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DOI: 10.1002/ccd.30020
ORIGINAL STUDIES
1
Interventional Cardiology Service,
“Montevergine” Clinic, Mercogliano, Italy Abstract
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Division of Cardiology, AOR “San Carlo”, Background: Endarterectomy is considered the gold standard therapy for common
Potenza – “San Giovanni di Dio” Hospital,
femoral artery (CFA) steno-occlusive lesions, but a significant risk of perioperative
Melfi, Italy
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Division of Cardiology, Department of mortality and complications has been reported.
Advanced Biomedical Sciences, University of Objective: Aim of this study is to evaluate the efficacy at a long-term follow-up of
Naples “Federico II”, Naples, Italy
patients with CFA steno-occlusive lesions treated with directional atherectomy and
Correspondence drug coated balloon (DCB).
Angelo Cioppa, Interventional Cardiology
Service, “Montevergine” Clinic, Mercogliano, Material and methods: In this single-center registry, 78 patients (male: 80.7%; age:
Italy. 71 ± 15 years; occlusions: 25%) with 80 CFA lesions were included, with 39.7% of
Email: cioppa68@gmail.com
them undergoing directional atherectomy and drug coated balloon due to critical limb
ischemia and 60.3% due to lower-limb intermittent claudication. The long-term
follow-up was completed by 75 patients (3 years).
The 31 patients with critical ischemia (39.7%) were further subdivided into
20 (25.6%) patients with pain at rest and 11 (14.1%) with trophic changes, ulcers
and/or tissue loss.
We considered the primary and the secondary outcome, referring, respectively to
peak systolic velocity ratio (PSVR) ≥ 2.4 on duplex or > 50% stenosis on digital sub-
traction angiography at 36 months and to clinically driven target lesion revasculariza-
tion at 36 months.
Results: The primary and secondary outcome was obtained in 84% and 86.7% of
patients, at 36 months of follow up. Bailout stenting was necessary in 6/80 cases
(7.5%) for suboptimal result. Freedom from MALE was obtained in 98.6% of patients.
Conclusions: These results confirm that directional atherectomy and drug coated bal-
loon strategy for the treatment of CFA lesions is effective at a long-term follow-up
and could be considered as a good alternative to surgery.
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Catheter ©
Cardiovasc Interv.
2021 Wiley 2021;1–7.
Periodicals LLC. wileyonlinelibrary.com/journal/ccd
wileyonlinelibrary.com/journal/ccd ©Cardiovasc
Catheter 2021 Wiley Periodicals
Interv. LLC. 1
2022;99:1310–1316.
2CIOPPA ET AL. CIOPPA 1311
ET AL3.
KEYWORDS
common femoral artery, directional atherectomy, peripheral artery disease
Minneapolis, MN, USA), was placed distal to the stenosis prior to the 2.3 | Definition and outcome measures
use of the peripheral directional atherectomy system, adopted a 1:1
filter-to-vessel ratio. Technical success was defined as the ability to successfully perform
Depending by the lesion anatomy, different strategies were DA and DCB post-dilation with a residual stenosis <30% or <10% if
adopted: bailout stent implantation was necessary.
Procedural success is defined as technical success without the
1. in case of 1-0-0 lesion, the filter was positioned in SFA if patent or occurrence of major adverse events during the hospital stay.
alternatively in the PFA in case of SFA occlusion; Major adverse cardiovascular events (MACEs) included myocar-
2. in case of 1-1-1 bifurcation, the filter was positioned sequentially dial infarction, stroke, and cardiovascular death.
in CFA and SFA and the result was optimized with a final kissing- Major adverse limb events (MALEs) referred to the composite of
balloon technique using drug-coated balloons (DCB); acute limb ischemia, major amputation (not including forefoot or toe),
3. in case of 1-1-0 or 1-0-1 bifurcations, the filter was positioned or urgent revascularization (thrombolysis or other intervention for
only in the vessel to treat.12 ischemia).
Arterial inflow revascularization involved any vessel proximal to
After filter placement directional atherectomy was performed. the CFA lesion (i.e., aortoiliac segment); arterial outflow revasculariza-
When the DA device nose was filled, it had to be removed and the tion involved the SFA, PFA, popliteal artery, or infrapopliteal vessels).
atherosclerotic plaque removed from the storage nose cone. The The primary outcome measure was freedom from binary resteno-
number of cutting passages was at discretion of the operator. No part sis as determined by a PSVR ≥ 2.4 on duplex or >50% stenosis on digi-
of the atherectomy system was blocked by calcified debris requiring tal subtraction angiography at 36 months.
the use of an additional device. The secondary outcome was freedom from clinically driven target
When the PFA or the SFA was affected, the DA was performed lesion revascularization (CD-TLR) at 36 months.
in each of them.
