1. BRANCH Bare Metal BifuRcAtion SteNt Clinical Trial in Humans Early Clinical Experience by Raoul Bonan, MD
On behalf of the BRANCH study investigators

2. Raoul Bonan, MD DISCLOSURES Consulting Fees
Medtronic CardioVascular, Inc.
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
ReCor Medical
I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation.
I intend to reference Medtronic-Corevalve percutaneous aortic valve replacement Mitral Sonic from ProRhythm.

3. Current Approaches & Limitations
Provisional Stenting:
Alters stent structure, putting stresses on stent that were not intended
PTCA in SB without scaffolding – same concerns as with balloon angioplasty
Acute recoil
Plaque shift
Suppression of Neointimal hyperplasia
T-Stenting:
Gap at Ostium of side branch
Lack of coverage at lesion site
Crush:
Overlapping / multiple layers of metal over Ostium and Carina
Culotte and V/Y:
False Carina, unnatural flow disturbance of metal sitting “naked” in the artery long-term
Provisional Stenting
“T-stenting”
“Y” or “V”
“V” 2 1
“Reverse-T”
Culotte Stenting 1 2
Crush technique 2 1

4. Challenges Associated with Treating Coronary Bifurcation Lesion
Simple Approaches
Inconsistent coverage
Ostial gap
Imprecise recrossing struts
Inadequate scaffolding of SB
Complex Approaches
Procedural complexity
More metal
Multiple layers of metal (crush, culotte)
Difficulty re-accessing with repeat procedures

5. MDT Branch Bifurcation Stent Investigational Device Design Features
Dual branch / Y – shaped
Driver platform - 3 stents welded
Dual balloon
Sprinter technology
Stepped balloon design to avoid proximal over-expansion
Dual-wire delivery system with simultaneous inflation
Single catheter / inflation lumen 7F
Cobalt alloy
Thin stent struts
Modular architecture
Flexibility, deliverability, conformability
Ostial marker band
No overlapping or gapping at the ostia or carina
Crossing profile ~ 0.06”
Side branch balloon
Main branch balloon
4 mm
8 mm
7 mm
4 mm, 8Crown
7 mm, 12 Crown
8 mm, 10 Crown

6. Bifurcation Stent System
BRANCH Study Design
Single De Novo Bifurcation Lesions in Native Coronary Arteries with RVDs of
Proximal Main Vessel: mm
Distal Main Branch: mm
Side Branch up to 2.5 mm
Pre-dilatation required; Plavix ≥ 30 Days
60 patients
7 sites
Bifurcation Stent System
30d
6mo
9mo
12mo
Clinic Visit
Contact
Contact
Contact
Primary Endpoint: A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target vessel revascularization (TVR) at 30 days
Secondary Endpoints:
Acute success (device, lesion, procedure) 4. Total index PCI procedure time
Total fluoroscopy time Composite of cardiac death,
Total volume of contrast used MI and clinically driven 6, 9 &12mo
6. TLR rate at 9 months

7. BRANCH Study Methods Baseline clinical and angiographic data
One bifurcation lesion per subject
Clinical follow-up at 30 days
Subsequent follow up at 6, 9 and 12 months
In the case of a failure to implant a trial stent subjects were included on an “Intent to Treat” basis through 30 d FU
A total 60 patients received the bifurcation stent with each site having 1 run in patient per site (7)

8. BRANCH Investigators Robert Whitbourn Ian Meredith* Stephen Worthley
Patients
Robert Whitbourn
St Vincent’s Hospital, Fitzroy, Melbourne 15
Ian Meredith*
Monash Heart, Monas Medical Centre, Melbourne 12
Stephen Worthley
Royal Adelaide Hospital, Adelaide
Mark Webster
Auckland City Hospital, Auckland , NZ 9
John Ormiston
Mercy Hospital, Northshore, Auckland, NZ 4 1
*Principal Investigator

9. BRANCH Study Management
QCA Core Lab
Beth Israel, Boston, MA, USA Jeffrey J. Popma, MD
IVUS Core Lab
Cardiovascular Core Analysis Lab Stanford Interventional Cardiology, CA, USA Peter Fitzgerald, MD
ECG Core Lab
Harvard Clinical Research Institute, Boston, MA, USA
Data Coordinating Center
Medtronic Santa Rosa
Clinical Events Committee/DSMB

10. BRANCH Inclusion/Exclusion Criteria
Single de novo bifurcation lesion in a native coronary artery with a RVD of
Proximal Main Vessel: 3.8 – 4.3 mm
Distal Main Branch: 3.0 – 3.5 mm
Side Branch: Up to 2.5 mm
Target lesion lengths any combination of:
≤16 mm proximally from the carina in the proximal main vessel
≤16 mm distally from the carina in the distal main branch
≤12 mm from the carina in the side branch
Exclusion:
Acute MI within 72 hrs of the index procedure
QWMI
Non-Q wave MI CK ≥2X lab ULN with CK-MB > lab ULN
History of stroke or TIA <6 mo
LVEF <30% at most recent evaluation
Participating in investigational drug / device study

