SlideShare a Scribd company logo
1 of 12
Martin B. Leon, MD
Columbia University Medical Center
Cardiovascular Research Foundation
New York City
Tuesday, October 13, 2015
5 mins
Disclosure Statement of Financial Interest
TCT 2015 San Francisco, CA; Oct 11-15, 2015
Martin B. Leon, MD
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
• Grant / Research Support Abbott, Boston Scientific, Edwards
Lifescience, Medtronic, St. Jude
Medical
• Consulting Fees / Honoraria Abbott, Boston Scientific, Medtronic,
St. Jude Medical
• Shareholder / Equity Claret, Coherex, Elixir, GDS, Medinol,
Mitralign, Valve Medical
Affiliation / Financial Relationship Company
TCT 2005: Stent Technology Innovation
Unfulfilled Promises?
Tryton:
The Sole
Survivor!
Tryton Study Design
DES (main vessel) +
Provisional side branch
Baseline Angiography – Eligible for Randomization
Angiographic F/U
at 9 months
Clinical F/U
at 9 months





% DS side branch
n~374
Tryton side branch +
DES (main vessel)

TVF
Primary Endpoint

N = 704
IVUS F/U
at 9 months

IVUS Cohort
n~96
Clinical F/U
at 9 months
Angiographic F/U
at 9 months
IVUS F/U
at 9 months
Largest Coronary
Bifurcation RCT Ever!
Tryton Pivotal RCT
Genereux P. J Am Coll Cardiol 2015; 65:533-43
Genereux P. Cath Cardiovasc Interv 2015; epub
Target Vessel Failure (TVF)
Primary Endpoint (not met)
%
12.8
0
10.7
3.6
17.4
0
15.1
4.7
0
2
4
6
8
10
12
14
16
18
20
TVF Cardiac Death Target Vessel MI Clinically Driven TVR
Non Hierarchical
P= 0.108
P = 0.109
P =0.564
Provisional
Tryton
%
15.6
0
12.1
4.3
11.3
0
9.2
3.5
0
2
4
6
8
10
12
14
16
18
TVF Cardiac Death Target Vessel MI Clinically Driven TVR
P= 0.383
P = 0.563
P =0.769
Provisional
Tryton
Target Vessel Failure (TVF)
Side Branch ≥ 2.25 mm
Provisional N=143 Tryton N=146
TVF Diff (95% CI) = -4.3%(-12.9,4.4%)
Non Hierarchical
(22/141) (16/141) (17/141) (13/141) (6/139) (5/141)
40.6
32.1
30.4
22.2
0
5
10
15
20
25
30
35
40
45
SB % Diameter Stenosis SB Binary Restenosis
Provisional
Tryton
P = 0.004
P = 0.260
Provisional N=81, Tryton =64
%
Angiographic Outcomes (QCA)
Side Branch ≥ 2.25 mm 9 Months
Confirmatory Study: Primary Endpoint
Peri-Procedural MI 3x ULN CKMB
11.2
10.5
0
5
10
15
20
PIVOTAL Provisional ≥2.25 Confirmatory Study
16/143 14/133
%
Performance Goal – 17.9%
Primary Endpoint Met
133 pts
Complex “True” Bifurcations
’Value’ of Tryton
Take Home Messages
Tryton in Bifurcations
• The TRYTON two-stent strategy in “true” and other
complex bifurcations with large side branches,
compared to a conventional provisional stent
strategy…
– Provides better coverage of the bifurcation (IVUS)
– Reduces the need for bail-out stenting
– Results in better acute angiographic results
– Has a similar low frequency of complications
(MIs and stent thrombosis)
Take Home Messages
Tryton in Bifurcations
• The main advantage of the TRYTON two-stent
strategy to the practicing interventionalists is the
ability to achieve predictable (“low stress”) excellent
angiographic and clinical outcomes in the most
complex bifurcation lesions!
• Stay tuned for…
– FDA approval after confirmatory registry results
– LM Tryton; the new standard for LM bifurcation stenting

