FRONTIER Registry

The Guidant MULTI-LINK FRONTIER™ Coronary Stent System for the Treatment of Pts with Native De Novo or Restenotic Bifurcation Coronary Artery Lesions

T. Lefèvre and W. Van der Giessen

On Behalf the FRONTIER Investigators

Objective

• To assess the safety, procedural success, performance and 6 month clinical outcome of bifurcation stenting

• To evaluate angiographic results and 6 month incidence of TSR

• With the use of the Guidant MULTI-LINK FRONTIER Coronary Stent System in patients with de novo or restenotic bifurcation lesions

Study design

• Prospective, non randomized

• 100 patients

• Up to 2 lead in patients per site

• 13 sites - Europe, New Zealand

• Clinical Follow-up

• In-hospital, 30 days and 6 months

• Angiography

• Pre and Post-Procedure

• 6 months

Specially designed dual lumen tipMain Branch (RX)

Side Branch (OTW)

• Designed for preserving side branch access

• Integrated-tip design allows single tip delivery, avoiding wire wrap

• Stent deploys with simultaneous “kissing balloon inflation”

• Wire position is maintained in both branches throughout the procedure

Guidant MUTI-LINK FRONTIER™ Coronary Bifurcation Stent System

Guidant ML FRONTIER™ Coronary Bifurcation Stent System

• Sizes

• Stent length – 18mm (main branch)

• 7 Fr. GC Compatible

Main Branch Balloon 2.5mm 3.0mm 3.5mm 4.0mm

Side Branch Balloon 2.0mm 2.5mm

Two balloons. Two wires. One very special stent.“Provisional T stenting” strategy

Guidant MULTI-LINK FRONTIER™ Deployment Technique

ML FRONTIER™ Deployment Sequence

Guidant MULTI-LINK FRONTIER™ Deployment Technique

Self rotation when out of phase

Primary endpoints

• Incidence of MACE* at 6 months follow-up

* Hierarchical occurrence of Death, Q-wave and non-Q-wave MI, Target Lesion Revascularization (main branch and/or side branch) including PTCA and CABG

Secondary endpoints

• Incidence of MACE at 30 days follow up

• Angiographic binary restenosis rate at 6 months

• Access site complications

• TVF at one and six months follow up

• TVR at six months follow up

• Acute success of stent delivery, deployment, and post dilatation

Key Inclusion Criteria

• Other lesions in different epicardial vessel successfully treated prior to bifurcation procedure

• Native or restenotic (no stent) vessel suitable to receive a 2.5 to 4.0 mm ML FRONTIER Stent

• Target main branch vessel is a major coronary artery with estimated stenosis > 50 and < 100%

• Angle of bifurcation < 75

• Main branch lesion suitable for a total stent length of < 31mm by visual estimate

• Appropriate lesion morphology

Key Exclusion Criteria

• Untreated lesion >50% proximal or distal to target lesion

• Target lesion contains thrombus

• Target lesion is aorto-ostial or left main stem location

• Target lesion or proximal vessel has excessive tortuosity unsuitable for stent delivery

• Heavy or severe calcification

Enrolling Sites (n= 11)

Patients enrolled

Dr. van der Giessen Rotterdam The Netherlands 16

Dr. Ormiston Auckland New Zealand 15

Prof. Schultheiss Berlin Germany 15

Dr. Quillet Tours France 12

Dr.Reimers Mirano Italy 11

Dr. Lefèvre Massy France 10

Dr. Guagliumi Bergamo Italy 9

Dr. Brunel Nantes France 7

Dr. Wijns Aalst Belgium 6

Dr. Büttner Bad Krozingen Germany 2

Dr. Hartmann Lübeck Germany 2

Total 105

FRONTIER Trial Enrollment

Baseline Demographics(Intent-to-treat patient population)

n = 105

Age (years) 62.4(60.3 – 64.5)

