MD Columbia University Medical Center Cardiovascular Research Foundation New York City Tuesday October 13 2015 Tryton Pivotal Randomized Trial and Confirmatory Study Implications for ID: 625903
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Slide1
Martin B. Leon, MD
Columbia University Medical CenterCardiovascular Research FoundationNew York City
Tuesday, October 13, 2015
Tryton
Pivotal: Randomized Trial andConfirmatory Study – Implications for Everyday Practice Key Messages
5 minsSlide2
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
CompanySlide3
TCT 2005: Stent Technology InnovationUnfulfilled Promises?
Tryton
:
The Sole
Survivor!Slide4
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
!Slide5
Tryton Pivotal RCTGenereux P. J Am
Coll Cardiol 2015; 65:533-43
Genereux P. Cath
Cardiovasc Interv 2015; epubSlide6
Target Vessel Failure (TVF)
Primary Endpoint (not met)
%
Non Hierarchical
P
= 0.108
P
= 0.109
P
=0.564
Provisional
TrytonSlide7
%
P
= 0.383
P
= 0.563P =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)Slide8
Provi
sional N=81,
Tryton =64
%
Angiographic Outcomes (QCA)Side Branch ≥ 2.25 mm 9 MonthsSlide9
Confirmatory Study: Primary Endpoint
Peri
-Procedural MI 3x ULN CKMB
14/133
%Performance Goal – 17.9%Primary Endpoint Met133 ptsSlide10
Complex “True” Bifurcations
’Value’ of
TrytonSlide11
Take Home MessagesTryton in BifurcationsThe 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 stentingResults in better acute angiographic resultsHas a similar low frequency of complications (MIs and stent thrombosis)Slide12
Take Home MessagesTryton in BifurcationsThe 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 resultsLM Tryton; the new standard for LM bifurcation stenting