More Related Content

What's hot

X x bartorelli tct 2015 (final)
X x bartorelli tct 2015 (final)X x bartorelli tct 2015 (final)
X x bartorelli tct 2015 (final)
trytonmedical
 

What's hot (20)

X x bartorelli tct 2015 (final)
X x bartorelli tct 2015 (final)X x bartorelli tct 2015 (final)
X x bartorelli tct 2015 (final)
 
Gilchrist IC 2015 radial outpatient PCI
Gilchrist IC 2015 radial outpatient PCIGilchrist IC 2015 radial outpatient PCI
Gilchrist IC 2015 radial outpatient PCI
 
11:20 Louvard - adjusting your level of competence to the difficulty of a CTO
11:20 Louvard - adjusting your level of competence to the difficulty of a CTO11:20 Louvard - adjusting your level of competence to the difficulty of a CTO
11:20 Louvard - adjusting your level of competence to the difficulty of a CTO
 
Sciahbasi A - AIMRADIAL 2013 - Radiation exposure
Sciahbasi A - AIMRADIAL 2013 - Radiation exposureSciahbasi A - AIMRADIAL 2013 - Radiation exposure
Sciahbasi A - AIMRADIAL 2013 - Radiation exposure
 
Nolan J - AIMRADIAL 2014 - Radialists and femoral access
Nolan J - AIMRADIAL 2014 - Radialists and femoral accessNolan J - AIMRADIAL 2014 - Radialists and femoral access
Nolan J - AIMRADIAL 2014 - Radialists and femoral access
 
Lesion Coverage: Insights from the Bench Top | Maciej Lesiak, M.D.
Lesion Coverage: Insights from the Bench Top | Maciej Lesiak, M.D.Lesion Coverage: Insights from the Bench Top | Maciej Lesiak, M.D.
Lesion Coverage: Insights from the Bench Top | Maciej Lesiak, M.D.
 
Carlo Di Mario - Recent Publications & Research in CTO: 2015-16
Carlo Di Mario - Recent Publications & Research in CTO: 2015-16Carlo Di Mario - Recent Publications & Research in CTO: 2015-16
Carlo Di Mario - Recent Publications & Research in CTO: 2015-16
 
Roberts J - AIMRADIAL 2015 - Ultrasound guidance
Roberts J - AIMRADIAL 2015 - Ultrasound guidanceRoberts J - AIMRADIAL 2015 - Ultrasound guidance
Roberts J - AIMRADIAL 2015 - Ultrasound guidance
 
Dedicated Bifurcation Stent Technology: Implications for Everyday Practice
Dedicated Bifurcation Stent Technology: Implications for Everyday PracticeDedicated Bifurcation Stent Technology: Implications for Everyday Practice
Dedicated Bifurcation Stent Technology: Implications for Everyday Practice
 
Debate: Is there a difference between RDR and reverse CART? – No
Debate: Is there a difference between RDR and reverse CART? – NoDebate: Is there a difference between RDR and reverse CART? – No
Debate: Is there a difference between RDR and reverse CART? – No
 
Uk1 On Q Hospital Committee Presentation
Uk1 On Q Hospital Committee PresentationUk1 On Q Hospital Committee Presentation
Uk1 On Q Hospital Committee Presentation
 
Guzman L - AIMRADIAL 2014 - Radiation exposure
Guzman L - AIMRADIAL 2014 - Radiation exposureGuzman L - AIMRADIAL 2014 - Radiation exposure
Guzman L - AIMRADIAL 2014 - Radiation exposure
 
NSM 2007 Ppt by Jason Musgrave
NSM 2007 Ppt by Jason MusgraveNSM 2007 Ppt by Jason Musgrave
NSM 2007 Ppt by Jason Musgrave
 
Biederman DM - AIMRADIAL 2014 Endovascular - Surefire catheter
Biederman DM - AIMRADIAL 2014 Endovascular - Surefire catheterBiederman DM - AIMRADIAL 2014 Endovascular - Surefire catheter
Biederman DM - AIMRADIAL 2014 Endovascular - Surefire catheter
 
