Abstract
Objective
To evaluate the safety and efficacy of drug-coated balloon (DCB) and conventional balloon (CB) in the treatment of venous stenosis in hemodialysis access.
Method
The clinical data of 403 hemodialysis patients with arteriovenous fistula stenosis who were admitted to our hospital from November 1, 2020 to January 1, 2024 were retrospectively analyzed and divided into DCB group (n = 163) and CB group (n = 240). The Kaplan-Meier curve was used to evaluate the target lesion primary patency (TLPP) of the two groups. The primary endpoint was the primary patency rate of target lesions 12 months after surgery, and the secondary endpoints were the primary patency rates of target lesions 6 months, 18 months, and 24 months. Cox proportional hazard models were applied to explore the association between DCB and the risk of hemodialysis access dysfunction.
Results
The primary patency rate of target lesions in DCB group was higher at 6 months, 12 months, 18 months and 24 months, and the difference was statistically significant at 6 months (85.0% VS 69.3%, P = 0.0109) and 12 months (64.6% VS 38.0%, 0.0300).There was no significant difference at 18 months (36.9% VS 14.9%, P = 0.1475) and 24 months (23.1% VS 7.5%, P = 0.5091). The median survival time of DCB group was 449 days, and that of CB group was 270 days. The patency time of DCB group was significantly higher than that of CB group (P < 0.0001). After full covariate adjustment, the analysis revealed that patients in DCB group (HR: 0.34, 95% CI: 0.16, 0.70) had a significantly lower risk of hemodialysis access dysfunction compared to those in CB group.
Conclusion
The results show that compared with CB, DCB can obviously improve the primary patency rate of target lesions with vascular access stenosis in hemodialysis and reduce the re-intervention of target lesions, which is an effective and safe treatment for hemodialysis patients.
Keywords: Drug-Coated balloon, Conventional balloon, Arteriovenous fistula stenosis, Target lesion primary patency, Hemodialysis access
Introduction
The increasing prevalence of end-stage renal disease (ESRD) has made it a global medical issue. Most patients with ESRD require hemodialysis access, making the patency of this access crucial [1, 2]. However, the incidence of dysfunction of hemodialysis access is still high, and one of the main reasons for the failure of hemodialysis access is the stenosis of arteriovenous fistula anastomosis, venous puncture point and outflow vein [3–6]. The primary pathological mechanism behind this issue involves proliferation and activation of smooth muscle cells, endothelial cells and macrophages, which ultimately leads to intimal hyperplasia and venous stenosis [7, 8].
Percutaneous transluminal angioplasty (PTA) is the standard treatment for restrictive stenosis in hemodialysis access. However, this procedure can lead to intimal hyperplasia due to the forced tearing of the intima and media layers, as well as dysfunction of the endothelial cells [9, 10]. In patients with uremia, this endothelial cell dysfunction worsens the hyperplasia of the venous neointima and the thickening of the intima media of the vascular wall, which can occur even before vascular pathways are established. This process further increases the recurrence rate of target lesions [11]. Various methods have been explored to enhance the long-term patency of dialysis access, including bare metal stents, cryoballoons, cutting balloons, and high-pressure balloons. Unfortunately, these approaches have not yielded satisfactory results, highlighting the need for new treatments to improve the long-term success of dialysis access [12–15].
The paclitaxel drug balloon is designed to deliver paclitaxel directly to the vascular wall, which helps inhibit cell division and prevent intimal hyperplasia. However, the effectiveness and use of paclitaxel drug balloons in treating hemodialysis arteriovenous stenosis remain controversial, especially among Chinese people [16–19]. This paper aims to compare the effectiveness of drug-coated balloons with conventional balloons in treating arteriovenous stenosis in hemodialysis patients and to summarize relevant findings from existing studies.
