Tryton Pivotal: Randomized Trial and Confirmatory Study - Key Messages

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