tryton pivotal: randomized trial and confirmatory study - key messages
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Martin B. Leon, MD Columbia University Medical Center
Cardiovascular Research FoundationNew York City
Tuesday, October 13, 2015
Tryton Pivotal: Randomized Trial andConfirmatory Study –
Implications for Everyday Practice Key Messages
5 mins
Disclosure Statement of Financial InterestTCT 2015 San Francisco, CA; Oct 11-15, 2015
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.
• 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 InnovationUnfulfilled Promises?
Tryton: The Sole Survivor!
Tryton Study Design
DES (main vessel) + Provisional side branch
Baseline Angiography – Eligible for Randomization
Angiographic F/Uat 9 months
Clinical F/U at 9 months
% DS side branchn~374
Tryton side branch + DES (main vessel)
TVF Primary Endpoint
N = 704
IVUS F/Uat 9 months
IVUS Cohort n~96
Clinical F/U at 9 months
Angiographic F/Uat 9 months
IVUS F/Uat 9 months
Largest Coronary Bifurcation RCT Ever!
Tryton Pivotal RCT
Genereux P. J Am Coll Cardiol 2015; 65:533-43Genereux P. Cath Cardiovasc Interv 2015; epub
Target Vessel Failure (TVF)Primary Endpoint (not met)
%
TVF Cardiac Death Target Vessel MI Clinically Driven TVR
02468
101214161820
12.8
0
10.7
3.6
17.4
0
15.1
4.7
Non Hierarchical
P= 0.108P = 0.109
P =0.564
ProvisionalTryton
%
TVF Cardiac Death Target Vessel MI Clinically Driven TVR0
2
4
6
8
10
12
14
16
18
15.6
0
12.1
4.3
11.3
0
9.2
3.5
P= 0.383
P = 0.563
P =0.769
ProvisionalTryton
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)
SB % Diameter Stenosis SB Binary Restenosis0
5
10
15
20
25
30
35
40
45
40.6
32.130.4
22.2
ProvisionalTryton
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
PIVOTAL Provisional ≥2.25 Confirmatory Study0
5
10
15
20
11.2 10.5
16/143 14/133
%
Performance Goal – 17.9%
Primary Endpoint Met
133 pts
Complex “True” Bifurcations’Value’ of Tryton
Take Home MessagesTryton 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 MessagesTryton 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
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