p. genereux, the tryton stent_dedicated bifurcation stent in coronary bifurcation
TRANSCRIPT
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Philippe Généreux, MD
Columbia University Medical CenterCardiovascular Research Foundation
New York City
The TRYTON StentDedicated Bifurcation Stent in Coronary
Bifurcation
TCT 2016, Washington
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Disclosure Statement of Financial Interest
Philippe Généreux, MDWithin 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
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• Boston Scientific, CSI, TRYTON Medical
• Abbott Vascular, CSI, Edwards Lifesciences, TRYTON Medical, Soundbite Medical Inc., SIG.NUM, SARANAS
• Soundbite Medical Inc., SIG.NUM
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Bifurcation Lesions Still a Challenge
• Require more time, anxiety, skill, and equipment (cost)
• Increased complicationsperi-procedural MIs,stent thrombosis, andrestenosis
• Suboptimal angiographic outcomes (esp. side branch ostium)
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Randomized Bifurcation Stent Studies(NORDIC, BBC ONE, CACTUS)
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TRYTON Side Branch Stent
Transition Zone
Side Branch Zone
Main Branch Zone
8 mm 4.5 mm 6.5 mm
Tryton is a Cobalt alloy bare metal stent
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Tryton Side Branch Stent Sizes
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Tryton Deployment Sequence
Tryton positioned and deployed after pre-dilatation
(secures and protects side branch)
Main vessel treated with approved DES through main
vessel portion of Tryton
Kissing balloon post-dilatation to
insure complete lesion & ostium coverage
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TRYTON Pivotal RCT
Généreux et al. J Am Coll Cardiol 2015;;65:533–43
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Tryton Study Design
DES (main vessel) + Provisional side branch
Baseline Angiography – Eligible for RandomizationTrue bifurcation with SB≥ 2.5mm by visual estimation
Angiographic F/Uat 9 months
Clinical F/U at 9 months
ê
ê
ê
ê
ê
% DS side branchn~374
Tryton side branch + DES (main vessel)
êê
TVFPrimary Endpoint
ê
N = 704
IVUS F/Uat 9 months
ê
IVUS Cohort n~96
Clinical F/U at 9 months
Angiographic F/Uat 9 months
IVUS F/Uat 9 months
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TRYTON Pivotal RCT Primary Non-Inferiority Endpoint
Not Met%
12.8
0
10.7
3.6
17.4
0
15.1
4.7
02468101214161820
TVF Cardiac Death Target Vessel MI Clinically Driven TVR
Non Hierarchical
P= 0.11P = 0.11
P =0.56
ProvisionalTryton
Généreux et al. J Am Coll Cardiol 2015;;65:533–43
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38.631.6
0
10
20
30
40
50
60
P=0.002
ProvisionalTryton
Side Branch %DS (In-segment)Secondary Endpoint
%
Secondary Superiority Endpoint MetAngiographic Cohort n=326
Généreux et al. J Am Coll Cardiol 2015;;65:533–43
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14
33
49
152
164
104
66 68
2410 11 60
20
40
60
80
100
120
140
160
180
≥ 2.25 mm:41% of ITT lesions
Side Branch RVD (Core Lab)#
Frequency
Pre Procedure Side Branch Size
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TRYTON Large SBs Sub-Analysis:Side Branches ≥2.25mm
Généreux et al. Catheter Cardiovasc Interv. 2015
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10.315.6
9.212.1
21.7
11.3
19.2
9.25.5 4.33.1 3.5
0
5
10
15
20
25
30
35
<2.25 mm ≥2.25 mm <2.25 mm ≥2.25 mm <2.25 mm ≥2.25 mm
Provisional TRYTON StentEvent Rate (%)
44/20320/195 22/141 18/195 17/141 6/195 6/13916/141 39/203 13/141 11/201 5/141
Side Branch Size
TVF
OR =2.42[1.37,4.28]
OR =0.69 [0.35,1.38]
P for interaction=0.006
Target Vessel MI
OR =2.34[1.29,4.25]
OR =0.74 [0.35,1.59]
P for interaction=0.02
Clinically Driven TVR
OR =1.82[0.66,5.03] OR =0.81
[0.24,2.73]
P for interaction=0.32
Généreux et al. Catheter Cardiovasc Interv. 2015
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40.6
32.130.4
22.2
0
5
10
15
20
25
30
35
40
45
SB % Diameter Stenosis SB Binary Restenosis
ProvisionalTryton
P = 0.004
P = 0.26
Angiographic Outcomes (QCA)Side Branch ≥ 2.25 mm 9 Months
Provisional N=81Tryton N=64
%
Généreux et al. Catheter Cardiovasc Interv. 2015
