Endovascular Therapy for Common Femoral Artery:

Is the Tide Turning?Katrine Zhiroff, MD, FACC, FSCAI

USC Keck School of Medicine

Los Angeles, CA

Disclosures

• Terumo (Consultant)

• Biotronic (Consultant)

• Abiomed (Consultant)

• Novartis (Speakers’ bureau)

Objectives

• Review surgical data for CFA revascularization

• Anatomical considerations for endovascular approach to CFA therapies

• Review of available data on CFA endovascular treatment

• Clinical appropriateness of CFA intervention

Common Femoral Artery Revascularization• “Gold Standard” = Surgical revascularization

• Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)

• No specific guidelines on isolated CFA disease

• TASC C/D for chronic total occlusion of CFA

Nogren et al. JVS 2007 45 (1): Supplement SVartanian et al. Circ Res. 2015;116:1614-16

Historical Surgical Data (Cardon 2001)

• 110 endarterectomies, 101 patients• 48% IC and 52% CLI

• 84.5% procedural success

• Perioperative mortality rate was 1%

• Local morbidity rate was 21.6%

• 18% of minor complications

• Mean follow-up was 43 months in 90 patients

• Primary patency

• 94.9% at 3 yrs and 88.8% at 5 yrs

Cardon et al Ann Chir. 2001 Oct;126(8)

• 713 vessels with CFE• 67% IC and 33 % CLI

• The primary end point was primary patency • Secondary endpoints: Secondary patency, limb salvage, and survival

• Patency rates• Primary patency 97.3% at 6 months and 90.2% at 3 year• Primary patency was 78.5% at 7 years

• No difference for CLI vs IC (76.3% vs 79.4%; P = .20) at 7 years • 11% target lesion revascularizations• Procedure-related complications 11.5% during 7 years f/u

Wicker et al. J Vasc Surg 2016;64:995-1001

What about endovascular treatment options?

Anatomical Considerations

• Frequent multi-vessel PAD involving inflow and outflow vessels• Large vascular territory at risk• Complex lesions

• Severe calcification• Involvement of bifurcation

• Limited collateral supply• Preservation of future access site for surgical and endovascular therapies

Endovascular Treatment Options

• Angioplasty • Plain• Drug coated balloon

• Atherectomy• Rotational,

directional, orbital, laser

• Stenting

CONCERNS:

• Rate of complications• Perforation• Dissection• Durability

• Risk of stent fracture

• In-Stent Restenosis

Deformation of Femoral Vessels

Poulson et al J Vasc Surg 2018;67:607-13

https://www.acc.org/latest-in-cardiology/articles/2018/10/25/12/42/peripheral-matters-common-femoral-interventions-is-endovascular-therapy-ready-for-prime-time

Current Status of CFA Intervention

• Limited data set

• Most data is retrospective

• Patient cohorts are heterogeneous

• No clearly defined endpoints

• No consensus guidelines

• CFA intervention is feasible and safe

• Long term surgical patency superior

• Short term endovascular morbidity superior

Endovascular Treatment of CFA Disease

• Prospectively single-center database

• 360 consecutive percutaneous interventions of the CFA• 77.9% IC and 22.1% CLI

• Outcomes:• Procedural success, in-hospital complications

• 1-year patency, and target lesion revascularization rates

Bonvini et al. J Am Coll Cardiol 2011;58:792–8

CFA Interventions• Lesions treated

• 26.9% isolated CFA

• Method of Revascularization

• 98.6% PTA

• 36.9% PTA + Stent

• 6.9% SilverhawkAtherectomy

• 92.8% Procedural success

• 6.4% complications

• 1.7% Contralateral access site complications

• 1.7%Distal embolization

• 1.7% Thrombotic vascular events

• 1.4% Minor complications (i.e., AV fistula, non–flow limiting dissection)

