Eulogio Garcia MD H. U. Gregorio Marañon Madrid

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1 Eulogio Garcia MD H. U. Gregorio Marañon Madrid

2 Coronary Bifurcation Lesions Open Issues Technically demanding Time consuming Low tech success rate Too much operator dependant Off-the the-shelf standard stents don t t fit bifurcations Poor clinical outcome

3 How to treat bifurcation lesions BMS DES Restenosis Thrombosis Restenosis 1 Stent 2 Stents

4 Evaluate the patient Can take dual anti-platelet therapy? Prepare the patient clopidogrel loading Plan the strategy Evaluation of the lesion with optimal angiographic imaging If planning a 2-stent strategy, consider using 7F guiding catheter, and abciximab Wire both branches Prepare the lesion Re-evaluate the strategy

5 Angle >70 T-stenting Two DS >50% DES RVD 2.5mm Long lesion length Evaluate the angle Angle <70 Crush, mini- Crush or Culotte Kissing balloons Consider 2nd DES in SB Evaluate the SB DS >50% RVD<2.5mm One DES in MB Kissing balloons Poor result Good result One DES in MB No significant SB disease One DES in MB Poor result in SB Good result Kissing balloons may not be necessary

6 The Promise of Dedicated Stents Conformance to vessel contour without disruption of the stent or coating Preservation of the side branch Enhanced long term outcomes Safety

7 Dedicated Bifurcation Stents Complete bifurcation Y stents BARD AVE GUIDANT CORDIS MDT

8 Dedicated Bifurcation Stents Sidebranch Stents Tryton Stent Capella Sideguard

9 Dedicated Bifurcation Stents Sidebranch access MV stents ABT Frontier Y-Med Side-kick TriReme Bifurcation Stent Minvasys Nile Invatec Twin-Rail StentYs TAXUS Petal Invatec Twin- Rail

10 Guidant ML FRONTIER TM Coronary Bifurcation Stent System Main Branch (RX) Specially designed dual lumen tip Side Branch (OTW) Designed for preseving side branch access Integrated-tip tip design allows single tip delivery, avoiding wire wrap Stent deploys with simultaneous kissing balloon inflation Wire position is maintained in both branches throughout the procedure

11 MACE (intent-to-treat patient population) In-Hospital 30 ± 5 days 180 ± 10 days (n=105) (n=105) (n=105) SAT (%) Q-wave MI (%) Non Q-wave MI (%) TLR, CABG or PCI (%) TVR, CABG or PCI (%) Death (%) MACE (%) Target Vessel Failure (%)

12 HUGM RESULTS ( 52 ) Device success 52 ( 100%) Technical success 52 ( 100%) Angiographic success 52 ( 100%) Procedural success 51 ( 98%) TLR 2 ( 4 %)

13 TAXUS Petal Polymer tribloque TransluteTM Drug : Paclitaxel Coberture of ostium and 2 mm of the side branch Cortesy of J. Ormiston y T. Lefèvre

14 TAXUS Petal Side branch catheter Petal Catheter main vessel Stent main vessel

15 TAXUS Petal : Aligment Right Wrong

16 TAXUS Petal 1 o 2 stents

17 AXXESS Stent Designed to preserver SB access Allows provisional treatment of branch vessels Elutes Bioliums A9 from bloabsorbable coating First self expanding DES

18 AXXESS Clinical Experience Now over 500 Patients Centers Patients AXXESS Pilot 3 41 AXXESS PLUS DIVERGE 17 >290* AXXENT-LEFT MAIN 4 33 *Currently enrolling-target 300 patients

19 Summary: Axxess BA9 Program The AXXESS stent provides positive, safe, and sustainable clinical outcomes in bifurcation lesions out 12 months. Stent thrombosis was 2.2%, all events occurring within 6 months. No very late events have been observed after 2 month follow up, despite frequent use of 2 or more stents. LMCA stenting is safe in selected patients. The AXXESS LM stent increases lumen size at 6 months. LCX remains a challenge.

20 Conclusion Contemporary therapy of bifurcation lesions utilises DES There is no single strategy for all bifurcations. Bifurcation dedicated stents are interesting but so far the expectations have overcome the results. To be really effective they should be : Easy to use ( deliverability and profile similar to regular stents ts ) Dependable Good inmediate and longterm results At the present time, there are several interesting promises (Capella, Tryton, Petal, Axxess ) and clinical results will determine their role in the era of DES.

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