Percutaneous Endovascular Approach to Symptomatic High-Grade Subclavian Artery Stenosis: A Retrospective Analysis

Keywords

subclavian artery stenosis - percutaneous angioplasty - endovascular stenting - restenosis - brachial approach - femoral approach

Introduction

Subclavian artery stenosis (SAS) is frequently attributed to the progressive accumulation of atherosclerotic plaques, which leads to narrowing of the proximal subclavian artery lumen, the most prevalent cause of this condition. Clinically, this condition is frequently associated with symptoms such as upper limb ischemia, vertebrobasilar insufficiency, and subclavian steal syndrome due to hemodynamic adjustments that redirect blood flow away from the vertebral circulation.[1] Additionally, less common causes (e.g., such as Takayasu arteritis, radiation-induced arterial injury, and fibromuscular dysplasia) can lead to SAS in specific patient groups.[2]

Historically, symptomatic high-grade SAS has been managed mainly with open surgical bypass (e.g., carotid–subclavian bypass), which is effective but more invasive and carries higher morbidity, longer recovery times, and increased perioperative risk. Over the past two decades, endovascular techniques have emerged as a less invasive alternative, yielding excellent technical success rates and significantly improving patient comfort levels. Advancements in catheter-based devices, imaging technologies, and guidewire systems have further solidified this shift toward percutaneous intervention. Endovascular therapy is now widely considered the first-line treatment to minimize operative trauma and expedite recovery, particularly in patients with multiple comorbidities.[3]

Depending on anatomical considerations, both antegrade femoral and retrograde brachial arterial access can be used to optimize procedural success.[4] [5] [6] The femoral (antegrade) route is often preferred for proximal subclavian lesions when suitable aortic arch access is available. The brachial (retrograde) approach may be advantageous for challenging total occlusions, ostial lesions, or heavily calcified plaques, especially when arch tortuosity limits a straightforward femoral route. The precise characterization of lesion morphology using advanced imaging (computed tomography [CT] angiography, magnetic resonance angiography, or high-resolution duplex) guides the decision-making process to ensure a targeted, patient-specific treatment strategy. This study aimed to evaluate the safety, efficacy, and midterm clinical and radiological outcomes of endovascular treatment, with particular emphasis on the various technical approaches used.

Methods

Patient Population

This was a single-center retrospective analysis of consecutive patients who underwent endovascular intervention for subclavian or brachiocephalic artery stenosis at Yashoda Hospitals, Somajiguda, between January 2016 and December 2023. All procedures were performed using uniform protocols with consistent operator expertise. Patient characteristics are summarized in [Table 1].

Table 1 Patient demographics and clinical features

Parameter	Number (%)
Male	45 (60.0%)
Female	30 (40.0%)
Hypertension	35 (46.7%)
Diabetes mellitus	28 (37.3%)
Smoking	55 (73.3%)
Dyslipidemia	20 (26.7%)
Coronary artery disease	18 (24.0%)

The study protocol was approved by the Institutional Ethics Committee of Yashoda Hospitals, Somajiguda, Hyderabad. Given the retrospective design and anonymized data collection, the requirement for written informed consent was waived.

Preprocedural Planning

All patients underwent contrast-enhanced CT of the thorax before the intervention. CT angiography provides detailed visualization of the aortic arch, its subclavian origin, and anatomical variations. In patients with recurrent disease or comorbidities, CT imaging enables risk stratification and helps operators choose appropriate access routes and stenting strategies. CT angiography localized lesions, guided catheter planning, and identified the calcific plaque burden affecting recanalization. Imaging of the arch anatomy helped predict the challenges related to arch angulation, vascular tortuosity, and ostial positioning ([Fig. 1]). A highly angulated arch favors the brachial approach, whereas a straight arch supports the femoral route. This planning reduced the fluoroscopy time and procedural complexity of the surgery. Lesion characteristics were assessed using CT to guide the device selection. Extensive calcification indicates the potential need for balloon-expandable stents or plaque modification tools. In chronic occlusions, CT determines the segment length, influences guidewire and balloon choices, and determines whether advanced techniques are needed for the procedure. CT aids in risk assessment by revealing disease beyond the subclavian origin or involving the vertebral artery ostium, indicating higher cerebral ischemic risks. These findings prompted the consideration of protective measures and surgical approaches. By anticipating the hardware requirements, the team ensured the availability of the necessary equipment. Thorough CT-based planning enables tailored strategies for subclavian lesions, leading to higher success rates and improved safety.

