Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae

Abstract

Purpose:

to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae.

Methods:

consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure.

Results:

The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas.

Conclusion:

APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated.

Clinical Impact

APERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.

Keywords

hemodialysis circuit dysfunction angioplasty drug-coated balloon randomized trial outcome

Introduction

Worldwide, almost 4 million patients receive renal replacement therapy, including peritoneal dialysis, hemodialysis, and ultimately kidney transplantation.¹ Hemodialysis can be performed through temporary or tunneled dialysis catheters, or through arteriovenous grafts or autologous fistulae. One of the main drawbacks of tunneled dialysis catheters is the high incidence of catheter infection and sepsis or mechanical catheter dysfunction up to 30% of cases.² Therefore, the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) favors arteriovenous grafts and fistulae instead of cuffed dialysis catheters when hemodialysis is preferred as an alternative to peritoneal dialysis.³

One of the most important limitations of arteriovenous shunts and fistulae is the relatively high incidence of stenosis or even thrombosis within the arteriovenous circuit, in up to 50% of hemodialysis patients with an arteriovenous shunt or autologous fistula.^4,5 Recently, drug-coated balloons (DCBs) have been used to increase the time period between 2 events of hemodialysis shunt/fistula dysfunction and the working mechanism is mainly based on the antiproliferative effect of the drug added to the vessel wall.^6,7 Longer periods of event-free dialysis will be associated with reducing the number of switches to catheter dialysis or creation of a new graft/fistula, and finally will increase patients’ quality of life. However, literature data are contradictory in demonstrating a clinical benefit when using DCBs^8–14 or not^15–18; in addition, a meta-analysis including 11 randomized clinical trials dealing with different types of DCB for dysfunctional hemodialysis circuits did not reveal superiority of the DCB versus standard angioplasty balloons¹⁹; another systematic review and meta-analysis, based on 12 studies could demonstrate a benefit for drug-coated angioplasty balloons.²⁰

In this randomized APERTO study, a new paclitaxel DCB is investigated as to whether this balloon is better than standard percutaneous transluminal angioplasty (PTA) balloons in increasing the event-free dialysis periods in patients with dysfunctional arteriovenous shunt or fistula.

Materials and Methods

Study Design

This is a prospective, multicenter, randomized (1:1), controlled trial, performed in 6 Dutch and 1 Belgian site in patients with dysfunctional dialysis access related to venous access stenosis. Patients were randomly assigned to one of 2 study arms: treatment arm, including APERTO-paclitaxel DCB angioplasty (Cardionovum GmbH, Bonn Germany) versus control arm, including standard percutaneous balloon angioplasty. Ethics Committees of participating centers approved the protocol and all study participants gave written informed consent before intervention. Demographic, procedural, and follow-up data were collected by each site; no central reading of the angiographies was performed.

Definitions and Endpoints

The primary endpoint of the study was assessment of adequate functioning of the hemodialysis circuit at 12 months of follow-up. Follow-up fistulography at 12 months of follow-up was not required.

Secondary endpoints include the following:

Device success, defined as the ability to position the DCB over the index stenosis, inflate the device up to rated burst pressure, and retrieve the device from the target lesion without burst.

Technical success is defined as obtaining a luminal diameter re-expansion of at least 70% of the nominal venous diameter by either the DCB or PTA by visual estimate and without bailout stenting.

Clinical success is defined as resumption of normal dialysis for at least 1 dialysis session after the index procedure.

Procedural success is defined as technical success with any major adverse event, including allergic reaction, thrombotic or pulmonary event, stroke, or death.

Eligibility Criteria for Study Inclusion

Patients were eligible to be included in the study if aged older than 18 years and younger than 90 years, presenting with a dysfunctioning fistula or graft, related to an underlying venous (re-)stenosis as summarized in Table 1.

Table 1.

Inclusion and Exclusion Criteria for the APERTO-Study.

