Martin B. Leon, MD for the Tryton Bifurcation Trial Investigators Columbia University Medical Center Cardiovascular Research Foundation New York City The Tryton Bifurcation Trial: A randomized comparison of a provisional one- stent vs. a dedicated two-stent strategy for true bifurcation coronary lesions
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Martin B. Leon, MD for the T ryton Bif u rcati o n T rial I n vestig a tors
The T ryton Bifurcation T ria l : A ra n domi z ed co mp a ri s on of a p r o visi o n a l one - s t e n t v s. a d e d ic at e d t w o - s t e n t stra te g y for tru e bifurc at i on c o r o n a r y l es i o ns. Martin B. Leon, MD for the T ryton Bif u rcati o n T rial I n vestig a tors - PowerPoint PPT Presentation
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Martin B. Leon, MDfor the Tryton Bifurcation Trial
Investigators
Columbia University Medical Center Cardiovascular Research Foundation New York City
Wednesday, October 30, 2013
The Tryton Bifurcation Trial: A randomized comparison of a provisional
one-stent vs. a dedicated two-stent strategy for true bifurcation coronary lesions
Disclosure Statement of Financial InterestTCT 25: San Francisco, CA; Oct 27 - Nov 1, 2013
Martin B. Leon, MDWithin the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
• Research Support (CUMC)
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• Abbott, Boston Scientific, Medtronic
• None
• None
Affiliation/Financial Relationship Company
Purpose of the Study
• To compare the clinical outcomes and angiographic results of the accepted provisional one-stent strategy vs. the Tryton bifurcation two-stent approach in a randomized controlled trial of true coronary bifurcation lesions.
• Single de novo “true” bifurcation lesion in a native coronary artery involving both the main vessel and the side branch (Medina classification 1.1.1, 1.0.1, or 0.1.1 by visual assessment)
• Symptoms or objective evidence of ischemia• Vessel diameter: main vessel ≥ 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• Limited treatment of multi-vessel disease and staging,
per protocol (after successful treatment of ≤ 2 non- complex, non-target lesions)
Inclusion Criteria
Clinical…• STEMI < 72 hours or STEMI/non-STEMI > 72 hours and
increased CK-MB• Hemodynamic instability• Creatinine > 2.5 mg/dL or dialysis• Bleeding diathesis or hypersensitivity to anticoagulant meds• LVEF < 30%
Anatomic…• Left main disease (unprotected or protected)• Trifurcation lesion• Complex morphology: severe Ca++, thrombus, TIMI 0/1 flow,
severe tortuosity
Key Exclusion Criteria
• Study design: Intention-to-treat (ITT) is primary analysis cohort, 1:1 randomization
• Secondary Endpoint: % diameter stenosis (in-segment) of side branch at 9 monthsfollow-up (angiographic cohort only): superiority
Primary and Secondary Endpoints
Operator Technique RecommendationsTryton
• Pre-dilation (optimal lesion preparation)• Tryton placement followed by POT (at ostium)• DES placement followed by final kissing balloon
dilation (with NC balloons)
Provisional• Standard operator technique for pre-dilation and DES
placement• Side branch intervention (balloons or stents) only
if…< TIMI 3 flow, ≥ type B dissection, or > 80% stenosis
• Final kissing balloon dilation (with NC balloons)
Trial AdministrationPrincipal Investigator
Martin B. Leon MDColumbia University Medical Center
Study ChairmanPatrick W. Serruys MD, PhD Erasmus MC, Rotterdam Imperial College, London
Executive CommitteeAntonio Bartorelli MD, Thierry Lefèvre MD Pieter Stella MD PhD, William Fearon MD James Hermiller MD, Dean Kereiakes MD David Williams MD
Data Management and BiostatisticsDonald E. Cutlip MDHarvard Clinical Research Institute
