Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Vascular Access: Results From a European,Multicenter,Single-Arm Retrospective Analysis

Abstract

Introduction:

This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS).

Materials and Methods:

Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2–4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8–12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP.

Results:

IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5–2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55–0.92), p=0.006; 5–7 mm group vs 8–12 mm group, p=0.025].

Conclusion:

In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.

Keywords

paclitaxel angioplasty central veins dialysis

Introduction

Stenosis constitutes a common finding in the central venous system (subclavian vein, brachiocephalic vein, superior vena cava) of hemodialysis (HD) patients. The main reasons for stenosis are the prior or current presence of foreign materials such as peripherally inserted central catheter, port catheters, cardiac rhythm–related devices, and central venous catheters, mainly those inserted in the left subclavian vein.^1–3 Although an incidental finding in many cases, central venous stenosis (CVS) can become symptomatic not only by preventing adequate HD but also presenting with other clinical manifestations predominantly, but not restricted to, arm swelling, pain, tenderness, and/or erythema of the ipsilateral extremity (in about 50% of the cases), ipsilateral breast swelling, neck swelling, and the presence of a visible collateral venous network.⁴

The gold standard treatment of CVS remains plain balloon angioplasty (PBA) with patency rates as low 28.9% at 6 months, rising in some cases to 60% when high-pressure balloon angioplasty is performed. Bare metal stenting (BMS) is reserved as a bail-out option when PBA fails but has proven to be an aggressive treatment with patency rates as low as 25% at 1 year.⁵ Lately, stent grafts (SG) have been proposed as an alternative to BMS, with a primary patency of 44% at 1 year.^6,7

Paclitaxel-coated balloons (PCB) have been suggested as a valid adjunctive option to PBA for the treatment of dysfunctional HD vascular access.⁸ Several randomized controlled trials (RCTs) and retrospective cohorts have shown a significant benefit over PBA, while a smaller number of studies showed a numerical but not significant benefit.^9–14 Furthermore, 3 meta-analyses verified the benefit of PCB in HD vascular access.^15–17 There are three studies exploring the use of PCB for the treatment of symptomatic CVS. A proof-of-concept RCT of 40 patients (20 treated with PCBs) by Kitrou et al¹⁸ has shown a significant improvement in intervention-free period (IFP) over PBA (PCB group: 179 days vs CBA group: 124.5 days; p=0.026). Another retrospective longitudinal analysis by Massmann et al¹⁹ with 25 patients treated several times with PCB and PBA (10 patients treated with PCBs) also came to the same conclusion (freedom from target lesion revascularization after PCB angioplasty 12 months vs 4 months after PBA; p=0.006). However, authors included axillary veins in this study so number of patients having a CVS treated with a PCB was smaller. A retrospective single-arm study by Hongsakul et al²⁰ assessed the use of PCBs for the treatment of early recurrent stenosis (<3 months). In the 16 patients included in the analysis, primary patency was 93.8% at 6 months. Although results from the aforementioned studies are encouraging, the total number of patients treated with a PCB in these published studies was less than 46.

The purpose of the current study was to assess the safety and the clinical outcomes of the use of PCBs for the treatment of symptomatic CVS in a multicenter, real-world setting.

Materials and Methods

This was a European, multicenter, investigator-initiated and run, single-arm, real-world retrospective analysis to assess the safety and the clinical benefit of the use of PCBs use for the treatment of symptomatic CVS. Ethics committee approval was acquired or waved as per each center’s local requirements. All patients signed an informed consent prior to the procedure but as this was a retrospective study, no dedicated form was needed. All procedures performed were in accordance with the ethical standards of the local institutional research committee and with the 1964 Helsinki declaration and its later amendments.

Inclusion and Exclusion Criteria

Patient to be included in the study should have been between 18 years and 90 years old, having an ipsilateral arteriovenous fistula (AVF) or arteriovenous graft (AVG). A minimum of one of the following clinical signs had to be apparent: arm swelling, pain, tenderness, and/or erythema of the ipsilateral extremity, ipsilateral breast swelling, neck swelling, visible collateral venous network, or performing inadequate HD. An angiographic verification of a stenosed central vein (≥50% stenosis by visual estimation) and a minimum of 6-months follow-up were also prerequisites. A patient was excluded from the study if a ≤50% stenosed vein was present (by visual estimation), vessel diameter was >12 mm angiographically verified by visual estimation, patient was pregnant or had an infected vascular access.

