PURPOSE: To assess the current use of drug-eluting devices for peripheral arterial disease (PAD) among interventional radiologists following the controversy caused by the 2018 meta-analysis suggesting an increased mortality risk for paclitaxel-eluting devices. METHODS: An anonymous survey was sent to 7035 CIRSE members via email; only complete responses were included and statistically analysed. RESULTS: Three hundred and seven members (4.4%) completed the survey. Among these, 95.8% indicated that they personally perform peripheral vascular procedures. Thirty-eight percentage of respondents did not see any change of practice since 2018, while 47% reported that the use of drug-eluting devices decreased; for 13%, the use stopped altogether, while it increased in 3% of responses. 45.6% of respondents also felt the impact of the controversy in terms of pricing, availability or directives from hospital administration. A large majority of respondents (83.7%) who perform peripheral vascular procedures consider the use of these devices as safe, 12.9% were undecided and 3.4% did not consider them as safe. Among the respondents who do not perform endovascular procedures, 77% considered these devices as safe and 23% were undecided. CONCLUSION: Although the 2018 meta-analysis had a disruptive impact on the use of drug-eluting devices in PAD, with the increasing body of evidence available, a majority of respondents continue to believe in the safety of these devices for use in femoropopliteal disease

Fanelli, F

Haage, P

Hamady, M

Loffroy, R

Morgan, RA

Müller-Hülsbeck, S

O'Sullivan, G

Slijepčević, B

Wolf, F

St George's Online Research Archive

SHORT COMMUNICATION ARTERIAL INTERVENTIONSThe Current Use of Drug-Eluting Balloons and Stentsin Peripheral Arterial Disease: An Online Surveyby the Cardiovascular and Interventional Radiological Societyof Europe (CIRSE)Robert A. Morgan1 • Stefan Müller-Hülsbeck2 • Fabrizio Fanelli3 •Patrick Haage4 • Mohamad Hamady5 • Romaric Loffroy6 • Gerard O’Sullivan7 •Florian Wolf8 • Birgit Slijepčević9Received: 3 August 2023 / Accepted: 7 September 2023 The Author(s) 2023AbstractPurpose To assess the current use of drug-eluting devicesfor peripheral arterial disease (PAD) among interventionalradiologists following the controversy caused by the 2018meta-analysis suggesting an increased mortality risk forpaclitaxel-eluting devices.Methods An anonymous survey was sent to 7035 CIRSEmembers via email; only complete responses were includedand statistically analysed.Results Three hundred and seven members (4.4%) com-pleted the survey. Among these, 95.8% indicated that theypersonally perform peripheral vascular procedures. Thirty-eight percentage of respondents did not see any change ofpractice since 2018, while 47% reported that the use ofdrug-eluting devices decreased; for 13%, the use stoppedaltogether, while it increased in 3% of responses. 45.6% ofrespondents also felt the impact of the controversy in termsof pricing, availability or directives from hospital& Robert A. Morganrmorgan@sgul.ac.ukStefan Müller-Hülsbeckmuehue@diako.deFabrizio Fanellifabrizio.fanelli@unifi.itPatrick Haagepatrick.haage@helios-gesundheit.deMohamad Hamadymhamady@imperial.ac.ukRomaric Loffroyromaric.loffroy@chu-dijon.frGerard O’Sullivanlahinchman1923@gmail.comFlorian Wolfflorian.wolf@meduniwien.ac.atBirgit Slijepčevićslijepcevic@cirse.org1 St George’s University of London, London, UK2 Academic Hospital Christian-Albrechts-University Kiel,Kiel, Germany3 Vascular and Interventional Radiology Department,‘‘Careggi’’ University Hospital – University of Florence,Florence, Italy4 Helios University Hospital, University Witten/Herdecke,Wuppertal, Germany5 Imperial College, St Mary’s Campus, London, UK6 Department of Diagnostic and Interventional Radiology,University of Burgundy, Dijon, France7 University Hospital Galway, Galway, Ireland8 Division of Cardiovascular and Interventional Radiology,Medical University of Vienna, Vienna, Austria9 CIRSE Central Office, Vienna, Austria123Cardiovasc Intervent Radiolhttps://doi.org/10.1007/s00270-023-03562-3administration. A large majority of respondents (83.7%)who perform peripheral vascular procedures consider theuse of these devices as safe, 12.9% were undecided and3.4% did not consider them as safe. Among the respon-dents who do not perform endovascular procedures, 77%considered these devices as safe and 23% were undecided.Conclusion Although the 2018 meta-analysis had a dis-ruptive impact on the use of drug-eluting devices in PAD,with the increasing body of evidence available, a majorityof respondents continue to believe in the safety of thesedevices for use in femoropopliteal disease.Keywords Drug-eluting devices  Current practice Member survey  Paclitaxel-coated balloons Paclitaxel-eluting stentsIntroductionSince