Materials and methods
Study design
This single-center retrospective study was approved by the Institutional Research Board of the hospital and was compliant with institutional guidelines for the retrospective studies. This retrospective study complied with the declaration of Helsinki and was approved by The Affiliated Suzhou Hospital of Nanjing Medical University Ethical Committee. Human participants’ names have been removed from all sections of the manuscript. The Affiliated Suzhou Hospital of Nanjing Medical University Ethical Committee waived the need for informed consent. The ethical approval number is KL901463. The clinical data of 403 hemodialysis patients with arteriovenous fistula stenosis who were admitted to our hospital from November 1, 2020 to January 1, 2024 were retrospectively analyzed and divided into DCB group (n = 163) and CB group (n = 240). As this study was designed as a retrospective observational analysis including all eligible patients within the study period, no a priori sample size or power calculation was performed. All patients were hospitalized. We confirm that informed consent was obtained from all subjects and/or their legal guardian. The primary endpoint is the primary patency rate of target lesions 12 months after surgery, and the secondary endpoints are the primary patency rates of target lesions 6 months, 18 months, and 24 months after surgery. TLPP: It is defined as no restenosis of the target lesion during follow-up. Simple stenosis: defined as only one type of stenosis, such as type I stenosis, type II stenosis, type III stenosis and type IV stenosis. Tandem stenosis: defined as two or more types of stenosis. Through telephone follow-up or retrieval of case data, the patency of the hemodialysis access of each patient after the operation was obtained. All imaging measurements were performed using digital subtraction angiography (DSA). The degree of stenosis was calculated as the ratio of the diameter of the narrowed segment to that of the adjacent normal vessel measured on DSA.
Angiography sheet placement
DSA images were obtained for all patients with the angiography sheets consistently positioned at the level of the stenotic segment and the adjacent normal vessel. This placement ensured standardized and accurate measurement of vessel diameters and calculation of stenosis rates. For each patient, the stenotic segment and the reference normal vessel were centered within the imaging plane to minimize measurement bias due to angle or positioning differences. All imaging procedures were performed by experienced interventionists, and all measurements were independently verified by two observers to ensure accuracy and reproducibility.
Inclusion criteria
Age between 18 and 80 years; At least one successful hemodialysis; Clinical evidence of significant hemodynamic stenosis, ultrasound or angiography confirmed stenosis ≥ 50%; Patients who cannot maintain hemodialysis, such as insufficient blood flow, difficulty in venipuncture, decreased tremor, and increased venous pressure.
Exclusion criteria
The presence of pregnancy, active malignancy, and known hypersensitivity to iodine contrast agent or lidocaine, sepsis or active infection, history of stent placement in target lesions, history of PTA surgery.
Interventional procedure
After anesthesia with 1% lidocaine, a short sheath (Terumo, Japan) was successfully inserted by percutaneous puncture under the guidance of ultrasound, and heparin was given intravenously according to body weight. Then 0.035inch hydrophilic super-slippery (Terumo, Japan) guide wire and catheter were used to select the arterial end of the hemodialysis pathway for angiography to determine the location of the stenosis target. The selection of the balloon refers to the diameter of normal blood vessels around the target lesion, which is the same as or 1 mm larger than the reference blood vessels. In some patients with calcification or stenosis and severe dilation difficulties, high-pressure balloon dilation was used. The balloon filled until the narrow segment of the waist disappeared and remained for 60 s, and technical success was confirmed by angiography. In CB group, the operation was finished at this time, while in DCB group, paclitaxel drug coated balloon (Acotec, China) was used for administration at this time (Fig. 1). The DCB utilized in this study comprises a lipophilic matrix of magnesium stearate, which is incorporated with paclitaxel at a density of 3.3 µg/mm². The diameter of the drug-coated balloon is equal to or 1 mm larger than the diameter of the last expanded conventional balloon to maintain normal contact with the blood vessel wall, and the length is at least 1 cm Longer than the target lesion to avoid omission, and it is maintained at the recommended standard pressure for 3 min. Finally, the entire hemodialysis pathway was radiographed to rule out any direct complications as well as potential lesions. The use of anticoagulant plates is not restricted after operation.
Fig. 1.
A: preoperative angiography of target lesions; B: vascular preparation; C: DCB； D: postoperative angiography
In the case of thrombus occlusion, mechanical thrombectomy, catheter directed thrombolysis, and balloon angioplasty are used to treat thrombosis according to different conditions. Immediately after surgery, residual thrombus was evaluated by digital subtraction angiography (DSA). In our study, 25 patients had a small amount of residual thrombus that did not affect blood flow.
