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TYPE Original Research

PUBLISHED 07 July 2023
DOI 10.3389/fcvm.2023.1194043

Outcomes of covered stents

versus bare-metal stents for
EDITED BY
Nicola Mumoli,
ASST Ovest Milanese, Italy
subclavian artery occlusive disease
REVIEWED BY
Omer Ibrahimagic,
Libing Wei†, Xixiang Gao†, Zhu Tong, Shijun Cui, Lianrui Guo
University Clinical Center Tuzla, Bosnia and and Yongquan Gu*
Herzegovina
Department of Vascular Surgery, Xuanwu Hospital and Institute of Vascular Surgery, Capital Medical
Elias Kehayas,
University, Beijing, China
University Hospital of Heraklion, Greece

*CORRESPONDENCE
Yongquan Gu Objective: To compare the clinical efficacy of covered stents and bare-metal
gyq_xw@163.com stents in the endovascular treatment of subclavian artery occlusive disease.
†
These authors have contributed equally to this Methods: Between January 2014 and December 2020, 161 patients (112 males)
work and share first authorship underwent stenting of left subclavian arteries; CSs were implanted in 55 patients
RECEIVED 26 March 2023 (34.2%) and BMSs in 106 (65.8%). Thirty-day outcomes, mid-term patency, and
ACCEPTED 27 June 2023 follow-up results were analyzed with Kaplan-Meier curves. Relevant clinical,
PUBLISHED 07 July 2023 anatomical, and procedural factors were evaluated for their association with
CITATION patency in the two groups using Cox proportional hazards regression.
Wei L, Gao X, Tong Z, Cui S, Guo L and Gu Y Results: Mean follow-up was 45 ± 18 months. The primary patency was 93.8%
(2023) Outcomes of covered stents versus
(95% CI, 81.9%–98.0%) in the covered stent group and 73.7% (95% CI, 63.2%–
bare-metal stents for subclavian artery
occlusive disease.
81.6%; P = 0.010) in the bare-metal stent group. The primary patency in the
Front. Cardiovasc. Med. 10:1194043. total occlusion subcategory was significant in favor of CS (93.3%, 95% CI,
doi: 10.3389/fcvm.2023.1194043 61.26%–99.0%) compared with BMS (42.3%, 95% CI, 22.9%–60.5%; P = 0.005).
COPYRIGHT Cox proportional hazards regression indicated that the use of BMSs [hazard ratio
© 2023 Wei, Gao, Tong, Cui, Guo and Gu. This (HR), 4.90; 95% CI, 1.47–16.31; P = 0.010] and total occlusive lesions (HR, 7.03;
is an open-access article distributed under the
95% CI, 3.02–16.34; P < 0.001) were negative predictors of patency, and the
terms of the Creative Commons Attribution
License (CC BY). The use, distribution or vessel diameter (HR, 3.17; 95% CI, 1.04–9.71; P = 0.043)) was a positive predictor
reproduction in other forums is permitted, of patency.
provided the original author(s) and the
Conclusion: Compared with bare stents, covered stents have a higher midterm
copyright owner(s) are credited and that the
original publication in this journal is cited, in primary patency in the treatment of subclavian artery occlusive disease.
accordance with accepted academic practice.
No use, distribution or reproduction is
KEYWORDS
permitted which does not comply with these
terms. subclavian artery occlusive disease, subclavian steal syndrome, bare-metal stent, covered
stent, primary patency

1. Introduction
Severe stenosis or total occlusion of the subclavian artery (SCA) or the innominate artery
proximal to the orifice of the vertebral artery is supposed to cause subclavian steal syndrome
(SSS), which makes the blood flow of the ipsilateral vertebral artery reverse into the affected
upper limb, resulting in a series of symptoms such as vertebrobasilar insufficiency and
subacute or chronic ischemia of the affected limb (1). The clinical symptoms of SSS are
related to the rate and degree of arterial occlusion, the compensation of collateral
circulation, and systemic blood pressure (2). In addition to the presence of symptoms,
mortality due to the disease itself and atherosclerosis-related vascular diseases will
increase (3, 4). The treatment of SSS mainly includes medication, SCA bypass or
transposition, and endovascular treatment. Endovascular SCA angioplasty with stenting is
the first choice for SSS because of its safety, minimal invasiveness, and effectiveness (5).
After endovascular procedures, in-stent restenosis is the most common long-term
complication, with an incidence of about 8%–15% (6). Many studies on in-stent