the meta-analysis of paclitaxel-eluting device usewas published by Katsanos et al. in 2018 [1], the landscapeon the use of drug-eluting devices for peripheral arterialdisease (PAD) has undergone significant change. Althoughseveral studies have called into question the mortalitysignal raised in the paper since then, reactions to the meta-analysis by national authorities such as the US Food andDrug Administration (FDA) impacted daily IR practice inmany regions. To better understand the real impact andcurrent use of drug-eluting devices for PAD within the IRcommunity more than 4 years after the controversy started,a CIRSE member survey was designed to better assess theeffect of the article on PAD practice by IRs. In parallel, thesociety’s Endovascular Subcommittee (EVSC) worked onan Expert Opinion paper, concluding that the re-analysis ofthe current available data does not support a link betweenpaclitaxel-eluting devices and mortality [2]. The analysiswas published at the same time as an update letter tohealthcare authorities by the FDA [3] on the mortality riskof paclitaxel-coated devices. The results of the CIRSEmember survey are presented at a time when this topic isreceiving significant attention, and we may start to seechanges in practice again.Materials and MethodsA survey questionnaire was developed by the authors andprogrammed into an online survey tool (Alchemer). Theanonymous survey was made available to 7035 CIRSEmembers on June 5, 2023. Two reminders were sent in thefollowing weeks, and the survey was closed on July 6,2023.Statistical AnalysisThe collected data were analysed using statisticalmethodology, including primarily univariate and multi-variate frequency analysis. All data analysis was performedin Microsoft Excel 2016.ResultsA total of 307 complete responses were submitted, corre-sponding to a response rate of 4.4%. Among EuropeanCIRSE members who took the survey, the response rateamounted to 5.3%.General Demographics and Geographic SpreadWith regard to the geographical distribution, a vastmajority of respondents were European CIRSE members(80%). Members from Germany (17%), the United King-dom (15%), Greece and Italy (6% each) and the Nether-lands (5%) accounted for almost half of the responses.Among non-European members, Australian CIRSE mem-bers accounted for the biggest group with 4% of responses.Respondents practice primarily at teaching or universityhospitals (58%) or in general/public hospitals (31%); fewerrespondents indicated that they work in private hospitals,clinics or foundations (10%).Among the 307 respondents, 95.8% indicated that theypersonally perform peripheral vascular procedures.Impact of the Controversy on Drug-Eluting DevicesRespondents were asked whether the controversy arounddrug-eluting devices (balloons, stents), which started fol-lowing the meta-analysis by Katsanos et al. [1] impactedthe availability, pricing or directives from hospitaladministration regarding the use of these devices at theircentre (see Fig. 1). A majority of members (54.4%)responded that there was no impact on these areas at theircentre. 19.2% indicated that there was an impact on deviceavailability, while directives from hospital administrationchanged for 18.6%. Price increase (2.6%) or decrease(2.9%) was only reported by very few responders. Fifteenpercent of respondents indicated that other aspects wereimpacted.When asked about the impact of the meta-analysis onthe daily IR practice at their centre, 38% of respondents didnot see any change in practice, while 47% reported that theuse of drug-eluting devices decreased. Thirteen percentage123R. A. Morgan et al.: The Current Use of Drug-Eluting Balloons...reported that the use of drug-eluting devices was stopped attheir centre, while it increased in 3% of cases (see Fig. 2).Based on their response to this question, the sample wassplit into three subgroups who were then asked a differentfollow-up question.All respondents who indicated that there was no impacton IR practice (n = 117) at their centre were asked if,meanwhile, IR practice has remained the same. In thisgroup, 89.7% of respondents indicated that the use of drug-eluting devices was still the same at their centre as it was in2019. The remaining 10.3% were asked to indicate whatchanged in an open response question; the most frequentresponse (open text) was that the use of these devicesfurther increased.Respondents who had replied that the use of drug-elut-ing devices increased (n = 8) or decreased (n = 143) due tothe above-mentioned controversy were then asked whethertheir practice with drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have remained the same since then.In this sub-sample, 48.3% of respondents indicated thattheir practice with drug-eluting devices has remained thesame since then (including all