Calcified below-the-knee lesions – overview of treatment options

Prof. Dr. Erwin Blessing

SRH Klinikum Karlsbad-Langensteinbach

Disclosure

Speaker name:

Erwin Blessing

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s): speakers honorarium

x I do not have any potential conflict of interest

BTK Interventions

Clinical Problem: Re-stenosis, Re-occlusions

Schmidt et al.1

PTA BTK in CLI patients (77 lesions)

Angiographic follow up after 3 months:

No Restenosis: 31,2 %

Restenosis ≥ 50%: 31,2 %

Re-Occluission 37,6 %

Fernandez et al.2

PTA BTK in CLI patients (123 lesions)

Follow up 12 months:

Primary patency: 33 %

Secondary patency: 56 %

TLR: 50 %

1 Schmidt A. et al. Catheter Cardiovasc Interven 2010 2 Fernandez N. et al. J Vasc Surg 2010

Treatment options?

Treatment options:

Specialty balloons?

Chocolate Bar Registry

Treatment options:

DCB?

Lutonix BTK registry

Case example

35 atm

LithotripsyCase example

Courtesy of Andrew Holden

LithotripsyDisrupt BTK

Zeller, LINC 2018

Multicenter FIH trial

CLI patients

20 moderate to severe calcified lesions

Mean lesion length: 52.2 mm

Technical success: 100%

Mean stenosis improved from

72.1% to 26.2%

Orbital AtherectomyMode of action

Centrifugal Force360° crown contact designed to create a smooth, concentric lumen

Allows constant blood flow and particulate flushing during orbit

Differential sanding 30 µm diamond coating Average particulate size1 = 2 µm Bi-directional sanding of

superficial calcium Healthy elastic tissue flexes

away minimizing damage to the vessel

Pulsatile forces1

Dual frequency Orbital Frequency: low

frequency of the crown orbiting against the vessel wall.

Rotational Frequency: high frequency corresponding to the crown rotational speed.

Observed in both crown motion and force.

1. Zheng Y, et al. 2016. Med Eng Phys. 2016;38:639-647.

CALCIUM 360°: Study Design & Demographics• Prospective, multi-center

• Randomized (1:1)

• Calcified BTK lesions

N=50

OAS + PTA

N=25

PTA ALONE

N=25

DemographicsOAS + PTA

N = 25PTA ALONE

N = 25p-value

Mean Age 70.7 ± 13.4 71.8 ± 10.9 0.75

Male / Female 68% / 32% 60% / 40% 0.77

Diabetic Type 1 4% 0% 1.00

Diabetic Type 2 68% 56% 0.56

Renal insufficiency (GFR < 90) 25% 24% 1.00

Smoker (current or previous) 60% 60% 1.00

CAD 44% 56% 0.57

Hypertension 84% 84% 1.00

Dyslipidemia 83% 72% 0.50

Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-8.

Orbital Atherectomy System changes compliance and provides durable

results out to 12 months vs. PTA alone

Mean Max Balloon

Pressure (atm)p = 0.001

Freedom From

Major Adverse Events*

p = 0.006

Freedom From

Revascularization

Results at 12 Months

5.9

9.4

0

5

10

OAS + PTA PTA ALONE

93.3%

80.0%

0%

50%

100%

OAS + PTA PTA ALONE

93.3% 57.9

%

0%

50%

100%

OAS +PTA

PTAALONE

n=15 patients n=15

patients

n=15 patients n=19 patients

*MAE (major adverse events: device- or procedure-related major amputation (above the ankle), all-cause

mortality and TLR/TVR).

