Below the Knee Stenting:
Trends & Usage in CLI
Bret N. Wiechmann, MD
Vascular & Interventional Physicians
Gainesville, Florida

Perspective: Tibial intervention for
CLI
Femoral-distal bypass gold standard for
revascularization (??)
Repeated frequently in literature
Presumably due to durability
Endovascular techniques have challenged this
Alternative access techniques
Low profile, high trackability, improved deliverability
devices
Achilles heel: RESTENOSIS!!
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CLI data
Problems
Endpoint of most CLI studies = limb salvage &
amputation-free survival at 6m/12m
Debate exists over appropriate endpoints
Clinical results (as above)
Vessel patency
Perhaps most important if assessing a technique’s
technique’
durability & efficacy
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Endovascular intervention, bypass surgery
and major amputation rates in the U.S.
(1996-2006)
(1996-2006)
Goodney PP, Beck AW, Nagle J, etBTK stenting SALSAL 2009 in lower extremity bypass surgery,
al. National trends
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endovascular interventions, and major amputations. J. Vasc. Surg. 2009; 50:54-60.

Infrapopliteal angioplasty (PTA)
Most published literature BTK intervention
Technical success rates from 77-100%
Limb salvage rates up to 91%
Restenosis rates 32-50% at 6 month F/U
angiography
 most of CLI data older – duplex not used very
But
frequently
Therefore vessel patency data not established
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BTK stenting
Historically in limited fashion
Failed PTA
Mostly small single-center data
Growing interest and improved technology
has spurred more published data
Small numbers but it’s something
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BTK stenting
BMS
DES
SES
Bioabsorbable
Biobsorbable-DES
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Long-term results of
infrapopliteal stenting
Bosiers M, Lioupis C, Deloose K, et al. Two-year outcome after Xpert stent implantation for
treating below the knee lesions in critical limb ischemia. Vascular 2009; 17:1-8.
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Infrapopliteal DES – Clinical Studies
Lesion
Study n length Treatment Group Restenosis after 6-mos.
(cm)
Siablis, 2005, 29 1.3 Various (historical) 55% (79% @1-year)
2007 29 1.4 Cypher 4.0% (37% @ 1 -year)
Commeau,
30 NR Cypher NR
2006
Scheinert, 30 NR Bx Velocity 39%
2006 30 NR Cypher 0%
Siablis, 2007 29 2.6 Taxus 18% (77% @ 1-year)
10% (mean F/U of 9
Rosales, 2008 24 NR Cypher (35)/Taxus (6)
mos.)
Siablis D, Kraniotis P, Karnabatidis D, et al. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb
ischemia. J. Endovasc. Ther. 2005;12:685-695. Siablis D, Karnabatidis K, Katsanos K, et al. Sirolimus-eluting versus bare stents after suboptimal
infrapopliteal angioplasty for critical limb ischemia: Enduring 1-year angiographic and clinical benefit. J. Endovasc. Ther. 2007;14:241-250.
Commeau P, Barragan P, Roquebert PO. Sirolimus for below the knee lesions: Mid-term results of the SiroBTK study. Cath. Cardiovasc. Interv.
2006;68:793-796. Scheinert D, Ulrich M, Scheinert S, et al. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal
obstructions. EuroInterv. 2006;2:169-174. Siablis D, Karnabatidis D, Katsanos K, et al. Infrapopliteal application of paclitaxel-eluting stents for critical limb
ischemia: midterm angiographic and clinical results. J. Vasc. Interv. Radiol.SALSAL 2009
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BTK stenting 2007;18:1351-1361. Rosales OR, Mathewkutty S, Gnaim C. Drug-eluting stent 9
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for below-the-knee lesions in patients with critical limb ischemia: Long-term follow-up. Cath. Cardiovasc. Interv. 2008;72:112-115.

29 pts BMS post failed PTA
65 lesions, 40 infrapopliteal arteries
Then 29 pts DES post failed PTA
66 lesions, 41 infrapopliteal arteries
12m angiographic endpoints
1° patency, binary ISR, in-segment restenosis
12m clinical endpoints
TLR, mortality, limb salvage, minor amputation
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BTK stenting: BMS vs. DES
(sirolimus) – Siablis, et al. JEVT
BMS DES
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 pts
24
 different types DES (sirolimus,paclitaxel)
2
83% limb preservation (f/u range 8-34m)
95% patency by DUS or angio (mean f/u
9.5m)
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BTK stenting: Abbott Xpert
 pts with CLI JVIR
35
Technical success, 1° patency, clinical
improvement (Rutherford) at 6m
Technical success 100%
Clinical improvement 80%
Limb salvage 100%
Minor amputation 17%
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Bioabsorbable stents
(polylactic acid/MG-based)
Most early data coming from Europe
Early stage data 2009
Restenosis rates & LLL somewhere between
BMS and DES
Less thrombosis
Use of advanced imaging techniques (OCT)
to evaluate luminal surface – positive
remodeling
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Absorbable Stents - Clinical Studies
Study Device Lesions n Outcome
Igaki-Tamai FIM coronary 50 18% restenosis @ 12-mos.
PERSEUS SFA 45 20% restenosis @ 6-mos.
6-
BE Poly-l-lactic acid
Poly-
PROGRESS AMS Coronary 63 48% restenosis @ 12-mos.
12-
BEST BTK infrapopliteal 20 90% clinical patency @ 3-mos.
3-
AMS INSIGHT BE Magnesium alloy infrapopliteal 37 68% restenosis @ 6-mos.
6-
ABSORB coronary 30 7.7% restenosis @ 6-mos.
6-mos.
Tamai H, Igaki K, Kyo E, KosugaBE Poly- lactic acidS, et al. Circ. 2000; 102(4):399-404.
K, Kawashima A, Matsui with
Poly-
everolimus
Waksman R. Cardiovascular Revascularization Therapeutics. Washington, D.C., 2007.
Erbel R, Di Mario C, Bartunek J, Bonnier J, de Bruyne B, Eberli FR, et al. Lancet 2007; 369:1869-1875.
Peeters P, Bosiers M, Verbist J, Deloose K, Heublein B. J. Endovasc. Ther. 2005; 12:1-5.
Bosiers M, Peeters P, D’Archambeau O, et al. AMS INSIGHT - Absorbable metals stent implantation for treatment of below-the-knee critical limb15
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ischemia: 6-month analysis. Cardiovasc. Intervent. Radiol. 2009.
Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MWI, et al. The Lancet 2008; 371(9616):899.

69yo WM
3wk h/o
inc rest pain
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87yo WM
w/rest pain &
acute
exacerbation
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4mm Xpert stent
3.5mm Vision stent
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Summary
Infrapopliteal endovascular intervention has become
standard initial therapy for CLI pts
 “Endo first” approach
 True despite lack of RCT, mostly single center data (doubtful we
will have this anyway)
Infrapopliteal PTA still frought with restenosis issues
Like elsewhere, stenting has become more popular to
achieve better acute results
Data is better and initially and may be enough clinically
(limb salvage)
 Some discordance btw vessel patency & limb salvage
Bioabsorbable and bioabs-DES platform very early but
may provide the “stent-free” solution
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