Data Safety Monitoring Board Chairman: Robert S. Safian MD Beaumont Health System
Clinical Events CommitteeDonald E. Cutlip MDHarvard Clinical Research Institute
Angiographic Core LabPhilippe Généreux MDCardiovascular Research Foundation
Side BranchRVD (mm) 2.24±0.31 2.29±0.29 0.103MLD (mm)
In-stent na 1.67±0.62 naIn-segment 1.36±0.38 1.56±0.56 <0.001
% DSIn-stent na 26.72±25.44 naIn-segment 38.63±16.16 31.57±22.91 0.002
31.6
Tryton50
P=0.00240
38.6
20
10
0
Secondary Superiority Endpoint Met
30
60 Provisional
Side Branch %DS (In-segment)Secondary Endpoint
%
Side Branch % DS (In-segment)Baseline
80%
60%
40%
20%
0
100%
0 20 40
60
% Diameter Stenosis
80 100
Per
cent
of P
atie
nts
Provisional Tryton
Side Branch % DS (In-segment)Final
80%
60%
40%
20%
0
100%
0 20 40
60
% Diameter Stenosis
80 100
Per
cent
of P
atie
nts
Provisional Tryton
Side Branch % DS (In-segment)9-Month FU
80%
60%
40%
20%
0
100%
0 20 40
60
% Diameter Stenosis
80 100
Per
cent
of P
atie
nts
Provisional Tryton
Angiographic ResultsBinary Restenosis (9 months)
Provisional Tryton P-Value(N=168) (N=158)
Main Vessel (%)In-stent 1.8 4.4 0.208
In-segment 8.9 10.1 0.851
Side Branch (%)In-stent na 20.4 na
In-segment 26.8 22.6 0.439
MV or SB (Total, %)In-stent na 21.6 na
In-segment 33.3 28.2 0.337
Restenosis Location (QCA)
Provisional
Proximal 9 (5.4%)
Restenosis @ SB ostium: 75% Provisional62% Tryton
Tryton
Proximal10 (6.3%)
Post-hoc SubsetAnalyses
Tryton Bifurcation Study
Target Vessel - MI3X, 5X, 10X CK-MB Only Criteria
%
6.6
3.3P = 0.123
0.3 1.7
9.6
5.2
20181614121086420
3X 5X 10X
P= 0.162
P = 0.256
ProvisionalTryton
Occulostenotic ParadoxRestenosis vs. TLR
(Side Branch)
24.5
2.2
%
504540353025201510
50
Combined Tryton Provisional
91.5%
RestenosisTLR
26.822.6 88.5% 94.4%
2.9 1.5
%
18
16
14
12
10
8
6
4
2
0
15.6
0 0
Cardiac Death
12.1
4.3
11.3
9.2
3.5
TVF Target Vessel MI Clinically Driven TVR
Non Hierarchical
P= 0.383
P = 0.563
P =0.769
ProvisionalTryton
Target Vessel Failure (TVF)Side Branch ≥ 2.25 mm
Provisional (N=141) Tryton (N=141)
Diff (95% CI) = -4.3% (-12.2, 3.7%)
40.6
SB In-segment % DS Binary Restenosis
ProvisionalTryton
P = 0.26032.1
22.2
30.4
%50454035302520151050
P = 0.004
Angiographic Outcomes (QCA)Side Branch ≥ 2.25 mm
Provisional (N=81) Tryton (N=63)
Conclusions• The Tryton two-stent strategy in true bifurcations
(88%) compared with the provisional strategy (8.0% side branch stents) did not meet the non-inferiority clinical endpoint (TVF), due to a relatively higher frequency of small peri-procedural CK-MB elevations.
• However, both strategies were safe (rare clinically significant MIs and stent thrombosis) and both had low 9-month clinically-driven TVR (P:3.6%,T:4.7%).
• DES in the main vessel performed well in both arms.• Tryton improved side branch % diameter stenosis
at FU (secondary endpoint; P=0.002)
Conclusions• Post-hoc subset analyses indicated:
A striking disparity between binary restenosis and clinically-driven TVR for both arms, indicating that side branch angiographic restenosis is uncommonly expressed clinically.
Improved clinical and angiographic outcomes with Tryton in larger side branches (> 2.25 mm side branches = 41% of enrolled patients).
Clinical Implications
• It’s difficult to enroll complex “high-risk” bifurcationlesions in clinical trials (only 41% had side branches≥ 2.25 mm).
• Small peri-procedural CK-MB elevations occur more frequently with a two-stent strategy and dominate the clinical endpoint (TVF).
• Moderate stenoses in smaller side branches are not clinically active (occulostenotic paradox).
• In larger side branches (≥ 2.25 mm), a Tryton two-stent strategy improved side branch angiographic results and clinical outcomes.