Patient and Vascular Access Baseline Characteristics

Eighty-six patients from 11 centers across 7 European countries were included in the study (59/86 male; 68.6%). Mean patient age was 62.6 years (SD 15.2 years). Leading reasons of end stage kidney disease were diabetic nephropathy (29/86; 33.7%), unknown (20/86; 23.3%) and arterial hypertension (13/86; 15.1%). There were 55 AVFs (55/86; 64%) and the rest were AVGs (31/86, 36%). Sixteen AVGs were looped (16/31; 51.6%) and the remaining were straight (15/31; 48.4%). Median vascular access age was 3.0 years [interquartile range (IQR) 1.2–4.8 years]. The main presenting symptoms were arm swelling (40/86; 46.5%), inadequate dialysis (27/86; 31.4%), visible collateral venous network (8/86; 9.3%). Forty patients suffered from diabetes (40/86; 46.5%), 52 from cardiovascular disease (52/86; 60.5%) and 27 from peripheral arterial disease (27/86; 31.4%). Sixty patients were on antiplatelet therapy (aspirin, clopidogrel, or both) (60/86; 69.8%) and 38 patients were on statins (38/86; 44.2%). In 40 cases (40/86; 46.5%) a foreign material was, priorly or at present, introduced in the central veins (Table 1).

Table 1.

Patient and Vascular Access Baseline Characteristics.

	No. of Cases/Total	Percentage
Patients	86/86
Men	59/86	68.6
Women	27/86	31.4
Age, years (mean/SD)	62.6/15.2
Reasons for ESKD
Diabetic nephropathy	29/86	31.4
Unknown	20/86	23.3
Arterial hypertension	13/86	15.1
Focal segmental GS	8/86	9.3
Glomerulonephritis	4/86	4.6
Vascular nephropathy	2/86	2.3
Interstitial nephritis	2/86	2.3
Other	8/86	9.3
Comorbidities
Diabetes	40/86	46.5
Cardiovascular disease	52/86	60.5
Peripheral arterial disease	27/86	31.4
Cerebrovascular disease	13/86	15.1
Hyperlipidemia	45/86	52.3
Medication
Clopidogrel	31/86	36
Aspirin	43/86	50
Statins	38/86	44.2
Heparin	16/86	18.6
Other	16/86	18.6
Presenting symptom
Arm swelling	40/86	46.5
Inadequate dialysis	27/86	31.4
Visible collaterals	8/86	9.3
Thrombosis	6/86	7
Other	5/86	5.8
Vascular access age, years (median/IQR)	3.0/1.2–4.8
Vascular access side
Left	49/86	57
Right	37/86	43
Vascular access site
Upper Arm	51/86	59.3
Forearm	13/86	15.1
Antecubital fossa	22/86	25.6
Vascular access type
AVF	55/86	63.9
AVG	31/86	36.1
AVG looped	16/31	51.6
AVG straight	15/31	48.4
Anastomosing artery
Brachial	72/86	83.7
Radial	12/86	13.9
Axillary	1/86	1.2
Ulnar	1/86	1.2
Anastomosing vein
Cephalic	44/86	51.2
Basilic	18/86	20.9
Axillary	13/86	15.1
Other	1/86	1.2
Presence of foreign body (currently or previously)	42/86	48.8

Abbreviations: AVF, arteriovenous fistula; AVG, arteriovenous graft; ESKD, end-stage kidney disease; GS, glomerulosclerosis; IQR, interquartile range.

Procedural and Lesion Variables

The procedures were performed according to each department’s protocol and operator’s preference. In 43 cases, lesions were situated in the subclavian vein (43/86; 50%), in 42 cases in the brachiocephalic vein (42/86; 48.8%) and 1 in the superior vena cava (1/86; 1,2%). Thirty-nine lesions were de novo (39/86; 45.3%) and the rest restenotic (47/86; 54.7%). From the 47 restenotic cases, 20 were in-stent restenosis (20/47; 42.5%). Predilation was performed in 73 cases (73/86; 84.9%). PCBs used were the Lutonix (BD, Tempe, AZ, USA) in 70 cases (70/86; 81.4%), the Elutax (Aachen Resonance, Aachen, Germany) in 9 cases (9/86; 10.5%), and the Inpact (Medtronic, Minneapolis, MN, USA) in 7 cases (7/86; 8.1%). The median balloon diameter was 10 mm (IQR 8–12 mm) and median length was 6 cm (IQR 4–6 cm) (Table 2).

Table 2.

Lesion and Procedural Characteristics.

