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• W3157341808 abstract "We read with great interest the editorial by Kitrou et al.1Kitrou P.M. Katsanos K. Karnabatidis New evidence to support the use of drug coated balloons in the treatment of dysfunctional vascular access.Eur J Vasc Endovasc Surg. 2021; 61: 540-541Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar commenting on the recent article in the New England Journal of Medicine by Lookstein et al.2Lookstein R.A. Haruguchi H. Ouriel K. Weinberg I. Lei L. Cihlar S. et al.Drug-coated balloons for dysfunctional dialysis arteriovenous.N Engl J Med. 2020; 383: 733-742Crossref PubMed Scopus (52) Google Scholar The latter is a well designed investigational device exemption (IDE) trial sponsored by Medtronic, which showed statistically significant improvements in target lesion primary patency (TLPP) and in access circuit primary patency at six months in favour of drug coated balloons (DCB) compared with plain balloons when used in dysfunctional arteriovenous fistulas (AVF). The one year results were recently presented showing sustained superior TLPP and were consistent with the positive six month findings.3LINC 2021 first time data releases in arteriovenous access: Positive results for IN.PACT AV DCB. Available at: https://interventionalnews.com/january-2021-top-stories-interventional-news/. [Accessed 5 March 2021].Google Scholar The article renewed interest in use of DCBs in dysfunctional AVFs, signalling the end of a period of uncertainty because of the conflicting results of many previous trials. An umbrella review performed by our group including all the eight related meta-analyses to date on the same topic, revealed only a modest benefit of using DCB.4Lazarides M.K. Christaina E. Antoniou G. Argyriou C. TrypsianisG Georgiadis G. Plain vs. paclitaxel-coated balloon angioplasty in arteriovenous fistula and graft stenosis: an umbrella review.J Vasc Access. 2021; ([in press])Crossref PubMed Scopus (3) Google Scholar However the Lookstein et al. trial and three additional more recent trials were not included.5Therasse E. Caty V. Gilbert P. Giroux M.-F. Perreault P. Bouchard L. et al.Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: A randomized trial comparing with angioplasty alone.J Vasc Interv Radiol. 2021; 32: 350-359Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar, 6Kim J.W. Kim J.H. Byun S.S. Kang J.M. Shin J.H. Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.Korean J Radiol. 2020; 21: 1239-1247Crossref PubMed Scopus (11) Google Scholar, 7PAVE trial finds “no evidence of a benefit” from paclitaxel-coated balloons in preserving AV fistula patency. Available at: https://vascularnews.com/pave-study-no-benefit-paclitaxel/. [Accessed 5 March 2021].Google Scholar Interestingly, one of those marginally failed to reach statistical significance in favour of DCB,5Therasse E. Caty V. Gilbert P. Giroux M.-F. Perreault P. Bouchard L. et al.Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: A randomized trial comparing with angioplasty alone.J Vasc Interv Radiol. 2021; 32: 350-359Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar one by Kim et al. reported no benefit from DCB use,6Kim J.W. Kim J.H. Byun S.S. Kang J.M. Shin J.H. Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.Korean J Radiol. 2020; 21: 1239-1247Crossref PubMed Scopus (11) Google Scholar and the PAVE trial which presented unpublished results at the 2020 annual meeting of the British Society of Interventional Radiology also reporting no benefit.7PAVE trial finds “no evidence of a benefit” from paclitaxel-coated balloons in preserving AV fistula patency. Available at: https://vascularnews.com/pave-study-no-benefit-paclitaxel/. [Accessed 5 March 2021].Google Scholar Additionally, Trerotola et al. reported two year results of a previously published IDE trial showing variable efficacy of DCB.8Trerotola S.O. Saad T.F. Roy-Chaudhury P. for the Lutonix AV clinical trial investigators. The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.J Vasc Interv Radiol. 