Mars C - AIMRADIAL 2015 - Allergic reactions SACRED study
Mars C - AIMRADIAL 2015 - Allergic reactions SACRED studyMars C - AIMRADIAL 2015 - Allergic reactions SACRED study
Mars C - AIMRADIAL 2015 - Allergic reactions SACRED study
 
08:05 Escaned - Final cto training for all
08:05 Escaned - Final cto training for all08:05 Escaned - Final cto training for all
08:05 Escaned - Final cto training for all
 
Speiser B - AIMRADIAL 2015 - Ambulation times
Speiser B - AIMRADIAL 2015 - Ambulation timesSpeiser B - AIMRADIAL 2015 - Ambulation times
Speiser B - AIMRADIAL 2015 - Ambulation times
 
Tryton - Addressing the Challenge of Bifurcation Stenting | Dean J. Kereiakes...
Tryton - Addressing the Challenge of Bifurcation Stenting | Dean J. Kereiakes...Tryton - Addressing the Challenge of Bifurcation Stenting | Dean J. Kereiakes...
Tryton - Addressing the Challenge of Bifurcation Stenting | Dean J. Kereiakes...
 
01 aimradial2016 fri2 Z Ruzsa
01 aimradial2016 fri2 Z Ruzsa01 aimradial2016 fri2 Z Ruzsa
01 aimradial2016 fri2 Z Ruzsa
 
Bariatric surgery and copra ossicon 2016 presentation
Bariatric surgery and copra ossicon 2016 presentationBariatric surgery and copra ossicon 2016 presentation
Bariatric surgery and copra ossicon 2016 presentation
 

Similar to Tryton Pivotal: Randomized Trial and Confirmatory Study - Key Messages

Packer Cabana
Packer CabanaPacker Cabana
Packer Cabana
enforme
 
Truvada Randomized Trial of HBIG Withdrawal February 7 2014
Truvada Randomized Trial of HBIG Withdrawal February 7 2014Truvada Randomized Trial of HBIG Withdrawal February 7 2014
Truvada Randomized Trial of HBIG Withdrawal February 7 2014
Dr. Lewis Teperman
 
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
MedicineAndFamily
 

Similar to Tryton Pivotal: Randomized Trial and Confirmatory Study - Key Messages (20)

5th Annual Early Age Onset Colorectal Cancer Summit - Session III
5th Annual Early Age Onset Colorectal Cancer Summit - Session III5th Annual Early Age Onset Colorectal Cancer Summit - Session III
5th Annual Early Age Onset Colorectal Cancer Summit - Session III
 
Packer Cabana
Packer CabanaPacker Cabana
Packer Cabana
 
CABANA
CABANACABANA
CABANA
 
BioNIR/EluNIR eDES: 1 Year Outcomes of BIONICS and NIREUS studies
BioNIR/EluNIR eDES: 1 Year Outcomes of BIONICS and NIREUS studiesBioNIR/EluNIR eDES: 1 Year Outcomes of BIONICS and NIREUS studies
BioNIR/EluNIR eDES: 1 Year Outcomes of BIONICS and NIREUS studies
 
Stent Expansion and Lesion Coverage Insights From Intravascular Imaging | Ant...
Stent Expansion and Lesion Coverage Insights From Intravascular Imaging | Ant...Stent Expansion and Lesion Coverage Insights From Intravascular Imaging | Ant...
Stent Expansion and Lesion Coverage Insights From Intravascular Imaging | Ant...
 
Топ достижений лечения ВИЧ в 2017 г / Top Advances in ART for 2017
Топ достижений лечения ВИЧ в 2017 г / Top Advances in ART for 2017Топ достижений лечения ВИЧ в 2017 г / Top Advances in ART for 2017
Топ достижений лечения ВИЧ в 2017 г / Top Advances in ART for 2017
 
TCT: EXCELLENT Trial
TCT: EXCELLENT TrialTCT: EXCELLENT Trial
TCT: EXCELLENT Trial
 
Truvada Randomized Trial of HBIG Withdrawal February 7 2014
Truvada Randomized Trial of HBIG Withdrawal February 7 2014Truvada Randomized Trial of HBIG Withdrawal February 7 2014
Truvada Randomized Trial of HBIG Withdrawal February 7 2014
 
