Treatment Strategies for SFA Disease€¦ · Treatment Strategies for SFA Disease Fabrizio Fanelli...
Transcript of Treatment Strategies for SFA Disease€¦ · Treatment Strategies for SFA Disease Fabrizio Fanelli...
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
Treatment Strategies for SFA Disease
Fabrizio Fanelli MD, EBIR, FCIRSE
Vascular and Interventional Radiology Unit
Department of Radiological Sciences
“Sapienza” - University of Rome