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Wei et al. 10.3389/fcvm.2023.1194043

restenosis of the SCA analyzed the corresponding risk factors, antiplatelet therapy (aspirin 100 mg QD and clopidogrel 75 mg
including smoking, diabetes, homocysteine concentration, stent QD) were given from at least 5 days before to 3 months after the
length, blood lipid level, postoperative antiplatelet therapy, and intervention; lifelong maintenance therapy with either aspirin or
others (7). However, there are few reports about the effect of the clopidogrel was prescribed thereafter.
stent type (covered or bare) on in-stent restenosis. Currently, the The CSs were used in cases that there was extravasation of
most commonly used stents are bare-metal stents (BMSs), which contrast agent after pre-dilation. In other cases, the choice was
are prone to induce diffuse intimal hyperplasia and finally lead based on the surgeon’s personal preference.
to in-stent restenosis. Compared with BMSs, covered stents (CSs) The forward flow of the vertebral artery was confirmed by
may effectively reduce diffuse intimal hyperplasia, which is angiography during the intervention in all the patients. CDUS
expected to improve the long-term results (8). The aim of this and upper extremity blood pressure measurements were obtained
study was to compare the outcomes in patients with during follow-up. Primary patency was defined as no evidence of
symptomatic subclavian artery severe stenosis or total occlusion restenosis ≥ 50% or total occlusion within the target lesion, based
who underwent endovascular management. on CDUS, with a peak systolic velocity ratio (PSVR) ≥ 2.0. The
severity of restenosis was evaluated independently by two
vascular sonographers who were blinded to the stent type.
2. Materials and methods Disagreements were resolved by a senior vascular sonographer.

2.1. Subjects
2.3. Statistical analysis
The study was approved by our institutional ethics review
board. From January 2014 to December 2020, consecutive Data were analyzed using the SPSS 22.0 statistical software.
patients who underwent stenting for de-novo arteriosclerotic Categoric variables were analyzed using the chi-square test or Fisher’s
occlusive disease of the left SCA at our department were exact test. Mean and standard deviation of continuous variables
retrospectively analysed. The patients enrolled in this study met between the two groups were compared by t-test. Kaplan-Meier
the following criteria: 1. Etiology considered to be survival curves were estimated for primary patency and the log-rank
arteriosclerosis; 2. Degree of SCA stenosis meeting the following P value was used to compare two procedures. Cox proportional
requirements: (a) Color duplex ultrasonography (CDUS) or hazards regression were assessed to determine the association of
computed tomography angiography (CTA) / digital subtraction relevant clinical, anatomical, and procedural factors within the two
angiography (DSA) showing left SCA stenosis ≥ 70% or groups. P-values < 0.05 were considered statistically significant.
occlusion; (b) Reverse vertebral artery flow confirmed by imaging
examination; (c) Lesion located at the segment of the SCA
proximal to the vertebral orifice; (d) Vertebral artery orifice not 3. Results
involved in the lesion. During this time, 106 patients treated with
BMSs and 55 with CSs were enrolled, respectively. 3.1. Demographic and clinical
characteristics

2.2. Endovascular intervention Overall, 161 patients (112 males) underwent left subclavian
artery stenting and matched the inclusion criteria. Among those,
After retrograde common femoral artery access with an 8F 55 (34.2%) were treated with CSs, and 106 (65.8%) were treated
sheath was obtained, heparin was administered according to the with BMSs. Demographics, cardiovascular risk factors were similar
standard protocol (80 U/kg). Angiography was performed to between the CS and BMS groups (Table 1). There were 45
confirm either severe stenosis or total occlusion at the origin of symptomatic patients (81.8%) in the CS group and 91 (85.8%) in
the SCA with reverse flow of the vertebral artery. Brachial artery the BMS group. The other 25 asymptomatic patients (10 in CS
access was adopted if the guidewire failed to cross the lesion group and 15 in BMS group) were treated because of planned
progradely through the femoral access. Brachial access was used coronary artery bypass grafting using the internal mammary
in 22 (51.2%) total occlusive patients (14 in the BMS group and artery, ipsilateral haemodialysis access, or significant bilateral
8 in the CS group). After crossing the lesion with a guidewire in subclavian stenosis for adequate blood pressure surveillance. The
total occlusive and extremely severe stenosis cases, pre-dilation anatomical characteristics, (e.g., lesion length, vessel diameter)
were performed with a balloon 3 mm in diameter. Either a BMS were similar between CS and BMS groups (Table 2).
(Express LD, Boston scientific) or a CS (Viabahn, WL Gore and
Associates) was accurately deployed to cover the lesion. Post-
deployment balloon dilatation was performed according to the 3.2. Early results within 30 days after
diameter of the normal vessel distal to the lesion in all the CSs. operation
The femoral accesses were sealed with Proglide (Abbott) and the
brachial accesses were compressed manually. Antiplatelet agents After operation, the pressure difference between bilateral upper
and statins were prescribed at the time of diagnosis. Dual limbs was significantly reduced, and the symptoms of most patients

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TABLE 1 Patient demographic characteristics.

