Comparative Analysis of Two Strategies for Iliac Vein Stenting: Thrombus Clearance-Assisted Versus Direct Stenting

Abstract

Background

This study aimed to compare the efficacy of mechanical thrombus clearance combined with stenting versus direct stenting alone in patients with iliofemoral venous disease,, and to analyze the characteristics of different diagnostic subgroups among non-thrombotic patients.

Methods

A retrospective analysis was conducted on 137 patients who underwent iliac vein stent implantation between January 2020 and March 2025. Based on the presence of acute/subacute thrombosis and surgical strategy, patients were divided into a Thrombus Treatment Group (Angiojet thrombus aspiration + stenting, n=87) and a Non-Thrombotic Treatment Group (direct stenting, n=50). Within the Non-Thrombotic Group, further stratification yielded Subgroup A (pure iliac vein compression syndrome, n=29) and Subgroup B (associated thrombotic disease, e.g., post-thrombotic syndrome, n=21). Baseline characteristics, perioperative data, and 3-6 month follow-up outcomes were compared.

Results

Patients in the Thrombus Treatment Group were older (70.2±11.4 vs. 62.1±7.2 years, P<0.001), required fewer stents (1.3±0.6 vs. 1.8±0.9, P<0.001), but had longer procedure times (122.7±38.3 vs. 87.8±51.3 minutes, P<0.001). No significant differences were found between the two main groups in post-operative ultrasound patency rates (69.1% vs. 59.1%, P=0.243) or adverse event rates (2.5% vs. 6.8%, P=0.224). Subgroup analysis revealed that compared to Subgroup A, Subgroup B had a higher prevalence of prior DVT history (47.6% vs. 0%, P<0.001) and pre-operative swelling symptoms (81.0% vs. 6.9%, P<0.001), and required more complex procedures (stent use: 2.3±1.0 vs. 1.5±0.7, P<0.001). However, short-term follow-up outcomes were similar between the subgroups.

Conclusion

For iliofemoral venous disease with concomitant thrombosis, a strategy of thrombus clearance combined with selective stenting can reduce stent usage while achieving short-term efficacy comparable to direct stenting alone in its respective clinical context. Among non-thrombotic patients, the subgroup with thrombosis-related disease presents distinct clinical features and higher procedural complexity, yet still benefits from endovascular reconstruction.

Keywords

iliac vein stent mechanical thrombectomy deep vein thrombosis post-thrombotic syndrome venous obstructive disease

Introduction

Iliofemoral venous outflow obstruction is a significant cause of chronic venous insufficiency, acute deep vein thrombosis (DVT), and its debilitating sequela—post-thrombotic syndrome (PTS), which severely impacting patients’ quality of life.^1,2 With advancements in endovascular technology, iliac vein stenting has become an effective treatment for symptomatic iliac vein obstruction, with its safety and mid- to long-term patency well-established.^3,4

However, two main patient populations exist in clinical practice: those with “pure” iliac vein compression syndrome without a history of acute thrombosis, and those with complex lesions involving acute, subacute, or chronic post-thrombotic changes. The optimal management strategy for the latter group remains under investigation.^5,6 Traditional direct stenting may face challenges from significant thrombus burden, potentially affecting stent patency rates.⁷ The application of percutaneous mechanical thrombectomy (PMT), exemplified by devices like Angiojet, offers a novel approach. PMT enables rapid thrombus clearance, theoretically reducing outflow tract resistance, restoring venous lumen patency, and potentially decreasing the length and number of stents required, or even obviating stent placement.^8,9 However, prospective data directly comparing the efficacy of PMT-assisted stenting versus direct stenting remain scarce.

Furthermore, significant heterogeneity exists within the cohort clinically diagnosed as “non-thrombotic” iliac vein disease. Some patients have purely anatomical compression (e.g., May-Thurner syndrome), while others have a definitive history of DVT or established PTS.¹⁰ These subgroups may differ fundamentally in pathophysiology, venous wall condition, lesion extent, and procedural difficulty, potentially influencing treatment strategies and outcomes. Nevertheless, few studies have systematically compared these internal differences.

