Dedicated Bifurcation Stent Technology: Implications for Everyday Practice Jens Flensted Lassen MD, PH.D., FESC The Heart Centre, Rigshospitalet University of Copenhagen Denmark

Disclosure Statement of Financial Interest I, (Jens Flensted Lassen) DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Disclosure Statement of Financial Interest ……. BUT !!! I, (Jens Flensted Lassen) am a Board member and one of the Directors of the European Bifurcation Club (EBC) and my view on bifurcation stenting is heavily influenced by the thoughts and consensus statements of EBC.

Treating coronary bifurcations Why is it difficult? True versus non-true bifurcations Small and Large SB Diameter difference between MB and SB MB tapering Angels between MB and SB 4-D movements Extension of disease in SB

EuroIntervention 2014;10: Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings

© 2015 EuroIntervention. All rights reserved. EuroIntervention 2015;11:V106-V110 Differences between the left main and other bifurcations

4-D movements

EuroIntervention 2014;10: Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings

Treating Bifurcation Lesions Why is it difficult? Anatomic Variation – Side Branch : Main Branch Diameter – Angle of Bifurcation Disease Burden: Wide Variation Difficult to Assess

Workhorse DES: Optimized for Straight Lesions Poorly Suited to of Bifurcation Lesions Wide Variety of Techniques Required Poorly Characterized/Inconsistently Performed: crush, culotte, reverse culotte, internal crush, reverse crush, T, provisional T, Y, extended Y, V, SKS, shotgun, Helqvist, sleeve, modified crush, Buchbinder, minicrush, mini crush, short back and sides, DK crush, flower

Predilate – side branch and/or main branch Safety wire P.O.T. Kiss/No Kiss Post Dilate – Non vs Semi Compliant – Sizing Many Techniques: Many Questions ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

EuroIntervention 2015;11:V96-V98

Patient level meta analysis of BBC1 & NORDIC 1 Circ Cardiovasc interv. 2011;4:57-64

EuroIntervention 2014;10: Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings

"Life can only be understood backwards; but it must be lived forwards.“ Søren Kirkegaard ( Danish philosopher) The dilemma in the provisional side branch stenting in Bifurcation lesions

EBC Consensus: Side branch diameter and length can both be used visually as surrogates for volume of muscle at risk. Large side branches with ostial disease extending >5mm from the carina are likely to require two stents. Side branches whose access is particularly challenging should be secured by stenting once accessed.

Bifurcation Lesions: Defining The Need Coverage Radial Strength Addresses All – Angulation – SB-MB Diameter Differences – Disease Burden Ease-of-Use Tracking (Single Wire) Equipment (Operator’s Choice) – Guide Catheters (5 or 6 Fr) – Guidewires Compatibility: Workhorse stent (DES or BMS ) USER ISSUES CLINICAL REQUIREMENTS

Dedicated Bifurcation Stents: Difficult Design Problem: Many Failures

Historical Dedicated Devices Failed Clinically Not ‘easy to use’ Larger profile than workhorse stents Rotational orientation required Two wire tracking Poor Clinical Outcomes Lower Procedural Success than standard stenting Higher Event Rates than standard stenting

The Ideal Dedicated Device Easy to use and safe Simplify the procedure - Shorten procedural time, reduce X-ray exposure - reduce contrast media Allow continuously SB access (wire) Predictable successful ostial SB-stenting High rate of procedural success Optimal long terms results (restenosis & ST-rates, low) Abel to treat all kinds of bifurcations. Abel to be flexible during cardiac cycles

Tryton Tryton Pivotal Trials (RCT and Confirmatory): Landmark studies Improvement in clinical outcomes in large branches. Long-term results required. Simplified 2-stent technique New guidelines include incorporation of dedicated stents (Tryton).

Complex (1.1.1) Bifurcation Lesion Involving a Large Side Branch (LAD-D1) Baseline Tryton

- Dedicated devices should focus on: 1)Easy, safe and quick, treatment of the Left Main 2)Protection of a side branch the operator don´t want to loose ESC & EBC 2014 (15) Consensus

Conclusion – the way forward Evaluate dedicated devices in “significant” SB Dedicated devices already challenge 2-stent techniques – Ease of use (simplified technique) – Designed, tested, and approved for bifurcation Indications for dedicated devices – Large Side branches – Complex Disease – Left Main Dedicated devices may challenge provisional stenting - Ease of use (simplified technique)

Thank you for your attention "Life can only be understood backwards; but it must be lived forwards.“ Søren Kirkegaard ( Danish philosopher)