New Strategies for Bifurcations: Selfexpanding Technologies Christoph K. Naber Contilia Herz- und Gefäßzentrum Elisabeth Krankenhaus Essen
Bifurcation Stenting Courtesy of A. Colombo
Dedicated Bifurcation Devices
My preference: selfexpanding STENTYS Selfapposing Stent
The Axxess TM Stent Dedicated bifurcation drug-eluting stent (DES) Nitinol self-expanding stent Abluminal biodegradable PLA polymer/ Biolimus BA9 coating technology Available sizes: 3.0 and 3.5 mm in diameter * 11 and 14 mm in length * Axxess bifurcation DES is CE approved
Goal: Span Both Vessels Cover the proximal lesion segment Cover the ostium of the side branch and distal parent vessel without compromising access to the side branch This is accomplished if 2 markers are in 1 branch and 1 is in the other Provide a convenient placement marker for additional distal stents
Axxess Stent Procedure Pre Final
Axxess Clinical Program AXXESS N=43 AXXESS PLUS N=139 DIVERGE N=302 AXXENT N=33 COBRA N=40 France and Germany Pilot study using bare metal stent Axxess Platform In-segment restenosis at 6 months 6 month follow-up completed, study completed Europe, Brazil and New Zealand FIM Safety and performance evaluation of Axxess DES In-stent late loss at 6 months 5 year follow-up completed, study completed Europe, Australia and New Zealand Evaluated best practices from AXXESS PLUS MACE 1 at 9 months 4 year follow-up available, follow-up planned up to 5 years Europe Pilot study for Axxess LM DES 2 MACE 3 at 6 months 12 month follow-up available, study completed Europe Randomized multicenter trial to compare Axxess DES along with BioMatrix with Cullotte technique using Xience V Stent strut coverage assessed by OCT at 9 months Enrolling 1. MACE: Composite of death, MI and ischemia-driven TLR 2. LM stent is not CE approved and not available. 3. MACE: composite of death, MI, or TLR by surgery or percutaneous intervention
AXXESS PLUS Trial Design
Medina classification * 1,0,0 0,1,0 1,1,0 13% prebranch 3 % 4% Parent vessel only postbranch 1,1,1 0,0,1 1,0,1 60% bifurcation 1% ostial 18% Prebranch & Ostial True bifurcations in 78%
Treatment Technique AXXESS only: 19% (26) AXXESS + PV * : 28%(40) AXXESS + SB * : 13% (17) AXXESS + PV * + SB * : 40% (53) SB stent in 53% (70)
In-Stent LLL@ 6 Months Axxess BA9 Stent Axxess Bare Metal Stent 1 p N (%) 126 (93%) 37 (90%) Late Lumen Loss - Axxess Stent 0.09 ± 0.56 mm 0.46 ± 0.51 mm <0.001 Grube et al., Am J Cardiol 2007;99:1691-1697 1 Historical data on file at Biosensors International
Binary Restenosis Angiographic FU 126/136 (92.6%) Parent Vessel - Axxess cone - In-stent (all PV stents * ) - In-segment (stents * + 5 mm edges) 4.0% 5.6% 10.5% Side Branch by Treatment Received No Treatment PTCA Stent * - In-stent - - 7.9% - In-segment 12.0% 25.0% 7.9% Grube et al., Am J Cardiol 2007;99:1691-1697
Ischemia-driven TLR Number at Risk 139 131 114 107 107 106 104 104 103 101 36
Definite & Probable ST (ARC) Number at Risk 139 132 124 117 117 116 113 113 113 111 41
DIVERGE Trial Design
Lesion Inclusion Criteria Any Type Bifurcation SB > 2.25 mm Parent Vessel Up to 15 mm Side Branch 70 Up to 10 mm Stents: Proximal = 10 or 14 mm Axxess Distal PV or SB = add Cypher to fit Up to 25 mm Distal Parent Vessel Verheye S et al. J Am Coll Cardiol 2009;53:1031-9
Medina Class All Patients 64.5% 77.4% True Bifurcation * 1,1,1* 6.3% 6.6% 0,1,1* 1,0,1* 6.6% 12.0% 3.3% 0.7% 1,0,0 1,1,0 0,1,0 0,0,1 Verheye S. et al., J Am Coll Cardiol, 2009. 53(12): p. 1031-9
Stent Distribution Patterns AXXESS only: 12.3% AXXESS + PV: 17.7% AXXESS + SB: 4.0% AXXESS + PV + SB: 64.7% SB Stent: 68.7% Verheye S. et al., J Am Coll Cardiol, 2009. 53(12): p. 1031-9
9-month QCA Results At Follow Up Parent Vessel (N=140) Side Branch (N=140) Late Loss (mm) Restenosis Per Vessel Overall Bifurcation Restenosis In-stent LL (AXXESS only) 0.18 ± 0.49 - In-stent LL (all stents) 0.29 ± 0.50 0.29 ± 0.45 In-lesion LL 0.20 ± 0.41 0.17 ± 0.34 In-stent - AXXESS Only 0.7% - In-stent - Cypher 2.3% 4.8% In-lesion restenosis (all stents + edges) 3.6% 4.3% In-stent - PV + SB 5.0% (7/140) In-stent or edges, within PV + SB 6.4% (9/140) Verheye S. et al., J Am Coll Cardiol, 2009. 53(12): p. 1031-9
4-year Clinical Outcomes N=292 (96.7% FU) 20 18,5 Cumulative rates (%) 15 10 5 5,1 3,8 7,9 10,6 13,4 0 MACE* Death Cardiac Death MI id-tlr id-tvr
Stent Thrombosis up to 4 Years N=302 Protocol ARC Definite* Probable Definite* Probable Possible Acute (In-hospital) Subacute (30 days) Late (>30 days - 1 year) Very Late (1 year - 4 years) 0% 0% 0% 0% 0% 0.7% (2) 0% 0.7% (2) 0% 0% 0.3% (1) 0% 0.3% (1) 0% 0% 1.0% (3) 0.7% (2) 1.0% (3) 0.7% (2) 2.1% (6) Only one definite VLST attributed to the Axxess stent whereas all events were present in the Cypher stent
Antiplatelet Agent Utilization All patients N=302 Aspirin - At 6 months 95.0% (286/301) - At 1 year 94.3% (280/297) - At 2 years 93.2% (272/292) - At 3 years 91.5% (260/284) - At 4 years 90.5% (249/275) Clopidrogel/Thienopyridine - At 6 months 92.7% (279/301) - At 1 year 73.1% (217/297) - At 2 years 43.2% (126/292) - At 3 years 40.5% (115/284) - At 4 years 34.9% (96/275) Ormiston et al., oral presentation, EuroPCR 2012
Conclusions AXXESS Plus and DIVERGE trials High procedural success in complex bifurcation lesions Late lumen loss in the Axxess stent aligned with results from other BA9 clinical studies Relatively low restenosis rates despite high lesion complexity, especially at the SB ostium treated with DES Sustained safety in the long-term follow-up Clinical efficacy with very low increment in TLR after 12 months Allows full reconstruction of the bifurcation carina Modular treatment according to lesion complexity By design, possibility to restore flow without metal distortion (crushed, gap, under-expansion, incomplete apposition)