Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions –

Balloon Angioplasty versus primary Stenting: A prospective, multi-centre,

randomised study

ETAP

Thomas Zeller, MDBad Krozingen, Germany

On behalf of the ETAP trial investigators

Disclosures

Advisory Board:

Medtronic-Invatec, W.L. Gore, Angioslide, Medtronic-Ardian, Covidien-ev3

Consulting Fees/Honoraria:

Sanofi-Aventis, C.R. Bard, J&J Cordis, Covidien-ev3, Boston Scientific, Straub Medical, Invatec, Biotronik, Pathway Medical, W.L. Gore

Research Grants:

Cook, Krauth Medical, Pathway Medical, Abbott Vascular, J&J Cordis, Angioslide, Ardian, Biotronik, Invatec, InnoRa, W.L. Gore, Veryan, Covidien-ev3, Medtronic-Ardian, Medtronic-Invatec, 480 Biomedical

ETAPBackground

• The popliteal artery is considered as a “no-stent”-zone due to potential excessive external forces applied to the stent in the popliteal fossa

• No prospective comparative controlled trials have yet investigated the performance of stents in the popliteal artery to date

• The ETAP trial is the first in man trial comparing primary stenting using a contemporary nitinol stent device (Lifestent) with the current “gold standard” POBA

Rationale for Stent-less InterventionFemoro-popliteal Artery - Biomechanics

Lansky, A; Angiographic Analysis of Strut Fractures in the SIROCCO Trial. TCT 2004

Zone A

Zone B

Zone C

Zone D

Bend / Kink

Fixed

Compress / Slight curve

Bend / Kink

ETAPKey Features

• Investigator initiated European prospective, randomized controlled multi-center trial (9 centers)

• Unrestricted grant by C.R. BARD-Angiomed

• Independent data management, corelab adjudication

• Study Design: 1:1 randomization POBA with provisional stenting vs.

primary stenting (Lifestent) in popliteal artery disease

• Patient cohort: 246 patients

• Patients with chronic PAD RCC 1-4

• No restrictions in lesion length

ETAPStudy Endpoints

Primary Endpoint• Restenosis rate at 12 months (duplex PSVR > 2.4)

Secondary Endpoints (6,12 & 24 months)• Restenosis rate (PSVR > 2.4)• Restenosis rate (PSVR > 2.0)• Primary patency rate• Secondary patency rate• Clinically driven TLR rate• Change in RCC• Walking distance (treadmill) • ABI • MACE • Stent fractur rate at 12 and 24 months (plain X-ray)

ETAPInclusion Numbers by Study Center

Treatment group (as randomized)TotalStent PTA

N % N % N %Center

84 71.2 92 71.9 176 71.5Bad KrozingenHamburg 13 11.0 13 10.2 26 10.6Heidelberg 2 1.7 3 2.3 5 2.0Bad Säckingen 0 0 1 0.8 1 0.4Leipzig 3 2.5 2 1.6 5 2.0Bern 8 6.8 9 7.0 17 6.9Wien 2 1.7 2 1.6 4 1.6Flensburg 2 1.7 3 2.3 5 2.0Graz 4 3.4 3 2.3 7 2.8Total 119 100.0 127 100.0 246 100.0

ETAP Patient Characteristics

All Patients

(N=246)

Stent

(N=119)

PTA

(N=127)

Age (years, range) 72 (41-89) 72 (42-89) 73 (41-89)

Male sex (%) 64.2 63.9 64.6

Body-mass-Index 26±4 27±4 26±4

Diabetes mellitus (%) 37 36.1 37.8

Dyslipidemia (%) 78.9 75.6 81.9

Hypertension (%) 85.4 82.4 88.2

Current smoker (%) 23.2 21.8 24.4

Coronary heart disease (%)43.1 42.9 43.3

Carotid artery disease (%)15.4 17.6 13.4

ETAPLesion Location

All

Patients

(N=246)

Stent

(N=119)

PTA

(N=127)

Popliteal I+II 46.7 46.2 47.2

Popliteal II+III 46.7 46.2 47.2

Popliteal I+II+III 6.6 7.6 5.6

ETAPLesion Characteristics

Stent

N=119

PTA

N=127

P

Lesion length [mm]

41.3±31.3 43.2±28.1 0.453

CTO 33% (39) 33% (42) 1.00

Mean diameter stenosis

93±7% 92±8% 0.87

ETAP1-year Primary Patency

[%]P < 0.05

ETAPClinical Outcomes at 1-Year Follow-up

Stent

(N=97)

PTA

(N=97)

P

Death 4 (3.9%) 2 (2.1%) 0.68

Major-or Minor Amputation 3 (3%) 3 (3%) 1.0

TLR (ITT) 15 (15.4%) 49 (50.4%) 0.0001

TLR (OT) 15 (15.4%) 22 (21.4%) 0.29

Myocardial infraction 1 (1%) 0 (0%) 1.0

Limb salvage 97 (100%) 97 (100%) 1.0

Change in ABI 0.22 (±0.3) 0.24 (±0.4) 0.9

Rutherford-Becker class

Median change (IQR) -2 (-3 to -1) -2 (-3 to -1) 0.52-2 (-3 to -1)

ETAPEvent-Free Survival (ITT)

(Death, TLR, MI, amputation)

P < 0.0001 (log-rank test)

ETAPChange in RCC at 12 Months

ETAPAbsolute Walking Distance

P < 0.05

ETAPInterims Analysis 1-Year Stent Fracture

Rate (Corelab)

Stent fracture [calc.]*Totalyes no

N % N % N %12 months

2 3.4 56 96.2 58 100.0

*One type I & II stent fracture each

ETAPSummary

• ETAP is the first controlled trial investigating the performance of POBA and primary stent placement (Lifestent) in the popliteal artery

• Lifestent placement in the popliteal artery is safe Corelab adjudicated 1-year fracture rate 3.4%

• Lifestent placement results in a significant higher primary patency rate as compared to POBA

• In ITT analysis no significant difference in change of Rutherford categories

• In ITT significant better improvement of absolute walking distance in the stent cohort