Summarizing, we have inserted the filter according to the follow-
ing indications: 2.4 | Statistical analysis
• for isolated CFA lesions, the filter was placed in the SFA, if patent, Continuous data are presented as the means ± SD; categorical data
or subordinately, if SFA is occluded, the filter was placed in the are given as the number (percentage). Categorical variables were com-
deep femoral artery (PFA). pared using the chi-squared or Fisher exact test as appropriate. The
• in contemporary lesions of SFA and ostial CFA, two filters were Student t test for independent samples was used to compare groups
placed alternately according to the cutting directions. of continuous variables. The threshold of statistical significance was
• in CFA and SFA lesions, or CFA and PFA lesions, the filter was p < 0.05. Primary and secondary outcomes were represented by the
placed in SFA and PFA, respectively. curves of Kaplan–Meier.
• When angiograms demonstrated that residual stenosis was lower The Kaplan–Meier estimate is one of the best options for calcu-
than 30%, a post-dilation with IN.PACT Admiral drug-coated balloon lating the percentage of subjects who live for a certain period of time
(Medtronic, Minneapolis, MN, USA) was performed (balloon-to- after treatment. In clinical trials, the effect of an intervention is mea-
reference vessel diameter ratio 1:1, 10 mm longer than the stenosis, sured over time by counting the number of subjects who survived or
lasting at least 180 s). were saved as a result of that intervention.
All data were analyzed using SPSS software (version 24.0 for
This is a 0.03500 peripheral balloon catheter coated with a matrix Windows; IBM Corporation, Armonk, NY, USA).
consisting of a drug (paclitaxel) combined with a hydrophilic spacer
(urea). Provisional stenting was allowed in the case of a suboptimal
result after prolonged balloon dilatations, that is,, flow-limiting dissec- 3 | RE SU LT S
tion, abrupt vessel occlusion or residual stenosis >50%.
Regard to the periprocedural therapy: all patients received aspirin From January 1, 2012 to December 31, 2016, 78 patients (male:
(100 mg/day) and should have been on clopidogrel (75 mg/day) for at least 80.7%; mean age: 71 ± 15 years; occlusions: 25%) with a total of 80
four days. At the time of admission, all patients taking ticlopidine were lesions were enrolled in the registry. All patients were asked written
switched to clopidogrel. Alternatively, patients received a clopidogrel pre- informed consent for study inclusion. Patients characteristics are sum-
load (300 mg) 24 h before the procedure. Post-procedurally, clopidogrel marized in Table 1.
was continued for 180 days, whereas aspirin was continued for life. 70– Between the 78 patients, 39.7% of them underwent DAART due
100 IU/kg of heparin was administered before wiring the lesion, with the to critical limb ischemia and 60.3% due to lower-limb intermittent
intention of achieving an ACT of > 250 s. Additional heparin was adminis- claudication. The long-term follow-up was completed by 75 patients
13
tered at the operator's discretion according to ACT values. (3 years).
4CIOPPA ET AL. CIOPPA 1313
ET AL3.
TABLE 1 Baseline characteristics SFA-popliteal occlusion (N = 4) and/or lesion of the BTK ves-
Total occlusion 20 (25%) and the proximal part of the popliteal artery; all lesions were
treated with drug-coated balloon (DCB) angioplasty; bailout ste-
Mean lesion length (mm) 48.0 ± 17
nting was only necessary in two patients.
Minimal luminal diameter (mm) 0.8 ± 0.9
• Nine patients had lesions of the BTK vessels, all treated with angio-
Calcium score > 3 64 (80%)
plasty and DCB. In only two cases, it was also necessary bailout
Bifurcation lesions 58 (72.5%)
stenting, of which in one case Mimic Stent Supera was implanted
Medina classification 1,1,0 34 (55.7%)
in the popliteal artery, while in the other case a coronary cobalt-
of bifurcation lesions 1,0,1 9 (14.7%) chromium stent was implanted in the anterior tibial artery.