Therefore, this retrospective cohort study aimed to: (1) compare the differences in patient characteristics, procedural parameters, and short-term outcomes between “thrombus clearance-assisted stenting” and “direct stenting” strategies; (2) within the direct stenting cohort, further stratify patients into “pure compression syndrome” and “thrombotic-related disease” subgroups to analyze their distinct clinical profiles, treatment complexity, and prognosis. The findings aim to provide important clinical evidence for individualizing endovascular treatment strategies for iliofemoral venous disease.

Methods

Study Design and Patient Population

This was a single-center retrospective observational study conducted in accordance with the principles of the Declaration of Helsinki. Ethical review was obtained, and the need for individual patient consent was waived due to the retrospective nature of the study. We retrospectively screened all patients who underwent endovascular iliac vein stenting for symptomatic iliofemoral venous disease at our institution between January 1, 2020, and March 31, 2025. Symptoms included lower limb swelling, pain, venous claudication, or ulceration. Exclusion criteria were: age <18 years, pregnancy, active systemic infection, known malignancy, and patients with missing key clinical data. All patients received standardized post-procedural anticoagulation with rivaroxaban (10 mg twice daily) for six months.

Group Definitions

1. Thrombus Treatment Group: Patients with pre-operative imaging (duplex ultrasound or computed tomography venography) confirming acute (≤14 days) or subacute (15–28 days) iliofemoral deep vein thrombosis (DVT), who underwent mechanical thrombus clearance using the Angiojet system (Boston Scientific, USA) via a pharmacomechanical approach (pulse-spray of 200,000–300,000 IU urokinase, followed by a 15–20 minute dwell time prior to aspiration), followed by stent implantation based on intraoperative venographic findings. All patients underwent prophylactic inferior vena cava filter placement prior to mechanical thrombectomy as a standard protocol to prevent peri-procedural pulmonary embolism.

2. Non-Thrombotic Treatment Group: Patients with no imaging evidence of acute or subacute thrombosis who underwent direct iliac vein balloon angioplasty and stent implantation.

3. Subgroup Analysis within No Acute Thrombus on Imaging Group: Based on the primary discharge diagnosis, the No Acute Thrombus on Imaging Group was further divided:

o Subgroup A (Pure Compression): Diagnosis explicitly stated as “iliac vein compression syndrome” or similar without any description related to thrombosis.

o Subgroup B (Thrombotic-Related): Diagnosis included terms directly related to thrombosis or its sequelae, such as “post-thrombotic syndrome,” “status post lower extremity deep vein thrombosis,” or “chronic deep vein thrombosis.”

Data Collection

The following data were extracted from the electronic medical record system:

• Baseline Data: Demographics (age, sex), body mass index (BMI), smoking history, comorbidities (hypertension, diabetes), prior history of DVT, pre-operative primary symptoms (swelling, ulcer) and their duration.

• Perioperative Data: Procedure date, total procedure time (from puncture to final bandaging), total hospital length of stay (LOS), types and quantities of balloons and stents used intraoperatively, access site(s).

• Follow-up Data: Obtained from postoperative outpatient records, focusing on the 3- to 6-month follow-up visit. Recorded variables included: whether lower extremity venous duplex ultrasound was performed; ultrasound-assessed stent patency (categorized as patent, >50% stenosis, in-stent thrombosis, or occlusion); patient-reported limb swelling status, with “swelling-free” defined as both subjective symptom resolution documented in clinic notes and objective circumference measurements; and any procedure-related re-interventions or complications. Patients lost to follow-up were excluded from outcome analyses; no imputation methods (such as last observation carried forward or treating lost patients as treatment failures) were applied.