Characteristic Overall (n = 161) Stenosis (n = 118) Occlusion (n = 43)

CS (n = 55) BMS (n = 106) P CS (n = 40) BMS (n = 78) P CS (n = 15) BMS (n = 28) P
Demographics
Age (years) 62.1 ± 6.6 63.4 ± 8.2 0.27 63.2 ± 7.3 63.6 ± 7.9 0.78 59.2 ± 2.9 63.0 ± 9.2 0.13
Male gender 40 (72.7) 72 (67.9) 0.59 30 (75) 52 (66.7) 0.68 10 (66.7) 20 (71.4) 1.00

Cardiovascular risk factor

Hypertension 26 (47.3) 55 (51.9) 0.62 22 (55.0) 51 (65.4) 0.32 13 (86.7) 18 (64.3) 0.16
Diabetes 15 (27.3) 27 (25.5) 0.85 11 (27.5) 19 (24.4) 0.82 4 (26.7) 8 (28.6) 1.00
Smoking* 18 (32.7) 32 (30.2) 0.86 13 (32.5) 25 (32.1) 1.00 5 (33.3) 7 (25.0) 0.72
Coronary artery disease 13 (23.6) 26 (24.5) 1.00 9 (22.5) 20 (25.6) 0.82 4 (26.7) 6 (21.4) 0.72
Renal insufficiency 2 (3.6) 6 (5.7) 0.72 2 (5.0) 4 (5.1) 1.00 0 2 (7.1) –
Hyperlipidemia 26 (47.3) 55 (51.9) 0.62 18 (45.0) 42 (53.8) 0.44 8 (53.3) 13 (46.4) 0.75

Medical therapy (before admission)

None 3 (9.4) 7 (10.4) 1.00 4 (10.0) 8 (10.3) 1.00 2 (13.3) 4 (14.3) 1.00
Antiplatelet 26 (81.3) 54 (80.6) 0.94 34 (85.0) 58 (74.4) 0.24 11 (73.3) 24 (85.7) 0.42
Dual antiplatelet 2 (3.6) 4 (3.8) 1.00 0 4 (5.1) – 2 (13.3) 0 –
Statins 32 (58.2) 68 (64.2) 0.50 20 (50.0) 48 (61.5) 0.24 12 (80.0) 20 (71.4) 0.72

Data are presented as mean ± standard deviation or as number (%).

*Includes current and former smokers.

TABLE 2 Clinical symptom and anatomical data.

Overall (n = 161) Stenosis (n = 118) Occlusion (n = 43)

CS (n = 55) BMS (n = 106) P CS (n = 40) BMS (n = 78) P CS (n = 15) BMS (n = 28) P
Symptoms 46 (83.6) 84 (79.3) 0.54 33 (79.5) 62 (82.5) 0.81 13 (86.7) 22 (78.6) 0.69
Upper limb ischemia 28 (49.1) 52 (50.9) 0.87 21 (52.5) 36 (46.2) 0.56 7 (46.7) 16 (57.1) 0.54
Vertigo 27 (49.1) 64 (60.4) 0.18 21 (52.5) 51 (65.4) 0.23 6 (40.0) 13 (46.4) 0.76
Ataxia 4 (7.3) 5 (4.7) 0.49 2 (5.0) 3 (3.9) 1.00 2 (13.3) 2 (7.1) 0.60
Syncope 1 (1.8) 1 (0.9) 1.00 1 (2.5) 0 – 0 1 (3.6) –

Anatomical data
Lesion length (mm) 21.4 ± 4.5 20.5 ± 4.8 0.24 21.1 ± 5.0 20.2 ± 5.2 0.37 22.1 ± 2.6 21.2 ± 3.2 0.34
Vessel diameter (mm) 7.7 ± 0.4 7.7 ± 0.3 0.63 7.8 ± 0.4 7.7 ± 0.4 0.54 7.6 ± 0.3 7.6 ± 0.2 0.89

