Supplementary Table 1. Inclusion and Exclusion Criteria
Inclusion
Patients must meet ALL of the following criteria:
Criteria
General Inclusion Criteria
1. The patient must be ≥18 and ≤ 90 years of age;
2. Symptomatic ischemic heart disease (CCS class 1-4, Braunwald
Class IB, IC, IIB, IIC, IIIB, IIIC, and/or have objective evidence of
myocardial ischemia);
3. Acceptable candidate for CABG;
4. Intent to treat the side branch of the target bifurcation based on
angiographic evaluation;
5. The patient is willing to comply with specified follow-up evaluations;
6. The patient or legally authorized representative has been informed of
the nature of the study, agrees to its provisions and has been provided
written informed consent, approved by the appropriate Medical
Ethics Committee (MEC) or Institutional Review Board (IRB).
7. Planned use of one of the following approved and commercially
available drug-eluting
stents
for subject’s index
procedure:
CYPHER®, RESOLUTE Family of products (ENDEAVOR®
RESOLUTE or RESOLUTE INTEGRITY), PROMUS®, PROMUS
ELEMENT Family of products (PROMUS® ELEMENT or
PROMUS ELEMENT PLUS), XIENCE™ Family of products,
XIENCE V, or XIENCE PRIME, XIENCE Xpedition and XIENCE
PRO.
Angiographic Inclusion Criteria
8. a) Single de novo lesion in a bifurcation involving both the main
branch and the side branch
b) The bifurcation: main branch and side branch with a visual
diameter stenosis ≥ 50% (Medina classification 1.1.1; 0.1.1; 1.0.1 by
visual assessment);
9. Target lesion located in a native coronary artery;
10. a) Bifurcation lesion main branch reference vessel diameter must be
≥ 2.5 mm to ≤ 4.0 mm, and
b) Side branch reference vessel diameter must be ≥2.5 mm to ≤ 3.5
mm by visual estimate;
11. a) Bifurcation lesion main branch lesion length ≤ 28 mm and
b) Side branch lesion length ≤ 5.0 mm (the ability to be treated with a
single stent for both main and side branch);
12. Target lesion ≥50% and <100% stenosed by visual estimate in both
the main branch and side branch;
13. Patients with multi-vessel coronary disease must have successful
treatment of no more than two distinct non-target lesions (<30%
diameter stenosis by visual estimate without intra-procedural
complication*) with approved devices during the index procedure
and prior to the target lesion treatment, provided non-target lesion(s):
(1) include no more than one lesion in the main branch target
vessel distinct from and distal to the target lesion provided
this non-index lesion is:
a. >10 mm from the margin of the index lesion
b. ≥2.25 mm in diameter, and
c. meets 2, 3, 4, and 5 below
(2) are not >28 mm (no overlapping stents),
(3) were not 100% occluded at baseline,
(4) are not highly calcified requiring rotoblator use and
(5) are not bifurcations.
*In addition to standard definitions of procedural success,
the non-target lesion intervention should be free of interprocedural event(s) which are likely to lead to CK-MB
elevation, i.e., no-reflow, flow-limiting dissection, loss of
side branch (<2.25 mm).
Randomization and inclusion in the ITT cohort will occur after repeat
angiography documenting successful treatment of the non-target
lesion(s) and baseline characteristics of the target lesion are assessed.
14. Patients with multi-vessel coronary disease may undergo successful
treatment of no more than two distinct non-target lesions (<30%
diameter stenosis by visual estimate without intra-procedural
complication*) with approved devices up to 60 days prior to target
lesion treatment, provided non-target lesion(s):
(1) include no more than one lesion in the main branch target
vessel distinct from and distal to the target lesion provided
this non-index lesion is:
a. >10 mm from the margin of the index lesion
b. ≥2.25 mm in diameter, and
c. meets 2 and 3 below
,
(2) are not >28 mm (no overlapping stents), and
(3) are not bifurcations.
Randomization and inclusion in the ITT cohort will occur after repeat
angiography documenting successful treatment of the non-target
lesion(s) and baseline characteristics of the target lesion are assessed.
If the non-target lesion intervention has been performed fewer than
14 days prior to the index procedure intervention, normal baseline
CK-MB must be documented.
Note: If CK-MB analysis is not available on-site, patients may
be included if serial Troponins (6 hours apart) are obtained
and demonstrate a downward trend. Baseline and follow-up
samples must be obtained for central lab CK-MB analysis.