	No. of Cases/Total	Percentage
Treatment area
Subclavian	43/86	50
Brachiocephalic	42/86	48.8
Superior vena cava	1/86	1.2
Type of lesion
De novo	39/86	45.3
Restenotic	47/86	54.7
In-stent restenosis	20/47	42.5
Predilation performed	73/86	84.9
PCB characteristics
PCB diameter, mm (median/IQR)	10/8–12
PCB length, mm (median/IQR)	6/4–6
PCB type
Lutonix	70/86	81.4
Elutax	9/86	10.5
InPact	7/86	8.1

Abbreviations: IQR, interquartile range; PCB, paclitaxel-coated balloon.

Outcome Measures

Primary outcome measures were clinically assessed IFP at 6 months defined as a dialysis access circuit with no need for clinically-driven target lesion repeat intervention for symptom recurrence and angiographic verification of the presence of a CVS, and procedural minor and major complications as described by the Quality Improvement Guidelines for Percutaneous Image-Guided Management of the Thrombosed or Dysfunctional Dialysis Circuit of Society of Interventional Radiology (SIR).⁶ The secondary outcome measures included access circuit survival and patient survival. Additionally, the investigation of independent factors that influence the primary outcome was also performed.

Statistical Analysis

Discrete variables are presented as counts and percentages, while continuous variables as medians and interquartile range (IQR) in parentheses, or as means ± standard deviation (SD) if originating from normal distributions (Kolmogorov-Smirnov test). Kaplan-Meier survival analysis was applied to demonstrate the incidence of loss of target lesion and circuit patency over time. Cox regression multivariable analysis (forced entry and backward stepwise regression) was performed to adjust for confounders and identify independent predictors of target lesion failure. Results of the Cox model were expressed as hazard ratios (HRs) with associated 95% confidence intervals (95% CIs). Forced entry of all explanatory variables in the Cox model was applied. Statistical analysis was performed in R language environment (version 3.6). The threshold of statistical significance was set at α=0.05 for all comparisons.

Results

The median patient follow-up time was 1.0 year (IQR: 0.5–2.2 years). According to the Kaplan Meier survival analysis clinically assessed IFP was 62.7% at 6 months, 34.6% at 12 months and 23.3% at 24 months (Figure 1). There was 1 minor complication (less than 48-hour hospitalization) and no major complications. Access circuit survival was 87.7% at 6 months, 78.5% at 12 months, and 67.6% at 24 months (Figure 2). Patient survival was 79.7% at 24 months (mortality rate: 20.3%) (Figure 3). In the exploratory subgroup analysis performed there was a significant difference in balloon diameter in favor of higher diameters. The result was consistent when Cox-regression analysis was performed [forced entry analysis HR: 0.72 (95% CI: 0.57–0.91); p=0.006, Backward stepwise analysis HR: 0.79 (95% CI: 0.68–0.93); p=0.004] or pairwise analysis between balloon diameters of 5 to 7 mm and 8 to 12 mm (p=0.025) (Figure 4). There was a trend toward significance in favor of forearm circuits when compared with upper arm vascular access circuits [HR: 0.42 (95% CI: 0.15–1.14); p=0.09] (Figure 5). There was no significant difference in any other of the baseline variables (Figure 6).

Discussion

The key element for the decision to treat a CVS is the actual manifestation of symptoms. According to the new Kidney Disease Outcomes Quality Initiative guidelines, a CVS appearing as an incidental finding should not be treated.²¹ Even when a CVS occurs with a tandem lesion within a dysfunctional vascular access circuit and the latter is treated, the chance of the CVS to become symptomatic remains low according to Ehrie et al²² describing this as an “unmasking” of the central lesion. When symptomatic, however, treatment of central venous stenosis is of utmost importance as symptomatology affects not only the vascular access itself but also the general condition of the HD patient. Apart from the problem of inadequate HD, symptomatic CVS reveals itself as swelling and edema of the upper extremities, breast, face, and neck.⁴ There is also a correlation between the site of stenosis and the symptoms.³ Additionally, central venous stenosis may occur with more rare complications such as ipsilateral pleural effusions, neurologic manifestations and respiratory distress syndrome.^5,23,24

In the current retrospective analysis, 86 patients underwent PCD angioplasty for the treatment of a symptomatic CVS with a 62.7% clinically assessed IFP observed at 6 months. This result is numerically superior compared to the previous RCT by Kitrou et al¹⁸ showing a 50% IFP at 6 months. This is the only study that an actual comparison could be made regarding the primary outcome measure. A meta-analysis by Kennedy et al¹⁵ found no significant difference between PBA and PCB angioplasty for CVS treatment (odds ratio 0.28 [95% CI: 0.07–1.14], p=0.08); however, this meta-analysis used the findings from the Massmann et al¹⁹ study, which included axillary veins as central veins. The different endpoints among studies on central veins and the veins included are variable among studies; not only those focusing on PCBs. An attempt toward common reporting standards was published by Dolmatch et al²⁵ and was endorsed by different societies. Another important finding of the study was the very low level of complications during these procedures. With only one minor complication reported, PCB angioplasty demonstrated a high safety profile in this study.

