The Detrimental Impact of Chronic Renal Insufficiency

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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
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• Disclosures
• Advisory Board
• Medtronic-Invatec, W.L. Gore, Angioslide,
  Medtronic-Ardian, Covidien-ev3
• Consulting Fees/Honoraria
• Sanofi-Aventis, C.R. Bard, JJ Cordis,
  Covidien-ev3, Boston Scientific, Straub Medical,
  Invatec, Biotronik, Pathway Medical, W.L. Gore
• Research Grants
• Cook, Krauth Medical, Pathway Medical, Abbott
  Vascular, JJ Cordis, Angioslide, Ardian,
  Biotronik, Invatec, InnoRa, W.L. Gore, Veryan,
  Covidien-ev3, Medtronic-Ardian,
  Medtronic-Invatec, 480 Biomedical

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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

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Rationale for Stent-less InterventionFemoro-popli
teal Artery - Biomechanics
Lansky, A Angiographic Analysis of Strut
Fractures in the SIROCCO Trial. TCT 2004
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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
• 11 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

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ETAPStudy Endpoints

• Primary Endpoint
• Restenosis rate at 12 months (duplex PSVR gt 2.4)
• Secondary Endpoints (6,12 24 months)
• Restenosis rate (PSVR gt 2.4)
• Restenosis rate (PSVR gt 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)

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ETAPInclusion Numbers by Study Center
Treatment group (as randomized) Treatment group (as randomized) Treatment group (as randomized) Treatment group (as randomized) Total Total
Stent Stent PTA PTA Total Total
N N N
Center 84 71.2 92 71.9 176 71.5
Bad Krozingen 84 71.2 92 71.9 176 71.5
Hamburg 13 11.0 13 10.2 26 10.6
Heidelberg 2 1.7 3 2.3 5 2.0
Bad Säckingen 0 0 1 0.8 1 0.4
Leipzig 3 2.5 2 1.6 5 2.0
Bern 8 6.8 9 7.0 17 6.9
Wien 2 1.7 2 1.6 4 1.6
Flensburg 2 1.7 3 2.3 5 2.0
Graz 4 3.4 3 2.3 7 2.8
Total 119 100.0 127 100.0 246 100.0
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ETAP Patient Characteristics
All Patients (N246) Stent (N119) PTA (N127)
Age (years, range) 72 (41-89) 72 (42-89) 73 (41-89)
Male sex () 64.2 63.9 64.6
Body-mass-Index 264 274 264
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
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ETAPLesion Location
All Patients (N246) Stent (N119) PTA (N127)
Popliteal III 46.7 46.2 47.2
Popliteal IIIII 46.7 46.2 47.2
Popliteal IIIIII 6.6 7.6 5.6
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ETAPLesion Characteristics
Stent N119 PTA N127 P
Lesion length mm 41.331.3 43.228.1 0.453
CTO 33 (39) 33 (42) 1.00
Mean diameter stenosis 937 928 0.87
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ETAP1-year Primary Patency

P lt 0.05
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ETAPClinical Outcomes at 1-Year Follow-up
Stent (N97) PTA (N97) 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 Rutherford-Becker class
Median change (IQR) -2 (-3 to -1) Median change (IQR) -2 (-3 to -1) -2 (-3 to -1) 0.52
-2 (-3 to -1)
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ETAPEvent-Free Survival (ITT)(Death, TLR, MI,
amputation)
P lt 0.0001 (log-rank test)
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ETAPChange in RCC at 12 Months
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ETAPAbsolute Walking Distance
P lt 0.05
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ETAPInterims Analysis 1-Year Stent Fracture Rate
(Corelab)
Stent fracture calc. Stent fracture calc. Stent fracture calc. Stent fracture calc. Total Total
yes yes no no Total Total
N N N
12 months 2 3.4 56 96.2 58 100.0
One type I II stent fracture each
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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