Fig. 1 Contrast-enhanced CT angiography depicting high-grade occlusion of the left subclavian artery. Coronal CT angiographic image demonstrating near-total occlusion of the proximal segment of the left subclavian artery after the origin of the vertebral artery (dashed arrow), with reduced opacification downstream (A). Oblique coronal reformat showing long-segment luminal nonopacification of the left subclavian artery (dashed arrow), consistent with chronic total occlusion (B). An axial CT image at the thoracic inlet level, highlighting an eccentric, calcified stenotic plaque within the left subclavian artery (dashed arrow), suggesting severe atherosclerotic disease (C). CT, computed tomography.

Technical Approach

Percutaneous angioplasty was performed via either an antegrade femoral, retrograde brachial, or combined approach ([Figs. 2], [3]), chosen according to the lesion location, vessel anatomy, and operator preference. For lesions located more proximally and readily reachable from the femoral artery, an antegrade approach allows for stable guide catheter positioning and precise stent deployment. Conversely, the retrograde brachial approach was preferred for distal subclavian lesions, total occlusion at the ostium, and complex arch anatomy cases in which the standard femoral approach was challenging. After local anesthesia and ultrasound-guided puncture of the chosen access site, a 6F or 7F introducer sheath was inserted. Angiography was performed to delineate the lesion. Guidewires (0.014–0.035 in) were cautiously advanced across the stenotic or occluded segment under fluoroscopic guidance. Once the lesion was crossed, an appropriately sized balloon catheter was inflated to predilate the stenosis, followed by stent placement when indicated. Meticulous attention was paid to stent sizing and landing zones to ensure optimal wall apposition and vessel patency. Hemostasis at the access site was achieved using manual compression or closure devices, according to the institutional protocol. [Table 2] provides a summary of the technical details, such as the severity and length of the lesions and the type of intervention (stent vs. percutaneous transluminal angioplasty [PTA] alone), whereas the flowchart in [Table 3] and [Fig. 4] outline the procedural specifics.

Fig. 2 Stepwise angiographic sequence illustrating endovascular recanalization of right subclavian artery chronic total occlusion (CTO). Initial retrograde contrast injection via brachial access revealed complete occlusion at the origin of the right subclavian artery (dashed arrow, A). Antegrade contrast injection through femoral access confirmed the ostial CTO with filling of the right common carotid artery (white asterisk, B). Advancement of a 0.014-inch hydrophilic guidewire through the retrograde approach across the occluded segment, followed by sequential balloon predilatation using larger balloons (C–E). The guidewire successfully crossed into the aortic lumen and could cross into the guide catheter via the femoral sheath (rendezvous technique, F). (H) Deployment of a balloon-expandable stent across the ostial lesion (dashed white line; G and H). Final angiogram demonstrating successful revascularization with brisk flow across the stented right subclavian artery segment (curved dashed white line) and across the right carotid artery (white asterisks) with no residual stenosis (I). CT, computed tomography.

Fig. 3 Stepwise angiographic sequence illustrating endovascular recanalization of left subclavian artery chronic total occlusion (CTO). An angiographic image demonstrating chronic total occlusion of the ostioproximal segment of the left subclavian artery (white solid arrow, A). Endovascular intervention for chronic total occlusion of the subclavian artery using retrograde brachial access is preferred when antegrade aortic access is challenging (B). A 0.035' Terumo guidewire crossed the occluded segment using a retrograde approach with the support of a diagnostic catheter (C). The image shows the restored flow through the subclavian artery after predilatation (D) and placement of an adequately sized stent and deployment (E), indicating successful recanalization to improve upper extremity blood flow (F) and alleviate symptoms such as arm claudication or subclavian steal syndrome.

Table 2 Lesion and procedural characteristics

Characteristic	Number (%)
Lesion severity
90–99% stenosis	50 (66.7%)
100% (total occlusion)	25 (33.3%)
Lesion length
< 30 mm	12 (16.0%)
30–60 mm	63 (84.0%)
> 60 mm	0 (0%)
Intervention type
Stent placement	73 (97.3%)
Balloon angioplasty only	2 (2.7%)

Table 3 Procedural steps and technical strategy for subclavian artery intervention

Step	Details
Access route selection	Antegrade femoral for proximal/straight arch; retrograde brachial for ostial/tortuous lesions
Imaging modality used	CT angiography preferred; duplex for follow-up; angiography during intervention
Guidewire selection	0.014” or 0.035” hydrophilic-coated wires for lesion crossing; stiff wires for support
Catheter type	6F or 7F guiding catheter; JR4, multipurpose, or LIMA shapes based on anatomy
Predilation strategy	Balloon predilation using 2–3.5 mm semi-compliant balloons; cutting balloons for calcified plaques
Stent type	Balloon-expandable (e.g., stainless steel) for precise deployment; self-expanding in tortuous segments
Postdilation	Non-compliant balloon postdilation to ensure apposition and expansion
Hemostasis method	Manual compression, radial band for brachial access, or vascular closure devices for femoral

