According to the findings of a European multicentre retrospective analysis, the use of drug-coated balloons (DCBs) for the treatment of symptomatic central venous stenosis in dialysis patients has been demonstrated as safe. Presented at the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), the investigation adds to a growing evidence-base for DCBs as a potential treatment for patients in dialysis access.
Panagiotis Kitrou (University of Patras, Patras, Greece), discussing the retrospective analysis, began his talk by explaining how patients in dialysis access develop central venous stenosis. “It is mainly due to the current or prior use of foreign materials, especially left-sided subclavian central venous catheters, and of course because of the actual use of the access circuit for dialysis,” he said.
In terms of the treatment options available for this condition, Kitrou underlined that percutaneous transluminal angioplasty (PTA) is the current gold standard, despite the fact that patency rates with this treatment can be as low as 29% at six months. However, as the speaker noted, this figure does seem to double—to about 60% patency at six months—with the use of a high-pressure balloon. “Stent placement, according to guidelines, can be used as a bailout option, but it is a much more aggressive treatment, with patency as low as 25% at one year,” Kitrou added.
Shifting his focus to the existing evidence for DCB use, Kitrou cited the findings of a retrospective analysis performed in 2015 by Alexander Massmann (Saarland University Medical Center, Saar, Germany) et al, which enrolled 10 patients who were treated with DCBs. Although this study also included axillary veins, as well as central venous stenosis, the outcome measure of freedom from target lesion revascularisation did show a significant difference in favour of DCB use.
Kitrou also drew attention to the randomised controlled trial that he and his colleagues conducted in 2017. Including de novo, restenotic and occluded lesions, and using the Lutonix DCB as part in the investigation arm of the trial, a significant difference was found in favour of DCB use, in terms of the primary endpoint of a clinically-assessed intervention-free period. While these results show promise, Kitrou was eager to assert that the evidence-base so far is less than 30 patients.
Commenting on his latest investigation, the presenter said: “This was a multicentre, single-arm retrospective analysis, evaluating the outcomes of DCB use for the treatment of symptomatic central venous stenosis in arteriovenous dialysis access.” As part of the study, 87 patients were included, while 17 physicians from 11 participating centres across Europe were also involved.
These included Patras University Hospital, Greece; Schön Klinik, Düsseldorf, Germany; Institut Mutualiste Montsouris, Paris, France; Attikon University Hospital, Athens, Greece; Policlinico Umberto I, Rome, Italy; Hospital “S. Eugenio”, Rome, Italy; Ambroise Paré University Hospital, Paris, France; Lumiar Vascular Access Center, NephroCare, Portugal; St Franziskus Hospital, Muenster, Germany; University Hospital of Muenster, Germany; and Bart’s Health NHS Trust, London, UK.
Inclusion criteria for the analysis required patients to have an ipsilateral arteriovenous fistula (AVF) or graft (AVG), stenosed central vein (subclavian vein, innominate vein, or superior vena cava), and clinical signs of central venous stenosis, such as arm/neck swelling or inadequate dialysis performance. “Outcome measures for this study were clinically assessing the intervention-free period of the treated segment at six months and procedure-related minor and major complications,” Kitrou explained.
Examining the findings, Kitrou highlighted that the primary patency rate at six months was 62.7%, while the rate of access circuit survival was 87.7%. “I think it is also very important to note that the patient-survival rate at 24 months was 79.7%,” he emphasised.
Observational analysis did not show any significant variation in terms of different lesion sizes, or whether the subclavian, brachiocephalic, or superior vena cava were treated. However, it was found that the bigger the diameter of the balloon, the better the result. On this point, Kitrou commented: “These findings are even more significant if you look at diameter-assisted patency, with the curve analysis showing that 12mm balloons have more than 50% patency at two years.
Kitrou concluded: “In this European, multicentre, retrospective analysis, DCB use in symptomatic central venous stenosis for dialysis access patients was safe. Furthermore, the figures are comparable to previous randomised controlled trials and the balloon size has a significant effect on patency rates.”