Exclusion
Patients will be excluded if ANY of the following conditions apply:
Criteria
General Exclusion Criteria
1. Pregnant or nursing patients and those who plan pregnancy in the
period up to 1 year following index procedure. Female patients of
child-bearing potential must have a negative pregnancy test done
within 7 days prior to the index procedure per site standard test;
2. Patient has had a known diagnosis of STEMI acute myocardial
infarction (AMI) within 72 hours preceding the index procedure or
>72 hours preceding the index procedure and CK and CK-MB have
not returned to within normal limits* at the time of procedure;
3. Patients with non-STEMI within 7 days prior to index procedure with
continued CK-MB elevation*;
4. Patients with non-target lesion PCI within 14 days prior to index
procedure with continued CK-MB elevation*;
*Note: If CK-MB analysis is not available on-site, patients
may be included if serial Troponins (6 hours apart) are
obtained and demonstrate a downward trend. Baseline and
follow-up blood samples must be obtained for central lab CKMB analysis.
5. Impaired renal function (serum creatinine >2.5 mg/dl or 221 μmol/l)
or on dialysis;
6. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC
<3,000 cells/mm3;
7. Patient has a history of bleeding diathesis or coagulopathy or patients
in whom anti-platelet and/or anticoagulant therapy is contraindicated,
or any other significant medical condition which in the Investigator’s
opinion may interfere with the patient’s optimal participation in the
study;
8. Patient has received an organ transplant or is on a waiting list for any
organ transplant;
9. Patient has other medical illness (e.g., cancer, known malignancy, or
congestive heart failure) or known history of substance abuse
(alcohol, cocaine, heroin etc.) that may cause non-compliance with
the protocol, confound the data interpretation or is associated with a
limited life expectancy (i.e., less than 1 year);
10. Patient has a known hypersensitivity or contraindication to aspirin,
heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, ticagrelor,
stainless steel alloy, cobalt-chromium alloy, rapamycin, everolimus,
zotarolimus, paclitaxel, and/or contrast sensitivity that cannot be
adequately pre-medicated;
11. Patient presents with cardiogenic shock or cardiac arrhythmias that
create hemodynamic instability;
12. Patient in whom a surgical or other procedure is planned within the
next year which would require discontinuation of dual antiplatelet
therapy;
13. Currently participating in another investigational drug or device study
or patient inclusion in another investigational drug or device study
where the primary endpoint of the study has not been reached.
14. Patient with any history of coronary brachytherapy treatment;
Angiographic Exclusion Criteria
15. Left main coronary artery disease (protected and unprotected);
16. Trifurcation lesion;
17. Totally occluded target vessel (TIMI flow 0 or 1);
18. Severely calcified target lesion(s);
19. Highly calcified target lesion(s) requiring rotational atherectomy;
20. Target lesion has excessive tortuosity unsuitable for stent delivery
and deployment;
21. Angiographic evidence of thrombus in the target lesion(s);
22. A significant (>50%) stenosis with an RVD of >2.0mm proximal or
distal to the target lesion in either the side branch or main branch that
cannot be covered by a single stent;
23. Diffuse distal disease to target lesion with impaired runoff;
24. Left ventricular ejection fraction (LVEF) 30% (LVEF must be
obtained within 6 months prior to the index procedure);
25. Planned pre-treatment with devices other than balloon angioplasty.
Cutting balloons, AngioSculpt® balloons, atherectomy devices, or
similar devices are not permitted;
26. Intervention (PCI or bypass) of another lesion performed within
6 months, except as noted in Steps 13 and 14 of the Angiographic
Inclusion Criteria Section, before or planned following the index
procedure;
27. Lesions located with proximal edge of main branch <10 mm from a
non-target large side branch (>2..0mm) causing Tryton stent to
obstruct large side branch if implanted (for the purposes of this study,
septal branches are not included);
28. Lesions with proximal edge of main branch <10 mm from the RCA,
LCX or LAD origin causing Tryton stent to obstruct parent vessel if
implanted.
Supplementary Table 2. Enrolling sites
Patients Enrollment by Clinical Site –United States
Principal
Site Name
Providence Regional Medical
City, State
Investigator(s)
Everett, WA
Mahesh Mulumudi
Tallahassee,
Wayne Batchelor
Center
Tallahassee Research Institute, Inc.