2020; 31: 1-14Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar A possible explanation for such persistent contradictory outcomes may be the different devices and techniques used in the studies (Table 1). Higher paclitaxel dose (3.5 μg/mm2) and longer inflation time (three minutes) may lead to better deposition of drug in the vessel wall and the subsequent beneficial results seen in the Lookstein et al. trial. The time delay to inflation (transit time), an additional procedural parameter was reported in only one of the new trials, although cardiologists have shown that a significant amount of paclitaxel is lost in the bloodstream and the blood contact time should be minimised to maximise the amount of drug delivered in the lesion.9Lee H.S. Kang J. Park K.W. Ki Y.-J. Chang M. Han J.-K. et al.Procedural optimization of drug-coated balloons in the treatment of coronary artery disease.Catheter Cardiovasc Interv. 2021; https://doi.org/10.1002/ccd.29492Crossref Scopus (3) Google ScholarTable 1Procedural characteristics of the recent trials comparing drug coated balloons (DCB) vs. plain balloon angioplasty in dysfunctional accessesStudyYearnDevice and paclitaxel concentrationDuration of DCB inflation – secTime delay to inflation (transit time)Trerotola et al.8Trerotola S.O. Saad T.F. Roy-Chaudhury P. for the Lutonix AV clinical trial investigators. The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.J Vasc Interv Radiol. 2020; 31: 1-14Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar2020285Lutonix Bard2 μg/mm230 – 120 (later in the study)Reported (< 30 sec in the majority)Lookstein et al.2Lookstein R.A. Haruguchi H. Ouriel K. Weinberg I. Lei L. Cihlar S. et al.Drug-coated balloons for dysfunctional dialysis arteriovenous.N Engl J Med. 2020; 383: 733-742Crossref PubMed Scopus (52) Google Scholar2020330IN.PACT Admiral, Medtronic3.5 μg/mm2180Not reportedKim et al.6Kim J.W. Kim J.H. Byun S.S. Kang J.M. Shin J.H. Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.Korean J Radiol. 2020; 21: 1239-1247Crossref PubMed Scopus (11) Google Scholar202040IN.PACT Admiral, Medtronic3.5 μg/mm2120Not reportedTherasse et al.5Therasse E. Caty V. Gilbert P. Giroux M.-F. Perreault P. Bouchard L. et al.Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: A randomized trial comparing with angioplasty alone.J Vasc Interv Radiol. 2021; 32: 350-359Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar2021120Passeo-18 Lux, Biotronik2.5 μg/mm260Not reportedPAVE trial7PAVE trial finds “no evidence of a benefit” from paclitaxel-coated balloons in preserving AV fistula patency. Available at: https://vascularnews.com/pave-study-no-benefit-paclitaxel/. [Accessed 5 March 2021].Google ScholarUnpublished data212Lutonix Bard2 μg/mm260Not reported Open table in a new tab The results of the recent trials weaken the important evidence that Kitrou et al. nicely presented. Their suggestion that more data and longer follow up were needed for the final verdict, in our view, should be further focused on changing paclitaxel dose, using a longer inflation time and minimising the time delay to DCB inflation, highlighting the importance of procedural optimisation to achieve probable better therapeutic results. New Evidence to Support the Use of Drug Coated Balloons in the Treatment of Dysfunctional Vascular AccessEuropean Journal of Vascular and Endovascular SurgeryVol. 61Issue 4PreviewThe recent publication in the New England Journal of Medicine by Lookstein et al. reported the results of a multinational, multicentre, randomised controlled trial (RCT) investigating the safety and effectiveness of drug coated balloons (DCBs) for treatment of dysfunctional arteriovenous fistulas (AVFs).1 Three hundred and thirty participants from the United States, Japan, and New Zealand were included in this investigational device exemption (IDE) study sponsored by Medtronic. The paclitaxel on the device was 3.5 μg/mm2, and the DCB inflation time was three minutes. Full-Text PDF Open Archive" @default.
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• W3157341808 title "Re: “New Evidence to Support the Use of Drug Coated Balloons in the Treatment of Dysfunctional Vascular Access”" @default.
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