Notes: This table summarizes essential decision-making components and procedural steps in the endovascular treatment of subclavian artery stenosis. It outlines criteria for access route selection based on lesion location and vascular anatomy, preferred imaging modalities for pre- and postprocedural assessment, selection of guidewires and catheters tailored to lesion complexity, and choices of stent types depending on lesion characteristics. Additional steps such as balloon pre- and postdilation and vascular access site management are also included to provide a comprehensive overview of technical planning and execution in subclavian interventions.

Fig. 4 Percutaneous endovascular management flowchart for subclavian artery stenosis. This flowchart outlines the clinical pathway for evaluating and treating symptomatic subclavian artery stenosis using endovascular techniques in our institution. Following symptom recognition, CTA guides lesion characterization and anatomical assessments. Based on the arch configuration and lesion location, either antegrade femoral or retrograde brachial access is selected. Lesions are managed with balloon angioplasty, with or without stenting. Postprocedural success was assessed, and patients were monitored using duplex ultrasonography or CTA to detect restenosis and guide reintervention strategies. CTA, computed tomography angiography.

Statistical Analysis

Statistical analyses were performed using SPSS version 26 (IBM Corp., Armonk, New York, United States). Continuous variables are expressed as mean ± standard deviation or median with interquartile range, as appropriate. Categorical variables are presented as frequencies and percentages. Normality was assessed using the Shapiro–Wilk test. Between-group comparisons for continuous data were performed using independent t-tests or Mann–Whitney U tests, depending on the distribution. Categorical data were compared using the chi-square or Fisher's exact tests. The primary endpoints included technical success, immediate clinical improvement, and restenosis rate at follow-up. Statistical significance was set at p < 0.05.

Results

Technical Success and Clinical Improvement

Technical success was achieved in all 75 cases (100%) with no major complications. All patients experienced substantial clinical improvement, as evidenced by the resolution of upper limb ischemic symptoms and normalization (or near-normalization) of interarm blood pressure differentials. These outcomes are consistent with prior reports of endovascular therapy for subclavian lesions, which achieved nearly 100% technical success and excellent symptomatic relief.[4] [5] [6]

Several procedural challenges were encountered, particularly in cases involving long-segment occlusions and chronic total occlusions (CTOs).

Quantitatively, 11 patients (14.7%) required dual-access strategies (brachial and femoral) for successful revascularization. In 6 patients (8%), the use of snare-assisted or rendezvous techniques was essential to facilitate guidewire externalization across complex occlusions.

Balloon trackability issues were noted in nine cases, necessitating the use of low-profile or over-the-wire balloons. Heavy calcification in five patients required higher inflation pressures and prolonged lesion preparation. Two patients required predilation with cutting balloon.

Nevertheless, other minor procedural challenges were indeed encountered, including

• Guidewire passage difficulties in 9 cases (12%) requiring use of CTO-specific wires.

• Subintimal dissection in 5 cases (7.3%) managed successfully with stent placement.

• One case of brachial access hematoma in 1 case, managed conservatively.

Importantly, although no major periprocedural complications, such as vessel rupture, stroke, or access site hematoma > 5 cm, were recorded, the retrospective nature of this study may have resulted in the underreporting of minor events. Minor challenges, such as transient vasospasm, catheter instability, or the need for guide catheter exchange, were not systematically captured in the source documentation and represent a limitation of the dataset.

Restenosis and Reintervention

During follow-up, 14 of the 75 patients (18.7%) developed significant restenosis of the treated segment, as confirmed by duplex ultrasonography or angiography. This corresponds to a midterm restenosis rate in line with reported values of approximately 10 to 20%. Each instance of restenosis was successfully managed with repeat PTA, resulting in prompt symptom relief and restoration of the vessel patency. These findings highlight the high primary success rate and feasibility of effective percutaneous reintervention in infrequent cases of recurrent stenosis.

Predictors of Restenosis: Exploratory Subgroup Analysis

A comparative analysis was performed between patients who developed restenosis (n = 14, 18.7%) and those who did not (n = 61, 81.3%), as shown in [Table 4]. Patients with restenosis had a significantly higher prevalence of diabetes mellitus (71 vs. 39%, p = 0.03) and long-segment lesions > 30 mm (64 vs. 28%, p = 0.01). A higher proportion of restenosis occurred in patients who underwent balloon angioplasty alone (29%) than in those who received stents. Although not statistically significant, there was a trend toward increased restenosis in stent-treated patients (71 vs. 88%, p = 0.09). There was a nonsignificant trend toward an increased use of balloon angioplasty alone (Drug-coated balloon (DCB)-only) in the restenosis group. The mean age and other comorbidities did not differ significantly between the groups.