FL
Northwestern University
Dartmouth Hitchcock Medical
Chicago, IL
Charles Davidson
Lebanon, NH
James De Vries
Atlanta, GA
John Douglas
Stanford, CA
William Fearon
Pensacola,
Franklin James
FL
Fleischhauer
Indianapolis,
James Hermiller
Center
Emory University Hospital
Interventional Cardiology
Stanford University Medical Center
Cardiology Consultants at Sacred
Heart Hospital
The Care Group, LLC (St. Vincent
Heart Center of Indiana, LLC)
The Carl and Edyth Lindner Center
for Research and Education at the
Christ Hospital
IN
Cincinnati,
OH
Dean Kereiakes
Patients Enrollment by Clinical Site –United States
Principal
Site Name
Wake Forest University Baptist
City, State
Investigator(s)
Winston
Michael Kutcher
Medical Center
Salem, NC
Columbia University Medical
New York,
Marty Leon,
NY
Jeff Moses
Kingsport,
Chris Metzger
Center, Center for Interventional
and Vascular Therapy
Wellmont CVA Heart Institute
(Wellmont Holston Valley Medical
TN
Center)
Swedish Medical Center
Seattle, WA
Mark Reisman
Scottsdale,
David Rizik
Cardiovascular Research
Scottsdale Healthcare
AZ
Mid America Heart Institute at
Saint Luke’s Hospital
Yale-New Haven Hospital
Kansas City,
Barry Rutherford
MO
New Haven,
Michael Cleman
CT
Austin Heart PLLC
Austin, TX
Matthew Selmon
Brigham & Women’s Hospital
Boston, MA
Pinak Shah
Patients Enrollment by Clinical Site –United States
Principal
Site Name
Florida Hospital Cardiovascular
City, State
Investigator(s)
Orlando, FL
Raviprasad Subraya
Takoma
Mark Anthony Turco
Research
Washington Adventist Hospital
Park, MD
Cardiovascular Group (St. Joseph’s
Atlanta, GA
Marc Unterman
Baltimore,
John Wang
Research Institute)
Union Memorial Hospital
MD
Weill Cornell Medical College
New York,
Shing Chiu Wong
NY
The Gerald McGinnis
Cardiovascular Institute (Allegheny
Pittsburgh,
David Lasorda
PA
General Hospital)
University of Illinois at Chicago
Chicago, IL
Mladen Vidovich
Miami, FL
Mauricio Cohen
Durham, NC
Manesh Patel
Medical Center
University of Miami Miller School
of Medicine, University of Miami
Duke University Hospital
Patients Enrollment by Clinical Site –United States
Principal
Site Name
University of North Carolina
Division of Cardiology
Mount Sinai Medical Center
Cardiovascular Institute
Mediquest Research Group at
City, State
Investigator(s)
Chapel Hill,
George Andrew Stouffer
NC
New York,
Samin Sharma
NY
Ocala, FL
Robert Feldman
Providence,
Paul Clark Gordon
Munroe Regional Medical Center
The Miriam Hospital
RI
Wake Heart Research
Raleigh, NC
J. Tift Mann
Geisinger Clinic
Danville, PA
James Blankenship
Asheville,
William Borden
NC
Abernethy, III
Daytona
David Henderson
Asheville Cardiology Associates
Cardiology Research Associates
Beach, FL
Mount Sinai Medical Center
Cardiology Research
Miami
Beach, FL
Nirat Beohar
Patients Enrollment by Clinical Site – Out of United States
Site Name
City, Country
Principal Investigator
Riga, Latvia
Indulis Kumsars
Jerusalem, Israel
Yaron Almagor
Petah-Tikva, Israel
Abid Assali
UZ Brussel
Brussels, Belgium
Peter Kayaert
ZOL Genk
Genk, Belgium
Jo Dens
CHU de Liège
Liege, Belgium
Victor Legrand
Antwerp, Belgium
Glenn Van Langenhove
Bruges, Belgium
Luc Muyldermans
Utrecht, the
Pieter R. Stella
P. Stradins University Hospital
Shaare Zedek – Jerusalem
Rabin Medical Center & Tel Aviv
University
Algemeneen Ziekenhuis
Middelheim
AZ Sint Jan
University Medical Center Utrecht
Netherlands
Erasmus University Medical Center
Rotterdam
St Antonius Ziekenhuis
Rotterdam,
Robert-Jan M. Van Geuns
the Netherlands
Nieuwegein,