High Sensitivity HIV Testing and Translational Science around PrEP
High Sensitivity HIV Testing and Translational Science around PrEPHigh Sensitivity HIV Testing and Translational Science around PrEP
High Sensitivity HIV Testing and Translational Science around PrEP
 
DRUG ELUTING BALLOONS
DRUG ELUTING BALLOONSDRUG ELUTING BALLOONS
DRUG ELUTING BALLOONS
 
Pcrsg results 03 01-14
Pcrsg results 03 01-14Pcrsg results 03 01-14
Pcrsg results 03 01-14
 
Contemporary Management of HIV. New Data From IDWeek 2018 and Other Fall 2018...
Contemporary Management of HIV. New Data From IDWeek 2018 and Other Fall 2018...Contemporary Management of HIV. New Data From IDWeek 2018 and Other Fall 2018...
Contemporary Management of HIV. New Data From IDWeek 2018 and Other Fall 2018...
 
Breast Cancer Highlights: ASCO 2015
Breast Cancer Highlights: ASCO 2015Breast Cancer Highlights: ASCO 2015
Breast Cancer Highlights: ASCO 2015
 
Update on HIV Prevention Issues Presented at 2016 CROI
Update on HIV Prevention Issues Presented at 2016 CROIUpdate on HIV Prevention Issues Presented at 2016 CROI
Update on HIV Prevention Issues Presented at 2016 CROI
 
Template for medical college core committee
Template  for medical college core committeeTemplate  for medical college core committee
Template for medical college core committee
 
Cohen MG 2016 Transradial primary PCI in shock
Cohen MG 2016 Transradial primary PCI in shockCohen MG 2016 Transradial primary PCI in shock
Cohen MG 2016 Transradial primary PCI in shock
 
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent 	 Endeavor...
Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor...
 
HIV Alert:Emerging Updates on Dual Therapy.2018
HIV Alert:Emerging Updates on Dual Therapy.2018HIV Alert:Emerging Updates on Dual Therapy.2018
HIV Alert:Emerging Updates on Dual Therapy.2018
 
Pancholy SB - AIMRADIAL 2014 Endovascular - Renal denervation
Pancholy SB - AIMRADIAL 2014 Endovascular - Renal denervationPancholy SB - AIMRADIAL 2014 Endovascular - Renal denervation
Pancholy SB - AIMRADIAL 2014 Endovascular - Renal denervation
 
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
Fall 2014 HIV Update.Clinical Impact of New Data From ICAAC 2014, IDWeek 2014...
 

Recently uploaded

Failure to thrive in neonates and infants + pediatric case.pptx
Failure to thrive in neonates and infants  + pediatric case.pptxFailure to thrive in neonates and infants  + pediatric case.pptx
Failure to thrive in neonates and infants + pediatric case.pptx
claviclebrown44
 
In Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait City
In Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait CityIn Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait City
In Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait City
Abortion pills in Kuwait Cytotec pills in Kuwait
 

Recently uploaded (20)

Tips to Choose the Best Psychiatrists in Indore
Tips to Choose the Best Psychiatrists in IndoreTips to Choose the Best Psychiatrists in Indore
Tips to Choose the Best Psychiatrists in Indore
 
ANAPHYLAXIS BY DR.SOHAN BISWAS,MBBS,DNB(INTERNAL MEDICINE) RESIDENT.pptx
ANAPHYLAXIS BY DR.SOHAN BISWAS,MBBS,DNB(INTERNAL MEDICINE) RESIDENT.pptxANAPHYLAXIS BY DR.SOHAN BISWAS,MBBS,DNB(INTERNAL MEDICINE) RESIDENT.pptx
ANAPHYLAXIS BY DR.SOHAN BISWAS,MBBS,DNB(INTERNAL MEDICINE) RESIDENT.pptx
 
TEST BANK For Lewis's Medical Surgical Nursing in Canada, 4th Edition by Jane...
TEST BANK For Lewis's Medical Surgical Nursing in Canada, 4th Edition by Jane...TEST BANK For Lewis's Medical Surgical Nursing in Canada, 4th Edition by Jane...
TEST BANK For Lewis's Medical Surgical Nursing in Canada, 4th Edition by Jane...
 