Number of men (%) 77.1

Current smoker (%) 27.9

Diabetes requiring treatment (%) 17.1

Hypertension requiring treatment (%) 46.2

Hypercholesterolemia requiring treatment (%) 64.8

Prior MI (%) 36.2

Stable angina: CCS III or IV (%) 14.3

Unstable angina: Braunwald class 1-2 A-B (%) 30.5

Prior CABG (%) 1.0

LAD location (%) 79.1

Baseline QCA Analysis(Intent-to-treat patient population)

Target vessel(n= 103 patients*)

Main branch (%)

Side branch (%)

Moderate to heavy Calcification 29.4 11.7

Thrombus 1.9 0

Pre-procedural TIMI flow

Grade 3 91.3 93.2

ACC / AHA lesion class

A 2.0 26.6

B1 20.8 60.9

B2 77.2 12.5

* Cardialysis, Rotterdam, The Netherlands

Bifurcation Lesion Classification(Intent-to-treat patient population)

Bifurcation angulation < 75 degrees 70.9%

7.9% 24.8%13.9%

36.6% 5.9%

10.9%

Prebranch

Postbranch

Parent Vessel Only

Bifurcation Ostial

Ostial

Prebranch and

A B C

D E F

Cardialysis, Rotterdam, The Netherlands

Device success* 92.2%

Procedural success 93.3%

Use of GPIIb/IIIa inhibitors 26.0%

Additional stent implant

- One only

- More than one

37.1%

6.7%

Reason why additional stent implanted

- To cover target lesion

- Inflow dissection

- Outflow dissection

16.7%

66.7%

16.7%

Stent used

- Diameter (mm)

- Length (mm)

3.03 ± 0.37

12.51 ± 5.57

Procedural data in Main Branch(Intent-to-treat patient population)

* Stent did not cross (8/9), twisted wire (1/9)

Device success* 92.2%

Procedural success 93.3%

Use of GPIIb/IIIa inhibitors 26.0%

Additional elective stent implant as allowed by protocol (n)

37.1%

(39/105)

More than one additional stent (n) **

-To cover target lesion (n)

-Inflow dissection (n)

- Outflow dissection (n)

6.7% (7/105)

1

4

1

Stent used

- Diameter (mm)

- Length (mm)

3.03 ± 0.37

12.51 ± 5.57

Procedural data in Main Branch(Intent-to-treat patient population)

* Stent did not cross (8/9), twisted wire (1/9) ** 1 reason unknown

Caution: Investigational device. Limited by Federal (US) law to investigational use only. Not available for sale

Pre-procedure reference vessel diameter (mm) 2.77 ± 0.51

Lesion length (mm) 12.16 ± 5.83

Pre-dilatation performed (%)

Maximum pre-dilatation balloon size:

- Diameter (mm) - Length (mm) - Balloon pressure (atm)

100

2.68 ± 0.4016.25 ± 3.7710.36 ± 3.13

FRONTIER stent max. deployment pressure (atm) 12.1 ± 2.3

Post stent implant dilatation performed (%)

Maximum post-dilatation balloon size:

- Diameter (mm)- Length (mm)- Balloon pressure (atm)

70.8

3.14 ± 0.4513.43 ± 4.0311.9 ± 3.80

Procedural data in Main Branch(Per protocol patient population)

Cardialysis, Rotterdam, The Netherlands

Lesion length (mm) 4.03 ± 2.71

Pre-procedure reference side branch diameter (mm) 2.10 ± 0.67

Side branch post treatment

- None (%)- Balloon (%)- Stent (%)

19.837.542.7

Stent diameter (mm) 2.64 ± 0.34

Stent length (mm) 9.92 ± 2.81

Maximum balloon diameter (mm) 2.53 ± 0.44

Maximum balloon length (mm) 15.03 ± 4.59

Maximum balloon pressure (atm) 10.15 ± 2.81

Kissing balloon technique performed (%) 79.5

Procedural data in Side Branch(Per protocol patient population)