Statistical Analysis

Statistical analysis was performed using SPSS software (version 26.0). Continuous variables with a normal distribution are presented as mean ± standard deviation (SD) and compared using the independent samples t-test. Non-normally distributed data are presented as median (interquartile range, IQR) and compared using the Mann-Whitney U test. Categorical variables are presented as frequency (percentage) and compared using the Chi-square test or Fisher’s exact test (when expected cell counts were <5). All statistical tests were two-sided, and a P-value < 0.05 was considered statistically significant.

Results

Overall Cohort Characteristics and Inter-group Comparison

A total of 137 patients were finally included in the study: 87 (63.5%) in the Thrombus Treatment Group and 50 (36.5%) in the Non-Thrombotic Treatment Group. The overall mean age was 66.8 ± 10.3 years, and 64.2% (88/137) of patients were female. The median follow-up duration was 4.2 months (IQR: 3.5–5.8) in the Thrombus Clearance Group and 4.5 months (IQR: 3.8–6.1) in the No Acute Thrombus on Imaging Group. Detailed baseline characteristics are shown in Table 1.

Table 1.

Baseline Characteristics Comparison

Variable	Thrombus treatment group (n=87)	Non-thrombotic treatment group (n=50)	P-value
Demographics
Age (years), mean ± SD	70.2 ± 11.4	62.1 ± 7.2	<0.001
Female, n (%)	51 (58.6)	38 (76.0)	0.038
Smoking History, n (%)	19 (21.8)	3 (6.0)	0.012
Body Mass Index (kg/m²), mean ± SD	24.7 ± 4.1	26.0 ± 3.3	0.050
Comorbidities
Hypertension, n (%)	37 (42.5)	15 (30.0)	0.144
Diabetes Mellitus, n (%)	11 (12.6)	4 (8.0)	0.393
Clinical Presentation
Preoperative Swelling Symptom, n (%)	87 (100.0)^†	19 (38.0)	<0.001
Preoperative Ulcer Symptom, n (%)	14 (16.1)	8 (16.0)	0.989

SD: Standard Deviation; DVT: Deep Vein Thrombosis.

†All patients in the Thrombus Treatment Group presented with swelling due to confirmed acute/subacute iliofemoral deep vein thrombosis.

Comparison of Perioperative Parameters

Significant differences were observed in perioperative parameters between the two groups (Table 2). The median procedure time was significantly longer in the Thrombus Treatment Group [120.0 (IQR: 95.0-145.0) minutes] compared to the Non-Thrombotic Treatment Group [70.0 (IQR: 48.8-106.3) minutes] (P<0.001).Conversely, the mean number of stents used was significantly lower in the Thrombus Treatment Group (1.3 ± 0.6 vs. 1.8 ± 0.9, P<0.001). No significant differences were found in hospital length of stay or the mean number of balloons used. The stents used were the Wallstent (Boston Scientific, USA) and the Zilver Vena venous stent (Cook Medical, USA), selected by the operator based on lesion length and vessel diameter. The predominant stent diameters were 14 mm and 12 mm, with institutional practice favoring 10–20% oversizing relative to the adjacent normal venous segment, though exact measurements were not consistently recorded.

Table 2.

Procedural Characteristics and Resource Utilization

Variable	Thrombus treatment group (n=87)	Non-thrombotic treatment group (n=50)	P-value
Procedural Metrics
Procedure Duration (minutes), median (IQR)	120.0 (95.0, 145.0)	70.0 (48.8, 106.3)	<0.001
Hospital Length of Stay (days), mean ± SD	4.3 ± 2.8	3.9 ± 2.0	0.392
Interventional Device Usage
Number of Balloons Used, mean ± SD	1.8 ± 1.1	2.1 ± 1.3	0.116
Number of Stents Used, mean ± SD	1.3 ± 0.6	1.8 ± 0.9	<0.001
Patients Receiving >1 Stent, n (%)	22 (25.3)	17 (34.0)	0.279

IQR: Interquartile Range; SD: Standard Deviation.