Bonvini et al. J Am Coll Cardiol 2011;58:792–8

Patency

• 1 year primary patency 72.4%

• TLR 19.9%

• Percutaneous 14.9%

• Surgical 5.0%

• In-hospital death 1.2%

Bonvini et al. J Am Coll Cardiol 2011;58:792–8

Stenting of the CFA

• 53 patients (primary stenting approach)

• 68% IC and 32% CLI

• Single-center, nonrandomized, prospective study

• Primary end point: absence of binary restenosis

• Secondary end points

• Freedom from TLR and stent fracture rate

• Procedural success 96%

• Mean follow-up of 24 months

• Primary patency 92.5%

• Stent fracture rate at 1 year was 9%

Thiney et al. Ann Vasc Surg 2015; 29: 960–967

Long Term Outcomes of CFA Stenting

Nasr et al. Ann Vasc Surg 2017; 40: 10–18

• N=40 limbs underwent stenting of CFA

• 70% IC and 30% CLI

• Mean follow-up was 64 months

• The mortality rate at 5 years was 38%

• Primary patency 79%

• In-stent restenosis rate was 28%

• PFA involvement was a predictor of ISR

• 1 stent fracture was noted at the first year follow-up without clinical consequence

CFA Interventions with Atherectomy

• PTA with provisional stenting vs atherectomy for CFA occlusive disease

• 50% to 79% CFA stenosis-- > PTA with PS

• > 80% CFA stenosis--> atherectomy (Jetstream/Pathway) and PTA

• 167 cases

• 55% IC and 45% CLI

• 68% PTA only

• 23% atherectomy +/- PTA

• 9% provisional stenting

Mehta et al. J Vasc Surg 2016;64:369-79

• Primary Patency• 1 year: PTA 78%, Ather 90%• 2 year: PTA 70%, Ather 92%• 5 year: PTA 60%

• During long-term mean follow-up of 42.5 months• Only 9 % of all patients received

stents• CFA provisional stent group had a

100% primary patency

P=0.04

Mehta et al. J Vasc Surg 2016;64:369-79

Outcomes with DEB in CFA

Kuo et al. J Vasc Surg 2019;69:141-7

• 100 cases; retrospective review• 40 patients with DEB angioplasty• 60 patients with femoral CFE

• Technical success was 100% in all patients

• DEB had lower 1-year primary patency• 75.0% vs 96.7%; P < .003

• At 2-year primary patency • 57.1% vs. 94.1%; P < .001

Atherectomy and DEB in CFA

• 30 consecutive patients treated using DA followed by DCB dilatation• Provisional stenting was allowed in the case of a suboptimal result• 6% IC and 94% CLI• Procedural success was achieved in 100%• Stenting was needed in 3 cases 10%• Primary patency in 1 year 90%

• TLR 10%

Cioppa et al. EuroIntervention 2017;12:1789-94.

TECCO Trial

• 117 patients with de novo CFA lesions• 87% IC and 13% CLI

• In type III lesions with occluded SFA, stent placed from CFA to PFA

• RCT of surgery vs. primary stenting• Procedural success 100% vs 94.6%

• Primary outcome: morbidity and mortality at 30 days

• Primary patency rate, target lesion and extremity revascularization rates were not different in the 2 groups

Goueffic et al. J Am Coll Cardiol Intv 2017;10:1344–54

• Primary patency was equivalent

• HR 0.9, p=0.93

• 1 stent fracture at 2 years• No clinical sx

2018: Updated SCAI guidelines

Feldman et al. Catheter Cardiovasc Interv 2018;92:124-40

Severity of PAD and Survival

Norgren, L. et al. JVS 2011;45(1) , S5 - S67

Summary: Clinical Applications

• Surgical and Endovascular Treatments are appropriate in different patient populations

• Patient selection

• Short term patency may be appropriate and applicable to CLI patient subset with higher risk of perioperative complications

• -> endovascular treatment

• Long term patency preferred for IC patients

• -> surgical treatment

• Future RCTs needed