11. BRANCH Inclusion Criteria
1,1,1
1,1,0
1,0,1
0,1,1
1,0,0
0,1,0
0,0,1
Must have a main vessel lesion ≥50%

12. BRANCH Demographics n = 53 n = 60 Age (yrs) 60 ± 12 61 ± 12 Male (%)85
Hyperlipidemia (%) 83
Diabetes Mellitus (%) 26 25
Insulin Dependent (%) 9 8
Prior PCI (%) 55 52
Prior MI (%) 58 53
Stable Angina (%) 43 48
Unstable Angina (%) 16
Ejection Fraction (%)
58 ± 12
59 ± 12
# Diseased Vessels (n)
Single 36 38
Double 51 50
Triple 13 12

13. BRANCH Pre Procedure Lesion Morphology
Vessel Location – % (n)
LAD
73.6 (39)
LCX
15.1 (8)
RCA
11.3 (6)
Bifurcation Type – % (n)
Medina Complex Bifurcation Type
(1,1,1; 1,1,0; 1,0,1; 0,1,1)
71.7 (38)
Medina Simple Bifurcation Type
(1,0,0; 0,1,0; 0,0,1)
28.3 (15)
Bifurcation Angle
<45°
77.4 (41)
≥45° – <90°
22.6 (12)
Group the 4 from the picture in slide 18 – show the true Medina types that are really requiring 2 stents

14. BRANCH Pre Procedure Bifurcation Morphology

15. BRANCH Pre Procedure Lesion and Procedure Characteristics
Device and Procedure Characteristics
Main Branch
(average)
Prox Main
Branch
Distal Main Branch
Side Branch
RVD (mm)
2.94 ± 0.38
3.34 ± 0.50
2.54 ± 0.34
2.32 ± 0.39
MLD (mm)
1.23 ± 0.42
1.41 ± 0.67
1.06 ± 0.44
1.29 ± 0.62
Lesion Length (mm)
13.68 ± 6.05
5.59 ± 3.91
8.08 ± 5.11
6.08 ± 3.92
% Stenosis
58.23 ± 12.60
57.67 ± 19.20
58.46 ± 16.08
44.45 ± 23.74
Pre dil (atm)
13.58 ± 3.34
11.90 ± 3.12
Stent Deployment (atm)
13.02 ± 2.06
12.46 ± 3.04
Post dil (atm)
15.95 ± 3.20
14.11 ± 2.71
Kissing Balloon Technique used
43.4% at pre dilatation
and
74.% at post dilatation

16. BRANCH Patient Flowchart
Patients Enrolled
N = 60, 7 sites
1 run in per site allowed
Evaluated
n = 53
49/53
Lesion Success
47/53
Procedure Success
44/53
Device Success
53/53
Completed 30 day f/up

17. BRANCH Acute Success By Definition
BRANCH defn
Historical defn
N = 53
N = 60
Lesion Success (%)
92.5
93.3
98.1
98.3
Device Success (%)
83.0
83.3
86.8
86.7
Procedure Success (%)
88.7
90.0
94.3
95.0
BRANCH
Device success <30% residual in-segment %DS for all target lesion/s with assigned stent
Lesion success <30% residual in-segment % DS for all target lesion/s with any percutaneous method
Procedure success <30% residual in-segment % DS for all target lesions and without in-hospital death, MI or TLR
HISTORICAL
Device success <50% residual in-segment % DS for all target lesion/s using the assigned stent
Lesion success <50% residual in-segment % DS for all target lesion/s with any percutaneous method
Procedure success <50% residual in-segment % DS for all target lesions and no in-hospital death, MI or TLR

18. BRANCH Acute Success
Main Branch/proximal
(%DS)
Main
Branch/distal
Side branch
(% DS)
Lesion Failure
(pt )
37.42
2.97
3.85
(pt )
5.12
15.66
32.46
(pt )
17.74
11.6
69.36
(pt )
11.17
18.23
49.36
Stent also not implanted in 7/53 patients
Lesion success 30% residual in-segment % DS for all target lesion/s with any percutaneous method

19. BRANCH Bifurcation

20. BRANCH Post Procedure Lesion Characteristics – QCA n= 53
Main Branch
(average)
Proximal Main Branch
Distal Main Branch
Side Branch
RVD (mm)
3.00 ± 0.35
3.38 ± 0.47
2.62 ± 0.33
2.36 ± 0.35
MLD (mm)
2.66 ± 0.32
2.95 ± 0.40
2.38 ± 0.35
2.05 ± 0.41
% Stenosis
11.08 ± 4.46
12.43 ± 6.43
9.23 ± 6.24
13.01 ± 11.03

