Pro-Contra - Verschluss der SFA > 25 cm: First Line Perkutan · Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships:

Pro-Contra - Verschluss der SFA > 25 cm:First Line Perkutan

Prof. Dr. T. Zeller

Universitäts-Herz-ZentrumFreiburg-Bad Krozingen

InterdisziplinäresGefäßzentrum

Bad Krozingen

BAD KROZINGENBAD KROZINGEN

Thomas Zeller, MD

For the 12 months preceding this presentation, I disclose thefollowing types of financial relationships:

• Honoraria received from: Abbott Vascular, Bard Peripheral Vascular,Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore &Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave,Biotronik

• Consulted for: Boston Scientific Corp., Cook Medical, Gore & Associates,Medtronic, Spectranetics, Veryan

• Research, clinical trial, or drug study funds received from: Biotronik, 480biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical,Gore & Associates, Abbott Vascular, Medtronic, Philips, Terumo, TriReme,Veryan, Shockwave

• Common stock: Veryan, QT Medical

2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with ESVS(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095)

www.escardio.org/guidelines

Revascularization of femoro-poplitealocclusive lesions

3

Recommendations Class Level

An endovascular-first strategy is recommended inshort(i.e. <25 cm) lesions.

I C

Primary stent implantation should be considered inshort(i.e. <25 cm) lesions.

IIa A

Drug-eluting balloons may be considered in short(i.e. <25 cm) lesions. IIb A

Drug-eluting stents may be considered for short(i.e. <25 cm) lesions. IIb B

Drug-eluting balloons may be considered for thetreatment of in-stent restenosis. IIb B

2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with ESVS(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095)

www.escardio.org/guidelines

Revascularization of femoro-poplitealocclusive lesions (continued)

4

Recommendations Class Level

In patients who are not at high-risk for surgery,bypass surgery is indicated for long (i.e. ≥25 cm) superficial femoral artery lesions when an autologousvein is available and life expectancy is >2 years.

I B

The autologous saphenous vein is the conduit ofchoice for femoro-popliteal bypass. I A

When above-knee bypass is indicated, in the absenceof any autologous saphenous vein, the use of aprosthetic conduit should be considered.

IIa A

In patients unfit for surgery, endovascular therapymay be considered in long (i.e. ≥25 cm) femoro-popliteal lesions.

IIb C

What are the arguments of the promotors ofsurgery first?

Old fashioned, outdated and underpowered!!

Study Flow Chart

Intention-to-Treat-Principle

Bradbury, 2005

BASILAmputation Free Survival & Overall Survival

BSX=APL BSX(>)APL BSX=APL BSX>APL

AFS OS

Bradbury et al., 2010

BASILAmputation Free Survival & Overall Survival


Post hoc analysis, numbers at risk to low for any relevant conclusion5-year data available only for 54% of the study cohort

BASILPatient Status at Final Follow-up


TASC C & D SFA LesionsBypass is considered the golden standard

Bosiers M. LINC 2018

First Author/Yr Type of Study Study Population Primary patency

Hines/2010 Retrospective27 patients with TASC D lesions

above- and below-knee venous FP bypass bypass12 months: 73.2%

McQuade/2009

Prospective, randomized

ePTFE/nitinol stent graft vs AK-

popliteal bypass with synthetic

material

86 patients/100 limbs

50 limbs: stent graft

50 limbs: bypass with Dacron graft or ePTFE

12-month:

Stent-graft: 72%

Bypass: 77%

Kedora/2007

Prosepctive,Randomized

Viabahn stent grafts vs

prosthetic femoro-(above-

knee) popliteal bypass

86 patients with femoro-popliteal artery occlusive disease

50 limbs treated with angio and stent

50 limbs treated with bypass with synthetic Dacron or PTFE

grafts

12-month:

Stent: 73.5%

Bypass: 74.2%

Jensen/2007

Prospective, Randomized:

PTFE and Dacron for above the

knee femoropopliteal bypass

427 patients with chronic lower limb ischemia with bypass for

suprageniculate bypass: 205 with PTFE and 208 with Dacron

12-month:

Dacron: ~78%

PTFE: ~70%

Berglund/2005

Retrospective comparison:

autologous saphenous vein

grafts to PTFE grafts

499 patients undergoing bypassfor CLI or claudication:

-139 with vein graft

-360 with ePTFE

Vein, claudication: ~87%

ePTFE, claudication: ~75%

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Analysis of PSV in 100 surgical, primary patentbypasses

Bosiers M. LINC 20188

Total(N=100)

Binaryrestenosis

(N=11)

F-P1 37 3

F-P2 0 0

F-P3 47 6

F-tibial 16 2

100% surgical primary patent = 89%endo primary patent

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Improved Durability of Endovascular Therapy inTASC C & D Lesions

4.4.11

4.4.11

VIASTAR2-Year Freedom from TLR

79.4%

73%

log rank p=0.37

80%

61.9%

log rank p=0.13

Lammer et al . CVIR 2014

Femoro-popliteal RecanalizationBypass-Prothesis vs. Viabahn

McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the

treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2010 Sep;52(3):584-90

ViabahnPrimarypatency

BypassPrimarypatency

ViabahnSecondary

patency

BypassSecondary

patency

1 year 72% 76% 83% 86%

2 years 63% 63% 74% 76%

3 years 63% 63% 74% 76%

4 years 59% 58% 74% 71%

P = 0.807 for primary patencyP = 0.891 for secondary patency

SuperB – Viabahn vs. Venous Bypass GraftStudy Design

Reijnen M. JACC CI 2018

SuperB – Viabahn vs. Venous Bypass Graft1-Year Primary Patency

intention-to-treat per protocol


SuperB – Viabahn vs. Venous Bypass Graft1-Year Secondary Patency

intention-to-treat per protocol


SuperB – Viabahn vs. Venous Bypass Graft30-Days Morbidity


5-year Freedom from TLRProvisional Zilver PTX vs. BMS

Provisional BMS

ProvisionalZilver PTX84.9%

71.6%

p = 0.06log-rank

Dake M et al. Circulation 2016;133:1472-1483.

ZILVER PTXBaseline Lesion Characteristics

Single-Arm Study:de novo long lesions

Lesions 135

Lesion length (mm) 226 ± 44

Diameter stenosis 97 ± 9%

Lesions > 15 cm 100%

Total occlusions 84%

Restenosis (all) 0%

In-stent restenosis (ISR) 0%

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Bosiers M. et al, J Cardiovasc Surg, 2013;54(1):115-122

Zilver PTX in de novo long lesions (>15cm)Primary Patency (PSVR <2.5)

77.6%

24


Zilver PTX in de novo long lesions (>15cm)Freedom from TLR

85.4%

25


ZILVERPASS study

The Cook Zilver PTX drug-eluting stent

versusbypass surgery

for the treatment offemoropopliteal TASC C&D

lesions.

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ZILVERPASS Study

• A prospective, randomized, multi-centerstudy.

Zilver PTX Surgical bypass

1:1randomizatio

n220 patients

4 countries13 clinical

centers

27Bosiers M. LINC 2018

ZILVERPASS - Primary Endpoints

• Primary patency at 12 months, defined as:

ZILVER PTX BYPASS

Absence of binaryrestenosis or occlusionwithin treated lesion*

Absence of binaryrestenosis or occlusion at

proximal and distalanastomoses and over theentire length of the bypass

graft*

Without TLR within 12months

Without clinically drivenreintervention to restore

flow in the bypass.