Table 4 Comparison of baseline and procedural characteristics between patients with and without restenosis

Variable	Restenosis group (n = 14)	No restenosis group (n = 61)	p-Value
Mean age (y)	66 ± 9	63 ± 10	0.31
Diabetes mellitus (%)	71%	39%	0.03
Lesion length >30 mm (%)	64%	28%	0.01
Balloon angioplasty Only (%)	29%	12%	0.08
Stent use (%)	71%	88%	0.09

Discussion

The percutaneous endovascular approach to symptomatic SAS offers several advantages, most notably a significant reduction in morbidity compared with traditional surgical methods.[1] [2] [3] This study corroborates previous findings by demonstrating a technical success rate approaching 100%, with symptomatic relief achieved in all treated patients.[4] [5] [6] The retrograde brachial approach is particularly advantageous in cases involving complex or ostial occlusions, because it improves lesion crossing and enhances catheter stability during the intervention.[7] [8] [9] In contrast, antegrade femoral access is optimal for lesions with an adequate proximal stump, facilitating precise stent placement and stability during deployment.[10] [11] [12]

Despite overall favorable outcomes, restenosis remains a clinical challenge, with midterm rates of approximately 10 to 20%, consistent with our observed restenosis rate of 18.7%.[6] [13] [14] Nevertheless, these restenoses typically respond well to repeated angioplasty, underscoring the importance of vigilant follow-up protocols involving duplex ultrasonography and clinical assessment.[15] [16] [17]

Technical refinements, such as the Controlled Antegrade and Retrograde Tracking technique, have significantly improved the success rates in managing CTOs, enabling safer and more effective subintimal recanalization.[18] [19] [20] Additionally, balloon-expandable stainless steel stents offer precise deployment and higher radial force, which is beneficial for highly calcified lesions often seen in advanced atherosclerosis.[8] [11] [12]

Our cohort included a high proportion of long-segment and CTO lesions. These cases pose several procedural challenges, including difficulty in guidewire crossing, the need for snare-assisted rendezvous techniques, and the requirement for stiff support catheters or angled microcatheters. Despite a reported technical success rate of 100%, this should be interpreted in the context of retrospective data collection, where minor complications may have been underreported. Additionally, extensive operator experience and institutional expertise likely contributed to favorable outcomes.

Although endovascular approaches are preferred as first-line therapy, surgical options, including carotid–subclavian bypass, remain relevant, especially for patients unsuitable for percutaneous intervention or those with failed endovascular treatment.[3] [4] [21] [22] Surgical outcomes for SAS are favorable, with long-term patency rates comparable to those of endovascular treatment, albeit at the expense of increased perioperative morbidity and a longer recovery period.[23] [24] For instance, carotid–subclavian bypass has demonstrated excellent durability, with primary patency often exceeding 95% at 5 years, although the initial invasive nature of surgery carries higher immediate risks, such as stroke or nerve injury, compared with stenting. Thus, patient selection remains crucial, and open surgery is generally reserved for cases in which endovascular repair is contraindicated or unsuccessful.

Limitations

The limitations of this study include its retrospective design, lack of randomization, and relatively small sample size. The follow-up period of 2 to 4 years is considered midterm. Long-term data would further elucidate the durability of endovascular repair compared with that of surgical bypass. This was a single-center study with a relatively small sample size. The findings may not be generalizable to other centers, and variations in operator technique cannot be assessed. Larger prospective randomized trials will be valuable for confirming these findings and potentially extending them, thereby enhancing their generalizability and robustness.

Conclusion

This retrospective study emphasized the technical feasibility, safety, and clinical efficacy of percutaneous endovascular approaches for treating symptomatic SAS. Both antegrade femoral and retrograde brachial strategies have proven to be highly effective, with low complication rates and durable midterm patency rates. Given these favorable outcomes, minimally invasive endovascular intervention is recommended as the primary treatment modality for symptomatic SAS, reserving open surgical revascularization for select cases (e.g., endovascular failure or unsuitable anatomy). Vigilant follow-up with clinical assessment and duplex imaging is essential for the early detection of restenosis and effective management with repeated interventions, thereby sustaining the long-term benefits of endovascular therapy for SAS.

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