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