Comparison of Post-operative Follow-Up Outcomes

A total of 125 patients completed the 3-6 month follow-up (loss to follow-up rate: 8.8%, 12/137). Six patients were lost from each group, with no significant difference in loss rate (6.9% vs. 12.0%, P=0.296). Follow-up results are presented in Table 3. Patency rates were calculated based only on patients with available follow-up data. The 12 patients (8.8%) lost to follow-up (6 from each group) were excluded from the denominator. No assumption was made regarding their outcomes.

Table 3.

Follow-Up Outcomes at 3-6 Months

Follow-up outcome	Thrombus treatment group (n=81)	Non-thrombotic treatment group (n=44)	P-value
Anatomic Outcomes (Ultrasound)
Stent Patency (Patent), n (%)	56 (69.1)	26 (59.1)	0.243
Clinical Outcomes (Symptom Assessment)
Clinically Swelling-Free, n (%)	79 (97.5)	42 (95.5)	0.520
Adverse Events, n (%)	2 (2.5)	3 (6.8)	0.224
Stent Stenosis (>50%)	0	1
In-Stent Thrombosis	2	1
Stent Occlusion	0	1

Analysis is based on patients with available follow-up data. A total of 12 patients (8.8%) were lost to follow-up (6 from each group).

Subgroup Analysis Within the Non-thrombotic Treatment Group

Among the 50 patients in the Non-Thrombotic Treatment Group, 29 were classified as Subgroup A (Pure Compression) and 21 as Subgroup B (Thrombotic-Related).

Comparison of Baseline Characteristics

As shown in Table 4, the proportion of patients with a prior DVT history (47.6%) and pre-operative swelling symptoms (81.0%) was significantly higher in Subgroup B compared to Subgroup A (0% and 6.9%, respectively, both P<0.001). No significant differences were observed in other demographic characteristics or comorbidities.

Table 4.

Subgroup Analysis: Baseline Characteristics of the Non-thrombotic Group

Variable	Subgroup A: Pure compression (n=29)	Subgroup B: Thrombotic-related (n=21)	P-value
Demographics
Age (years), mean ± SD	61.0 ± 7.6	63.7 ± 6.3	0.186
Female, n (%)	24 (82.8)	14 (66.7)	0.187
Smoking History, n (%)	1 (3.4)	2 (9.5)	0.361
Body Mass Index (kg/m²), mean ± SD	25.7 ± 3.0	26.5 ± 3.7	0.374
Comorbidities
Hypertension, n (%)	9 (31.0)	6 (28.6)	0.849
Diabetes Mellitus, n (%)	2 (6.9)	2 (9.5)	0.729
Clinical History & Presentation
Prior DVT History, n (%)	0 (0.0)	10 (47.6)	<0.001
Preoperative Swelling Symptom, n (%)	2 (6.9)	17 (81.0)	<0.001

SD: Standard Deviation; DVT: Deep Vein Thrombosis.

Group definitions: Subgroup A (Pure Compression): IVCS without thrombotic history; Subgroup B (Thrombotic-Related): Post-thrombotic syndrome or chronic DVT.

Comparison of Perioperative Parameters

Procedural complexity was significantly higher in Subgroup B (Table 5). The mean procedure time was 117.0 ± 58.9 minutes in Subgroup B compared to 67.1 ± 32.6 minutes in Subgroup A (P<0.001). Subgroup B also required more balloons (2.6 ± 1.5 vs. 1.8 ± 0.9, P=0.015) and stents (2.3 ± 1.0 vs. 1.5 ± 0.7, P<0.001), and had a slightly longer hospital stay (4.6 ± 1.9 vs. 3.4 ± 1.9 days, P=0.043).

Table 5.