M. J. Suttorp
the Netherlands
Amphia Hospital
Breda, the
Netherlands
Peter den Heijer
Patients Enrollment by Clinical Site – Out of United States
Site Name
Amsterdam Medical Center
City, Country
Principal Investigator
Amsterdam,
Joanna Wykrzkowska
the Netherlands
Hagaziekenhuis Den Haag
Den Haag,
Pranoba Oemrawsingh
the Netherlands
OLVG
Amsterdam,
Ton Slagboom
the Netherlands
Karol-Marcinkowski University
Poznan, Poland
Maciej Lesiak
Bydgoszcz, Poland
Jacek Kubica
University Hospital Krakow
Krakow, Poland
Dariusz Dudek
Beaumont Hospital
Dublin, Ireland
David P. Foley
Szeged, Hungary
Imre Ungi
Budapest, Hungary
Geza Fontos
Hospital Clinico San Carlos
Madrid, Spain
Eulogio Garcia
Institut Jacques Cartier
Massy, France
Thierry Lefevre
Toulouse Cedex 9,
Didier Carrie
Hospital
Antoni Jurasz University Hospital
University Hospital Szeged
National Institute of Cardiology
Hopital Rangueil
France
Clinique Pasteur
Paris, France
Bruno Farah
Monzino Hospital
Milan, Italy
Antonio L. Bartorelli
Patients Enrollment by Clinical Site – Out of United States
Site Name
Azienda Ospedaliera di Padova
New Cross Hospital
City, Country
Principal Investigator
Padova, Italy
Giuseppe Tarantini
Wolverhampton,
Michael S. Norell
United Kingdom
Castle Hill Hospital
East Yorkshire,
Angela Hoye
United Kingdom
Golden Jubilee
Dunbartonshire,
United Kingdom
Keith Oldroyd
Principal Investigator
Martin B. Leon MD
Columbia University Medical Center
Study Chairman
Patrick W. Serruys MD, PhD
Erasmus MC, Rotterdam
Executive Committee
Antonio Bartorelli MD
William Fearon MD
James Hermiller MD,
Dean Kereiakes MD
Thierry Lefèvre MD
Pieter Stella MD PhD,
David Williams MD
Data Management and Biostatistics
Donald E. Cutlip MD
Harvard Clinical Research Institute
Sponsor
Tryton Medical, Inc.
Aaron V. Kaplan MD,
Linn Laak BSN
Data Safety Monitoring Board
Chairman: Robert S. Safian MD
Beaumont Health System
Clinical Events Committee
Donald E. Cutlip MD
Harvard Clinical Research Institute
Angiographic Core Lab
Philippe Généreux MD
Cardiovascular Research Foundation
IVUS & 3D Angiographic Core Lab
Hector Garcia-Garcia MD, PhD
Cardialysis, Rotterdam, The Netherlands
Clinical Monitoring
genae associates nv
Antwerp, Belgium
Clinipace
Irvine, California
Supplementary Table 3. Clinical Endpoints and Quantitative Coronary
Angiography Methodology
Clinical Endpoints and Quantitative Coronary Angiography Methodology
Primary Endpoint (non-inferiority):
Target Vessel Failure (TVF) defined as the composite of cardiac death, target vessel
myocardial infarction (Q wave or non-Q wave) and target vessel revascularization (main
branch or side branch) of the Tryton Side Branch StentTM with main branch DES
compared to side branch balloon angioplasty and main branch DES at 9 months.
Secondary Endpoints (superiority):
Powered Secondary Angiographic Endpoint (Angiographic Cohort):
In-segment % diameter stenosis of the Tryton Side Branch StentTM compared to side
branch balloon angioplasty at 9 months post-procedure.
Additional Endpoints:
Safety:
1.
All-cause and cardiac mortality at 30 days, 6 and 9 months, and annually up to 5
years;
2.
Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual
at 30 days, 6 and 9 months, and annually up to 5 years;
3.
Major Adverse Cardiac Event (MACE) defined as a composite of all cause death,
MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG),
or target lesion revascularization (TLR) by repeat PTCA or CABG at hospital
discharge, 30 days, 6 and 9 months, and annually up to 5 years;
4.
