How Do I Use DCBs for Femoropopliteal Artery Revascularization? Herbert D. Aronow, MD, MPH, FSCAI, FACC, FSVM Director, Interventional Cardiology, Cardiovascular Institute Director, Cardiac Cath Labs, Rhode Island &The Miriam Hospitals Alpert Medical School of Brown University
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How Do I Use DCBs for Femoropopliteal Artery
Revascularization?
Herbert D. Aronow, MD, MPH, FSCAI, FACC, FSVM
Director, Interventional Cardiology, Cardiovascular Institute
Director, Cardiac Cath Labs, Rhode Island &The Miriam Hospitals
Alpert Medical School of Brown University
Disclosures
• None
“How Do I Use DCBs?” (for definitive therapy) …is really 2 questions:
• When do I use a balloon only?
• When using a balloon only, when do I choose a DCB?
“How Do I Use DCBs?” (for definitive therapy) …is really 2 questions:
• When do I use a balloon only?
• When using a balloon only, when do I choose a DCB?
When Do I Use A Balloon Only?RCT Protocol Recommendations Regarding Bailout Stenting
Stent only if balloon/DCB result is suboptimal:
If despite prolonged balloon inflation, there is…
1) Residual stenosis ≥ 50%
2) Flow limiting (grade D-F) dissection
IN.PACT SFA Circulation. 2015;131:495-502LEVANT 2 N Engl J Med 2015;373:145-53, PACIFIER Circ Cardiovasc Interv. 2012;5:831-840BIOLUX P-1 J Endovasc Ther 2015, Vol. 22(1) 14–21
“How Do I Use DCBs?” (for definitive therapy) …is really 2 questions:
• When do I use a balloon only?
• When using a balloon only, when do I choose a DCB?
If Balloon is First-Line Strategy, POBA or DCB?
Meta-analysis of DCB vs. POBA RCTs: 12-Month TLR
Giacoppo D, et al. J Am Coll Cardiol Intv 2016;9:1731–42
If Balloon is First-Line Strategy, POBA or DCB?
Meta-analysis of DCB vs. POBA RCTs: Intermed-Term TLR
Giacoppo D, et al. J Am Coll Cardiol Intv 2016;9:1731–42
Mean follow-up 1.9 years; 1843 patient-years
DCB vs. POBA RCTs
Real World Patients: ISR, CTOs, Long Lesions
Giacoppo D, et al. J Am Coll Cardiol Intv 2016;9:1731–42van den Berg JC. Eur J Radiol 2017;91:106-115
SCAI Consensus Guidelines: Device Selection in Fem-Pop Intervention: POBA vs. DCB
Feldman DN, et al. Catheter Cardiovasc Interv. 2018;1–17
CFA Bifurcation AK Pop Ostial SFA Focal SFA IntermedSFA
Diffuse SFA
Mod-Sev Ca++ Focal Mod-Sev Ca++ Intermed Mod-sev Ca++ Diffuse
POBA IIb III IIb IIb III III IIb III III
DCB IIa I I I I I I I I
CTO Focal CTO Intermed CTO Diffuse ISR Focal ISR Intermed ISR Diffuse
POBA IIb III III IIb III III
DCB I I I I I I
Focal < 10 cm
Intermed 10-20 cm
Diffuse > 10 cm
Even When We ’Leave Nothing Behind,’ We Usually Leave Something Behind
Katsanos K. JACC Intv 2016;9:1743-5
Does It Matter If We Leave Paclitaxel Behind?Some Say ‘Yes’
Katsanos K, et al. J Am Heart Assoc 2018:e011245
All-Cause Death at 2 Years All-Cause Death at 4-5 Years
Does It Matter If We Leave Paclitaxel Behind?Some Say ‘No’
Schneider PA, et al. J Am Coll Cardiol 201910.1016/j.jacc.2019.01.013
Erratum https://doi.org/10.1016/j.jacc.2019.02.029
FDA Recommendations Regarding Use of Paclitaxel-Containing Devices – 3/15/19
SCAI Consensus Guidelines: Device Selection in Fem-Pop Intervention: POBA vs. DCB
Feldman DN, et al. Catheter Cardiovasc Interv. 2018;1–17
CFA Bifurcation AK Pop Ostial SFA Focal SFA IntermedSFA
Diffuse SFA
Mod-Sev Ca++ Focal Mod-Sev Ca++ Intermed Mod-sev Ca++ Diffuse
POBA IIb III IIb IIb III III IIb III III
DCB IIa I I I I I I I I
CTO Focal CTO Intermed CTO Diffuse ISR Focal ISR Intermed ISR Diffuse
POBA IIb III III IIb III III
DCB I I I I I I
Focal < 10 cm
Intermed 10-20 cm
Diffuse > 10 cm
Case Examples
DCB vs. POBA for Focal Disease?
Focal SFA
POBA IIb
DCB I
DCB vs. POBA for Intermed/Diffuse Calcified Disease?
IntermedSFA
Diffuse SFA
POBA III III
DCB I I⁇
DCB vs. POBA for Short CTOs?
CTO Focal
POBA IIb
DCB I
DCB vs. POBA for Long CTOs?
CTO Diffuse
POBA III
DCB I⁇
Conclusions
• DCBs were previously the default balloon strategy for fem-pop PVI
• Currently available study-level meta-analytic data and resultant FDA
warning suggest a recalibration is needed pending more definitive info
• In the interim, there will likely be a shift from Class I DCB to Class II
POBA treatment strategies
• Whether operators will shift from Class I DCB to Class III POBA
treatment strategies remains to be seen
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