Statistical analysis
All findings were subjected to statistical analysis using SPSS 26.0, and the measurement data were presented as mean ± standard deviation. The Independent Samples t-test or Kruskal-Wallis test was utilized to compare the two groups. The enumeration data were presented as the number of cases or percentage, and χ2 test or Fisher’s exact test was utilized to compare patient groups. Kaplan-Meier survival curves of the two groups were plotted respectively, and the Kaplan-Meier survival curves were compared by Log-rank test, and P < 0.05 was considered statistically significant. Cox proportional hazards regression models were employed to calculate hazard ratios (HRs) with 95% confidence intervals (95%CIs) for the association between DCB and the risk of hemodialysis access dysfunction. Three models were developed with varying levels of covariate adjustment: Model 1 had no adjustments, Model 2 adjusted for sex, age, hypertension, diabetes, hyperlipidemia, and smoke, and Model 3 additionally adjusted for stenosis type, occlusion, artery diameter, reference vessel diameter, lesion length, diameter of target lesion vein before operation, loss of target venous lumen before operation, stenosis rate of target lesions before operation, diameter of target lesion after vascular preparation, loss of target venous lumen after vascular preparation, residual stenosis rate of target lesions after vascular preparation, target lesion diameter after operation, loss of lumen of target lesion after operation, residual stenosis rate of target lesion after operation, left hand, forearm arm, thrombus, and antiplatelet. Subgroup analyses were conducted to evaluate whether the impact of the DCB on the risk of hemodialysis access dysfunction varied among different demographic groups. These analyses were stratified by several factors, including sex, hypertension, diabetes, hyperlipidemia, smoke, stenosis type, and thrombus.
Results
Results of patient basic data
There are 184(45.7%) males and 219(54.3%) females, There were 63 (38.7%) cases of simple stenosis in DCB group and 73 (30.4%) cases in CB group, There were 58 cases (35.6%) of occlusive disease in DCB group and 96 cases (40.0%) in CB group. There were 54 cases of thrombus in DCB group and 102 cases in CB group. Compared with CB group, DCB group had smaller normal venous diameter, less loss of target lumen before and after surgery, and lower residual stenosis rate after surgery. The DCB group and CB group had significant differences in reference vessel diameter, loss of target venous lumen before operation, loss of target venous lumen after vascular preparation, residual stenosis rate of target lesions after vascular preparation, loss of lumen of target lesion after operation, residual stenosis rate of target lesion after operation, diabetes and hyperlipidemia (P < 0.05) (Table 1). Regarding perioperative complications, two cases of local infection were observed and resolved with appropriate management. Three cases of localized vascular dissection occurred, all of which were managed without the need for stent implantation. Five patients developed postoperative bleeding with hematoma formation, and one case of thrombosis was recorded. Additionally, three patients experienced transient heart failure, which improved after symptomatic treatment. Notably, no cases of steal syndrome or allergic reactions were observed in this cohort.
Table 1.
