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Tryton Pivotal IDE-RCT ResultsImplications For Everyday PracticeIntegrating Dedicated TechnologyAntonio L. Bartorelli, FACC, FESCCentro Cardiologico MonzinoUniversity of MilanMilan, ItalyStent Expansion & Lesion CoverageInsights From Intravascular Imaging

Disclosure Statement of Financial Interest

Speaker bureauConsulting Fees/Honoraria

Tryton, Abbott VascularAbbott VascularWithin the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.Affiliation/Financial RelationshipCompany

AgendaInsights from intravascular imagingIVUS: IUVANT StudyOCTClinical Cases

TRYTON Side-Branch Stent: Intents and BenefitsComplex Bifurcation Lesions: Predictability & Durability of Stenting Side BranchSecure Side BranchProvide Scaffolding and ExpansionMain BranchState-of-the-Art DES

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IUVANT StudyIntravascular Ultrasound Evaluation of Tryton StentPost-procedural and 9-month IVUS analysisMV: proximal and distal 5 mm from carinaSB: proximal 5 mm from carina

Bartorelli AL et al. CCI 20015;85:54455332 patients (33 BL) with angiographic apparent disease in MV and SB in 87.9% by site and 75% by core lab evaluation100% procedural success (Tryton+Xience V) including FKB

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IUVANT Study: Intravascular Ultrasound Evaluation of Tryton StentIVUS analysis siteMain Vessel (%)96 (93,109)Side Branch (%)88 (77,100)Carina Main Vessel (%)135 (99,166)Carina Side Branch (%)116 (91,130)

Mean Post-procedure Percent Stent Expansion (defined as minimumstent area divided by distal reference lumen area)

D1LADCarina frames were choses as the first end-diastolic frames showing figure-of-eight shape for carina analysis Impressive Carinal Expansion

Bartorelli AL et al. CCI 20015;85:544553

In-segment late lumen loss(mm)In-segment diameter stenosis (%)In-stent late lumen loss(mm)In-segment diameter stenosis (%)Proximal MV0.29 0.46 17.6 14.10.31 0.3513.5 11.7Distal MV0.13 0.26 12.0 9.60.34 0.242.5 13.9Side Branch 0.31 0.2618.5 11.50.41 0.2725.4 9.6

IUVANT StudyIntravascular Ultrasound Evaluation of Tryton StentQCA Results @ 9-month Follow-upBinary Restenosis: One MV in-segment and one SB in-stentBartorelli AL et al. CCI 2015;85:544553

Tryton Design:Transition Zone Panels: Flare and rotate, accommodates SB-MV transition and angleThin struts (84 m) Main Branch Zone: Insures MV DES access and full expansionIUVANT Study: Impressive Carinal ExpansionStent Design & Delivery Technique Bartorelli AL et al. CCI 2015;85:544553Transition ZoneSide Branch Zone

Main Branch Zone

Implantation Protocol (Key Features):Tryton Pivotal & Confirmation Study ProtocolAggressive lesion preparationPrecise positioningPost-Tryton deployment POT dilationFinal kissing balloon (NC balloons of appropriate size)IUVANT Study: Impressive Carinal ExpansionStent Design & Delivery Technique Bartorelli AL et al. CCI 2015;85:544553

Tryton Assessment With OCT

Final angio result (LCx-OM1)CFxOM1LCxwireLCx max strut separation= 160 mLCx max strut separation= 150 mFerrante G et al. CCI 2009;73:69-72OCT MV and SB Images shows good apposition and uniformstrut coverage with minimal strut-vessel separation OCT high spatial resolution: accurate strut apposition & lesion coverage

Prospective Evaluation of the Tryton Side-Branch Stent with OCT The PYTON Study

Dubois C et al CCI 2013;81:E155-E16420 patients treated with Tryton + Xience VLesion success 95% (1 failure to advance Tryton)9-month angio and OCT follow-up (high-quality OCT available in 13 patients)

OCT assessed strut coverage in proximal MV, POC (polygon of confluence), distal MV & SBProx MVVessel fly3-D reconstructionDist MVPOC

