Debulking Below the Knee: - PowerPoint Presentation

Slide1

Debulking Below the Knee:Devices & Techniques

Jihad A. Mustapha, MD, FSCAI, FACC

Advanced Cardiac & Vascular Centers for Amputation Prevention

Grand Rapids, MI

Slide2

Disclosures

Bard Peripheral Vascular – Consultant

Boston Scientific – Consultant, Scientific Advisory Board, Research

CardioFlow

– Equity, Research

Cardiovascular Systems, Inc. – Consultant, Research

Medtronic – Consultant

Micromedical

Solutions – Chief Medical Officer

Philips – Consultant

PQ Bypass – Research

Reflow Medical – Chief Medical Officer

Terumo - Consultant

Slide3

Atherectomy Devices

Jetstream™ Atherectomy System(Boston Scientific)Peripheral Rotablator™ Rotational Atherectomy System(Boston Scientific)Diamondback 360™, Stealth 360™ Atherectomy System(Cardiovascular Systems, Inc)SilverHawk™, TurboHawk™Plaque Excision System(Covidien)Turbo-Elite™ Laser Atherectomy Catheter(Spectranetics)Front-CuttingN/ADifferential CuttingN/AActive AspirationConcentric LumensLesion Morphology:CalciumSoft/Fibrotic PlaqueThrombus

Sources: Endovascular Today Buyer’s Guide 2014. JETSTREAM System Brochure, Boston Scientific Website, 2014. Peripheral

Rotablator

product website, Boston Scientific, 2014. Diamondback 360 product website, CSI, 2014. Covidien website, Directional Atherectomy products, 2014. Turbo-Elite Laser Atherectomy Catheter Instructions for Use, May 2014.

Slide4

The LACI Studies

The LACI Trial: 6 Month ResultsLaird et al145 pt, 155 critical ischemic limbs423 lesions41%SFA, 15% Popliteal, 41% Infrapop 70% of Pts had combo occlusion and stenosis29% Rutherford Class 471% Rutherford Class 5 or 6Limb salvage 92% at 6 months

Slide5

DEFINITIVE LE

Study Design and Oversight:

Prospective, non-randomized, global study

800 subjects enrolled at 47 centers

CEC and Steering Committee oversight and CEC

adjudicaiton

Angiographic and Duplex core laboratory analyses

Inclusion Criteria

RCC 1-6

≥ 50% stenosis

Lesion lengths up to 20cm

Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm

Exclusion Criteria

Severe calcification

In-stent restenosis

Aneurysmal

target vessel

Slide6

Lesion Assessment

CharacteristicClaudication (RCC 1-3)CLI(RCC 4-6)All Subjects (RCC 1-6)Number of Patients598201799Number of Lesions 7432791022Mean Length (cm)7.57.27.4Baseline Stenosis (%)737674 Occlusions (%)173021 Anatomic location based on proximal edge of lesion treatment, % (N)SFA72% (536)48% (135)66% (671)Popliteal15% (114)17% (48)16% (162)Infrapopliteal13% (93)34% (96)18% (189)

Core lab reported

M

cKinsey JF et al JACC

Interv

2014

Slide7

Primary Patency in Subgroups

Subgroup

Claudicants (n=743)

CLI (n=279)

Patency

(PSVR

<

2.4)

Lesion Length (cm)

Patency

(PSVR

<

2.4)

Lesion Length (cm)

All (n=1022)

78%

7.5

71%

7.2

Lesion type

Stenoses (n=806)

81%

6.7

73%

5.8

Occlusions (n=211)

64%

11.1

66%

10.3

Lesion Location

SFA (n=671)

75%

8.1

68%

8.6

Popliteal (n=162)

77%

6.0

68%

5.4

Infrapopliteal (n=189)

90%

5.5

78%

6.0

Slide8

Primary Patency in Subgroups

Subgroup

Claudicants (n=743)

CLI (n=279)

Patency

(PSVR

<

2.4)

Lesion Length (cm)

Patency

(PSVR

<

2.4)

Lesion Length (cm)

All (n=1022)

78%

7.5

71%

7.2

By Lesion Length

< 4 cm (n=318)

81%

2.2

84%

2.3

4-9.9 cm (n=418)

83%

6.5

62%

6.6

≥ 10 cm (n=283)

67%

14.4

65%

15.1

SFA Only By Lesion Length

< 4 cm (n=184)

78%

2.3

82%

2.3

4-9.9 cm (n=253)

83%

6.5

60%

6.9

≥ 10 cm (n=232)