CALCIUM 360°: Results

Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-8.

p = 0.14

Prospective, randomized, multi-center

study that compared acute and long-

term results of OAS+PTA and PTA

alone in calcified BTK lesions

n=27 lesions n=34 lesions

OPTIMIZE BTK: RCT For OAS+DCB vs. DCB Alone

In calcified BTK Lesions

N= Approx.50

OAS + DCB

Approx. 25

DCB

Approx. 25

Study Details:

• Pilot study

• Prospective, 1:1 Randomization

• Below the knee lesions

• 2-year follow-up

Active Sites:

• Austria (Prof. Brodmann/Deutschmann & Dr. Werner)

• Germany (Prof. Zeller, Prof. Tepe, Prof. Andrassy, Prof. Blessing, Prof. Scheinert)

• Switzerland (Dr. Banyai)

Purpose: Demonstrate the ability of the OAS to prepare calcified, BTK lesions for optimal DCB deployment

Orbital AtherectomyCase example

pre Diamond-

backpost Lutonix final

PhoenixMode of Action

• Hybridatherectomy isanewcategoryofatherectomy– Notrotationalordirectional

– Itcombinesthebenefitsofexistingatherectomy systemstoauniqueatherectomy solutionthat

allowsphysicianstotailortreatmenttopatients

*DirectionalcuttingabilityonlyavailablewithPhoenix2.4mmdeflectingcatheter

PhoenixCase example

pre post final

Courtesy of Grigorios Korosoglou

PhoenixStudy update

PhoenixRegistryObjectiveandOverview

To evaluate the short and long-term clinical outcomes of patients treated with

Phoenix atherectomy system for peripheral artery disease (PAD)

• Upto600subjects;allcomers(Rutherford2-6)

• 17sites(US)

• On-labelusewith1.8mm(5F),2.2mm(6F),2.4mm(7F)devices

• Follow-up:30Days;and12months(forCLIpatientsonly)

• PrimaryEndpoints:

– Safety– Devicerelatedcomplication

– Efficacy– Proceduralsuccess

• SecondaryEndpoints:TLR,TVR,TargetLimbAmp,Wifi

Post-approval,singlearmobservationalregistry

PhoenixStudy update (interim analysis)

TargetLesionAssessmentsCharacteristics Rutherford 2-3 CLI(4-6) All-comers

NumberofPatients 106 142 248*

NumberofLesions 142 190 332

MeanLength(mm) 86.2 114.2 102.2

MinLength(mm) 1 2 1

MaxLength(mm) 600 460 600

BaselineStenosis(%) 88.6% 90.4% 89.6%

StenosisMin(%) 5 50 5

StenosisMax(%) 100 100 100

Anatomical Location

ATK 45.7% 25.8% 34.2%

BTK 54.3% 74.2% 65.8%

CTO(%) n/a n/a 41.7

• 248outof250patientshadvaluabledatafortargetlesionassessments

DCB usage post debulking ∼ 1/3

PhoenixStudy update (interim analysis)

Primaryandsecondaryendpoints:CLISubgroup PrimaryEndpoint(N=142)ProceduralSuccess(≤30% stenosisattheendofprocedure) 99.2%

SecondaryEndpoint

30 Days(N=125)

12Months(N=30)

TLR 0.8% 6.7%

UnplannedTarget LimbAmputation 7.6% 12.5%(4)*

*12Months AmputationDetails

AmputationType Baseline RCC Tissueloss@baseline

Metatarsal 6 Minor

AKA 6 Major

BKA 5 Minor

BKA 6 Extensive

PRESTIGE Trial

N=75; prospective, single-arm, multi-center pilot study

Investigator sponsored (PI: Dr M. Lichtenberg, co-PI Dr T.Zeller)

Objective: assess lesion prep strategy with Phoenix atherectomy before DCB in CLI-BTK setting complicated by moderate/severe calcium

Primary Efficacy EP: 6-month Patency (freedom from occlusion by DUS and freedom from TLR)

Primary Safety EP: Major Adverse Limb Event (composite of either major amputation or major re-intervention through 30 days)

Clinical and DUS follow up @ 6, 12, 24 months

Full Core-lab imaging adjudication (Angiographic, Duplex, IVUS)

PhoenixStudy update

Conclusions

Treatment of calcified btk lesions is plagued be high rate of re-stenosis and re-occlusion

Intravascular Lithotripsy is safe and effective in calcified lesions, incl. btk lesions in CLI patients

Debulking of calcified btk lesions ist feasable and safe

Debulking plus DCB currently under evaluation in a single-arm registry (PRESTIGE) and in a RCT (OPTIMIZE BTK)

Calcified below-the-knee lesions – overview of treatment options

Prof. Dr. Erwin Blessing

SRH Klinikum Karlsbad-Langensteinbach