Primary patency rate of target lesions of Hemodialysis pathway in DCB and CB groups
| Characteristic | Overall | CB | DCB | p-value |
|---|---|---|---|---|
| N = 403 | N = 240 | N = 163 | ||
| Sex | 0.080 | |||
| Female | 219 (54.3%) | 139 (57.9%) | 80 (49.1%) | |
| Male | 184 (45.7%) | 101 (42.1%) | 83 (50.9%) | |
| Age(years) | 62.83 ± 12.46 | 62.54 ± 12.73 | 63.25 ± 12.08 | 0.539 |
| Lesion length(cm) | 3.84 ± 2.19 | 3.93 ± 2.19 | 3.71 ± 2.20 | 0.208 |
| Artery diameter(mm) | 3.95 ± 1.22 | 3.96 ± 1.06 | 3.94 ± 1.43 | 0.421 |
| Reference vessel diameter(mm) | 5.81 ± 1.15 | 6.03 ± 1.16 | 5.50 ± 1.07 | < 0.001 |
| Diameter of target lesion vein before operation(mm) | 1.00 ± 1.10 | 1.02 ± 1.20 | 0.96 ± 0.93 | 0.754 |
| Loss of target venous lumen before operation(mm) | 4.80 ± 1.31 | 4.98 ± 1.33 | 4.54 ± 1.24 | 0.001 |
| Stenosis rate of target lesions before operation (%) | 83 ± 18 | 83 ± 18 | 82 ± 16 | 0.356 |
| Loss of target venous lumen after vascular preparation (mm) | 2.10 ± 1.03 | 2.24 ± 1.04 | 1.90 ± 0.99 | 0.001 |
| Diameter of target lesion after vascular preparation (mm) | 3.71 ± 0.97 | 3.79 ± 1.03 | 3.60 ± 0.85 | 0.272 |
| Residual stenosis rate of target lesions after vascular preparation (%) | 35 ± 14 | 37 ± 14 | 34 ± 14 | 0.042 |
| Loss of lumen of target lesion after operation (mm) | 2.10 ± 1.03 | 2.24 ± 1.04 | 1.70 ± 1.32 | 0.001 |
| Target lesion diameter after operation (mm) | 3.80 ± 0.95 | 3.79 ± 1.03 | 3.81 ± 0.82 | 0.251 |
| Residual stenosis rate of target lesion after operation (%) | 0.34 ± 0.14 | 0.37 ± 0.14 | 0.30 ± 0.14 | < 0.001 |
| Hypertension | 0.114 | |||
| No | 217 (53.8%) | 137 (57.1%) | 80 (49.1%) | |
| Yes | 186 (46.2%) | 103 (42.9%) | 83 (50.9%) | |
| Diabetes | < 0.001 | |||
| No | 264 (65.5%) | 141 (58.8%) | 123 (75.5%) | |
| Yes | 139 (34.5%) | 99 (41.3%) | 40 (24.5%) | |
| Hyperlipidemia | 0.018 | |||
| No | 288 (71.5%) | 161 (67.1%) | 127 (77.9%) | |
| Yes | 115 (28.5%) | 79 (32.9%) | 36 (22.1%) | |
| Smoke | 0.052 | |||
| No | 325 (80.6%) | 186 (77.5%) | 139 (85.3%) | |
| Yes | 78 (19.4%) | 54 (22.5%) | 24 (14.7%) | |
| Antiplatelet | 0.649 | |||
| No | 283 (70.4%) | 171 (71.3%) | 112 (69.1%) | |
| Yes | 119 (29.6%) | 69 (28.8%) | 50 (30.9%) | |
| Left/Right hand | 0.955 | |||
| Right | 116 (28.9%) | 69 (28.8%) | 47 (29.0%) | |
| Left | 286 (71.1%) | 171 (71.3%) | 115 (71.0%) | |
| Stenosis type | 0.174 | |||
| Simple stenosis | 140 (34.7%) | 77 (32.1%) | 63 (38.7%) | |
| Tandem stenosis | 263 (65.3%) | 163 (67.9%) | 100 (61.3%) | |
| Forearm/upper arm | 0.242 | |||
| upper arm | 99 (24.6%) | 54 (22.5%) | 45 (27.6%) | |
| Forearm | 304 (75.4%) | 186 (77.5%) | 118 (72.4%) | |
| Thrombus | 0.058 | |||
| No | 247 (61.3%) | 138 (57.5%) | 109 (66.9%) | |
| Yes | 156 (38.7%) | 102 (42.5%) | 54 (33.1%) | |
| Stenosis/occlusion | 0.371 | |||
| Stenosis | 249 (61.8%) | 144 (60.0%) | 105 (64.4%) | |
| Occlusion | 154 (38.2%) | 96 (40.0%) | 58 (35.6%) |
Comparison of primary patency rate of target lesions between DCB group and CB group
The primary patency rate of target lesions in DCB group was higher at 6 months, 12 months, 18 months and 24 months, and the difference was statistically significant at 6 months (85.0% VS 69.3%, P = 0.0109) and 12 months (64.6% VS 38.0%, 0.0300). There was no significant difference at 18 months (36.9% VS 14.9%, P = 0.1475) and 24 months (23.1% VS 7.5%, P = 0.5091) (Table 2).
Table 2.