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TRYTON Confirmatory Study
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TRYTON Confirmatory StudyRationale
• To prospectively confirm the safety (periprocedural MI) of the TRYTON dedicated bifurcation stent in the treatment of true bifurcation lesions involving large side branches (≥2.25mm by QCA analysis)
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TRYTON Confirmatory Study Angiographic Inclusion Criteria: No Change
• Single de novo “true” bifurcation lesion • Native coronary artery • Medina 1.1.1, 1.0.1, or 0.1.1 by visual estimation
• Symptoms or objective evidence of ischemia• Vessel diameter: • Main branch: ≥ 2.5 mm and ≤ 4.0 mm;;• Side branch: ≥ 2.5 mm and ≤ 3.5 mm
• Lesion length: • Main vessel ≤ 28 mm;; Side branch ≤ 5 mm
• Multi-vessel disease and staging allowed• Enrolment allowed after successful treatment of ≤ 2 non-complex non-target lesions
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TRYTON Confirmatory StudyReview Clinical Selection Criteria/Informed Consent
Baseline AngiographyReview Angiographic Selection Criteria
N=133 patients TRYTON stent side branch first stepDES in Main branch second step
Primary End point: Periprocedural MI >3X URL CK-MB 48hrs post PCI
Clinical F/U: 30 days and 1 year
ITT when TRYTON stent enters the guide catheter
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TRYTON Confirmatory StudyPerformance Goal: Sample Size Calculation
• Powered Endpoint: • Peri-procedural MI 3x CK-MB @48hrs • Observed Rate in IDE provisional: 11.9% • Power: 90% • Delta: 6.0%• 1-sided 95% upper confidence bound
• Performance Goal: 17.9%• N = 133
• Anticipated 4% lost of follow-up• CK-MB missing, RVD <2.25mm
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TRYTON Confirmatory Study:Study Recruitment
28 Investigational CentersUS =13, OUS =15
12 months enrolment
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Baseline Characteristics: DemographicConfirmatory Study Randomized IDE ≥2.25mm
TRYTON(N=133)
TRYTON(N=146)
Provisional(N=143)
Age (years) 65.6±9.5 64.5±10.7 65.2±9.2Male 69.9% 79.5% 81.8%MI 32.3% 29.7% 40.4%PCI 39.8% 37.0% 43.4%CABG 2.3% 3.4% 3.5%TIA / CVA 6.8% 8.9% 5.7%CHF 6.0% 1.4% 0.0%Diabetes Mellitus 25.8% 25.3% 28.7%Hypertension * 82 %* 68.5% * 76.8%Hypercholesterolemia 71.2% 72.2% 77.0%Current Smoking 21.1% 17.1% 15.5%Atrial Fibrillation 7.5% 12.3% 8.4%* P<0.05
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Baseline Characteristics: PresentationConfirmatory Study Randomized IDE ≥2.25mm
TRYTON (N=133)
TRYTON(N=146)
Provisional(N=143)
Recent MI NA 8.9% 11.2%Angina TypeStable 73.7% 74.0% 68.5%Unstable 18.0% 19.2% 23.8%
CCS ClassI 15.3% 15.7% 17.0%II 55.1% 56.9% 58.5%III 27.6% 24.5% 20.2%IV 2.0% 2.9% 4.3%
Ischemia + 64.2% 61.7% 63.9%LVEF 56.3±9.5 57.1±9.4 56.8±10.7
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Medina Classification: Angio Core Laboratory Confirmation
T: 0%P: 2.8%Con: 0%
“True”Bifurcation
T: 88.3%P: 86.8%Con: 100%
T: 45.9%P: 39.9%Con: 50.4%
T: 16.4%P: 16.8%Con: 15.0%
T: 26.0%P: 30.1%Con: 34.6%
T: 2.1%P: 5.6%Con: 0%
T: 4.1%P: 2.8%Con: 0%
T: 5.5%P: 2.1%Con: 0%
P=Provisional T=Tryton Con=Confirmatory
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Baseline Characteristics: Main BranchConfirmatory Study Randomized IDE ≥2.25mm
TRYTON(N=133)
TRYTON(N=146)
Provisional(N=143)
Vessel LocationLAD 75.2% 71.2% 65.7%LCX 20.3% 19.9% 25.2%RCA 3.8% 8.9% 9.1%Lesion LocationOstial 10.5% 8.2% 7.0%Proximal 50.4% 44.5% 44.1%Mid 15.8% 20.5% 18.2%Distal 23.3% 26.7% 30.8%RVD (mm) 3.12±0.37 3.09±0.35 3.06±0.34Lesion Length (mm) 17.23±7.89 16.14±6.84 16.05±6.53Morphologyangulation ≥45o 8.3% 11.0% 9.8%thrombus 1.5% 0.0% 1.4%calcification – mod/severe 29.3% 13.7% 18.9%TIMI Flow (baseline) < 3 15.0% 7.5% 14.0%
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Baseline Characteristics: Side Branch
Confirmatory Study Randomized trial ≥2.25mm TRYTON(N=133)
TRYTON(N=146)
Provisional(N=143)
Vessel LocationLAD 75.2% 72.6% 65.0%LCX 21.1% 18.5% 25.9%RCA 3.8% 8.9% 9.1%Lesion LocationOstial 98.5% 96.6% 95.8%Proximal 1.5% 2.7% 2.8%Mid 0.0% 0.0% 0.0%Distal 0.0% 0.7% 1.4%RVD (mm) 2.49±0.20 2.53±0.23 2.52±0.22Lesion Length (mm) 5.94±2.53 4.80±1.24 4.60±0.86Morphologyangulation ≥45o 18.0% 12.3% 24.5%thrombus 0.9% 0.0% 0.0%calcification – mod/severe 9.8% 5.5% 5.6%TIMI Flow (baseline) < 3 8.2% 4.1% 4.2%