Inclusion criteria:
1. Age >18 years and <90 years.
2. Patient or legally authorized representative providing written informed consent.
3. Patient willing and likely to comply with the follow-up schedule.
4. Patients with previously well-functioning hemodialysis circuit on the upper limb, presenting with any of the following clinical abnormalities as defined in the NFK-DOQI-protocol criteria, including
(a) Abnormal physical examination findings (eg, change in bruits, thrill, and pulse)
(b) Abnormal urea recirculation measurements.
(c) Elevated venous pressure during dialysis.
(d) Decreased access flow.
(e) Previous thrombosis in the access line.
(f) Development of collateral veins.
(g) Upper limb swelling.
(h) Low arterial pressure during dialysis.
(i) Unexplained decreases in dialysis dose.
5. Target lesion is hemodynamically relevant and consists of a median luminal diameter <3 mm as judged by the local investigator.
6. Target lesion is a de novo or (non–stent-related) restenosis.
7. Target lesion in the dialysis fistulas is located at the anastomosis or in the outflow venous trajectory up to the level (but excluding) the subclavian vein or beyond.
8. Target lesion in dialysis shunts is located at the arterial or venous anastomosis, inside the graft, or in the outflow venous trajectory up to the level (but excluding) the subclavian vein.
9. Multiple target lesions are allowed per patient if they can be treated by a number of APERTO DEB aggregate maximal length of 160 mm.
10. Nontarget lesions (eg, in the subclavian vein) must be successfully treated with standard PTA prior to the target lesion treatment.
Exclusion criteria:
1. Patients unable to give informed consent.
2. Patients enrolled in another study with any investigational drug or device.
3. Patients previously enrolled in the APERTO trial.
4. Female patients of childbearing potential without a negative pregnancy test at the time of intervention.
5. Major surgical procedures within 30 days prior to the study or planned within 30 days of entry into the study.
6. Patients previously treated with a DEB in the hemodialysis circuit.
7. Patients with a thrombosed hemodialysis access.
8. Immature hemodialysis access and never used before due to insufficient shunt flow volume.
9. Lesion treated within 30 days prior to screening.
10. Failure to successfully treat nontarget lesions prior to target lesion treatment.
11. Instent restenosis
12. Patients with known allergy, hypersensitivity, or intolerance to contrast medium, aspirin, clopidogrel, ticlopidine or paclitaxel.
13. Graft infection in patients with dialysis shunt
14. Life expectancy <1 year.

Abbreviations: NFK-DOQI, National Kidney Foundation Kidney Disease Outcomes Quality Initiative; PTA, percutaneous transluminal angioplasty; DEB, drug-coated balloon.

Technique of Angioplasty

Percutaneous puncture of the fistula or graft was performed antegradely or retrogradely after administration of local anesthesia, based on clinical and ultrasound examination of the dialysis access, and was at the discretion of the attending interventional radiologist. Iodized-contrast angiography was performed from the arteriovenous anastomosis up to the right atrium to identify underlying efferent vein stenosis. In case of an additional central venous stenosis, which was considered as nontarget lesion, the central venous stenosis was first conventionally dilated using standard balloon angioplasty. Furthermore, the efferent vein stenosis, considered as target lesion, was treated if the stenosis was visually estimated as >50%. If the patient was randomized into the study arm, the balloon angioplasty was performed with use of the study device: APERTO 0.035” Paclitaxel drug-coated angioplasty balloon (Cardionovum GmbH, Bonn Germany) with an inflation time of 1 to 2 minutes. The APERTO-paclitaxel drug-coated angioplasty balloon (DCB) uses a Paclitaxel dose of 3.0 µg/mm² and has a rated burst pressure of 20 to 22 atmosphere; the diameter of the DCB ranges between 4 and 8 mm and the length is 4 cm. If the patient was randomized to the control arm, a standard percutaneous angioplasty (PTA) balloon was used at the discretion of the attending interventional radiologist; the inflation duration is also 1 to 2 minutes. The diameter of the angioplasty balloon used is 1.1/1 to the nominal diameter of the efferent vein proximal and distal to the treated stenosis.

After the angioplasty procedure, the patient was sent to the dialysis unit for routine dialysis session. No additional anticoagulant drugs were prescribed to the patient after the intervention.

Patients’ Follow-up

Patients’ follow-up consisted primarily of the clinical evaluation of the dialysis efficiency. If re-dysfunction was identified, patients were sent to the interventional radiology for fistulography and redo-angioplasty.

No additional duplex-ultrasound nor contrast-fistulography was performed at fixed time periods during follow-up.

Statistical Analysis

Based on experimental⁶ and clinical data, either in coronary or superficial femoral artery stenosis DCB-angioplasty,^21,22 a significant difference in degree of restenosis at 6 months of follow-up after DCB-angioplasty can be found with a patient sample size of 20 patients in each arm. If dialysis access dysfunction, instead of angiographically based restenosis in the efferent vein, is considered as primary endpoint, 50 patients in each study arm are estimated sufficient to reach statistical significance.

Results

Demographic and Dialysis Data

We included 103 patients, who were randomly assigned to the study arm (n=51) or to the control arm (n=52). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm, related to a recurrent venous stenosis, as summarized in Table 2.

Table 2.

Patients’ Baseline and Index Procedure Characteristics.