The composite of cardiac death, myocardial infarction (Q wave or non-Q wave) >
30 days post-procedure, stent thrombosis, and target vessel revascularization
(main branch or side branch);
5.
Rates of stent thrombosis using ARC definition of definite and probable stent
thrombosis and categorized as early, late or very late, at 30 days, 6 and 9 months,
and annually up to 5 years.
Effectiveness:
6.
Device success, defined as attainment of <30% residual stenosis within the side
branch;
7.
Lesion success defined as attainment of <50% residual stenosis using any
percutaneous method;
8.
Procedure success defined as lesion success without the occurrence of in-hospital
MACE;
9.
Clinically or ischemia-driven target lesion revascularization at 30 days, 6 and 9
months, and annually up to 5 years;
10.
Clinically or ischemia-driven target vessel revascularization at 30 days, 6 and 9
months, and annually up to 5 years;
11.
Clinically or ischemia-driven target vessel failure (defined as cardiac death, target
vessel MI (Q wave or non-Q wave) or target vessel revascularization TVR) at 30
days, 6 and 9 months, and annually up to 5 years;
12.
Clinically or ischemia-driven target lesion failure (defined as cardiac death, target
lesion MI (Q wave or non-Q wave) or target lesion revascularization TLR) at 30
days, 6 and 9 months, and annually up to 5 years;
13.
Target lesion failure (TLF) defined as cardiac death, target lesion MI (Q wave or
non-Q wave) and target lesion revascularization (TLR) at 30 days, 6 and 9
months, and annually up to 5 years.
Angiographic Cohort
1.
In-stent and in-segment angiographic binary restenosis in the main branch and
bifurcation lesion at 9 months;
2.
In-stent and in-segment lesion minimal lumen diameter (MLD) in the side branch,
main branch at 9 months;
3.
In-stent, proximal and distal side branch, and main branch late lumen loss at 9
months.
Angiographic analysis: Bifurcation Methodology
For the QCA analysis, QAngio XA QCA software (version 7.2.34) was used (Medis
Medical Imaging Systems, Leiden, The Netherlands). At the start of the trial, bifurcation
QCA algorithms were not yet validated against precision phantoms, and therefore it was
decided to use the conventional single-vessel algorithm. The main branch (proximal and
distal from the side branch) and side branch were analyzed separately. After calibration
and automatic detection of the vessel contour by the QCA software, manually editing of
the vessel contour was allowed when the contour did not appeared to be smooth or
appropriately delineated. The main branch reference vessel diameter (RVD) was defined
as the average between the proximal and distal RVD. The percentage diameters stenosis
(%DS) of the main branch was calculated by dividing the absolute difference of the
minimal lumen diameter (MLD) and the RVD (RVD-MLD) by the RVD itself. Since
conventional single vessel QCA software does not recognize the side branch origin,
segmentation of the bifurcation lesion was performed manually, with the carinal point as
the beginning of the side branch segment. To calculate the %DS of the side branch, only
the distal RVD of the side branch was taken into account. Pre-procedural, post-procedural
and 9-month follow-up QCA results were reported according to two segments (main
branch and side branch).
In addition, a post-hoc QCA analysis (9-month follow-up only) was performed using
bifurcation QCA software (Coronary Angiography Analysis System [CAAS], version
5.10, Pie Medical Imaging, Maastricht, the Netherlands). For each bifurcation, only one
analysis was performed, including the proximal main branch, distal main branch, and side
branch segments. After automatic vessel contour detection, the point of bifurcation
(POB) is automatically determined by the software and is defined as the midpoint of the
largest circle that can be fitted in the bifurcation area, touching all three contours. The
centerlines of each of the three segments meet at the POB. Segmentation of the
bifurcation in three individual segments was performed automatically using the POB and
centerlines. %DS was automatically calculated using the interpolated RVD at the MLD
site of each segment.