Association between the DCB and the risk of Hemodialysis access dysfunction
| Group | DCB(n=163) | CB(n=240) | P |
|---|---|---|---|
| TLPP | |||
| 6 months | 85.0% | 69.3% | 0.011 |
| 12 months | 64.6% | 38.0% | 0.030 |
| 18 months | 36.9% | 14.9% | 0.148 |
| 24 months | 23.1% | 7.5% | 0.509 |
Kaplan-Meier survival curve of DCB group and CB group
The median survival time was 449 days in the DCB group and 270 days in the CB group. Kaplan-Meier survival curve was used to plot the primary patency rate of target lesions in the DCB group and the CB group, and the results showed that the patency time in the DCB group was significantly higher than that in the CB group (P < 0.0001) (Fig. 2).
Fig. 2.
Kaplan-Meier survival curve (95%CI 1.233 ~ 1.981, P < 0.0001)
Association between DCB and the risk of Hemodialysis access dysfunction
A total of 299 patients (74.2%) experienced a hemodialysis access dysfunction. After full covariate adjustment (Model 3), the analysis revealed that patients in DCB group (HR: 0.34, 95% CI: 0.16, 0.70) had a significantly lower risk of hemodialysis access dysfunction compared to those in CB group. The data clearly demonstrates that patients in DCB group had a 66% low risk of hemodialysis access dysfunction, when compared to those in CB group (Table 3).
Table 3.
Association between the DCB and the risk of hemodialysis access dysfunction
| Characteristic | Event, n | Model 1 | Model 2 | Model 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HR | 95%CI | p | HR | 95%CI | p | HR | 95%CI | p | ||
| DCB | 299 | |||||||||
| No | 190 | Ref | Ref | Ref | ||||||
| Yes | 109 | 0.53 | 0.34, 0.83 | 0.006 | 0.60 | 0.37, 0.96 | 0.033 | 0.34 | 0.16, 0.70 | 0.004 |
HR Hazard Ratio, CI Confidence Interval
Model 1: unadjusted for any covariates
Model 2: adjusted for sex, age, hypertension, diabetes, hyperlipidemia, and smoke
Model 3: adjusted for sex, age, hypertension, diabetes, hyperlipidemia, smoke, stenosis type, occlusion, artery diameter, reference vessel diameter, lesion length, diameter of target lesion vein before operation, loss of target venous lumen before operation, stenosis rate of target lesions before operation, diameter of target lesion after vascular preparation, loss of target venous lumen after vascular preparation, residual stenosis rate of target lesions after vascular preparation, target lesion diameter after operation, loss of lumen of target lesion after operation, residual stenosis rate of target lesion after operation, left hand, forearm arm, thrombus, and antiplatelet
Subgroup analysis
To further explore the relationship between DCB and cancer hemodialysis access dysfunction, subgroup analysis was carried out. As shown in Fig. 3, the results revealed that DCB was consistent across different subgroups, including non-hypertension, diabetes, non-hyperlipidemia, simple stenosis, and non-thrombus, regardless of sex.
Fig. 3.
Subgroup and interaction analyses of the association between DCB and the risk of hemodialysis access dysfunction. Adjusted for sex, age, hypertension, diabetes, hyperlipidemia, smoke, stenosis type, occlusion, artery diameter, reference vessel diameter, lesion length, diameter of target lesion vein before operation, loss of target venous lumen before operation, stenosis rate of target lesions before operation, diameter of target lesion after vascular preparation, loss of target venous lumen after vascular preparation, residual stenosis rate of target lesions after vascular preparation, target lesion diameter after operation, loss of lumen of target lesion after operation, residual stenosis rate of target lesion after operation, left hand, forearm arm, thrombus, and antiplatelet
Discussion
This study retrospectively analyzed the clinical data of 403 patients with hemodialysis access disorder treated in our hospital and divided them into DCB group and CB group according to different treatment methods. The median survival time of DCB group was significantly higher than that of CB group, and the primary patency rate of target lesions in DCB group was higher at 6 months, 12 months, 18 months and 24 months, with statistical difference at 6 months and 12 months. The results demonstrates that patients in DCB group had a 66% low risk of hemodialysis access dysfunction, when compared to those in CB group. Additionally, the results revealed that DCB was consistent across different subgroups, including non-hypertension, diabetes, non-hyperlipidemia, simple stenosis, and non-thrombus, regardless of sex.