SEMESTER-V CHILD HEALTH NURSING-UNIT-1-INTRODUCTION.pdf
SEMESTER-V CHILD HEALTH NURSING-UNIT-1-INTRODUCTION.pdfSEMESTER-V CHILD HEALTH NURSING-UNIT-1-INTRODUCTION.pdf
SEMESTER-V CHILD HEALTH NURSING-UNIT-1-INTRODUCTION.pdf
 
Creating Accessible Public Health Communications
Creating Accessible Public Health CommunicationsCreating Accessible Public Health Communications
Creating Accessible Public Health Communications
 
Failure to thrive in neonates and infants + pediatric case.pptx
Failure to thrive in neonates and infants  + pediatric case.pptxFailure to thrive in neonates and infants  + pediatric case.pptx
Failure to thrive in neonates and infants + pediatric case.pptx
 
A thorough review of supernormal conduction.pptx
A thorough review of supernormal conduction.pptxA thorough review of supernormal conduction.pptx
A thorough review of supernormal conduction.pptx
 
The Orbit & its contents by Dr. Rabia I. Gandapore.pptx
The Orbit & its contents by Dr. Rabia I. Gandapore.pptxThe Orbit & its contents by Dr. Rabia I. Gandapore.pptx
The Orbit & its contents by Dr. Rabia I. Gandapore.pptx
 
Overview on the Automatic pill identifier
Overview on the Automatic pill identifierOverview on the Automatic pill identifier
Overview on the Automatic pill identifier
 
World Hypertension Day 17th may 2024 ppt
World Hypertension Day 17th may 2024 pptWorld Hypertension Day 17th may 2024 ppt
World Hypertension Day 17th may 2024 ppt
 
Gallbladder Double-Diverticular: A Case Report المرارة مزدوجة التج: تقرير حالة
Gallbladder Double-Diverticular: A Case Report  المرارة مزدوجة التج: تقرير حالةGallbladder Double-Diverticular: A Case Report  المرارة مزدوجة التج: تقرير حالة
Gallbladder Double-Diverticular: A Case Report المرارة مزدوجة التج: تقرير حالة
 
VVIP Whitefield ℂall Girls 6350482085 Heat-flaring { Bangalore } Worthy Girl ...
VVIP Whitefield ℂall Girls 6350482085 Heat-flaring { Bangalore } Worthy Girl ...VVIP Whitefield ℂall Girls 6350482085 Heat-flaring { Bangalore } Worthy Girl ...
VVIP Whitefield ℂall Girls 6350482085 Heat-flaring { Bangalore } Worthy Girl ...
 
Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)
 
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
5Cladba ADBB 5cladba buy 6cl adbb powder 5cl ADBB precursor materials
 
Dermatome and myotome test & pathology.pdf
Dermatome and myotome test & pathology.pdfDermatome and myotome test & pathology.pdf
Dermatome and myotome test & pathology.pdf
 
Let's Talk About It: Ovarian Cancer (The Emotional Toll of Treatment Decision...
Let's Talk About It: Ovarian Cancer (The Emotional Toll of Treatment Decision...Let's Talk About It: Ovarian Cancer (The Emotional Toll of Treatment Decision...
Let's Talk About It: Ovarian Cancer (The Emotional Toll of Treatment Decision...
 