Supplementary Table 4. Procedural and Devices Characteristic
Tryton Stent
Provisional
P Value
(N = 355)
(N = 349)
314/352 (89.2)
277/347 (79.8)
<0.001
Balloon diameter (mm)
2.55±0.45
2.49±0.33
0.059
Balloon length (mm)
13.92±3.13
14.74±3.67
0.004
Balloon pressure (atm)
11.73±3.17
11.77±3.11
0.90
339/354 (95.8)
205/337 (60.8)
<0.001
Balloon diameter (mm)
2.40±0.29
2.35±0.38
0.07
Balloon length (mm)
13.55±3.06
13.88±3.39
0.24
Balloon pressure (atm)
10.61±2.96
10.88±3.30
0.32
317/355 (89.3)
309/348 (88.8)
0.90
Not attempted
23/355 (6.5)
30/348 (8.6)
0.32
Unsuccessful
15/355 (4.2)
9/348 (2.6)
0.30
Main branch balloon diameter
3.11±0.41
3.06±0.42
0.10
Main branch balloon length
14.77±3.95
14.41±3.53
0.22
Main branch balloon pressure
11.11±4.20
11.29±3.90
0.56
Side branch balloon diameter
2.57±0.37
2.43±0.39
<0.001
Side branch balloon length
13.39±3.25
13.77±3.5
0.15
Pre-dilatation of the main vessel
performed
Pre-dilatation of the side branch
performed
Final kissing balloon technique
Attempted
Side branch balloon pressure
10.82±4.10
10.41±3.62
0.18
Tryton stent successfully delivered
341/355 (96.1)
2/349 (0.6)
<0.001
2.5/2.5 x 19 mm
30/341 (8.8)
—
3.0/2.5 x 19 mm
144/341 (42.2)
—
3.5/2.5 x 19 mm
113/341 (33.1)
2/2 (100)
3.5/3.0 x 18 mm
50/341 (14.7)
—
4.0/3.5 x 18 mm
4/341 (1.2)
—
349/355 (98.3)
344/349 (98.6)
Main vessel-study stent
Drug-eluting stent successfully deployed
Drug-eluting stent type
0.67
Everolimus-Xience
206/349 (59.0)
203/343 (59.2)
Everolimus-Promus
96/349 (27.5)
105/343 (30.6)
Zotarolimus-Resolute Integrity
21/349 (6.0)
18/343 (5.2)
Zotarolimus-Endeavor
15/349 (4.3)
9/343 (2.6)
Sirolimus
11/349 (3.2)
8/343 (2.3)
Other
0/349 (0.0)
1/344 (0.3)
43/355 (12.1)
59/349 (16.9)
Non-target lesion treated
0.78
Additional non-study stent implanted*
0.09
0.28
0
259/355 (73.0)
241/349 (69.1)
1
72/355 (20.3)
83/349 (23.8)
2
17/355 (4.8)
17/349 (4.9)
≥3
7/355 (2.0)
8/349 (2.3)
Bare metal stent
9/129 (7.0)
3/143 (2.1)
0.07
Drug-eluting stent
120/129 (93.0)
140/143 (97.9)
6/355 (1.7)
5/349 (1.4)
1.00
Rotational atherectomy
2/6 (33.3)
2/5 (40.0)
1.00
Cutting or AngioSculpt balloon
1/6 (16.7)
2/5 (40.0)
0.55
Other
3/6 (50.0)
1/5 (20.0)
0.55
Procedure time (min)
70.5±33.1
56.9±31.5
<0.001
Fluoroscopic time (min)
25.3±14.4
19.3±12.7
<0.001
260.9±105.5
223.3±92.5
<0.001
Adjunctive devices
Contrast volume (mL)
*Defined as additional stents used during the procedure, including non-target lesion
Supplementary Table 5. Post-hoc QCA analysis using dedicated bifurcation software according to the
three-segment model
Tryton Stent
(N = 156*)
Balloon
angioplasty
(N = 167*)
P Value
Proximal main branch
3.27±0.52
3.32±0.54
0.35
In-segment RVD (mm)
2.57±0.60
2.65±0.54
0.24
In-segment MLD (mm)
21.19±14.47
20.11±11.44
0.46
In-segment %DS (%)
Distal main branch
2.62±0.42
2.70±0.44
0.09
In-segment RVD (mm)
2.03±0.46
2.11±0.48
0.12
In-segment MLD (mm)
22.26±13.06
21.81±11.94
0.75
In-segment %DS (%)
Side Branch
In-segment RVD (mm)
2.06±0.39
2.18±0.41
0.009
In-segment MLD (mm)
1.34±0.46
1.47±0.41
0.006
In-segment %DS (%)
34.75±19.61
32.03±16.28
0.18
QCA: quantitative coronary angiography, RVD: reference vessel diameter, %DS: percentage diameter
stenosis, MLD: minimal lumen diameter. *In three patients (2 in the Tryton group, 1 in the balloon
angioplasty group) the post-hoc analysis using bifurcation software was not possible because of technical
issues.