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TRYTON Confirmatory Study: Acute Angiographic Result
Confirmatory Study Randomized Trial ≥2.25mm
TRYTON (N=133)
TRYTON(N=146)
Provisional(N=143)
Main Vessel (mm)Acute gain In-stent 1.81±0.47 1.77±0.46 1.78±0.40In-segment 1.49±0.48 1.38±0.46 1.45±0.44
Side Branch (mm)Acute gainIn-stent 1.58±0.43 1.53±0.36 naIn-segment 1.37±0.41* 1.26±0.36 0.59±0.48*
* p<0.001
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TRYTON Confirmatory Study: Acute SuccessConfirmatory Study Randomized Trial
≥2.25mm
Acute Success(%) TRYTON(N=133)
TRYTON(N=146)
Provisional(N=143)
Procedure SuccessAchievement of final in-stent diameter <50% in SB with assigned study device
89.3%*(117/131)
87.4% (125/143)
66.9%*(95/142)
Device SuccessAchievement of final in-stent residual stenosis <30% (by QCA) in SB using the assigned study device without malfunction
93.8%*(122/130)
94.4%(135/143)
35.9%*(51/142)
Lesion SuccessAchievement of final in-stent diameter of <50% (by QCA) within the side branch
100%*(133/133)
100% (141/141)
84.5%*(120/142)
* p<0.001
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TRYTON Confirmatory Study: Resources Utilization
Confirmatory Study Randomized Trial ≥2.25mm
TRYTON (N=133)
TRYTON(N=146)
Provisional(N=143)
Procedure Time (min) 64.6±26.2 68.7±30.7 55.9±27.3Fluoroscopy Time (min) 23.3±11.4* 24.0±13.8 11.6±5.4Contrast Used (ml) 248.2±85.6 269.2±98.3 227±88.7
*p <0.001
~10 min more and ~30 ml more contrast
NORDIC IV 2 stents(n=229)
92.6 min
22.8 min
238 ml
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TRYTON Confirmatory Study: Additional Stents (Site Reported)
2.2% (3/133)1.5% (2/133)
Dissection: 2Lesion Coverage: 0 Dissection: 1
Lesion Coverage: 2
Dissection: 1Lesion Coverage: 3
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TRYTON Confirmatory Study: Peri-Procedural MI 3x ULN CK-MB
16/143 14/133
%
Performance Goal: 17.9%
Primary Endpoint Met
Error bars represent 1-sided 95% CI
Pivotal Provisional ≥2.25mm
Confirmatory Study
11.2% 10.5%
16/143 14/133
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TRYTON Confirmatory Study: Peri-Procedural MI 5x ULN CKMB
Pivotal Provisional ≥2.25mm
Confirmatory Study
6.8%5.4%
7/103 7/130
%
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TRYTON Confirmatory Study: Procedural and 30-day Follow-up
Confirmatory Study Randomized Trial ≥2.25mm
Endpoints (%) TRYTON(N=133)
TRYTON(N=146)
Provisional(N=143)
DeathProcedural 0% (0) 0% (0) 0% (0)30 day 0% (0) 0% (0) 0% (0)
Myocardial Infarction
Procedural (3x CKMB) 10.5% (14/133) 9.2% (13/141) 12.1% (17/141)
Procedural (5x CKMB) 4.5% (7/133) 3.4% (4/118) 6.8% (7/103)
30 day 10.8% (14/130)* 8.2% (12/146) 11.9% (17/143)*
Stent Thrombosis 0% (0) 0.7% (1/146) 0.0% (0/143)
* 2 patients in Confirmatory study have not completed 30 day follow-up at datalock and 1 patient withdrew at 30 days
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TRYTON Confirmatory Study Conclusions
• The TRYTON Confirmatory Study, assessing the safety of the TRYTON stent in the treatment of bifurcation involving large side branches, met its primary endpoint (performance goal) related to peri-procedural MI
• This finding confirms the safety and efficacy of the TRYTON dedicated bifurcation stent in the treatment of bifurcation involving large sides branches
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TRYTON Confirmatory Study Conclusions
• In light of the higher procedural success rate, improved acute angiographic result, and higher rate of side branch patency at 9-month follow-up compared to provisional stenting, the TRYTON Confirmatory Study and the TRYTON IDE trial support the use of the dedicated bifurcation TRYTON stent in conjunction with standard DES in the treatment of bifurcation lesions involving large side branches
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Tryton-The Vision : To treat Bifurcation Lesions with the Same Ease, Confidence & Efficacy as Straight Lesions
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Thank You