who replied that it initiallyincreased), while it changed for 52%. In the latter group(n = 78), 62.8% indicated in an open response explanationthat the use of DEB/DES increased again, while 23respondents (29.5%) indicated that practice furtherdecreased.If the use of DEB/DES had been stopped completely,respondents (n = 39) were asked whether the use of thesedevices had been taken up again in the meantime. Fifty-nine percentage of respondents in this subgroup havestarted using drug-eluting devices again. Forty-one per-centage of respondents still do not use drug-eluting devi-ces. The most frequent reasons (open text) for why it hasnot been taken up again include hospital directives andinsufficient evidence or guidance.Safety of DEB/DES for PADAll participants who indicated that they personally performperipheral vascular procedures (95.8%) were asked whe-ther they consider the use of drug-eluting devices as safe intheir daily practice. An overwhelming majority ofrespondents (83.7%) replied positively, while 3.4% indi-cated that they do not consider the practice as safe. 12.9%were undecided (see Fig. 3).IRs who do not personally perform peripheral vascularprocedures (4.2%) were asked whether, from availableliterature and practice in their department, they considerthe use of drug-eluting devices as safe. In this group, 77%replied positively, while 23% were undecided; no respon-dent replied negatively.Support for Endovascular PracticeIn the last section of the questionnaire, CIRSE memberswere asked, which tools would help in their dailyendovascular practice. The analysis of open responsesshowed four main clusters: firstly, the need for guidelines,598 95746167020406080100120140160180Device availability Price increase ofdrug-eluting devicesPrice decrease ofdrug-eluting devicesDirectives fromhospitaladministrationregarding the use ofthese devicesOther - please specify No (none of theabove was impacted)Did the controversy around drug-eluting devices (balloons, stents), which started following the meta-analysis by K.Katsanos et al. (EHJ, 2018), impact any of the following at your centre? (select all that apply) (n=307)Fig. 1 Impact of thecontroversy at the hospital levelYes, the use of drug-eluting devices was decreased46%No, there was no impact38%Yes, the use of drug-eluting devices was stopped13%Yes, the use of drug-eluting devices was increased3%Did the above-mentioned controversy around drug-eluting devices (balloons, stents) have an impact on the daily IR practice at your centre? (n=307)Fig. 2 Impact of the controversy on daily IR practice123R. A. Morgan et al.: The Current Use of Drug-Eluting Balloons...standards and specific guidance documents in the field(15.3%); secondly the need for more (long-term) evidenceon these therapies (7.2%); thirdly a request for an updatedCIRSE statement (5.2%), which has been published in themeantime [2]; and fourthly authority approval and/or can-cellation of warnings (2.9%). Finally, 80% of respondentswere aware of the new European Certification forEndovascular Specialists (EBIR-ES), which aims to sup-port IRs as experts in the endovascular field, and 15.3%were already certified.DiscussionThe survey was answered predominantly by IRs who areactive in the field (95.8%), and in 15.3% of cases by EBIR-ES holders. The sample was thus highly specialised andcan be assumed to be knowledgeable about the Paclitaxelsituation. While the CIRSE membership can be consideredto be representative of interventional radiology practice inEurope, a potential selection bias must be acknowledgedfor the present survey, as IRs who work in the endovascularfield were more likely to open and respond to this survey,as were those with strong opinions on the topic.While the benefits of paclitaxel-device use in thefemoropopliteal segment are supported by medium termoutcomes data [2], more evidence on the benefits of drug-eluting stents in treatments below the knee, such as thelong-term data on the PADI trial [4], are needed. Therecent FDA statement concludes that the currently avail-able data do not support an excess mortality risk [3].Similarly, the CIRSE Statement [2] advocates the benefitsof drug coated device use in the absence of a proven risk ofmortality in patients with femoropopliteal disease.The present survey illustrates the disruptive impact thatone meta-analysis can have in a field that had until thenbeen considered to be reasonably well supported by clinicaldata. In retrospect, it is surprising that a single publicationcould disrupt an entire field of medical practice to theextent that the 2018 Katsanos publication did. The worldmedical media reacted to the findings of this one publica-tion by rapidly advertising the published potential mortalityrisk to all vascular practitioners. These headlines wereassimilated by National