Cardialysis, Rotterdam, The Netherlands

Main Branch In-stent(n = 96)

Pre-procedure ref. diameter (mm) 2.77 ± 0.51

Pre-procedure DS (%) 60.7 ± 12.2

Pre-procedure MLD (mm) 1.07 ± 0.35

Post-procedure DS (%) 15.1 ± 9.6

Post-procedure MLD (mm) 2.43 ± 0.41

6-month DS (%) 38.8 ± 19.1

6-month MLD (mm) 1.59 ± 0.56

Binary restenosis (>50%) 25.3 %

Acute gain in-stent (mm) 1.36 ± 0.46

Late loss in-stent (mm) 0.84 ± 0.55

QCA Analysis(Per-protocol patient population)

In-stent + 5 mm (n=96)

-

-

-

24.5 ± 9.5

2.04 ± 0.40

40.3 ± 19.29

1.51 ± 0.54

27.6 %

-

-

Cardialysis, Rotterdam, The Netherlands

Side Branch In-segment Total

(n = 96)

Pre-procedure ref. diameter (mm) 2.10 ± 0.67

Pre-procedure DS (%) 39.1 ± 18.1

Pre-procedure MLD (mm) 1.23 ± 0.45

Post-procedure DS (%) 25.1 ± 12.7

Post-procedure MLD (mm) 1.47 ± 0.40

6-month DS (%) 39.4 ± 20.9

6-month MLD (mm) 1.13 ± 0.47

Binary restenosis (>50%) 29.1 %

QCA Analysis(Per-protocol patient population)

Stented

(n = 39)

Ballooned

(n = 36)

Non-treated

(n = 21)

2.32 ± 0.79 2.01 ± 0.53 1.81 ± 0.54

46.7 ± 19.4 37.0 ± 13.9 27.4 ± 15.1

1.17 ± 0.46 1.27 ± 0.44 1.30 ± 0.43

23.8 ± 12.7 27.3 ±11.7 23.6 ± 14.6

1.59 ± 0.42 1.42 ± 0.37 1.30 ± 0.36

44.8 ± 26.2 33.9 ± 14.0 37.6 ± 15.2

1.02 ± 0.56 1.24 ± 0.35 1.19 ± 0.40

36.8 % 18.8 % 31.3 %

MACE(intent-to-treat patient population)

In-Hospital n=105

30 ± 5 days n=105

SAT (%)

Q-wave MI (%)

Non Q-wave MI (%)

0

1.0

1.0

0

1.0

1.0

TLR, CABG or PCI (%) 1.0 1.0

TVR, CABG or PCI (%) 1.0 1.0

Death (%) (Death, MI, TLR) 0 0

MACE (%) 2.9 2.9

Target Vessel Failure (%) (Death, MI, TVR)

2.9 2.9

Hierarchical Ranking

180 ± 10 daysn=105

0

1.9

1.9

13.4

19.1

0

17.1

22.9

Sample calculation (MACE)

Study Alpha Rate n Lower Limit Upper Limit

Finci et al 0.05 37.4% 91 27.4% 48.1%

Yamashita et al 0.05 37.8% 37 22.5% 55.2%

Finci et ali 0.05 62.2% 45 46.5% 76.2%

Yamashita et al 0.05 50.9% 53 36.8% 64.9%

Lefèvre et al 0.05 29.1% 182 17.5% 36.3%

Karvouni et al 0.05 48.4% 62 35.5% 61.4%

Al Suwaidi et al 0.05 26.8% 75 17.1% 38.1%

Al Suwaidi et al 0.05 47.7% 51 32.9% 61.5%

Wt. Avg 29.5% 51.2 %

Conclusion

This new stent specifically designed for treating bifurcation lesions and preserving side branch access can be used with a high procedural success rate.

Compared to previous studies with workhorse stents, the clinical outcome as well as acute angiographic and 6-months results are very encouraging.