Characteristic	DEBN (%)	PTAN (%)
Age (y)
Mean±SD	72.3±11.8	67.4±15.3
Median	74	70.2
Sex
Female	26 (51)	13 (25.5)
Male	25 (49)	38 (74.5)
Type of dialysis access
Autologous AV-fistula	37 (72.5)	42 (82.4)
Prosthetic graft	14 (27.5)	9 (17.6)
Position of the dialysis access
Lower arm	31 (60.8)	29 (56.9)
Above the elbow	20 (39.2)	22 (43.1)
Hemodialysis access age (years)
Mean±SD	3.0±2.3	3.5±3.1
Median	2.3	2.2
Type of target lesion
De novo	20 (39.2)	13 (25.5)
Recurrent	31 (60.8)	38 (74.5)
Index procedure
Diameter of the angioplasty balloon (mm)
Mean±SD	5.7±2.1	6.5±1.0
Median	7.0	6.0
Inflation time (minutes:seconds)
Mean±SD	1:48±0:23	1:59±1:11
Median	1:35	2:00

Abbreviations: AV, arteriovenous; PTA, percutaneous transluminal angioplasty; DEB, drug-coated balloon.

Indication for referral to the interventional radiology department to manage the dysfunctional fistula or shunt was decreased access flow in the large majority of cases, as summarized in Table 3.

Table 3.

Indication for Treatment of Dysfunctional Fistula or Graft.

Clinical indication	DEBN (%)	PTAN (%)
Abnormal physical examination	3 (5.8)	4 (7.8)
Abnormal urea circulation measurement	0	3 (5.8)
Elevated venous pressure during dialysis	0	3 (5.8)
Decreased access flow	25 (49.0)	28 (54.9)
Previous thrombosis in access line	0	0
Development of collateral veins	0	0
Upper limb swelling	0	0
Low arterial pressure during dialysis	2 (3.9)	3 (5.8)
Unexplained decreases in dialysis dose	0	4 (7.8)
None of the above	5 (9.8)	1 (1.9)

Abbreviation: PTA, percutaneous transluminal angioplasty; DEB, drug-coated balloon.

Procedural Data

No nontarget, central venous stenosis was identified in any of the included study patients.

The stenotic lesions in patients with a dysfunctional prosthetic graft were located at the venous anastomosis; in patients with a dysfunctional autologous fistula, the underlying stenosis was found in the efferent vein. All included index lesions could be dilated with both the DCB or standard PTA balloon with full expansion of the balloon (Figure 1); mean diameter and inflation time of the angioplasty balloons are summarized in Table 2. No adverse events occurred during or immediately after the angioplasty procedure and all patients could successfully be dialyzed afterward.

Follow-up Data

One patient (in the control arm) was lost to follow-up; overall, 11 patients (10.7%) died during follow-up; death was unrelated to the angioplasty procedure; and 3 patients (2.9%) were transplanted during the follow-up period; 73 patients (70.9%) presented with a clinical failure of the treated dialysis access, with target lesion revascularisation in 66 patients (64.1%), resulting in a functional hemodialysis access without need for additional revascularisation procedure, at 12 months of follow-up, in 15 patients (14.6%), as summarized in Table 4.

Table 4.

Clinical Outcome Results.

	DEB (n = 51)	PTA (n = 52)
Functional hemodialysis access at 12 months of follow-up	10 (19.6%)	5 (9.6%)
Clinical failure until 12 months of follow-up	36 (70.6%)	37 (71.2%)
Target lesion revascularisation	33 (91.5%)	33 (89.2%)
Death	4 (7.8%)	7 (13.5%)
Kidney transplantation	1 (2%)	2 (3.8%)
Withdrawal	0 (0%)	1 (1.9%)

Abbreviation: PTA, percutaneous transluminal angioplasty; DEB, drug-coated balloon.

At 12 months of follow-up, n=10 (19.6%; study arm) and n= 5 (9.6%; control arm) patients presented with a functional dialysis circuit without need for re-intervention (p=0.612; Figure 2); sub-analysis of DCB versus PTA for arteriovenous graft and arteriovenous fistula, respectively (n=9; 23% vs n=6 14% and n= 3; 23% vs n=1; 13%), could not demonstrate any statistical difference (p=0.629; Figure 3), neither could DCB versus PTA for de novo and recurrent lesions, respectively (n=5; 25% vs n=1; 11% and n=7; 22% vs n=6; 15%; p=0.306; Figure 4), or DCB versus PTA in stenotic lesions in fistula younger than 1 year (p=0.948) (Figure 5) or in stenotic lesions in fistulas older than 1 year (p= 0.712; Figure 6). The randomization, procedural, and follow-up process of included patients are summarized in a flowchart (Figure 7).