Government agencies responsiblefor patient safety, and these agencies promoted cessation orsevere restriction of Paclitaxel device use worldwide.Although this might be considered to be an overreaction,particularly in the light of the recent publications from theFDA and CIRSE, it was correct for governments andvascular specialists to be cautious because of the perceivedmortality signal.There are potential ways to prevent a similar situationfrom occurring again in future. As pointed out in severalopen responses in the survey, in a field that is largely basedon industry-driven studies, evidence on long-term data wasabsent in all studies that evaluated Paclitaxel devices.Similarly deficient were independent studies with end-points other than primary patency or target lesion revas-cularisation. In an evolving field such as peripheral arterialdisease intervention, to avoid a similar situation withanother novel device or device class, a more independentand open research culture should be adopted with longerpatient follow-up and less focused endpoints.ConclusionWhile recognising the importance of industry-drivenresearch for the development and availability of medicaldevices globally, the authors make a plea for a more openresearch culture in interventional radiology. Independentscientific research with longer follow-up must be a fun-damental component of endovascular therapies. This wouldbe in the interests of the practitioners who know the ben-efits of these therapies, but ultimately in the interest of allpatients who will benefit from well-researched and safetherapies and devices.Funding This study was not supported by any funding.DeclarationsConflict of interest The authors declare that they have no conflict ofinterest.Ethical Approval This article does not contain any studies withhuman participants performed by any of the authors.Consent for Publication For this type of study consent for publi-cation is not required.Yes84%No3%I am undecided13%In your daily practice, do you consider the use of drug-eluting devices (stents, balloons) as safe? (n=294) Fig. 3 Opinion on safety of drug-eluting devices123R. A. Morgan et al.: The Current Use of Drug-Eluting Balloons...Informed Consent For this type of study informed consent is notrequired.Open Access This article is licensed under a Creative CommonsAttribution 4.0 International License, which permits use, sharing,adaptation, distribution and reproduction in any medium or format, aslong as you give appropriate credit to the original author(s) and thesource, provide a link to the Creative Commons licence, and indicateif changes were made. The images or other third party material in thisarticle are included in the article’s Creative Commons licence, unlessindicated otherwise in a credit line to the material. If material is notincluded in the article’s Creative Commons licence and your intendeduse is not permitted by statutory regulation or exceeds the permitteduse, you will need to obtain permission directly from the copyrightholder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.References1. Konstantinos, K, et al. Risk of death following application ofpaclitaxel-coated balloons and stents in the femoropopliteal arteryof the leg: a systematic review and meta-analysis of randomizedcontrolled trials. J Am Heart Assoc. 2018;7(24):e011245.2. Müller-Hülsbeck S, Fanelli F, Haage P, et al. Re-analysis of olddata and new outcomes data do not support a link betweenpaclitaxel coated balloons and paclitaxel eluting stents andmortality: these devices should be used in PAD (PeripheralArterial Disease) treatment in femoropopliteal disease on the basisof their published efficacy. Cardiovasc Intervent Radiol.2023;46:977–80.3. FDA Letter to Health Care Providers: UPDATE: Paclitaxel-CoatedDevices to Treat Peripheral Arterial Disease Unlikely to Increase Riskof Mortality. July 11, 2023. Accessible via: https://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality4. Konijn LCD, Wakkie T, Spreen MI, et al. 10-Year paclitaxel dose-related outcomes of drug-eluting stents treated below the knee inpatients with chronic limb-threatening ischemia (The PADI Trial).Cardiovasc Intervent Radiol. 2020;43:1881–8.Publisher’s Note Springer Nature remains neutral with regard tojurisdictional claims in published maps and institutional affiliations.123R. A. Morgan et al.: The Current Use of Drug-Eluting Balloons...

The Current Use of Drug-Eluting Balloons and Stents in Peripheral Arterial Disease: An Online Survey by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

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The Current Use of Drug-Eluting Balloons and Stents in Peripheral Arterial Disease: An Online Survey by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

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