21. BRANCH Major Adverse Events
All Patients
In-Hospital
n = 60
30 days
Death (all) – % (n)
Cardiac
MI (all) – % (n)
3.3 (2)
3.4 (2)
Q Wave
Non Q wave
Death (cardiac) + MI (all) – % (n)
Stent Thrombosis (all) – % (n)
0-30 days
TLR – % (n)
TVR (non-TL) – % (n)
TVR – % (n)
MACE – % (n)
TVF – % (n)
31.7% usage of IIb/IIIa inhibitors and 100% DAPT compliance.

22. BRANCH Major Secondary Endpoints – Summary
Acute Success – % (n)
Device Success
83.0 (44)
Lesion Success
92.5 (49)
Procedure Success
88.7 (47)
Total Fluoroscopy Time (secs)
22.89 ± 10.55
Total Volume of Contrast Used (ml)
± 87.84
Total Index PCI Procedure Time (mins)
70.85 ± 22.84

23. BRANCH Clinical Follow Up Events
43 yo M
LAD/1st Diag
Plaque disruption distal to the LAD stent lead to chest pain and CKMB elevation – Non–Q-Wave MI. Driver stent implanted
73 yo M
Proximal LAD dissection treated with Driver stent. Protocol required CKMB assessment showed procedural elevation – Non–Q-Wave MI

24. BRANCH Summary and Conclusions
In the majority of cases, bifurcation lesions can be treated with a simple approach using one DES with excellent clinical outcomes
Provisional side branch stenting remains the most reasonable strategy
When 2 stents are needed, the optimal approach is still a matter of debate but the use of the Medtronic Bifurcation stent appears to be safe and practical in a large number of bifurcation lesion types with a low peri-procedural and 30 day MACE

27. BRANCH Endpoint Definitions
MACE
All cause mortality, all MIs, TLR, Emergent CABG
Myocardial Infarction
CK ≥ 2X UPLN with the presence of an elevated CK-MB (any amount above the lab ULN)
Device success
<30% residual in-segment % DS for all target lesion/s with assigned stent
Lesion success
<30% residual in-segment % DS of all target lesion/s with any percutaneous method
Procedure success
<30% residual in-segment % DS for all target lesions & no in-hospital death, MI or TLR

28. BRANCH Procedure Information Summary of Stent Usage
Stent Size 3025 34
Stent Size 3525 12
Main Branch
Side Branch
Additional Stents 32 20

29. BRANCH Acute Success Device Success (%) 83.0 Lesion Success (%) 92.5
Procedure Success (%)
88.7 
Device success <30% residual in-segment percent diameter stenosis of all target lesion/s with assigned stent
Lesion success <30% residual in-segment percent diameter stenosis of all target lesion/s with any percutaneous method
Procedure success <30% residual in-segment percent diameter stenosis of all target lesions and no inhospital death, MI or TLR

30. BRANCH Post Procedure Lesion Characteristics IVUS n = 41
Proximal Main Branch (stent)
Distal Main Branch (stent)
Side Branch
(stent)
Length of Segment (mm)
4.87 ± 1.06
6.36 ± 1.87
3.50 ± 0.88
Luminal Diameter (mm)
3.65 ± 0.35
3.00 ± 0.27
2.62 ± 0.23
Lumen Area (mm2)
10.55 ± 2.07
7.05 ± 1.30
5.37 ± 1.00
Vessel Diameter (mm)
4.81 ± 0.49
4.00 ± 0.37
3.43 ± 0.43
Vessel Area (mm2)
18.31 ± 3.68
12.58 ± 2.40
9.30 ± 2.41
Plaque Area (mm2)
7.83 ± 2.12
5.60 ± 1.79
3.94 ± 1.63

31. BRANCH Major Adverse Events
Protocol Followed
In Hospital
n = 53
30 days
Death (all) – % (n)
Cardiac
MI (all) – % (n)
3.8 (2)
Q Wave
Non Q wave
Death (cardiac) + MI (all) – % (n)
Stent Thrombosis (all) – % (n)
0-30 days
TLR – % (n)
TVR (non-TL) – % (n)
TVR – % (n)
MACE – % (n)
TVF – % (n)
34% usage of IIb/IIIa inhibitors and 100% DAPT compliance.

32. BRANCH Post Procedure Morphology – IVUS n=41
Main Branch
Tissue Prolapse (%)
2.5
Incomplete Apposition (%)
5.0
Bifurcation
0.0
Incomplete Apposition
23.1
Side Branch
21.4