Techniques, Outcome and New Devices CRT 2012 Washington, February 8, 2012 Bifurcation Lesions: Techniques, Outcome and New Devices Eberhard Grube MD, FACC, FSCAI University Bonn, School of Medicine, Bonn, Germany Hospital Alemão Oswaldo Cruz - Dante Pazzanese, São Paulo, Brazil Stanford University, Palo Alto, California, USA

Disclosure Statement of Financial Interest Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Company/Relationship Eberhard Grube, MD Medtronic, CoreValve: C, SB, AB, OF Sadra Medical: E, C, SB, AB Direct Flow: C, SB, AB Mitralign: AB, SB, E Symetis: AB Boston Scientific: C, SB, AB Biosensors: E, SB, C, AB Cordis: AB Abbott Vascular: AB Capella: SB, C, AB InSeal Medical: AB Valtec: E, SB Claret, SB Key G – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘ 2 2

Types of Involvement of Coronary Bifurcations by Atherosclerosis Atherosclerosis occur predominantly close to bifurcation Carinal involvement by atherosclerosis is extremely unusual. Renu Virmani

Bifurcation Stenting: Not all Bifurcations are created equal! LM Stenting Peripheral Bifurcations 4 4

Bifurcation stenting: Questions to be answered Two stents or one? Types of bifurcations Should I have kissing stents? What is plaque shifting? What Technique.. IVUS/OCT…? 5

Need for treating Bifurcations. Bifurcations are a high risk region for the formation of atherosclerotic plaque. >20% of all PCI involve treatment of Bifurcations: cannot be avoided!! Procedural and clinical success rates are inferior to non-complex treatments. Drugs have helped greatly but still not solved the underlying problem. Restenosis Simple Strategy Complex Strategy MB 2% -7.3% 3.1% - 10% SB 4% -15% 9% - 21% Combined 6% - 21.3% 15.4% - 27% MACE Simple Strategy Complex Strategy At 6mths 9.6% 12.6% Meta Analysis: Hakeem et al 2009 (BBC,Nordic,Cactus,Colombo,Pan,Ferenc)

Evolution in the efficacy of Bifurcation treatments. Note: Review of significant peer review articles from 2000 to 2008, (BBC,Nordic,Cactus,Colombo,Pan,Ference bad Krosigen, Gallassi etc

Bifurcation Stent Techniques More Complex Technique Culotte Crush Kissing Less Ostial Coverage More Ostial Coverage T-Stent Provisional Less Complex Technique

Issues with 2 Stent Techniques Images from in vivo provisional stent studies at 180 days: PTCA in SB distortion, fracture dissection at SB ostium PV Cypher 3x23 + SB PTCA PV Cypher 3x23 + SB Stent Excessive overlap, obstructed lumen Ostial gaps, persistent flow restriction, restenosis 9

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1 vs. 2 vs. Dedicated Bifurcation Stent Approach…

1 Stent ? 2 Stents ? 12

Ideal Bifurcation Stent Design Requirements Coverage of Full Bifurcation Effective at all angles. Simple to deliver. Nitinol is an important characteristic for the stent, but there are other factors which are necessary to create an optimal design for the sidebranch stent. Correct radial force is needed to trigger remodeling. The cell design provides appropriate scaffolding & permits crossing the stent with the main vessel stent. The design will also have an impact on the anchoring in the vessel & assure appropriate fixation. The delivery system needs to adapt to tortuous & calcified lesions & therefore should provide ease in delivering the stent to the lesion site. It is also important to see the device for optimal placement. The shape memory is important for the variability of the sidebranch ostium as well as the scaffolding. All of these points help to create the optimal design for a sidebranch stent. Optimal Design < 5% TLR @12mths Simple selection criteria. 13

Design Approach Fundamentally there exist two design philosophies: Modified Provisional: Objective: Provide sidebranch access without main branch compromise. e.g. BSC petal, Abbott Frontier, Trireme Antares, Stentys. Dedicated devices: Objective: Provide treatment of the bifurcation segment using an anatomically considered design. e.g. Cappella Sideguard, Tryton, Devax Axxess.

1. Modified Provisional: Pros: Simplest design concept. Cost effective, single stent for majority. Conceptually easy to use. Cons: Deliverability. Guidewire twist, guidewire bias, delivery-system rotation.

AntaresTM Family Treating Main Vessel with Side Branch Access AntaresTM II Continuous SB Access, Single balloon MV stent engineered for ostial scaffolding Continuous SB access and no wire crossing by design Can be considered for all anatomies and lesion types at or near bifurcations AntaresTM Lite Single wire, Single balloon Ultra-low profile, single wire system (No SB wire required) Stent crossing profile smaller than most regular stents (0.037”)

Disconnectors along the stent STENTYS® Technology Nitinol, self-apposing stent (BMS and DES) 6F single-wire, rapid exchange, CE-marking Disconnectable struts over full length* Disconnectable interconnector Disconnection Disconnectors along the stent 17 * Except the first and last 2mm 17

Deploying a STENTYS® Self-Apposing Stent in an AMI patient 1. Position the STENTYS® stent over the lesion 2. Retract the outer sheath to deploy the stent from distal to proximal 3. The stent is fully deployed in the vessel of the AMI patient with perfect apposition 4. The STENTYS® stent expands with the vessel during vasodilation and as thrombus resolves ensuring perfect apposition.