In the exploratory subgroup analysis, a numerical, but not significant, difference between upper arm and forearm access circuits was observed, favoring the latter [HR: 0.42 (95% CI: 0.15–1.14); p=0.09]. One could argue that this result may be explained by the presence of AVGs in the upper arm access circuits in which symptomatic CVS are known to be more frequently observed.²⁶ However, subgroup analysis provided no significant differences in terms of IFP between AVGs and AVFs in this study [HR: 0.89 (95% CI: 0.27–2.91); p=0.844]. Thus, a possible explanation for this could be that turbulence and pressure is relieved due to the bigger distance between the forearm anastomosis and the central venous stenosis together with the smaller diameters of vessels in the forearm.

The only significant variable that influenced IFP in this study was the diameter of the PCBs. According to Cox regression analysis, every millimeter increase in diameter, improved IFP by 29% [HR: 0.71 (95% CI: 0.57–0.91); p=0.006]. The results were consistent even when a stratification between low (5–7 mm) and high (8–12 mm) balloon diameters was performed (p=0.025). As there was no difference in patency rates between the different treatment areas (subclavian vein, brachiocephalic vein, superior vena cava) [HR: 0.94 (95% CI: 0.51–1.71); p=0.84] that could explain the sizing difference, the actual balloon diameter could be the reason for improved patency rates.

A meta-analysis by Katsanos et al²⁷ on the effect of paclitaxel on claudicants treated for their superior femoral artery lesions showed a significant increase in mortality when PCBs where used compared with PBA. The study triggered a Food and Drug Administration investigation with the panel in June 2019 concluding that patients with end-stage kidney disease are a different population treated in a different way.²⁸ A second meta-analysis coming from the same group of authors focused on the effect PCBs have on critical limb ischemia patients with below the knee lesions.²⁹ HD patients, however, do constitute a unique population with many comorbidities.²¹ Mortality rate of dialysis patients is 33% at 2 years according to the United States Renal Data System.³⁰ Furthermore, a recent Bayesian analysis on the results from the Photo-Graph V3 study by Siga et al³¹ concluded that the mortality rate for the 9,010 patients included in the study was 34.1% at 2 years. The most important factors contributing to this high mortality rate in this analysis were age, C-reactive protein, serum albumin, and vascular access type. A meta-analysis by Dinh et al³² restricted to a median follow-up of 1 year, showed no significant difference between PCB and PBA angioplasty [relative risk ratio: 1.26 (95% CI: 0.85–1.89); p=0.25] Trerotola et al¹² published 2-year results on the biggest RCT available so far, showing no significant difference between PCB and PBA angioplasty groups [33/141 subjects in the PCB group (23%) vs 26/144 subjects in the control group (18%); (p=0.27)]. Additionally, mean time to target lesion primary patency intervention for subjects with an event was longer for PCB group (322 days vs 207 days, p<0.0001). In addition, fewer interventions were needed to maintain target lesion patency in the PCB group at 9 months (p=0.02). In the current study mortality rate was 20.3% at 2 years, which is lower compared with the aforementioned data. Hence, the ability of offering less hospital visits to a population attending in the majority of cases HD 3 times a week, together with the fact that mortality rates with the use of PCB is not increased, could offer HD patients an improved quality of life.

Study suffers the inherent limitations of a retrospective single-arm analysis by lacking a comparator. Additionally, as 11 centers contributed their data, there was variability in the methodology of the procedures, further enforcing inhomogeneity of the results, while on the other hand, the same reason allows this study to provide real-world evidence. The total number of procedures performed in these departments, excluding those present in the study, were not able to be recorded, while additional procedures in other parts of the circuit were also missing. However, investigators were able to provide data regarding circuit survival and death rates. Finally, although there was sufficient number of cases included, study was not adequately powered to validate results from subgroup analyses and the event per variable ratio is low restricting the multivariable model to an exploratory scope.

To conclude, the current study provides the biggest cohort of patients undergoing PCB angioplasty for the treatment of symptomatic central venous stenosis. Study findings suggest PCB angioplasty to be safe and effective. Increased balloon diameter was the only independent predictor of significantly improved patency.

Footnotes

Declaration of Conflicting Interests

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

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Panagiotis M. Kitrou

Stavros Spiliopoulos

Alessio Spinelli

Konstantinos Stavroulakis

Raphael Coscas

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