Discussion

This study demonstrates that catheter-directed balloon angioplasty for the treatment of dysfunctional hemodialysis access, using the APERTO-DCB with a paclitaxel-based coating, is safe and not associated with early circuit-related thrombosis. In addition, a very high technical success, defined a disappearance of the underlying stenosis immediately after angioplasty was obtained in all procedures, which is in line with other studies.^11,23 However, this study could not show superiority of the APERTO-DCB with regard to functional, re-intervention-free, hemodialysis through the dilated hemodialysis circuit at 1 year of follow-up (p=0.612). This observation seems to be in contradiction with the findings of Lookstein et al,⁹ showing superior target-lesion primary patency using a different type of DCB, namely, the IN.PACT (Medtronic) angioplasty balloon: 82.2% versus 59.5% (p<0.001) at 6 months of follow-up. Whereas, Trerotola et al,^15,24 using the LUTONIX paclitaxel-coated balloon did not find a superior target lesion primary patency (71% vs 63%; p=0.06) at 6 months of follow-up; adversely, these authors revealed fewer re-interventions to maintain target lesion patency at 6 months of follow-up, but not at 12, 18, or 24 months of follow-up. These findings are in line with Yildiz’²⁵ study, demonstrating better primary patency at 6 months in the DCB arm, compared with the control arm (p< 0.001). However, many important methodological differences between the presented and the other randomized studies using DCB for dysfunctional hemodialysis circuits exist, making direct comparison very difficult. First, the amount of paclitaxel, coated on the different brands of DCB, is different: the APERTO-DCB uses 3.0 µg/mm² of paclitaxel, whereas the IN.PACT and LUTONIX DCB use 3.5 µg/mm² and 2 µg/mm², respectively. In addition, the characteristics of the hemodialysis accesses of included patients is also different: In the presented study, both native arteriovenous fistulae as well as grafts were included, irrespective whether the access did undergo balloon angioplasty for circuit dysfunction before inclusion in the study or not. Trerotola et al¹⁵ and Lookstein et al⁹ excluded patients with a graft, but included both de novo lesions and lesions previously dilated. This study also identified a numerically better re-intervention free outcome in de novo stenosis in native arteriovenous fistulae dilated with DCB versus PTA, which is in line with findings by Tozzi et al,²³ based on a multicenter, prospective registry. Furthermore, the interventional technique of angioplasty was different. In this study, the angioplasty was performed with the study balloon or with a conventional angioplasty balloon without predilating the lesion with a high pressure balloon. Although the APERTO DCB can be inflated up to 22 atmosphere (atm), predilation with use of a high-pressure balloon (up to 40 atm) might be more effective²⁶; Trerotola et al¹⁵ performed predilatation >25 atm to efface the waist on the balloon in 30% of included cases. Finally, the duration of inflation of the DCB and efficacy to deliver the antiproliferative drug might influence the clinical outcome. In this study, inflation time was in between 1 and 2 minutes as judged by the attending interventional radiologist. Lookstein et al⁹ did not mention the real inflation time and Trerotola et al¹⁵ had inflation times between 5 and 240 seconds. Potentially, a randomized, multicenter study, including patients with a de novo efferent vein stenosis in a dysfunctional autologous AV-fistula and treated with an angioplasty using the APERTO DCB might be an interesting future project as this study shows a numerically, but nonsignificant better outcome in patients with de novo versus recurrent stenotic lesions.

This study has also some limitations. First, the number of the included patients is low; however, based on a power analysis, 50 patients included in each arm was estimated enough for statistical difference. Second, this study did not include an independent clinical events committee, neither an independent core laboratory for analysis of angiographic images. Third, the quality of surgically created hemodialysis accesses might differ among participating centers and variation in interventional technique among investigators, outside the different steps mentioned in the study protocol, might influence the overall outcome. Finally, patients with an additional central venous stenosis related to dialysis circuit were included if the central stenosis could be successfully treated using a conventional angioplasty balloon before treatment of the index lesion. Treatment of central venous stenoses might result in better outcome if treated with DCB as suggested by Kitrou et al.²⁷

Conclusion

The APERTO-paclitaxel DCB angioplasty is safe and technically very efficacious in the management of efferent vein stenosis related to dysfunctional fistulae or grafts; however, no superiority at 1 year of follow-up compared with conventional balloon angioplasty could be depicted. Numerically better, nonsignificant results were found in the native arteriovenous fistula-related de novo lesions treated with DCB, compared with PTA.

Footnotes

Author Contributions

All authors contributed to the writing of the text and they all read and approved the final manuscript.

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.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The Research Ethics Committee granted favorable advice for this study (ClinicalTrials.gov; NCT02558153).

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent of Publication

Consent for publication was obtained for all individual person’s data included in the study.

ORCID iD

Geert Maleux

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