FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3134653135> ?p ?o ?g. }

• W3134653135 endingPage "84" @default.
• W3134653135 startingPage "83" @default.
• W3134653135 abstract "Free AccessThe paclitaxel files – reasonable doubt or acquittal?Comment on Böhme et al., pp. 132–138Christian-Alexander Behrendt and Frederik PetersChristian-Alexander Behrendt Department of Vascular Medicine, Research Group GermanVasc, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Search for more papers by this author and Frederik Peters Department of Vascular Medicine, Research Group GermanVasc, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Search for more papers by this authorPublished Online:February 28, 2021https://doi.org/10.1024/0301-1526/a000912PDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinkedInReddit SectionsMoreCurrently, we are all living in dire straits not only because a global pandemic threw the world into turmoil. There is evidence for collateral damage particularly affecting patients with cardiovascular and cerebrovascular conditions [1]. Certainly, another major health problem affected the same target population, and most of us might have forgotten that two sensational meta-analyses recently initiated a heated discussion among physicians treating patients with peripheral artery disease [2, 3].In 2018 and 2020, Katsanos et al. used summary-level data from randomized controlled trials (RCT) and revealed worse overall survival and amputation-free survival in patients exposed to paclitaxel-coated devices in femoropopliteal and crural arteries, respectively [4, 5]. Since then, although hidden behind the Covid-19 pandemic, the paclitaxel controversy is still ongoing and the end is not yet in sight. Interestingly, in a follow-up meta-analysis using patient-level data on 2,185 patients, the authors confirmed the safety signal, which was not the case in other recent studies [6–8]. Adding to the notably conflicting knowledge base, Böhme et al. now presented new evidence on the matter using data from a large consecutive cohort from a renowned high-volume centre in Germany [9]. Among 8,377 patients that have been treated at the study centre between 2010 and 2016, 624 patients with femoropopliteal lesions were included in the study and subsequently followed for 36 months. In their analyses, the authors found no evidence for a survival disadvantage of patients exposed to paclitaxel-coated balloons when compared to uncoated balloons neither in the full sample nor when taking cumulative paclitaxel dose into account [9]. Within the study period, a staggering 66% of all patients died with carcinoma as most common cause confirming the relevance of cancer in these patients [10]. These findings represent crucial new information for a particularly interesting and high-risk population. While RCTs typically included patients with milder disease severity, younger age and predominantly male sex, the current study focussed on older patients with critical limb ischaemia (Rutherford 5) and exhibited a well-balanced sex ratio. It appears also of great benefit to use data from a single center whereas meta-analyses often draw their conclusions from heterogenous cohorts. Having that said, the central question is how cohorts in RCTs vs. real-world cohorts differ. Yet, in this study patients exposed to paclitaxel were younger and potentially suffered more often from chronic comorbidities compared to unexposed patients. The slightly higher rates of relevant post-discharge medication, especially regarding lipid-lowering drugs, may also point at general differentials in treatment among the study groups. In light of the various cautions from regulators worldwide, these results and conclusions appear heartening. Remarkably enough, to date, no single real-world study using a registry or administrative data was able to confirm the association of paclitaxel usage and increased overall mortality. If anything, there are large-scale observational studies using weighting methods and propensity score matching to adjust for confounding that revealed no mortality differences or even improved overall survival in patients exposed to paclitaxel-coated devices [11–14]. Against that backdrop, it has to be emphasized that data from unselected registries are commonly-accepted to be the first choice for quality assurance, most importantly for rare and late (safety) outcomes, while RCTs remain the gold standard in causal research and clinical efficacy.However, even the strongest proponent of real-world evidence must admit that the challenge of residual confounding remains unsolved to date. The patient populations likely differ across RCT and real-world data. Moreover, patients suffering from peripheral artery disease often exhibit complex comorbidities and numerous succeeding treatments in different vascular beds. Therefore, marginal differences in the inclusion and exclusion criteria, variable selection, and statistical models likely have a significant impact on the results. However, even RCTs are not beyond reproach, and secondary analysis of data from a RCT might be potentially less valid if it was not sufficiently powered from the beginning [15].Having that said, is the current study by Böhme et al. just another brick in the great wall of evidence or should the cardiovascular community finally close the case? In May 2021, after a transition phase of three years, the new European Union Medical