DCB technology combines balloon-forming and drug-elution techniques, utilizing paclitaxel to inhibit cell proliferation, which is applied to the surface of the balloon. In 2003, Professor Scheller from Germany published the results of animal studies demonstrating that paclitaxel effectively inhibits restenosis in coronary artery stents, attracting significant attention [20]. By 2004, his team conducted the first study on treating human stent restenosis, confirming that drug-coated balloons were significantly more effective than ordinary balloons in this treatment. This foundational research paved the way for further studies on drug-coated balloons [21]. Subsequently, DCB began to be utilized for treating various atherosclerotic stenoses, including those in the coronary artery and superficial femoral artery. Over time, DCBs were progressively applied to treat lesions in the carotid artery, vertebral artery, and subclavian artery, demonstrating clear advantages in inhibiting intimal hyperplasia [22, 23]. In recent years, DCB have also showed great application prospects in hemodialysis access. Stenosis in the hemodialysis access primarily results from vascular injury caused by repeated punctures, venous arterialization, fibrosis, and turbulence from increased shear force within thin-walled outflow tract veins. This condition often involves vascular endothelial dysfunction and intimal injury arising from repeated PTA [24]. The main pathological mechanism is intimal hyperplasia, driven by the proliferation and migration of smooth muscle cells. Paclitaxel-coated balloons can effectively inhibit this intimal hyperplasia, thereby preventing restenosis [25].
Mehmet et al. conducted a retrospective analysis comparing the initial patency rates of 52 hemodialysis patients treated with DCB and CB. Their results indicated a high primary patency rate for DCB at 12 months, with no significant difference observed at 6 months [26]. Similarly, Kocaaslan et al. analyzed 80 hemodialysis patients with juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistulae, dividing them into DCB and CB groups. Their findings showed that both groups had similar primary patency rates at 6 months, but the DCB group demonstrated a significantly higher rate at 12 months [27]. There were discrepancies in the primary patency rates at 6 months post-operation between these two studies and our own research. These differences might be attributed to factors such as small sample sizes, varying types and locations of stenosis, and different access sites for hemodialysis. Trerotola et al. conducted a randomized trial involving 207 subjects with impaired arteriovenous vascular access for hemodialysis across 23 research centers. They applied a high-pressure balloon to prepare the vessels at target lesions and compared the efficacy of paclitaxel-coated balloons with high-pressure balloons in treating arteriovenous fistula stenosis. The primary patency rate for the paclitaxel drug-coated balloon group was significantly higher at 9, 12, 18, and 24 months post-surgery, showing statistical significance at 9 and 12 months, but not at 18 and 24 months. The median survival time for the drug-coated balloon group was 322 days, compared to 207 days for the high-pressure balloon group [28]. Holden et al. performed a prospective, single-blind clinical trial involving 330 patients treated with drug-coated balloons in a hemodialysis obstruction study conducted at 29 international research centers. Their results revealed that treatment with drug-coated balloons was superior to that of the control group at 12 months post-surgery, showing a significantly higher primary patency rate than high-pressure balloons [29]. The findings of the studies by Holden and Trerotola are consistent with our own results; however, our center utilized ordinary balloons instead of high-pressure balloons for vascular dilation. In our center, the median survival time for DCB was 449 days, compared to 270 days for the CB group. This difference may be due to the fact that patients in our center with hemodialysis disorders generally exhibit simpler stenosis types, less thrombosis, fewer occlusive lesions, and overall less complicated pathology. Additionally, the stronger tearing effect of the high-pressure balloon on the vessel intima may lead to severe intimal hyperplasia in the later stages, potentially undermining long-term patency for hemodialysis access preparation. Lučev et al. and Liao et al. both demonstrated in their studies that the primary patency rate of DCB was significantly higher than that of CB at 6 months post-operation [30, 31]. Irani et al. compared the effectiveness of DCB and CB in treating arteriovenous access disorders in hemodialysis across 119 patients, concluding that DCB was effective in prolonging the patency rates of target lesions at both 6 and 12 months after the procedure [32]. Moreover, the meta-analysis by Yan and Liu, which encompassed 1,113 patients with hemodialysis pathway dysfunction, indicated that DCB is a superior choice over CB for treating hemodialysis pathway stenosis at 6 and 12 months, aligning with our findings [33, 34].