65%

14.6

63%

15.5

Slide9

Jetstream System Overview

Control POD

Console

Over-the-Wire

Approved for use with BSC 0.014” 300cm Thruway Guidewire

Approved for use with Atherectomy Lubricants, such as Rotaglide

XC 2.1/3.0mm

XC 2.4/3.4 mm

SC 1.85mm

JETSTREAM XC Catheters

JETSTREAM SC Catheters

(Tibial Sizes)

(SFA & Popliteal Sizes)

SC 1.6mm

Slide10

Patient Characteristics

241 patients (258 lesions)

 

Overall

(N=241)

Age (years), mean ± SD

67.1 ± 9.8

Male

66.0%

Medical History

 

Hypertension

82.6%

Hypercholesterolemia

66.8%

Smoking

50.6%

Heart Disease

47.7%

Diabetes

41.1%

Race

 

Caucasian

80.1%

African American

16.6%

Native American

2.1%

Other

1.2%

Slide11

Lesion Characteristics

 Overall(N=258 lesions)Non-Stenta(N=165 lesions)Stenta(N=93 lesions)Lesion location Superficial Femoral75.6%72.1%81.7% Common Femoral10.9%15.2%3.2% Popliteal13.6%12.7%15.1%Lesion length, mean ± SD16.4 ± 13.6 cm14.1 ± 12.6 cm20.5 ± 14.4 cmCalcium Gradeb   010.0%10.2%9.5%116.2%14.6%19.0%224.1%17.8%35.7%328.2%31.8%21.4%419.5%21.0%16.7%Lesion RVD, mean ± SD5.7 ± 0.9 mm5.5 ± 0.9 mm5.9 ± 0.9 mmOcclusion (100% stenosis)36.1%28.7%50.0%Pre-treatment stenosis estimate, mean ± SD91.1% ± 9.8%90.2% ± 10.0%92.7% ± 9.4%

aPost hoc analysis of patients who received and did not receive adjunctive stents.bCalcium grading: 0= no visible calcification; 1= one individual segment of vessel calcification representing <25% of the length of the entire segment; 2= aggregate calcification representing <50% of the segment length; 3= aggregate calcification representing >50% of the segment length; 4= dense circumferential calcification along the segment length.

Slide12

Procedures

98.3% procedural success (≤30% residual diameter stenosis post-procedure)84 patients (35%) received adjunctive stentsStent placement performed at operator’s discretionEmbolic protection used in 22.4% of cases

 Post-treatment stenosis estimate, mean ± SDOverall(N=258 lesions)Non-Stent(N=165 lesions)Stent(N=93 lesions)Post-Jetstream44.4% ± 20.0% 38.5% ± 16.2%54.8% ± 22.0%Post Adjunctive Treatment9.8% ± 11.4%11.6% ± 11.7%6.6% ± 10.2%

Procedure time:

73.4 ± 37.5 min

Total Jetstream

run time:

4.7 ± 3.5

min

Number of Passes

Blades Down:

2.0 ± 1.5

Blades Up:

1.8 ± 1.4

Slide13

Unique Mechanism of Action

Preferential Sanding

Elastic healthy tissue “gives” and is not affected by diamond gritDiseased tissue provides resistance and allows grit to “sand” the plaque

Compliant Tissue

Diseased Tissue

Diamond Grit

No detrimental effect

Effective plaque removal

Slide14

6 month data

124 patients for infrapopliteal revascularization (201 lesions)Claudicants 55%CLI 45%Treatment OA either stand alone or with adjuctive Rx

Slide15

`

Slide16

LIBERTY 360

Prospective, observational, multi-center clinical study to evaluate acute and long-term clinical, functional and economic outcomes of endovascular device intervention in patients with distal outflow peripheral arterial disease (PAD)

No inclusion and exclusion

Independent core laboratory analyses and adjudications

Angiographic

Duplex Ultrasound

Six Minute Walk Test

Health Economics

Includes separate analyses for

Claudicants

Critical limb ischemia (RB4 and 5)

Critical limb ischemia (RB6)

Slide17

Device Usage by Lesion Balloon and/or atherectomy were preferred devices.

*Bailout stent group is a subset of Stent group. Bailout stent defined as stent placed due to an angiographic complication or sub-optimal result (>50% stenosis).Core Lab reported lesions.Patients with reported values may be less than total number of patients enrolled in each arm.

Comparison between Rutherford

categories significant (p<0.05)

Slide18

Major Adverse Events (MAEs) to 6 MonthsHigh freedom from 6-Month Major Adverse Events (MAE), indicating even RC6 subjects can be treated with PVI.