5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now
5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now
5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now
 
5cladba raw material 5CL-ADB-A precursor raw
5cladba raw material 5CL-ADB-A precursor raw5cladba raw material 5CL-ADB-A precursor raw
5cladba raw material 5CL-ADB-A precursor raw
 
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS by Dr M.KARTHIK EMMANUEL
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS  by Dr M.KARTHIK EMMANUELCONGENITAL HYPERTROPHIC PYLORIC STENOSIS  by Dr M.KARTHIK EMMANUEL
CONGENITAL HYPERTROPHIC PYLORIC STENOSIS by Dr M.KARTHIK EMMANUEL
 
In Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait City
In Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait CityIn Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait City
In Kuwait Abortion pills (+918133066128)@Safe abortion pills in Kuwait City
 

Tryton Pivotal: Randomized Trial and Confirmatory Study - Key Messages

  • 1. Martin B. Leon, MD Columbia University Medical Center Cardiovascular Research Foundation New York City Tuesday, October 13, 2015 5 mins
  • 2. Disclosure Statement of Financial Interest TCT 2015 San Francisco, CA; Oct 11-15, 2015 Martin B. Leon, MD Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. • Grant / Research Support Abbott, Boston Scientific, Edwards Lifescience, Medtronic, St. Jude Medical • Consulting Fees / Honoraria Abbott, Boston Scientific, Medtronic, St. Jude Medical • Shareholder / Equity Claret, Coherex, Elixir, GDS, Medinol, Mitralign, Valve Medical Affiliation / Financial Relationship Company
  • 3. TCT 2005: Stent Technology Innovation Unfulfilled Promises? Tryton: The Sole Survivor!
  • 4. Tryton Study Design DES (main vessel) + Provisional side branch Baseline Angiography – Eligible for Randomization Angiographic F/U at 9 months Clinical F/U at 9 months      % DS side branch n~374 Tryton side branch + DES (main vessel)  TVF Primary Endpoint  N = 704 IVUS F/U at 9 months  IVUS Cohort n~96 Clinical F/U at 9 months Angiographic F/U at 9 months IVUS F/U at 9 months Largest Coronary Bifurcation RCT Ever!
  • 5. Tryton Pivotal RCT Genereux P. J Am Coll Cardiol 2015; 65:533-43 Genereux P. Cath Cardiovasc Interv 2015; epub
  • 6. Target Vessel Failure (TVF) Primary Endpoint (not met) % 12.8 0 10.7 3.6 17.4 0 15.1 4.7 0 2 4 6 8 10 12 14 16 18 20 TVF Cardiac Death Target Vessel MI Clinically Driven TVR Non Hierarchical P= 0.108 P = 0.109 P =0.564 Provisional Tryton
  • 7. % 15.6 0 12.1 4.3 11.3 0 9.2 3.5 0 2 4 6 8 10 12 14 16 18 TVF Cardiac Death Target Vessel MI Clinically Driven TVR P= 0.383 P = 0.563 P =0.769 Provisional Tryton Target Vessel Failure (TVF) Side Branch ≥ 2.25 mm Provisional N=143 Tryton N=146 TVF Diff (95% CI) = -4.3%(-12.9,4.4%) Non Hierarchical (22/141) (16/141) (17/141) (13/141) (6/139) (5/141)
  • 8. 40.6 32.1 30.4 22.2 0 5 10 15 20 25 30 35 40 45 SB % Diameter Stenosis SB Binary Restenosis Provisional Tryton P = 0.004 P = 0.260 Provisional N=81, Tryton =64 % Angiographic Outcomes (QCA) Side Branch ≥ 2.25 mm 9 Months
  • 9. Confirmatory Study: Primary Endpoint Peri-Procedural MI 3x ULN CKMB 11.2 10.5 0 5 10 15 20 PIVOTAL Provisional ≥2.25 Confirmatory Study 16/143 14/133 % Performance Goal – 17.9% Primary Endpoint Met 133 pts
  • 11. Take Home Messages Tryton in Bifurcations • The TRYTON two-stent strategy in “true” and other complex bifurcations with large side branches, compared to a conventional provisional stent strategy… – Provides better coverage of the bifurcation (IVUS) – Reduces the need for bail-out stenting – Results in better acute angiographic results – Has a similar low frequency of complications (MIs and stent thrombosis)
  • 12. Take Home Messages Tryton in Bifurcations • The main advantage of the TRYTON two-stent strategy to the practicing interventionalists is the ability to achieve predictable (“low stress”) excellent angiographic and clinical outcomes in the most complex bifurcation lesions! • Stay tuned for… – FDA approval after confirmatory registry results – LM Tryton; the new standard for LM bifurcation stenting