1. Endovascular Therapy for Common Femoral Artery: Is the Tide Turning?
Katrine Zhiroff, MD, FACC, FSCAI
USC Keck School of Medicine
Los Angeles, CA

2. Disclosures Terumo (Consultant) Biotronic (Consultant)
Abiomed (Consultant)
Novartis (Speakers’ bureau)

3. 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

4. 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 (1): Supplement S
Vartanian et al. Circ Res. 2015;116:

5. 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
52% were limb salvage = CLI
only CFA in 20% of cases (patch angioplasty in 55% of cases)
common and deep femoral arteries in 50.5% of cases (82% of patch)
CFA, DFA and SFA at its origin in 29.1% of cases (93% of patch)
Cardon et al Ann Chir.  2001 Oct;126(8)

6. The primary end point was primary patency
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:

8. What about endovascular treatment options?

9. 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

10. Endovascular Treatment Options
CONCERNS:
Rate of complications
Perforation
Dissection
Durability
Risk of stent fracture
In-Stent Restenosis
Angioplasty
Plain
Drug coated balloon
Atherectomy
Rotational, directional, orbital, laser
Stenting

11. Deformation of Femoral Vessels
Poulson et al J Vasc Surg 2018;67:607-13
Retrievable nitinol markers were deployed using a custom-made catheter system into 28 in situ FPAs of
14 human cadavers. Contrast-enhanced, thin-section computed tomography images were acquired with each limb in
the standing (180 degrees), walking (110 degrees), sitting (90 degrees), and gardening (60 degrees) postures. Image
segmentation and analysis allowed relative comparison of spatial locations of each intra-arterial marker to determine
axial compression and bending using the arterial centerlines
Poulson et al J Vasc Surg 2018;67:607-13

13. 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

14. 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
16.5% CLI (R-4)
Bonvini et al. J Am Coll Cardiol 2011;58:792–8

15. CFA Interventions Lesions treated 26.9% isolated CFA
Method of Revascularization
98.6% PTA
36.9% PTA + Stent
6.9% Silverhawk Atherectomy
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)
5% complications required re-intervention
Bonvini et al. J Am Coll Cardiol 2011;58:792–8

16. Patency 1 year primary patency 72.4% TLR 19.9% Percutaneous 14.9%
Surgical 5.0%
In-hospital death 1.2%
Restenosis (50%) rate at months 74/268 (27.6)
Late restenosis (i.e., 18 months) 36/174 (20.7)
Late TLR (i.e., 18 months) 34/174 (19.5)
Percutaneous 24/174 (13.8)
Surgical 10/174 (5.7)
1-yr ABI‡
Bonvini et al. J Am Coll Cardiol 2011;58:792–8

18. Stenting of the CFA Procedural success 96% Mean follow-up of 24 months
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%
disabling intermittent claudication (n ¼ 36) or chronic critical limb ischemia (n ¼ 17
Thiney et al. Ann Vasc Surg 2015; 29: 960–967

19. Long Term Outcomes of CFA Stenting
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
Freedom from target lesion revascularization and target extremity revascularization were 79% and 73%, respectively.
Balloon expandable stents only used in Type III lesions (5 out of 13), the rest were self expanding
Nasr et al. Ann Vasc Surg 2017; 40: 10–18

20. 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
standardized treatment choices included primary PTA only, atherectomy (Jetstream/Pathway atherectomy, Boston Scientific) +/- PTA, and provisional stenting.
In the entire population (167 patients), the atherectomy group had a greater degree of pretreatment lesion stenosis vs the PTA-only group, whereas no significance was found in runoff status between these groups.
Disease extending into the proximal SFA or PFA was also treated at the time of the intervention. Distal embolic protection devices were not used in any of the cases. All patients were systemically anticoagulated during the procedure with intravenous heparin to achieve activated clotting times >275 seconds. After the procedure, patients were discharged home on a 3-month course of antiplatelet agents (aspirin 6 clopidogrel).
Mehta et al. J Vasc Surg 2016;64:369-79

21. During long-term mean follow-up of 42.5 months
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
during long-term mean follow-up of
42.5 months, the CFA provisional stent group had a
100% primary patency, which was significantly better than
the primary patency in the CFA nonstent groups combined
(77.0%; P ¼ .0424
Mehta et al. J Vasc Surg 2016;64:369-79

22. Outcomes with DEB in CFA
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
Kuo et al. J Vasc Surg 2019;69:141-7

23. Endarterectomy group more calcification, more CTO
DEB hostile groin

24. CFE: higher rate of transfusions : 76%; longer hospital days 11 vs 4

25. 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:

26. 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
SE stents
Balloon expandable for type III lesions involving the bifurcation
In type III lesions, in case of occlusion of the superficial
femoral artery, the superficial femoral artery was
abandoned and a self-expandable stent was placed
from the CFA into the deep femoral artery.
Goueffic et al. J Am Coll Cardiol Intv 2017;10:1344–54

28. Primary patency was equivalent HR 0.9, p=0.93
1 stent fracture at 2 years
No clinical sx

30. 2018: Updated SCAI guidelines
Optimal strategy is not clear and remains at the discretion of the operator
Feldman et al. Catheter Cardiovasc Interv 2018;92:124-40

31. Severity of PAD and Survival
Norgren, L. et al. JVS 2011;45(1) , S5 - S67

32. 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
Future studies
Stent fractures