Endovascular Treatment of
Atherosclerotic Popliteal Artery Lesions –
Balloon Angioplasty versus primary
Stenting: A prospective, multi-centre,
randomised study
ETAP
Thomas Zeller, MD
Bad 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, MedtronicInvatec, 480 Biomedical
ETAP
Background
•
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 Intervention
Femoro-popliteal Artery - Biomechanics
Zone A
Zone B
Zone C
Zone D
Bend / Kink
Compress /
Slight curve
Fixed
Bend / Kink
Lansky, A; Angiographic Analysis of Strut Fractures in
the SIROCCO Trial. TCT 2004
ETAP
Key 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:

•
Patient cohort:

•
•
1:1 randomization POBA with provisional stenting vs.
primary stenting (Lifestent) in popliteal artery disease
246 patients
Patients with chronic PAD RCC 1-4
No restrictions in lesion length
ETAP
Study 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)
ETAP
Inclusion Numbers by Study Center
Treatment group (as randomized)
Stent
PTA
N
%
N
%
Center
Bad Krozingen
Hamburg
Heidelberg
Bad Säckingen
Leipzig
Bern
Wien
Flensburg
Graz
Total
84
13
2
0
3
8
2
2
4
119
71.2
11.0
1.7
0
2.5
6.8
1.7
1.7
3.4
100.0
92
13
3
1
2
9
2
3
3
127
71.9
10.2
2.3
0.8
1.6
7.0
1.6
2.3
2.3
100.0
Total
N
%
176
26
5
1
5
17
4
5
7
246
71.5
10.6
2.0
0.4
2.0
6.9
1.6
2.0
2.8
100.0
ETAP
Patient Characteristics
All Patients
Stent
PTA
(N=246)
(N=119)
(N=127)
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
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
Age (years, range)
Diabetes mellitus (%)
ETAP
Lesion Location
All
Patients
Stent
PTA
(N=119)
(N=127)
(N=246)
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
ETAP
Lesion 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
93±7%
92±8%
0.87
Mean diameter
stenosis
ETAP
1-year Primary Patency
[%]
P < 0.05
ETAP
Clinical Outcomes at 1-Year Follow-up
Death
Major-or Minor Amputation
Stent
PTA
(N=97)
(N=97)
4 (3.9%)
3 (3%)
P
2 (2.1%)
0.68
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
(-3toto-1)
-1)
-2-2(-3
-2 (-3 to -1)
0.52
Rutherford-Becker class
Median change (IQR)
ETAP
Event-Free Survival (ITT)
(Death, TLR, MI, amputation)
P < 0.0001 (log-rank test)
ETAP
Change in RCC at 12 Months
ETAP
Absolute Walking Distance
P < 0.05
ETAP
Interims Analysis 1-Year Stent Fracture
Rate (Corelab)
Stent fracture [calc.]*
yes
no
N
%
N
%
Total
N
%
58
100.0
12 months
2
3.4
56
96.2
*One type I & II stent fracture each
ETAP
Summary
• 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