1,1,1 15 (18.7%)
DCB diameter, mm 6.3 ± 0.7 Obviously, the outflow lesions were treated after the treatment
DCB length, mm 52.2 ± 14.1 of the common femoral artery.
FKB 21 (26.2%) Bailout stenting was necessary in 6/80 cases (7.5%) for sub-
Post dilatation 28 (35%) optimal result. In these six cases, we used Self Expandable Bare Metal
Bailout stenting 6 (7.5%) Nitinol Stent, because implanted after drug-coated balloon treatment.
Post-procedural dissection 0 (0%) No post-procedural dissection was reported. Interestingly, the ste-
nting rate was higher in the early phase of the enrollment, decreasing
Associated revascularization 25 (31.3%)
(inflow and/or outflow) as the procedures volume and the operators experience was growing
(Figure 3), reaching a plateau after 30 procedures performed.
No adverse events (MALE or MACE) from intervention to dis-
The 31 patients with critical ischaemia (39.7%) were further sub- charge were reported, leading to a 100% procedural success.
divided into 20 (25.6%) patients with pain at rest and 11 (14.1%) with There were no complications related to distal embolization, perfo-
trophic changes, ulcers and / or tissue loss. ration, or the access site (hematoma needing surgery or bleeding
Among 31 patients with critical ischemia, 18 had occlusion or resulting in a loss of > 3 g of Hb requiring surgery).
subocclusion of the common femoral upstream of its bifurcation, There was no acute rupture of the vessel at the treatment site, and no
13 had critical common femoral stenosis associated with subsequent pseudoaneurysms formed as a result of the wall collapsing.
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CIOPPA ET AL. CIOPPA ET AL5.
procedure.
Of the 12 restenosis > 50%, 10 patients required a TLR; one
patient reported a major amputation and one other patient was showed trophic lesions: in particular, two patients had foot ulcer (heel
asymptomatic and did not require TLR. and I toe) and the other two had parcel necrosis of a toe.
Among TLR, eight lesions were treated with percutaneous trans- Minor amputations are to be referred to surgical therapeutic
luminal angioplasty (PTA) and two lesions were treated with surgery. completion of revascularization aimed at removing parcel necrosis
Only 20% of TLR occurred in stented patients and 80% occurred of one or two toes in three cases and of a part of the heel in
in nonstented patients (p = 0.3). another case.
Freedom from CD-TLR was obtained in 65 patients (86.7%) The only patient with the major amputation underwent restenosis
(Figure 2). in the first 6 months (Figure 3).
During the entire follow-up, a single case of major amputation
was reported in a patient with restenosis; four other patients reported
a minor amputation (three of them after a TLR). Consequently, free- 4 | DI SCU SSION
dom from MALE was 98.6% (74/75).
The vascular situation at baseline of patients undergoing major This study suggests that the combined use of DA and DCB for the
and minor amputations can be summarized as follows: all patients endovascular treatment of CFA obstructive disease is feasible and
were diabetic and arrived at treatment in Rutherford class 6; they all associated with good clinical outcome at a 3-year follow-up.
6CIOPPA ET AL. CIOPPA 1315
ET AL3.
At our knowledge, this is the longest follow-up available for a The orbital atherectomy is a novel type of atherectomy that employs
large population of patients treated with DAART strategy for CFA orbital sanding and pulsatile forces to cause cracking in the lesions, all-
lesions. owing for easier inflation of a drug-coated balloon. Even this device,
The need for a less invasive strategy compared to surgery for the while useful in vessel preparation procedures, appears to be best suited
treatment of CFA stenosis has been addressed in several previous studies. for small caliber lesions like femoral popliteal and below-knee lesions.20
Bonvini et al examined a large series of patients (n = 321) under- On the other hand, directional atherectomy and DCB was the
going CFA angioplasty with provisional stenting (37%) and found a strategy of choice for our study. In a cohort of 78 patients up to
74% PP and 84.1% freedom from TLR4 at a 1-year follow-up.4 3-year follow-up, the primary patency and freedom from TLR were
The landmark trial that added evidence to the endovascular treat- 84% and 86.7%, respectively. These results confirm that directional
ment of CFA was the endovascular versus open repair of the common atherectomy and drug coated balloon strategy for the treatment of
femoral artery (TECCO) trial comparing endarterectomy to stenting in CFA lesions is effective at a long-term follow-up and could be consid-
6
117 patients with de novo CFA stenosis. At 24 months, there were no ered as a good alternative to surgery.
significant differences in freedom from TLR (HR 0.9; 95% CI 0.3–2.5;
p = 0.83) and primary patency (HR 1.7; 95% CI 0.5–5.6; p = 0.42).