Supplementary Figure Legends
Supplementary Figure 1. Tryton Side Branch Stent.
The Tryton Side Branch Stent consists of a non drug-eluting stent made of three zones: 1)
side branch zone, 2) transition zone, and 3) main branch zone. The side branch zone is a
typical slotted tube design for insertion into the side branch, the transition zone is
composed of undulating struts designed to provide adequate radial strength and coverage
throughout the carina, and the main branch zone has a minimal metal-to-artery ratio
intended as an open path for a main branch stent which will further lock the Tryton Side
Branch Stent in place. Tryton stent sizing available at the time of the study were
(MB/SB) 2.5/2.5 mm, 3.0/2.5 mm, 3.5/2.5 mm, 3.5/3.0 mm, and 4.0/3.5 mm.
Supplementary Figure 2. Medina Bifurcation Classification at Baseline
(A) Site reported and (B) angiographic core laboratory reported. T denotes Tryton, P
provisional.
Supplementary Figure 3. Time-to-Event Curves for the Primary and Other Selected End
Points.
Comparison of the cumulative event rates through nine months of (A) Target vessel failure,
(B) Target vessel myocardial infarction, (C) Clinically-driven target vessel revascularization,
(D) Academic Research Consortium defined stent thrombosis (definite/probable). KaplanMeier rate estimates. TVR denotes target vessel revascularization, MI myocardial infarction,
and ARC Academic Research Consortium.
Supplementary Figure 1
Main Branch
Zone
Transition
Zone
Side Branch
Zone
Supplementary Figure 2A
T: 73.2%
P: 68.7%
T: 11.5%
P: 12.4%
T: 14.6%
P: 18.7%
True
Bifurcation
T: 99.3%
P: 99.8%
T: 0.3%
P: 0%
T: 0%
P: 0%
T: 0%
P: 0%
T: 0.3%
P: 0.3%
Supplementary Figure 2B
T: 49.2%
P: 42.1%
T: 1.4%
P: 2.6%
T: 15.8%
P: 16.0%
T: 2.3%
P: 4.9%
T: 24.9%
P: 28.1%
T: 2.8%
P: 4.0%
True
Bifurcation
T: 89.9%
P: 86.2%
T: 3.4%
P: 2.3%
Target Vessel Failure (%)
Supplementary Figure 3A
50%
Provisional
Tryton
40%
HR: 1.38 [95% CI: 0.93, 2.05]
P (log rank) = 0.09
30%
20%
17.0%
12.4%
10%
0
1
2
3
5
4
Months
6
7
8
9
355
310
309
306
304
301
297
291
289
288
Provisional 349
315
310
307
306
304
304
302
300
299
0
No. at Risk
Tryton
Supplementary Figure 3B
Target Vessel MI (%)
50%
Provisional
Tryton
40%
HR: 1.43 [95% CI: 0.93, 2.17)
P (log rank) = 0.08
30%
20%
14.7%
10.3%
10%
0
1
2
3
5
4
Months
6
7
8
9
355
310
309
307
305
303
300
298
297
296
Provisional 349
315
311
308
308
308
308
307
307
306
0
No. at Risk
Tryton
Clinically-driven TVR (%)
Supplementary Figure 3C
10%
Provisional
Tryton
8%
HR: 1.32 [95% CI: 0.62, 27.8]
P (log rank) = 0.47
6%
4.6%
3.5%
4%
2%
0
1
2
3
5
4
Months
6
7
8
9
355
354
352
349
347
344
340
334
332
331
Provisional 349
348
344
340
339
337
337
333
330
329
0
No. at Risk
Tryton
ARC stent thrombosis (%)
Supplementary Figure 3D
5%
Provisional
Tryton
4%
HR: 1.97 [95% CI: 0.18, 21.7]
P (log rank) = 0.57
3%
2%
1%
0.6%
0.2%
0
1
2
3
5
4
Months
6
7
8
9
355
354
353
351
350
349
347
346
345
344
Provisional 349
349
346
343
343
343
343
341
341
340
0
No. at Risk
Tryton