Treatment Strategies for SFA Disease

Fabrizio Fanelli MD, EBIR, FCIRSE

Vascular and Interventional Radiology Unit

Department of Radiological Sciences

“Sapienza” - University of Rome

Disclosures

Speaker name: Fabrizio Fanelli

I have the following potential conflicts of interest to report:

Consulting

Abbott; Bayer; Bard; Boston Scientific; Cook; Cordis; Medtronic; Spectranetics; Trireme Medical; Volcano; W.L. Gore & Associates

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

• TASC II guidelines (2007): No mention.

• ESC guidelines (2011): Brief mention of early promising evidence based on the THUNDER trial.

• ESVS CLI guidelines (2011): Brief mention on encouraging early data (reference to THUNDER and PACIFIER trials), on short lesions. Call for larger & randomized trials.

• ACCF/AHA guidelines (2011): No mention.

[1] Norgren L, at al. J Vasc Surg. 2007;45:S5A–S67A. [2] European Stroke Organisation, Tendera M, et al; Eur Heart J. 2011 Nov;32(22):2851-906. [3] Setacci C, et al. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S43-59. [4] Lower limb peripheral arterial disease, Diagnosis and management. NICE Clinical Guideline 147 , Methods, evidence and recommendations, August 2012. [5] American College of Cardiology Foundation, et al. Vasc Med. 2011 Dec;16(6):452-76. [6] Klein AJ, et al. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):529-38. [7] Katsanos K, et al. Cardiovasc Intervent Radiol. 2014 Jun;37(3):592-603.

What do guidelines tell us?

Inter-Society Consensus for the Management of Peripheral

Arterial Disease (TASC II)

L. Norgren, W.R. Hiatt, J.A. Dormandy, M.R. Nehler, K.A. Harris, and F.G.R. Fowkes

on behalf of the TASC II Working Group

European Heart Journal (2011) 32:2851-2906 ESC GUIDELINES ESC Guidelines on the diagnosis and treatment of peripheral artery diseases

Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries

The Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of

the European Society of Cardiology (ESC)

European Journal of Vascular and Endovascular Surgery (2011) 42(S2):543-559

Chapter IV: Treatment of Critical Limb Ischaemia

C. Setacci, G. deDonato, M. Teraa et.al.

Management of Patients With Peripheral Artery

Disease (Compilation of 2005 and 2011 ACCF/AHA

Guideline Recommendations) A Report of the American College of Cardiology

Foundation/American Heart Association Task Force on Practice Guidelines

Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery

ACC/AHA Practice Guidelines

Clinical Use of DCB in PAD: Scarce Information

• NICE PAD guidelines (2012): Not considered in the guideline. Included note that DCB may prove of value in the future.

• SCAI guidelines (2014): Brief mention of DCB as showing tremendous promise – as a “future direction” for treatment.

• CIRSE guidelines (2014): PTX-balloons have been shown to outperform Balloon Angioplasty in several RCTs but long-term evidence is still missing.

[1] Norgren L, at al. J Vasc Surg. 2007;45:S5A–S67A. [2] European Stroke Organisation, Tendera M, et al; Eur Heart J. 2011 Nov;32(22):2851-906. [3] Setacci C, et al. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S43-59. [4] Lower limb peripheral arterial disease, Diagnosis and management. NICE Clinical Guideline 147 , Methods, evidence and recommendations, August 2012. [5] American College of Cardiology Foundation, et al. Vasc Med. 2011 Dec;16(6):452-76. [6] Klein AJ, et al. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):529-38. [7] Katsanos K, et al. Cardiovasc Intervent Radiol. 2014 Jun;37(3):592-603.

Cardiovasc Intervent Radiol (2014) 37:592-603

CIRSE Standards of Practice Guidelines

Standards of Practice for Superficial Femoral and

Popliteal Artery Angioplasty and Stenting Konstantinos Katsanos, Gunnar Tepe, Dimitris Tsetis, Fabrizio Fanelli

SCAI Expert Consensus Statement for Femoral-Popliteal Arterial Intervention Appropriate Use

Andrew Klein, Duane Pinto, Bruce Gray, Michael Jaff,

Christopher White, Douglas Drachman

Catheterization and Cardiovascular Interventions 85:529-538 (2014)

Clinical Use of DCB in PAD: Scarce Information

THE NEED: Drug-coated balloons are not yet classified in international guidelines because relevant data had not yet been published when literature research was performed for the guidelines. FILLING THE KNOWLEDGE GAP: This International Positioning Document addresses the gap in knowledge by providing an evidence-based recommendation for the use of DCB technology in the peripheral vascular territory.

FINAL RECOMMENDATION:

“… the use of DCB in femoro-popliteal TASC II A and B de novo and restenotic lesions would be highly recommended because the given treatment is beneficial, useful, and

effective and the data are derived from multiple randomized clinical trials…”

Cortese B, Granada JF, Scheller B, Schneider PA, Tepe G, Scheinert D, Garcia L, Stabile E, Alfonso F, Ansel G, Zeller T. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document†. Eur Heart J. 2015 May 24.

Clinical Use of DCB in PAD: Scarce Information

THE NEED: Drug-coated balloons are not yet classified in international guidelines because relevant data had not yet been published when literature research was performed for the guidelines. FILLING THE KNOWLEDGE GAP: This International Positioning Document addresses the gap in knowledge by providing an evidence-based recommendation for the use of DCB technology in the peripheral vascular territory.

FINAL RECOMMENDATION:

“… the use of DCB in femoro-popliteal TASC II A and B de novo and restenotic lesions would be highly recommended because the given treatment is beneficial, useful, and

effective and the data are derived from multiple randomized clinical trials…”

Cortese B, Granada JF, Scheller B, Schneider PA, Tepe G, Scheinert D, Garcia L, Stabile E, Alfonso F, Ansel G, Zeller T. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document†. Eur Heart J. 2015 May 24.

Clinical Use of DCB in PAD: Scarce Information

SPRING 2014 SUPPLEMENT TO ENDOVASCULAR TODAY - Modified by Prof. F. Fanelli, Personal Communication

CTO Stenosis

PTA predilatation

Flow-limiting dissection or >50% residual stenosis?

Is the lesion severely calcified?

Consider atherectomy

Stent

Bypass

Can it be crossed?

No Yes

No

Yes

Debulk successful?

Flow-limiting dissection or >50% residual stenosis?

Finished

Yes No

DCB

No

Yes

No Yes

Stent

Spot stent Post-Dilatation 1st

2nd

SFA Treatment Strategy – According to My Practice:

Current Therapies Complement DCB as Workhorse Therapy

fabrizio.fanelli@uniroma1.it

Treatment Strategies for SFA Disease

Fabrizio Fanelli MD, EBIR, FCIRSE

Vascular and Interventional Radiology Unit

Department of Radiological Sciences

“Sapienza” - University of Rome