Mehta et al analyzed 167 patients who underwent percutaneous 5 | LIM ITAT IONS
CFA interventions with PTA only (68.2%), atherectomy ± PTA (22.8%)
and provisional stenting (9%) for failed atherectomy ± PTA. The cumu- This is a single center nonrandomized study and the size of the popu-
lative patency at 20 months was 85.9% in the atherectomy group and lation is not really great. The study population is heterogeneous, rang-
70.7% in the angioplasty groups.14 ing from patients with claudication to those with CLI. This should
Our working-group reported good results at a 1-year follow-up of indicate a difference in outcome.
a smaller population of patients (n: 30) with severely calcified CFA
obstructions treated with DA and prolonged paclitaxel-coated balloon
angioplasty that showed a 90% primary patency and a 93.3% freedom 6 | CONCLU SIONS
15
from TLR.
In a recent experience, Guo et al. performed a 4-year follow-up of This study demonstrates good results up to 3-year follow-up of com-
90 patients with CFA lesions (81% IC) treated with PTA (n: 45) or DA mon femoral artery steno-occlusive lesions treated with DAART strat-
(n: 31) with 87.1% PP in the atherectomy group and 66.7% PP in the egy. These data are consistent with recent studies and suggest that
PTA group (p = 0.043). 16
directional atherectomy and drug coated balloon could be a safe and
Despite the long-term follow-up, this study included a smaller, effective alternative to surgery for these patients.
lower-risk population compared to our study, nevertheless the long-
term outcome was similar. ACKNOWLEDG MENTS
There are numerous treatment options for calcified lesions of the The author Donato Gerardi is currently attending the CardioPaTh
lower limb arteries in clinical practice. Peripheral intravascular litho- PhD program. The author Attilio Leone is currently attending the
tripsy (IVL) is a novel calcium modification technique that employs CardioPaTh PhD program.
sonic pressure waves to alter both intimal and medial calcium. The
sonic pressure waves pass harmlessly through the soft tissue and frac- CONFLICT OF INTEREST
ture the calcium, minimizing risk to the vessel's noncalcified portions. The authors declare no conflict of interest.
Despite a lack of real-world experience, IVL is a safe and effective
treatment option for calcified, stenotic CFAs.17,18 DATA AVAILABILITY STATEMEN T
It seems important to remember that this method was not consid- Data available on request due to privacy/ethical restrictions.
ered at the time of the procedure because it lacked sufficient evi-
dence and was not available in our catheterization laboratory. OR CID
Specialty balloons (e.g., cutting, scoring, ultra-high-pressure) are Angelo Cioppa https://orcid.org/0000-0003-4324-4227
being used to treat calcified lesions, although they have limits. Indeed, Eugenio Stabile https://orcid.org/0000-0001-9763-6010
balloon dilation might not be strong enough to cause calcium fracture Giovanni Esposito https://orcid.org/0000-0003-0565-7127
and arterial expansion. Furthermore, these devices create a significant
amount of barotrauma, increasing the chance of dissection. RE FE RE NCE S
The rotational atherectomy (Jetstream) is a rotational cutter that 1. Lin Y, Tang X, Fu W, Kovach R, George JC, Guo D. Stent fractures
does not perform directional cutting and will only cut in the center of after superficial femoral artery stenting: risk factors and impact on
patency. J Endovasc Ther. 2015;22(3):319-326.
the lumen. This, in our opinion, makes it unsuitable for treating large
2. Ballotta E, Gruppo M, Mazzalai F, De Giau G. Common femoral artery
vessels such as the common femoral artery, despite being the device endarterectomy for occlusive disease: an 8-year single-center pro-
of choice for femoropopliteal lesions.19 spective study. Surgery. 2010;147:268-274.
1
2 316
CIOPPA ET AL. CIOPPA ET AL7.