Opening the STENTYS® Self-Apposing Stent at a Bifurcation 1. Position the guidewire into the side branch at the most distal point close to the carina. 2. Inflate a regular PTCA balloon at 8 atm at the side branch opening to disconnect the struts. 3. Deflate and withdraw the balloon allowing the stent to expand fully to create the opening to the side branch. 4. The STENTYS® stent expands with the vessel during vasodilation and as thrombus resolves ensuring perfect apposition.

APPOSITION II DESIGN: International, prospective, randomized, two-arm multi-center trial OBJECTIVE: To compare the STENTYS® Stent with balloon-expandable stents in AMI ENDPOINTS: Stent strut apposition and expansion at 3 days (measured by OCT) MACE @30 days and 6 months Independent monitoring: Genae Core Lab: Cardialysis 80 STEMI patients enrolled between 12/09 and 06/10 in 9 European sites STENTYS® stent Clinical follow-up at 30 days and 6 months Invasive follow-up at 3 days (QCA, OCT) VISION / Driver Balloon Expandable Stent - Day 3 Stentys Stent - Day 3 p<0.001 Results (patients with severe malapposition )

2. Dedicated Devices: Pros: Effective treatment of entire bifurcation anatomy. Minimal main branch impact. Cons: Cost (price and time) since 2 stents required. More complex design than modified provisional.

Current Stent Design Options (Provisional). While simple in concept they fail to deal with the complexity of the anatomy.

Current Stent Design Options (Dedicated)

Current Stent Design Inputs Their simplicity lies in their ability to treat the complexity of the anatomy in a repeatable and effective way.

Cappella Sidebranch Stent (ostial protection device) Sideguard address the complexities associated with ostial and bifurcated lesions Precise BE Delivery System Bare Metal Sidebranch Stent Peel-away Split Sheath, Balloon Expandable Delivery Self-Expanding (SE) Stent Sideguard is a self-expanding, anatomically-shaped stent Target is a balloon-release delivery system for SE stents 25 25

Tryton Side Branch Stent Side Branch Region Standard Design Transition Zone Coverage Hoop Strength Main Vessel Main Vessel Region 3 Fronds - Minimal Coverage Wedding Band Cobalt Chromium Strut Thickness: 0.003” Diameter: 2.5 mm 26

Dedicated bifurcation stents Cappella sideguard 6 month FU At the moment for true bifurcation with short lesions on the side branch when the operator feel unconfident to recross an unprotected side branch Tryton

AXXESS PLUS LM System Flared Distal-End Stent Design Self Expanding Nitinol Material 6, 8, 10, or 12 mm flare diameter Biolimus A9 antiproliferative strut coating 4.8F Rx Delivery System

Complete Ostial Coverage Stent flares to cover ostia of Both branching vessels Carina area is covered By stent struts

Example of Stent Conformity Stent Boost Imaging shows SB ostial coverage 30

Example of Stent Conformity Stent Boost Imaging shows SB ostial coverage Final Angiogram PV: Axxess + Cypher SB: PTCA 31

Angiographic Outcome (DIVERGE) Any in-bifurcation restenosis: 6.4% (9/140 at 9 months) Proximal edge: 2.8% SB stent: 4.8% (105 SB stents) Distal PV Cypher: 2.1% AXXESS: 0.7% Location Analysis: Parent Vessel RS 2 pts Side Branch RS 3 pts Both 4 pts Lowest restenosis rates ever reported in a bifurcation study of any kind 32

Summary of Ideal Stent Design. Must not impact on main vessel treatment. Must scaffold ostium entirely and effectively. Easy and quick to deliver. Allows further treatment of SB if required Reduces the need for further interventions. Will treat wide variety of Bifurcations lesions.

Conclusions 1 Stenting coronary bifurcations requires more than deciding to implant 1 or 2 stents The most important decisions should be taken by examining: the clinical setting (age of the patient, general conditions, extent of ischemia), the extent of the disease of both branches, their size, the territory of distribution and how confident is the operator with a specific approach

Conclusions 2 Dedicated bifurcation stents address ideally the specific needs of bifurcation lesions Due to the variable anatomy of bifurcation lesions, variable stent designs or deployment techniques are most likely needed Dedicated bifurcation DES are needed to combine the benefits of both technologies

Thank you

Tryton Side Branch Stent: Complex Bifurcation Lesions Wide Angle Narrow Angle Prox LAD Baseline Final 37