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Tryton Breakfast Symposium Session Introduction: The Challenge of Treating Bifurcation Lesions David G. Rizik, M.D., F.A.C.C., F.S.C.A.I. Chief Scientific Officer Director of Structural & Coronary Interventions HonorHealth and the Scottsdale - Lincoln HealthNetwork HonorHealth / Scottsdale - Lincoln Health Network
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D.Rizik, tryton breakfast symposium introduction_the challenge of treating bifurcation lesions

Apr 14, 2017

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Page 1: D.Rizik, tryton breakfast symposium introduction_the challenge of treating bifurcation lesions

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k Tryton Breakfast SymposiumSession Introduction:

The Challenge of Treating Bifurcation Lesions

David G. Rizik, M.D., F.A.C.C., F.S.C.A.I.Chief Scientific Officer

Director of Structural & Coronary InterventionsHonorHealth and the Scottsdale-Lincoln

HealthNetworkHon

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Page 2: D.Rizik, tryton breakfast symposium introduction_the challenge of treating bifurcation lesions

Disclosure Statement of Financial Interest

I, (David G Rizik, MD), 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

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kQ1: Why is stenting the standard for the

treatment of these lesions subsets?

• Discrete• Long Segmental• Calcified• Eccentric • Saphenous Vein Graphs• CTO’s• In-­Stent Restenosis• Thrombotic• Type A, B1, B2, C

A1: Stenting provides a wide variety of lesion subsets predictable procedural

success with a durable result.

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kQ2: What is the only major lesion subset which

stenting is not the current Standard?

A2: Bifurcation Lesions: Workhorse stents do not provide the same predictable and durable results as straight lesion

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Bifurcation Lesions are Common

“All Comers” Studies % Patients % Lesions

Leaders Trial1,2 29.1% 21.6%

Nobori 23 17.5% 16.9%

xSearch4 22.2% N/A

Average 22.9% 19.3%

1. Windecker et al. Lancet 2008;; 372: 1163–732. Wykrzykowska, EuroPCR ’093. Danzi, EuroPCR ‘094. Serruys, ACC ‘08

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kTreatment of Branching Geometry Lesions Using

Currently Available Technology Yield Complications

• Thrombosis Rate– Incidence: 3.6-­3.9%

– Hazard Ratio: 4.6-­6.5

• Restenosis Rates– Angiographic 20-­40%

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kBifurcation Lesions:

Large Variation: Extent of Disease, Angle & Diameter

Case Courtesy of DrsKutcher & Holland, USA

Courtesy of P Brunel, France

Courtesy of Dr. Dumonteil, France

Courtesy of Prof. R. Kornowski, Israel

Courtesy of Dr. Th. Lefèvre, France

Courtesy of Dr. Schulze, Germany

Courtesy of Dr. M. Lesiak, Poland

Courtesy of Drs. E. Grübe -­R. Müller, Germany

Like finger prints: No two bifurcations are alike

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k5 Year Follow-Up Nordic Bifurcation StudySimple vs Complex Stenting Strategy in Non-­LM PCI

• MACE event were low and did not differ significantly in patients treated with a simple versus a complex bifurcation stenting technique.

• Stent thrombosis rate was not increased in patients treated with 2-stents.

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kMeta-Analysis: NORDIC I & BBC I (Non LM Bifurcations)

Probability of MACE (Death/MI/TVR)

Difference in MACE favoring a simple strategy

What is the relevance of peri-­procedural MI ?

25-­50% of patients in randomizedtrials have little or no SB disease.

Most one vs two stent trials have focused on bifurcations with diminutive SB diameters

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kMore Contemporary Trials Involving Large Side

Branches Favor 2- stent Strategy

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Key Points• Bifurcation Lesions: Continues to be problem Only Lesion Subset Not Routinely Stented

• Combined Literature: Supports Provisional over 2 Stent Strategies

• Study Population Primarily Focused on Small SB– BBC 1– Nordic 1

• Studies with Large SB Favors 2 Stent Approach– DK Crush– 2 Stent ‘Simple’ Dedicated Stent

• Tryton is a Dedicated Side Branch Stent: Focused on Providing Straight Forward 2 stent solution

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kTryton Side Branch StentProduct Features

• Cobalt Chromium (CoCr)• Strut thickness: 84µm• Delivery System: Rapid Exchange • Side Branch Diameters: 2.5-­3.5 mm

• Guide Size: ≥ 5 Fr (Operator’s Choice)• Guide Wire: 0.014” (Operator’s Choice)

• Main Vessel Stent: Workhorse DES (Operator’s Choice)

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kTryton Side Branch Stent™

Main Branch Zone & wedding band

8mm

*: 5.5mm for Large Vessel diameters**: 18mm for Large Vessel diameters

Total stentlength: 19mm**

Transition Zone

4.5mm

Side Branch Zone

6.5mm*

Necessarily Employs a Save the Side Branch Strategy

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Tryton Deployment Sequence1. Wire both vessels and pre-­dilate SB 2. Position Tryton

3. Perform P.O.T. 4. Position DES and remove ‘jailed’ wire

5. Deploy DES and re-­wire SB 6. Simultaneous Kissing Balloon

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kComplex LAD-Diagonal Lesion

A2: Treated Electively via right radial 6 Fr. Sheath with Tryton Side Branch Stent

Case Courtesy of Michael Kutcher, M.D. Wake Forest Baptist Medical Center

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Tryton Breakfast Symposium