Data are presented as mean ± standard deviation or as number (%).

were relieved. There were 1 case of ipsilateral axillary artery died of myocardial infarction one year after the operation.
embolism in the CS group which was treated by surgical-open Restenosis occurred in 3/50 patients (6.0%). One patient
embolectomy, and 4 cases (1 in CS group and 3 in BMS group) developed in-stent stenosis 18 months after the operation, and
of hematoma at the puncture site (Table 3). There was no stroke, the other two patients developed in-stent occlusion 24 months
major cardiac event, death, dialysis, wound infection and artery after the operation. However, the three patients were
rupture in both groups. asymptomatic and were treated conservatively.
The 6-year cumulative primary patency was 93.8% (95% CI,
81.9%—98.0%) vs. 73.7% (95% CI, 63.2%–81.6%; P = 0.010) for
3.3. Postoperative follow-up CSs versus BMSs, respectively (P = 0.010) (Figure 1). In
particular, no significant difference was found in the stenosis
Mean follow-up considering all patients was 45 ± 18 months. subcategory (CS, 94.1% (95% CI, 78.47%–98.5%); BMS, 85.1%
Fourteen patients (9.1%) were lost (5 cases in the CS group and (95% CI, 73.5%–91.83%); P = 0.292), whereas primary patency in
9 in the BMS group) during follow-up. All the lost patients were the total occlusion subcategory was significant in favor of CS
followed up for at least two years and 6 of them were followed (93.3%, 95% CI, 61.26%–99.0%) compared with BMS (42.3%,
up for more than 4 years. 95% CI, 22.9%–60.5%; P = 0.005; Figure 2). Interestingly, the
The mean follow-up time for the BMS and CS groups were Cox proportional hazards regression showed the use of BMSs
45 ± 18 months and 46 ± 20 months, respectively. In the BMS [hazard ratio (HR), 4.90; 95% CI, 1.47–16.31; P = 0.010] and
group, restenosis occurred in 25/97 patients (25.8%), among total occlusive lesions (HR, 7.03; 95% CI, 3.02–16.34; P < 0.001)
which 12 cases (12.4%) underwent balloon angioplasty, 5 (5.2%) were negative predictors of patency, and the vessel diameter
underwent stent implantation, and 8 asymptomatic cases (8.2%) (HR, 3.17; 95% CI, 1.04–9.71; P = 0.043) was a positive predictor
were treated conservatively. In the CS group, one case (1.8%) of patency.

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TABLE 3 Early results within 30 days after operation.

Overall (n = 161) Stenosis (n = 118) Occlusion (n = 43)

CS (n = 55) BMS (n = 106) P CS (n = 40) BMS (n = 78) P CS (n = 15) BMS (n = 28) P
Pressure difference
Before (mmHg) 34 ± 10 33 ± 13 0.69 33 ± 11 30 ± 10 0.25 37 ± 8 40 ± 18 0.41
After (mmHg) 4±3 5±3 0.80 4±3 4±3 0.46 5±3 5±3 0.46
Symptom relief 47 (85.5) 94 (88.7) 0.32 32 (80.0) 68 (87.2) 0.42 15 (100) 26 (93.3) 0.53

Complication
Stroke 0 0 – 0 0 – 0 0 –
Major cardiac events 0 0 – 0 0 – 0 0 –
Death 0 0 – 0 0 – 0 0 –
Ipsilateral limb artery embolism 1 (1.8) 0 – 0 0 – 1 (6.7) 0 –
Hematoma 1 (1.8) 3 (2.8) 1.00 0 2 (2.6) – 1 (6.7) 1 (3.6) 1.00
Wound infection 0 0 – 0 0 – 0 0 –
Artery rupture 0 0 – 0 0 – 0 0 –

Data are presented as mean ± standard deviation or as number (%).