* Based on CFDU measuring a PSV ratio <2,4


ZILVERPASS - Lesion Characteristics

TotalN = 220

ZILVER PTXN = 113

BYPASSN = 107

P value

Study LimbLeft 114 (51.80%) 61 (53.98%) 53 (49.53%)

P = 0.509Right 106 (48.20%) 52 (46.02%) 54 (50.47%)

Lesion TypeStenosis 12 (5.45%) 9 (7.96%) 3 (2.80%)

P = 0.092Occlusion 208 (94.55%) 104 (92.04%) 104 (97.20%)

Lesion Lengthmm ± SD

(min – max)

247.11 ± 69.26

( 100* - 500)

241.67 ± 63.33

(120* – 500)

252.86 ± 74.89

(100* – 400)P = 0.104

Prox Ref VesselDiameter

mm ± SD(min – max)

5.88 ± 0.73

(4.00 – 8.00)

5.72 ± 0.65

(4.40 – 8.00)

6.05 ± 0.77

(4.00 – 8.00)P = 0.320

*6 PD’s were seen with lesion length <150mm

Very complex lesions:94.55% were occluded and mean lesion length

was 247.11mm


ZILVERPASS - Procedure Characteristics

TotalN = 220

ZILVER PTXN = 113

BYPASSN = 107

P value

Procedure Timeminutes ±

SD(min – max)

90.46 ± 44.77

(17 – 240)

59.60 ± 22.65

(17 – 135)

123.05 ± 38.88

(53 – 240) P < 0.001

Bypass material

Dacron 42 (39.25%)

PTFE 65 (60.75%)

Hospital stay*Nights

(min – max)

5.26 ± 5.65

(0.00 – 34.00)

2.52 ± 3.50

(0.00 – 20.00)

8.14 ± 6.03

(1.00 – 34.00) P<0.001

*Data on hospital stay for 219 patients. 1 Patient (ZILVER PTX group) died during hospital stay


12-month Primary Patency [180 / 220 pts]

FMRP - 2018

Baseline 30 days 6MFU12MFU –

D36512MFU –

D395

ZILVER PTXTar 91 89 83 66 63

% 100 100 94.40 78.10 74.50

BYPASSTar 89 86 75 62 59

% 100 97.70 87.30 73.10 70.60

Preliminary180 patients

Zilver PTX : 78.10 %

BYPASS : 73.10%

Primary Patency, defined asabsence of binary restenosis

in both groups


12-month freedom from TLR [180 / 220 pts]

FMRP - 2018

Baseline 30 days 6MFU12MFU –

D36512MFU –

D395


% 100 100 95.00 82.40 81.10

BYPASSTar 89 87 75 64 62

% 100 98.90 88.30 76.30 76.30



BYPASS : 76.30%


30-day Freedom from Complication rate

FMRP - 2018

Baseline

10days

20 days 30 days

ZILVER PTXTar 91 87 86 86

% 100 96.70 96.70 96.70

BYPASSTar 89 85 80 79

% 100 96.60 90.90 89.80



BYPASS : 87.90%


24-month Primary Patency [110 / 220 pts]

FMRP - 2018

Baseline 30 days 6MFU 12MFU 24MFU


% 100 100 98.00 77.60 68.20

BYPASSTar 58 56 46 40 30

% 100 98.20 82.30 71.40 63.70



BYPASS : 63.70%

Primary Patency, defined asabsence of binary restenosis

in both groups


24-month freedom from TLR [110 / 220 pts]

FMRP - 2018

Baseline 30 days 6MFU 12MFU 24MFU


% 100 100 100 85.40 80.40

BYPASSTar 58 56 46 42 32

% 100 98.20 83.80 76.30 70.30



BYPASS : 70.30%


Femoro-popliteale Verschlüsse – Ist die endo-vaskuläre Therapie der neue Goldstandard?

Ja!

• Die Morbidität der endovaskulären Techniken istsignifikant niedriger als die der Bypass Operation

• Selbst die Ergebnisse der VENÖSEN Bypassanlagesind nicht besser als die endovaskuläre Therapie!

• Die aktuellen Leitlinien berücksichtigen nicht denaktuellen Stand der klinischen Forschung.

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Documents

Pro-Contra - Verschluss der SFA > 25 cm: First Line Perkutan · Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships: