m.lesiak, eu perspective on left main - the final frontier

EU Perspective on Left Main -The Final Frontier

Maciej Lesiak, MD

Department of Cardiology, University of Medical Sciences in Poznan

Disclosure Statement of Financial Interest

• Grant/Research Support• Consulting Fees/Honoraria

• Abbott Vascular• Abbott Vascular, AstraZeneca,

Biotronik, Boston Scientific, Volcano, St Jude

Within 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 Relationship Company

ESC/EACTS Guidelines 2014 CABG = PCI for low risk patients

PCI-LMCA: Guide Line IB (equal to CABG)

61

5678

80 77103

131

0

200

400

600

800

1000

1200

1400

1600

2010 2011 2012 2013 2014 2015 2016 (9mo)

PCI PCI LM3.9%

3.8%5.6%

6.2% 6.0% 8.4% 12.2%

PCI-LMCA Ist Dept. of Cardiology, Medical University in Poznan

ESC/EACTS Revasc. Guidelines

PCI in Left Main – Meta-analysis

Athappan et al. JACC Cardiovasc Interv 2013;;6:1219-304

Favors PCI Favors CABG

Mortality

1 year 3 years

5 years



P=0.26

P=0.80

P=0.13

PCI in Left Main – Meta-analysis

Athappan et al. JACC Cardiovasc Interv 2013;;6:1219-304

TVR at 5 years


Stroke at 5 years


MI at 5 yearsP=0.00

P=0.00

P=0.34

Left Main Stem

Large

ShortImportant side branch (LCX is the largest side branch in coronary system)

Wide bifurcation angle

Optimal main vessel stenting an SB protection of crucial importance

Magro M et al. EuroIntervention 2013;8:1259-‐1269

Tryton LM Registry

Retrospective, 9 European centers2008-‐2011 (learning curve)Medina 1,1,1 – 63%

Prospective LMCA Registry

• European collaboration of 8 sites• Large Diameter Device (3.0-3.5 and 3.5-4.0 mm)• Standardized Operation Procedure (SOP)

¡ Post Tryton Deployment ‘POT’ inflation• Angiographic Analysis (Procedural & 6 months)• IVUS Analysis (Procedural & 6 months)• Independent CoreLab analysis• LM > 10 mm

R-J. van Geuns, EuroPCR 2014

Clinical Outcome


Angiographic analysis


Tryton LM PCILimitations Addressed with Current Design

• Procedural reliability¡ Loss of LCx¡ Hemodynamic instability

• Long term durability¡ Restenosis¡ Stent thrombosis

• Impact Main vs Side Branch First Strategy

Addressed with current designs

May require DES Design?



Standard Design: Published Experience

• Safety¡ High Procedural Success¡ No Thrombosis Signal observed (Low numbers)

• Efficacy¡ High Procedural Success¡ TVR = 13%

• All SB (LCx or Ramus)• All RVD <2.3 mm

STANDARD Length (18mm)*

Tryton SHORT Design: Product Details

SHORT Length (15mm)

Design Features• Stent Design: 3 mm shorter main vessel zone• Markers Position Optimized for Large Vessels • Improved delivery system

* Large vessels sizes

4.5mm

3mm

Left Main Clinical Path

Tryton Standard•Studied in e-Tryton and Pivotal Trial

Large Vessel•Studied in Pivotal•Rotterdam Initiated Left Main Study

Left Main Stent (CE)•Designed specifically for ULMCA disease•Facilitates usage with stents up to 6.0mm in diameter

Left Main Clinical Indication (CE)•Evidence supporting “larger vessels”

eTryton Left Main Registry•Real World Usage•POT vs. No KISS•OCT•SHORT stent

Standard Large Diameter Left Main Stent (CE) Left Main Indication(CE) eTryton Left Main Registry SHORT

2008 2011 2013 2014 2016

Confidential

59 YO male patient. Previous MI, HT, DM type IIEF ~30%, ICD

LM restenosis after BVS implantation (LM-LAD)

Difficult LCx take-off Pre-dilat. 3.0 x 15 mm

Tryton positioning & implantation

SB stenting

MV stenting (SB protected, wire removed)

MV DES positioning & implantationPost implantation. Good access to MV

POT, final kissing and IInd POT

Final result

ClearStent view

LCx

LAD

LM

OCT Image

Conclusion

• LMCA stenting more and more common in current practice• LCx - the largest side branch in coronary system• Clinical studies support safety and efficacy of Tryton SB stent compared with provisional stenting in lesions involving large SBs

• LD short design makes Tryton a perfect tool for distal LM stenting

• Drug version very welcome to further improve long term durability

m.lesiak, eu perspective on left main - the final frontier

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