Subgroup Analysis: Procedural Characteristics of the Non-thrombotic Group

Variable	Subgroup A: Pure compression (n=29)	Subgroup B: Thrombotic-related (n=21)	P-value
Procedural Metrics
Procedure Duration (minutes), mean ± SD	67.1 ± 32.6	117.0 ± 58.9	<0.001
Hospital Length of Stay (days), mean ± SD	3.4 ± 1.9	4.6 ± 1.9	0.043
Interventional Device Usage
Number of Balloons Used, mean ± SD	1.8 ± 0.9	2.6 ± 1.5	0.015
Number of Stents Used, mean ± SD	1.5 ± 0.7	2.3 ± 1.0	<0.001
Patients Receiving >1 Stent, n (%)	6 (20.7)	11 (52.4)	0.015

SD: Standard Deviation.

Comparison of Post-operative Follow-Up Outcomes

After excluding 3 patients lost to follow-up from each subgroup, the follow-up results for Subgroups A and B are shown in Table 6. Despite greater procedural complexity, Subgroup B showed no statistically significant difference compared to Subgroup A in post-operative ultrasound patency rate (61.1% vs. 57.7%, P=0.823), clinical swelling-free rate (94.4% vs. 96.2%, P=0.775), or adverse event rate (11.1% vs. 3.8%, P=0.341).

Table 6.

Subgroup Analysis: Follow-Up Outcomes of the Non-thrombotic Group

Follow-up outcome	Subgroup A: Pure compression (n=26)	Subgroup B: Thrombotic-related (n=18)	P-value
Anatomic Outcomes (Ultrasound)
Stent Patency (Patent), n (%)	15 (57.7)	11 (61.1)	0.823
Clinical Outcomes (Symptom Assessment)
Clinically Swelling-Free, n (%)	25 (96.2)	17 (94.4)	0.775
Adverse Events, n (%)	1 (3.8)	2 (11.1)	0.341

Discussion

This comparative analysis revealed that for iliofemoral venous disease, the “thrombus clearance first, then stent” strategy (Thrombus Treatment Group) for patients with acute/subacute thrombosis and the “direct stenting” strategy (Non-Thrombotic Treatment Group) for patients without significant acute thrombosis achieved similar short-term (3-6 months) clinical patency and symptom relief rates. However, these two strategies showed significant differences in patient demographics, procedural characteristics, and resource utilization. Importantly, the two strategies were applied in distinct patient populations – acute/subacute thrombosis versus chronic non-thrombotic lesions – and our comparison should be interpreted as an evaluation of strategy performance in different clinical contexts rather than a head-to-head comparison of directly comparable cohorts.

Firstly, the Thrombus Treatment Group consisted of older patients with a higher proportion of males and smokers, aligning with the epidemiological profile of a population at high risk for acute venous thromboembolism.¹⁰ Although procedure time was significantly longer in this group (primarily due to the thrombus clearance step), the average number of stents used (1.3) was significantly lower than in the Non-Thrombotic Group (1.8). This finding holds important clinical implications. The number of stents implanted is associated with potential risks of intimal hyperplasia, re-stenosis, and long-term healthcare costs.^11,12 PMT devices like Angiojet may reduce the acute inflammatory burden and external compression on the venous wall by rapidly clearing thrombus, thereby allowing operators to adopt a more precise and conservative stent placement strategy, targeting only residual stenoses or compression sites.^13,14 Our results support the concept that “thrombus debulking facilitates optimized stent implantation,” which aligns with the recent trend advocating for “simplification and precision in venous disease interventional therapy”.¹⁵ The uniform post-procedural anticoagulation regimen of rivaroxaban 10 mg twice daily for six months was adopted in accordance with contemporary guideline recommendations for extended-duration anticoagulation in patients with venous stents, particularly in those at high risk of re-thrombosis after acute deep vein thrombosis intervention.¹¹ This standardized protocol minimizes the confounding effect introduced by heterogeneous anticoagulation strategies, thereby enabling observed outcome differences to be more confidently attributed to the procedural approach and lesion characteristics. Consistent with this, the low rate of early in-stent thrombosis observed in both groups likely reflects the effectiveness of this uniform regimen, supporting the safety of both strategies within a guideline-concordant anticoagulation framework.