In this study involving 403 patients, 136 had simple stenosis, 267 had tandem stenosis, 154 had occlusive lesions, and 156 experienced complications related to thrombosis. The study does not mandate that the residual stenosis rate for all patients be below 30% after vascular preparation. Interestingly, the median survival time in this study is relatively longer compared to other studies, indicating that achieving perfect imaging during vascular preparation may not be necessary. A lower residual stenosis rate could lead to more significant tearing of blood vessels, potentially resulting in serious intimal hyperplasia, which may worsen vascular stenosis. The data show that the advantages of the drug-coated balloon (DCB) group diminish after 12 months post-operation, although it remains superior to the conventional balloon (CB) treatment. Thrombosis poses a challenge with DCBs, as thrombus formation can interfere with the release of paclitaxel from the blood vessel wall, and any residual thrombus can reduce the effectiveness of the DCB. Additionally, diabetes is a notable risk factor. Patients with diabetes often present with advanced vascular disease and severe vascular calcification, which can impair the absorption of paclitaxel. Furthermore, the preoperative reference vein diameter in the DCB group is smaller than that in the CB group. The DCB used in this study is over 1 mm larger than normal blood vessels, which may expand to the size of normal blood vessels during vascular preparation, potentially causing intimal tears in healthy vessels. This, too, can affect the long-term effectiveness of the DCB. Patients with recurrent conditions typically exhibit multiple stenoses, refractory stenosis, and venous calcification, which may skew the efficacy of DCB treatment in these individuals. Although there have been large-scale prospective studies comparing DCB and CB, real-world data for Asian hemodialysis patients is still limited. This study provides evidence-based evidence for the Chinese population, helps guide clinical practice, and enriches the comparative results of patients in different regions. We also conducted subgroup analysis to further explore the role of DCB in different populations, which provides a unique perspective on its real-world applications.
However, there are some limitations to our study. Firstly, this was a single-center retrospective study, rather than a multicenter or prospective study. Secondly, in the whole process of our study, it was not completely completed by one principal surgeon, but by three experienced principal surgeons. Small differences caused by personal experience and techniques of principal surgeons cannot be ruled out. Thirdly, different lesion locations, stenosis types, and thrombosis may have a certain impact on the final study results. Fourthly, this study is retrospective in design, and assigning patients to the DCB or CB group is not randomized, so residual bias cannot be completely ruled out. Therefore, these findings should be considered exploratory and need to be confirmed in future prospective randomized controlled trials. Fifthly, although multivariable adjustment was applied to mitigate baseline imbalances, residual confounding cannot be fully excluded due to the retrospective design and significant initial differences between groups. Sixth, the limitation of our study is the lack of formal power calculations, as retrospective designs need to include all available cases rather than a predetermined sample size. Although this may limit the statistical ability to detect small differences, our findings provide valuable real-world evidence for the clinical application of DCB.
Conclusion
Our research findings indicate that compared to CB, DCB has potential benefits in reducing hemodialysis access dysfunction. DCB can improve the primary patency rate of target lesions and reduce the re-intervention of arteriovenous vascular access in hemodialysis.
Acknowledgments
Clinical trial number
Not applicable.
Authors’ contributions
JH conceived and designed the study and wrote the main manuscript text. DZ analyzed the data. XW and YZ conducted the literature search and prepared figures.GH performed the manuscript review. All authors reviewed and approved the final manuscript.
Funding
None.
Data availability
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
This retrospective study complied with the declaration of Helsinki and was approved by The Affiliated Suzhou Hospital of Nanjing Medical University Ethical Committee. Human participants’ names have been removed from all sections of the manuscript. The Affiliated Suzhou Hospital of Nanjing Medical University Ethical Committee waived the need for informed consent.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Jian Huang and Dayong Zhou contributed equally to this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.