3. Nguyen BN, Amdur RL, Abugideiri M, Rahbar R, Neville RF, 14. Mehta M, Zhou Y, Paty PS, et al. Percutaneous common femoral
Sidawy AN. Postoperative complications after common femoral end- artery interventions using angioplasty, atherectomy, and stenting.
arterectomy. J Vasc Surg. 2015;61(6):1489-94.e1. J Vasc Surg. 2016;64(2):369-379.
4. Bonvini RF, Rastan A, Sixt S, et al. Endovascular treatment of common 15. Cioppa A, Stabile E, Salemme L, et al. Combined use of directional
femoral artery disease: medium-term outcomes of 360 consecutive atherectomy and drug-coated balloon for the endovascular treatment
procedures. J Am Coll Cardiol. 2011 Aug 16;58(8):792-798. of common femoral artery disease: immediate and one-year out-
5. Bonvini RF, Rastan A, Sixt S, et al. Angioplasty and provisional stent comes. EuroIntervention. 2017;12(14):1789-1794.
treatment of common femoral artery lesions. J Vasc Interv Radiol. 16. Guo J, Guo L, Tong Z, Gao X, Wang Z, Gu Y. Directional atherectomy
2013 Feb;24(2):175-183. is associated with better long-term efficiency compared with angio-
6. Gouëffic Y, Della Schiava N, Thaveau F, et al. Stenting or surgery for plasty for common femoral artery occlusive disease in Rutherford 2-4
De Novo common femoral artery stenosis. JACC Cardiovasc Interv. patients. Ann Vasc Surg. 2018;51:65-71.
2017;10(13):1344-1354. 17. Brodmann M, Schwindt A, Argyriou A, Gammon R. Safety and feasi-
7. Feldman DN, Armstrong EJ, Aronow HD, et al. SCAI consensus guide- bility of intravascular lithotripsy for treatment of common femoral
lines for device selection in femoral-popliteal arterial interventions. artery stenoses. J Endovasc Ther. 2019;26(3):283-287.
Catheter Cardiovasc Interv. 2018 Jul;92(1):124-140. 18. Adams G, Shammas N, Mangalmurti S, et al. Intravascular lithotripsy for
8. Li J, Tzafriri A, Patel S, Parikh S. Mechanisms underlying drug delivery treatment of calcified lower extremity arterial stenosis: Initial analysis of
in peripheral arteries. Intervent Cardiol Clin. 2017;6:197-216. the disrupt PAD III study. J Endovasc Ther. 2020;27(3):473-480.
9. Korosoglou G, Giusca S, Andrassy M, Lichtenberg M. The role of 19. Shammas NW. JETSTREAM atherectomy: A review of technique, tips,
atherectomy in peripheral artery disease: current evidence and future and tricks in treating the femoropopliteal lesions. Int J Angiol. 2015;
perspectives. Vasc Endovasc Rev. 2019;2(1):12-18. 24(2):81-86.
10. Cioppa A, Stabile E, Popusoi G, et al. Combined treatment of heavy 20. Saab F, Martinsen BJ, Wrede D, Behrens A, Adams GL, Mustapha J.
calcified femoro-popliteal lesions using directional atherectomy and a Orbital atherectomy for calcified femoropopliteal lesions: a current
paclitaxel coated balloon: one-year single centre clinical results. review. J Cardiovasc Surg (Torino). 2019;60(2):212-220.
Cardiovasc Revasc Med. 2012;13(4):219-223.
11. Diehm N. Clinical endpoints in peripheral endovascular revasculariza-
tion trials: a case for standardized definitions. Eur J Vasc Endovasc
Surg. 2008;36:409-419. How to cite this article: Cioppa A, Franzese M, Gerardi D,
12. Medina A, de Lezo JS, Pan M. A new classification of coronary bifur-
Pucciarelli A, Popusoi G, Stabile E, et al. Three-year outcome
cation lesions. Revista Española de Cardiología (English Ed). 2006;
59(2):183. of directional atherectomy and drug coated balloon for the
13. Stabile E, Nammas W, Salemme L, et al. The CIAO (Coronary treatment of common femoral artery steno-occlusive lesions.
Interventions Antiplatelet-based Only) Study: a randomized study Catheter Cardiovasc Interv. 2022;99:1310–1316.
2021;1–7. https://doi.org/10.
https://doi.
comparing standard anticoagulation regimen to absence of anti-
1002/ccd.30020
org/10.1002/ccd.30020
coagulation for elective percutaneous coronary intervention. J Am
Coll Cardiol. 2008;52(16):1293-1298.