Secondly, a more innovative finding emerged from the internal dissection of the Non-Thrombotic Treatment Group. Traditionally, these patients are often broadly categorized as having “non-thrombotic” or “compressive” lesions. However, our subgroup analysis clearly delineated two distinct populations: Subgroup A (Pure Compression) and Subgroup B (Thrombotic-Related). Nearly half of Subgroup B patients had a clear DVT history, and over 80% presented with chronic swelling symptoms, strongly suggesting their pathology is essentially PTS or chronic post-thrombotic occlusion.^16,17 Compared to Subgroup A, procedural complexity was significantly greater in Subgroup B, evidenced by longer procedure times and higher utilization of balloons and stents. This likely reflects more extensive venous segment involvement, more severe venous wall fibrosis, richer collateral circulation, and tougher chronic occlusive lesions in PTS patients, all factors increasing the technical difficulty of endovascular reconstruction.^18,19

Notably, despite greater procedural complexity and higher device usage in Subgroup B, its short-term follow-up patency and symptom relief rates showed no statistical difference from Subgroup A. This result carries a positive clinical implication. It suggests that for patients with symptomatic iliofemoral PTS, even with complex lesions, aggressive endovascular revascularization remains safe and effective, providing early benefits comparable to those seen in patients with pure IVCS. This provides data to support encouraging more proactive interventional treatment for PTS patients.^20-22 The uniform post-stenting anticoagulation protocol ensures that outcome differences are more likely attributable to the procedural strategy and lesion characteristics rather than variations in medical therapy.

The findings of this study carry two direct messages for clinical decision-making in iliofemoral venous disease. First, in patients with acute/subacute iliofemoral deep vein thrombosis, effective upfront thrombus debulking using pharmacomechanical thrombectomy allows for a more targeted and stent-sparing reconstruction, which may reduce long-term risks related to multi-stent constructs without compromising short-term patency or symptom relief. Second, within the cohort traditionally labeled as “non-thrombotic,” a distinct subgroup of patients with thrombotic-related pathology (post-thrombotic syndrome or chronic post-thrombotic occlusion) exhibits greater lesion complexity and requires more extensive endovascular instrumentation, yet these patients still derive significant early clinical improvement from stent reconstruction.

This study has several limitations. Its retrospective design is associated with potential selection bias. With the exception of inferior vena cava filter use in the Thrombus Treatment Group, which was uniform (100% per institutional protocol), detailed anatomical and technical data — including access strategies, presence of associated femoropopliteal disease, precise lesion length, and segmental involvement (common iliac vein, external iliac vein, inferior vena cava) — were not consistently recorded, limiting more granular analysis of procedural complexity. The relatively short follow-up period precludes assessment of mid- to long-term stent patency and post-thrombotic syndrome (PTS) recurrence rates. Future studies should be multicenter, prospective, randomized controlled trials with long-term follow-up, incorporating quality-of-life assessments and cost-effectiveness analyses to elucidate the relative merits of different strategies. Furthermore, this study compares management strategies applied in different clinical contexts rather than directly comparable populations; therefore, the findings should be interpreted within this framework, and caution is warranted when extrapolating to head-to-head comparisons.

Conclusion

This study demonstrates that in treating iliofemoral venous disease, a strategy of mechanical thrombus clearance combined with selective stenting can effectively manage thrombus burden, reduce the number of stents implanted, and maintain short-term efficacy comparable to direct stenting alone. Simultaneously, this study highlights the importance of meticulous diagnostic stratification among patients with no evidence of acute thrombus on imaging. The subgroup with thrombotic-related disease (e.g., PTS) presents with unique clinical features and higher procedural complexity but can still achieve favorable early outcomes through aggressive endovascular therapy.

Footnotes

ORCID iD

Guili Wang

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.*

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