Kaplan-Meier method used to obtain estimate of freedom from MAE.Greenwood’s method used to obtain the 95% confidence interval for the estimate.Pairwise Log-Rank P-values at 180-Days: RC2-3 vs. RC4-5, P<0.0001; RC2-3 vs. RC6, P<0.0001; RC4-5 vs. RC6, P=0.0453

Major Adverse Event defined as:Death (within 30 days of the index procedure)Unplanned major amputation of the target limb (above the ankle)Clinically-driven TVR (inclusive of TLR) of the target limb

Slide19

6-Month Freedom from MAEs

(Point Estimate and 95% Confidence Intervals)Kaplan-Meier method used to obtain estimate of freedom from MAE.Greenwood’s method used to obtain the 95% confidence interval for the estimate.

73.7%

81.2%

92.6%

At Risk

54Events23Censored22

At Risk406Events102Censored81

At Risk414Events35Censored50

6-Month

RC2-3 vs. RC4-5

RC2-3 vs. RC6

RC4-5

vs. RC6

Hazard

Ratio

P

Hazard

Ratio

P

Hazard

Ratio

P

MAE

0.40 [0.29, 0.56]

<0.0001

0.26 [0.16, 0.41]

<0.0001

0.63 [0.42, 0.95]

0.0271

Slide20

6-Month Freedom from MAE Components

Point Estimate and 95% Confidence IntervalsKaplan-Meier method used to obtain estimate of freedom from MAE.Greenwood’s method used to obtain the 95% confidence interval for the estimate.

RC 2-3RC 4-5RC 6At risk44548561Events11811Censored538627

85.1%

95.3%

97.1%

87.1%

96.8%

99.8%

85.1%

83.1%

93.0%

For calculation of MAE rate, death capped at 30 days.

Death

Major Amputation

TVR

RC 2-3

RC 2-3

RC 4-5

RC 6

At risk44649866Events142613Censored396520

RC 2-3RC 4-5RC 6At risk41441159Events339112Censored528728

RC 4-5

RC 6

Cox proportional hazards model identifies no difference between any RC group/arm at 6 months.

Slide21

Phoenix catheter

5 Fr, OTW, front cutting atherectomyRotational speed 10000RPMDebris withdrawn through Archimedes screw systemEASE trial >100 patients, 0.8% embolic events

Slide22

Pantheris

VISION trial130 pts55 (24 month results)91.4% treated stand alone Pantheris9.6% DCB5.1% stent82% freedom from TLR at 24 months

Slide23

DEFINITIVE AR Study Design

No

Yes

Registry arm for severely calcified lesions created to limit bail-out stenting (and therefore variables) in randomized arm.

*

D

irectional Atherectomy + Anti-Restenotic Therapy

Purpose: assess and estimate the effect of treating a vessel with directional

atherectomy

+ DCB (DAART

) compared to treatment with DCB alone

Slide24

Clinical Limitations & Unmet Needs

Calcium as a Barrier

Longer Lesion Length

Calcium Limits Vessel Expansion

1

Calcium May Limit Drug Effect

2

Increased lesion length is an independent predictor of decreased patency

5

.

1

Freed MS, Manual of Interventional Cardiology,

2Fanelli DEBELLUM, 3Laird, CCI, June 2010, 4SMART Control IFU, 5Matusumura, DURABILITY IIJVS, July 2013, 6Davaine, European Journal of Vascular and Endovascular Surgery 44 (2012)

Slide25

Baseline Lesion CharacteristicsPer Core Lab

Baseline CharacteristicsDAART(N= 48)DCB (N = 54)p-Value*DAARTSevere Ca++ Arm (N=19)Lesion Length (cm)11.29.70.0511.9Diameter Stenosis82%85%0.3588%Reference vessel diameter (mm)4.94.90.485.1Minimum lumen diameter (mm)1.00.80.340.7Calcification70.8%74.1%0.8294.7%Severe calcification25.0%18.5%0.4889.5%

*

p-value for DAART and DCB groups

Slide26

Key Study Outcome at 12 Months - Angiographic Patency shows similar pattern

N = 34 N = 39

N = 22 N = 16

N = 24 N = 7

Results for all patients who returned for angiographic follow-up

Slide27

What’s out there and what to choose?

Several devices now available for debulking

Critical question remains is debulking part of vessel prep “all” or “some” of the time

Each device has compelling data

Some better for calcific disease

Some better for ease of use

There is no question that in some cases either for DCB or stenting a debulking strategy is critical to obtain best initial and probably long-term outcomes

Combined therapy appear compelling though not fully tested