Device Regulation (MDR) will come into force. Regulators, notified bodies, and medical device industry will have to find a consensual agreement how they can handle emerging device-related health problems in the future to guide physicians through the best possible care of patients receiving implantable devices. Global public-private partnerships such as the Medical Device Epidemiology Network (MDEpiNet) with international chapters in five countries can help to connect all stakeholders in a certain framework and implement a graduated model of approval.While focusing intensively on potential benefits or harms of drug coating with still insufficient evidence for either of the two, we learned an important general lesson in this innovative field. In the face of the dramatically impaired life expectancy of vascular patients at an advanced disease stage, research on factors affecting long-term survival should definitively receive a much higher priority.References1 Seiffert M, Brunner FJ, Remmel M, Thomalla G, Marschall U, L’Hoest H, et al. Temporal trends in the presentation of cardiovascular and cerebrovascular emergencies during the COVID-19 pandemic in Germany – An analysis of health insurance claims. Clin Res Cardiol. 2020;109:1540–8. First citation in articleCrossref Medline, Google Scholar2 Mills JL, Conte MS, Murad MH. Critical review and evidence implications of paclitaxel drug-eluting balloons and stents in peripheral artery disease. J Vasc Surg. 2019;70:3–7. First citation in articleCrossref Medline, Google Scholar3 Zeller T, Noory E, Beschorner U, Böhme T, Reijnen MMPJ. Outstanding effectiveness of paclitaxel-based technologies for the treatment of femoropopliteal artery occlusive disease on the potential expense of increased late all-cause mortality? No reason to panic. VASA. 2019;48:109–11. First citation in articleLink, Google Scholar4 Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. JAHA. 2018;7:e011245. First citation in articleCrossref, Google Scholar5 Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Paraskevopoulos I, Karnabatidis D. Risk of death and amputation with use of paclitaxel-coated balloons in the infrapopliteal arteries for treatment of critical limb ischemia: a systematic review and meta-analysis of randomized controlled trials. J Vasc Interv Radiol. 2020;31:202–12. First citation in articleCrossref Medline, Google Scholar6 Rocha-Singh KJ, Duval S, Jaff MR, Schneider PA, Ansel GM, Lyden SP, et al. Mortality and paclitaxel-coated devices. Circulation. 2020;141:1859–69. First citation in articleCrossref Medline, Google Scholar7 Dinh K, Gomes ML, Thomas SD, Paravastu SCV, Holden A, Schneider PA, et al. Mortality after paclitaxel-coated device use in patients with chronic limb-threatening ischemia: a systematic review and meta-analysis of randomized controlled trials. Journal of Endovascular Therapy. 2020;27:17585. First citation in articleCrossref, Google Scholar8 Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, et al. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. Journal of the American College of Cardiology. 2019;73:2550–63. First citation in articleCrossref Medline, Google Scholar9 Böhme T, Noory E, Beschorner U, Jacques B, Bürgelin K, Macharzina R, et al. Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience. VASA. 2021;50:132–138. First citation in articleAbstract, Google Scholar10 Kaschwich M, Peters F, Hischke S, Rieß HC, Gansel M, Marschall U, et al. Long-term incidence of cancer after index treatment for symptomatic peripheral arterial occlusive disease – A health insurance claims data analysis. VASA. 2020;49:493–9. First citation in articleLink, Google Scholar11 Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA, et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol. 2019;4:332–40. First citation in articleCrossref Medline, Google Scholar12 Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, et al. Editor’s Choice - long term survival after femoropopliteal artery revascularizations with paclitaxel-coated devices – a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg. 2020;59:587–96. First citation in articleCrossref Medline, Google Scholar13 Heidemann F, Peters F, Kuchenbecker J, Kreutzburg T, Sedrakyan A, Marschall U, et al. Long-term outcomes after revascularizations below the knee with paclitaxel-coated devices – a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg. 2020;60:549–58. First citation in articleCrossref Medline, Google Scholar14 Saratzis A, Lea T, Yap T, Batchelder A, Thomson B, Saha P, et al. Paclitaxel and mortality following peripheral angioplasty: an adjusted and case matched multicentre analysis. Eur J Vasc Endovasc Surg. 2020;60:220–29. First citation in articleCrossref Medline, Google Scholar15 Behrendt CA, Peters F, Mani K, The swinging pendulum of evidence – Is there a reality behind results from randomized trials and real-world data? Lessons learned from the Paclitaxel debate. Eur J Vasc Endovasc Surg. 2020;59:510–1. First citation in articleCrossref Medline, Google ScholarPriv.-Doz. Dr. Christian-Alexander Behrendt, Department of Vascular Medicine, Research Group GermanVasc, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany, E-mail behrendt@hamburg.deFiguresReferencesRelatedDetails Volume 50Issue 2February 2021ISSN: 0301-1526eISSN: 1664-2872 InformationVasa (2021), 50, pp. 83-84 https://doi.org/10.1024/0301-1526/a000912.© 2021Hogrefe AGPDF download" @default.