The main complication after SCA stenting is in-stent

restenosis. There are many reports about the restenosis rate of
SCA stenting. Japanese scholars determined a primary patency at
5 years of 80.5% (10). Patel et al. analyzed 170 cases of SSS
during 13 years, reporting a patency of 93% at one year and 84%
at five years (11). In a retrospective study by De Vries et al., 110
patients with SCA occlusive disease who underwent percutaneous
transluminal angioplasty were analyzed (12). The patency of
patients with SCA stenosis and total occlusion were 93% and
65%, respectively, three years after treatment, and the difference
between the two groups was statistically significant (P < 0.05). In
this study, we considered 118 cases with left SCA severe stenosis
and 43 with left SCA total occlusion. The primary patency at 1
and 5 years of BMSs was 93.4 and 73.7%, which is comparative
to the aforementioned studies. The 6-year cumulative primary
FIGURE 1
Overall primary patency for 99 patients treated with BMSs or CSs. The
patency in BMS group for severe stenosis and total occlusion
black dashed lines stand for 95%CI. lesions was 85.1% and 42.3%, respectively. In comparison, the
primary patency in the CS group for severe stenosis and total
occlusive lesions was 94.1% and 93.3%. The primary patency in
the total occlusion subcategory was significant in favor of CS
4. Discussion over BMS (P = 0.005). Furthermore, the result obtained from Cox
proportional hazards regression analysis that the use of BMS and
CSs were predominantly used in aortoiliac artery and femoral occlusion lesions are strong negative predictors of patency may
artery diseases, and led to a better primary patency than BMSs corroborate the concept of using CSs in subclavian artery lesions,
(8, 9). However, there are fewer literatures on the comparison of especially in total occlusive lesions.
the efficacy of CSs and BMSs for SCA occlusive disease. This is In this study, arterial access was routinely obtained by femoral
the first study to compare the midterm results of CSs versus artery puncture. Brachial access was used in 22 (51.2%) total
BMSs in patients with left SCA occlusive disease. In this study, occlusive patients when the guidewire failed to cross the lesion
the two groups were followed up for 45 ± 18 months. The 6-year progradely through the femoral access. The femoral artery
cumulative primary patency of the BMS group was 73.7%, while approach should be taken as the first candidate for vessel access
that of the CS group was 93.8% (P = 0.010). Besides other risk as far as possible, and the brachial artery approach should be
factors, the type of stent (CSs or BMSs) is an important factor chosen when the femoral artery approach is unavailable or
affecting the patency, because the traditional BMS is prone to unable to afford a successful intervention. The brachial access is
diffuse intimal hyperplasia leading to in-stent restenosis. very important for total occlusive lesions. It can not only
Compared with BMS, CS guarantees a mechanical barrier to improve the technical success rate, but also reduce the incidence
intimal hyperplasia and also allows aggressive dilatation of of complications.
calcified vessels, which is expected to improve the long-term This study has several limitations that are worthy of mention.
patency (8). First, this was a retrospective, nonrandomized study; thus, the

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Wei et al. 10.3389/fcvm.2023.1194043

FIGURE 2
Primary patency for 99 patients treated with BMSs or CSs stratified by stenosis or occlusion.

choice of using a CS or a BMS was mainly at the surgeon’s Author contributions

discretion, leading to inherent biases. Second, the sample size is a
little small and there was some loss of follow-up in both groups Conceptualization: LW, XG, YG; Analysis and interpretation: LW,
of patients, which may have affected the final results. XG, YG; Data collection: LW, XG; Writing the article: LW, XG, LG,
YG; Critical revision of the article: LW, XG, ZT, SC, LG, YG; Final
approval of the article: LW, XG, ZT, SC, LG, YG; Statistical
analysis: LW, XG, YG; Obtained funding: YG. All authors
5. Conclusions contributed to the article and approved the submitted version.

Interventional therapy has become the primary treatment for

SCA occlusive disease because of its minimal invasiveness and
safety. The primary patency of CS was significantly higher than
Funding
that of BMS in left SCA disease. Randomized controlled trials are
This work was supported by the National Key Research
needed to confirm these results.
and Development Projects of China (2021YFC2500500,
2021YFC2500504) and (2022YFC3602400, 2022YFC3602404).

Data availability statement

Conflict of interest
The original contributions presented in the study are included
in the article, further inquiries can be directed to the corresponding The authors declare that the research was conducted in the
author. absence of any commercial or financial relationships that could
be construed as a potential conflict of interest.

Ethics statement Publisher’s note

The studies involving human participants were reviewed and All claims expressed in this article are solely those of the authors
approved by the Institutional Review Board of Xuanwu Hospital, and do not necessarily represent those of their affiliated organizations,
Capital Medical University [protocol code LYS(2018) 002 and or those of the publisher, the editors and the reviewers. Any product
date of approval 4-2-2018]. The patients/participants provided that may be evaluated in this article, or claim that may be made by its
their written informed consent to participate in this study. manufacturer, is not guaranteed or endorsed by the publisher.

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Wei et al. 10.3389/fcvm.2023.1194043

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