: "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."— Presentation transcript:

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 A prospective, randomized, multicenter TITAX AMI trial

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) Stent geometryHELICOIDAL DESIGN Material316L+TITANOX COATING Strut thickness70-90 MICRONS Crimped profile< 1mm

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 3 Years Follow up of the PORI Stent Registries PURPOSE OF THE STUDY

9 Baseline Clinical Characteristics TITANOX(201)PES(204)BMS (184 ) Age (years) 67 ± 10 64 ± 10* 68 ± 10 Men, n (%) 143 (71) 147 (72) 120 (65) Diabetes, n (%) 34 (17) 37 (18) 45 (24) Current smoking, n (%) 58 (29) 53 (26) 44 (24) Hypercholesterolemia, n (%) 181 (90)* 167 (82) 147 (80) Hypertension, n (%) 133 (66)* 110 (54) 107 (58) Medical Treatment, n (%) Acetylsalicylic acid Acetylsalicylic acid 189 (94) 190 (93) 175 (95) ß-Blockers ß-Blockers 152 (76) 160 (78) 147 (80) ACE inhibitor ACE inhibitor 33 (16) 36 (18) 37 (20) Lipid-lowering agents Lipid-lowering agents 177 (88) 164 (80) 155 (84) * p < 0.05

10 Baseline Clinical Characteristics TITANOX(201)PES(204)BMS (184 ) Previous myocardial infarction, n (%) 89 (44)* 65 (32) 58 (32) Previous PCI, n (%) 29 (14) 49 (24)* 13 (7) Previous CABG, n (%) 25 (12) 20 (10) 20 (11) Multivessel disease, n (%) 133 (66) 137 (67) 120 (65) Acute STEMI, n (%) 62 (31)* 41 (20) 39 (21) Primary angioplasty, n (%) Primary angioplasty, n (%) 22 (11)* 10 (5) 9 (5) Rescue angioplasty, n (%) Rescue angioplasty, n (%) 40 (20) 31 (15) 29 (16) Acute NSTEMI, n (%) 52 (26) 49 (24) 71 (39)* Unstable angina, n (%) 20 (10) 15 (8) * p < 0.05

11 Procedural and Lesion Characteristics TITANOX (218 lesions/ 221 stents ) PES (244 lesions/ 247 stents) BMS (202 lesions/ 218 stents) Target Vessel, n (%) LAD LAD 100 (46) 124 (51) 68 (34) LCX LCX 48 (22) 37 (15) 57 (28) RCA RCA 54 (25) 68 (28) 57 (28) Left Main Left Main 7 (3) 8 (4) Bypass graft (venous) Bypass graft (venous) 9 (4) 8 (3) 12 (6) Lesion Type, n (%) A 26 (12) 54 (22) 49 (24) B1 / B2 B1 / B2 137 (63) 171 (70) 145 (72) C 55 (25)* 19 (8) 8 (4) Thrombus present, n (%) 35 (16) 34 (14) 24 (12) * TITANOX vs. PES / BMS, p < 0.05

12 Procedural and Lesion Characteristics TITANOX (218 lesions/ 221 stents) PES (244 lesions/ 247 stents) BMS (202 lesions/ 218 stents) RVD, (mm) 2.95 ± 0.34 2.97 ± 0.35 3.00 ± 0.48 Lesion length, (mm) 13.1 ± 3.4 13.5 ± 4.2 13.4 ± 4.5 Stent diameter 2.98 ± 0.34 2.97 ± 0.34 3.04 ± 0.5 Stent length used 15.6 ± 3.5 21.2 ± 6.7 * 16.4 ± 5.2 Direct stenting, n (%) 48 (22) 46 (19) 46 (23) Gp IIb/IIIa inhib. n (%) 54 (27) 49 (24) 37 (20) Clopidogrel, (months) 7.7 ± 3.3 8.2 ± 3.0 8.3 ± 3.6 * PES vs. TITANOX / BMS, p < 0.05

13 30 Days MACE Composition % p = 0.02 p = 0.04 p = 0.02 p = 0.004

14 12 Months MACE Composition % Control Angiography TITANOX20% TITANOX20% PES19% PES19% BMS22% BMS22% p = 0.03

15 Late Follow up: End points > 12 months TITANOX(201)PES(204)BMS(184) P value FU, months ± SD, (median) 40 ± 5 (39) 43 ± 5 (43) 42 ± 5 (41) 0.001 Death, n (%) 6 (3.0) 5 (2.5) 8 (4.3) 0.6 Death from cardiac causes, n (%) 1 (0.5) 2 (1.0) 5 (2.7) 0.2 Myocardial infarction, n (%) 6 (3.0) 19 (9.3) 10 (5.4) 0.03 TVR, n (%) 1 (0.5) 9 (3.9) 11 (6.0) 0.01 TLR, n (%) TLR, n (%) 1 (0.5) 9 (4.4) 9 (4.9) 0.03 TVR (non-TLR), n (%) TVR (non-TLR), n (%) 0 (0) 2 (1.1) 0.1 MACE, n (%) 7 (3.5) 21 (10.3) 25 (13.6) 0.002 Stent thrombosis, n (%) 0 (0) 8 (3.9) 2 (1.1) 0.007

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 TITANOX(201)PES(204)BMS(184) P value FU, months ± SD, (median) 40 ± 5 (39) 43 ± 5 (43) 42 ± 5 (41) 0.001 Death, n (%) 11 (5,5) 13 (6.4) 16 (8.7) 0.4 Death from cardiac causes, n (%) 2 (1.0) 7 (3.4) 11 (6.0) 0.06 Myocardial infarction, n (%) 15 (7.5) 40 (19.6) 27 (14.7) 0.002 TVR, n (%) 17 (8.5) 23 (11.3) 27 (14.7) 0.2 TLR, n (%) TLR, n (%) 11 (5.5) 19 (9.3) 22 (12.0) 0.08 TVR (non-TLR), n (%) TVR (non-TLR), n (%) 6 (3.0) 4 (2.0) 5 (2.7) NS MACE, n (%) 29 (14.4) 49 (24.0) 58 (31.5) <0.001 Stent thrombosis, n (%) 0 (0) 15 (7.4) 5 (2.7) <0.001

19 The 519 patients (TITANOX 184, PES 183, BMS 152) The 519 patients (TITANOX 184, PES 183, BMS 152) who were MACE free at the time of the discontinuation who were MACE free at the time of the discontinuation of clopidogrel treatment were followed for an of clopidogrel treatment were followed for an additional 12 months after discontinuation. additional 12 months after discontinuation. The goal was to evaluate late thrombotic events The goal was to evaluate late thrombotic events related to clopidogrel discontinuation. 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 BMSLower 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 %) 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 BMSPES  higher rates of MI and Stent Thrombosis after the discontinuation of clopidogrel compared with TITANOX coated stent or BMS

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