Nicolas Diehm, M.D. Swiss Cardiovascular Center Clinical and Interventional Angiology University Hospital Bern, Switzerland

Specificities for infrapopliteal stents

Speaker`s Bureau: MEDRAD, Biotronik, Bristol-Myers Squibb,

EV3, Cook Medical.

Consulting: MEDRAD.

Research Grants: Medtronic, Biotronik, Swiss National Foundation, Swiss Heart Foundation.

Disclosures

Endovascular first in CLI!

Truths in BTK Therapy Evidence Level A

"There is increasing evidence to support a recommendation for angioplasty in patients with CLI and infrapopliteal artery occlusion where in-line flow to the foot can be re-established and where there is medical co-morbidity."

"In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival !.." Basil trial participants, Lancet 2005; 366: 1925–1934

Restenosis after POBA / Stenting of BTK Arteries

Romiti et al. J Vasc Surg 2008;47:975-81

•! Meta-analysis of 30 studies published 1990 – 2006 •! n = 2653 limbs treated

Endovascular BTK Therapy Angiographic Restenosis

Different Stent Requirements

Commercially available BMS

No results from randomized controlled trials. Study with small sample sizes.

Patency data largely based on duplex ultrasound.

INPERIA Study

Rand et al., Cardiovasc Intervent Radiol 2006;29(1):29-38

•! 95 lesions in 51 CLI patients. •!Mean lesion length: 24 mm. •!Randomized POBA (53 lesions) versus

Carbostent (balloon-expandable; 42 lesions). •! Follow-up: DSA or CTA at 6 months •! Primary patency: 83.7% (Stent) versus 61.1%

(POBA), p=0.02. •! Limb salvage: 92% (Stent) versus 95%

(POBA), p=n.s.

Objective: Evaluation of safety and efficacy of XPERT stent vs. PTA in subjects with CLI Design: Prospective, randomized, two-arm, multi-center

Baseline Proc. 24 hr 30 d 6 mo 12 mo Clinical

Duplex ultrasound

Angiography

Key Secondary endpoints

Primary endpoint

Subjects: 180 (90 Xpert : 100 PTA), Rutherford 4-6, maximum BTK lesion length: 15cm. Sites: 13 European

•! Procedural success, TLR @ 6 &12 months; TVR @ 6 &12 months; •! Wound healing; & walking distance

!! % Diameter stenosis (MLD) by angio @ 12 months

Source: www.Clinical trials.gov;

PI: G Tepe (Klinikum Rosenheim Institut für Diagnostische und Interventionelle Radiologie, Germany)

XXS Study

Commercially available DES

Two randomized studies (positive).

ACHILLES Study

•! Cypher DES versus POBA (n=200 Rutherford 3 – 5 patients).

•! De novo or restenotic (after PTA only) lesion(s).

•! Total lesion length: <3cm.

•! Binary restenosis (ITT): 19.4% (DES) versus 41.9% (POBA), p=0.006.

Scheinert D, CX Symposium 2011

DESTINY Study

•! Xience DES versus Multilink BMS (n=140 Rutherford 4 – 5 patients).

•! Total lesion length: <2cm.

•! Angiographic patency: 85.2% (DES) versus 54.5% (BMS), p<0.001.

•! TLR: 8.7% (DES) versus 33.6% (BMS), p<0.001.

•! Freedom from amputation: 98.7% (DES) versus 97.1% (BMS), p=n.s..

YUKON BTK Study

•! Polymer-free DES (Sirolimus) versus BMS (n=161 Rutherford 2 – 5 patients).

•! Total lesion length: 3 cm.

•! Angiographic patency: 80.6% (DES) versus 55.6% (BMS), p=0.004.

•! Clinical improvement (Rutherford) @ 1 year higher in DES group, p=0.004.

•! Event-free survival at 1 year: n.s..

Morphology of BTK lesions in CLI

•! Two thirds of all BTK lesions are occlusions.

•! 50% of all lesions are occlusions >10 cm.

Graziani, et al. Eur J Vasc Endovasc Surg. 2007;33:453–460

Limitations of BTK Stents!

•! Late and very late stent thrombosis?

•! Permanent implant left behind.

•! Biomechanics not understood.

•! Stent fractures?

Biomechanics of BTK Arteries

Endovascular BTK Therapy in CLI Current Treatment Options

Long diffuse lesion

Bailout Stenting

Others Calcified / Ostial / Focal

DES SES? End

PTA (DEB PTA?)

Focal lesion

DES

Patient with Critical Limb Ischemia

AMS?

Conclusions •!DES associated with better patency

compared to BMS or POBA for focal lesions.

•!Higher patency rates with BMS / DES do not translate into lower amputation rates.

•!Patency is only part of the answer to clinical success.

•!More randomized data for longer lesions needed.