Proximal MVDistal MVSide BranchPOCCovered struts/patient245 84193 76131 2383 31RUTSS (%)4.00 5.790.73 1.2602.47 3.64Free floating struts/patient0001.85 3.34Uncovered free floating struts (%)---16 31

Prospective Evaluation of the Tryton Side-Branch Stent with OCT The PYTON StudyAt 9 months, ratio of uncovered to total stent struts (RUTSS) in POC was low (2.47) with only 1.85 struts/patient floating, 16% of which not covered by neointima Dubois C et al CCI 2013;81:E155-E164

Monzino Case 1

Baseline May 4, 2009 Coronary angiographyProximal LAD lesion and mid LAD-D1 lesion: Medina 1,1,1 with large plaque burden and long side branch lesionCase concerns Preserve large D1 and fully cover long side branch diseaseDurability of the acute result in a young patient45-year-old man with hypercholesterolemiaRecent onset of rest angina, severe LAD lesion at MSCT coronary angiography

POST TRYTONMay 4, 2009Complete treatment of MV and long SB lesionsD1 secured with a Tryton stent (3.5/2.5 x 19 mm)D1 long lesion fully covered with a 2.5 x 8 mm Xience V stentDeployment of a DES (3.0 x 28 mm Xience V) in mid LADSequential post-dilation of LAD and D1 and FKB with NC balloonsProximal LAD lesion treated with a 3.5 x 12 mm Promus stentMonzino Case 1

6-month F/UDecember 14, 2009 9-month follow-upNo symptomsNo restenosis in LAD or D1Monzino Case 1

56-month F/UJanuary 9, 2014 56-months F/UPerformed because atypical chest pain and equivocal ECG stress testUnchanged angiographic results from 9 to 56 monthsMonzino Case 1

Monzino Case 259-year-old menRisk factors: family history of CAD, previous smoker, hypertension, hypercolesterolemiaPrevious (July 2015) primary PCI of RCA for inferior STEMILAD-D1 Medina 1,1,1 bifurcation lesion scheduled for September 2015

OCT Evaluation

D1 ostiumDistal LAD

Prox LAD

POCDragonfly OPTIS OCT catheter

Tryton Side-Branch Stent

Transition ZoneSide-Branch Zone

Main-Branch Zone3.5/2.5 x 19 mm (tapered DS)Tryton positioning3.5/2.5 x 19 mm @ 12 atmTryton deployment @12 atmSB post-dilationAccuforce 2.75 x 6 mm @18 atm

BVS Implantation in Main Vessel (LAD)

Absorb BVS 3.5 x 28 mm@ 14 atmPOT in LADAccuforce 3.5 x 6 @ 16 atm

Mini-KBPDLAD: Accuforce 3.0 x 5 mm @ 10 atmD1: Accuforce 2.75 x 5 mm @ 10 atm

BVS cell dilation Accuforce 3.0 x 8 mm @ 10 atm

Final Result

Final Angiographic and OCT Result

Pull back from LADD1LAD

Prox LAD

POC D1LADPull back from D1POC

Distal LAD

D1Prox LADDistal LAD

Complex Bifurcation LesionsWhen Do I Use the Tryton Stent?Key questions (in doubt ask IVUS!) SB size: Diameter and territory supplied?SB disease: Severity and length of disease?Angle of bifurcation?SB accessibility: Ease of wiring (and re-wiring) Bailout complexityMV lesion severity

ConclusionsBifurcation lesions: Increased complication/reduced success (with both single- or two-DES approach) when compared to straight (non-bifurcation) lesionsPoorer outcomes with standard stents and techniques: Reduced stent expansion and lesion coverageTryton Side-Branch Stent:Preserves SBAccommodates broad spectrum of bifurcation angleProvides impressive carinal expansionProvides good coverage in all bifurcation segments with minimal stent strut overlap in proximal MVPreserves high performance of state-of-the-art main vessel DESImplantation technique:Straightforward and central to success

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