• W3134653135 created "2021-03-15" @default.
• W3134653135 creator A5024377668 @default.
• W3134653135 creator A5046476456 @default.
• W3134653135 date "2021-02-01" @default.
• W3134653135 modified "2023-09-26" @default.
• W3134653135 title "The paclitaxel files – reasonable doubt or acquittal?" @default.
• W3134653135 cites W2903350476 @default.
• W3134653135 cites W2913667111 @default.
• W3134653135 cites W2918193220 @default.
• W3134653135 cites W2946328497 @default.
• W3134653135 cites W2952858284 @default.
• W3134653135 cites W3000556138 @default.
• W3134653135 cites W3008031432 @default.
• W3134653135 cites W3008589133 @default.
• W3134653135 cites W3015601156 @default.
• W3134653135 cites W3022552345 @default.
• W3134653135 cites W3023289929 @default.
• W3134653135 cites W3047345853 @default.
• W3134653135 cites W3049227642 @default.
• W3134653135 cites W3074556163 @default.
• W3134653135 cites W3095143313 @default.
• W3134653135 doi "https://doi.org/10.1024/0301-1526/a000912" @default.
• W3134653135 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/33645235" @default.
• W3134653135 hasPublicationYear "2021" @default.
• W3134653135 type Work @default.
• W3134653135 sameAs 3134653135 @default.
• W3134653135 citedByCount "0" @default.
• W3134653135 crossrefType "journal-article" @default.
• W3134653135 hasAuthorship W3134653135A5024377668 @default.
• W3134653135 hasAuthorship W3134653135A5046476456 @default.
• W3134653135 hasConcept C126322002 @default.
• W3134653135 hasConcept C17744445 @default.
• W3134653135 hasConcept C199539241 @default.
• W3134653135 hasConcept C2776694085 @default.
• W3134653135 hasConcept C2777292972 @default.
• W3134653135 hasConcept C2777710833 @default.
• W3134653135 hasConcept C71924100 @default.
• W3134653135 hasConceptScore W3134653135C126322002 @default.
• W3134653135 hasConceptScore W3134653135C17744445 @default.
• W3134653135 hasConceptScore W3134653135C199539241 @default.
• W3134653135 hasConceptScore W3134653135C2776694085 @default.
• W3134653135 hasConceptScore W3134653135C2777292972 @default.
• W3134653135 hasConceptScore W3134653135C2777710833 @default.
• W3134653135 hasConceptScore W3134653135C71924100 @default.
• W3134653135 hasIssue "2" @default.
• W3134653135 hasLocation W31346531351 @default.
• W3134653135 hasOpenAccess W3134653135 @default.
• W3134653135 hasPrimaryLocation W31346531351 @default.
• W3134653135 hasRelatedWork W1565879769 @default.
• W3134653135 hasRelatedWork W2046402906 @default.
• W3134653135 hasRelatedWork W2147610643 @default.
• W3134653135 hasRelatedWork W3101350942 @default.
• W3134653135 hasRelatedWork W3115349922 @default.
• W3134653135 hasRelatedWork W3167407721 @default.
• W3134653135 hasRelatedWork W4256655821 @default.
• W3134653135 hasRelatedWork W832122363 @default.
• W3134653135 hasRelatedWork W1953290398 @default.
• W3134653135 hasRelatedWork W2899150863 @default.
• W3134653135 hasVolume "50" @default.
• W3134653135 isParatext "false" @default.
• W3134653135 isRetracted "false" @default.
• W3134653135 magId "3134653135" @default.
• W3134653135 workType "article" @default.