Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

Nordanstig, Joakim; James, Stefan; Andersson, Manne; Andersson, Mattias K.; Danielsson, Peter; Gillgren, Peter; Delle, Martin; Engström, Jan; Fransson, Torbjörn; Hamoud, Maher; Hilbertson, Anna; Johansson, Pernilla; Karlsson, Lars; Kragsterman, Björn; Lindgren, Hans; Ludwigs, Karin; Mellander, Stefan; Nyman, Niklas; Renlund, Henrik; Sigvant, Birgitta; Skoog, Per; Starck, Joachim; Tegler, Gustaf; Toivola, Asko; Truedson, Maria; Wahlgren, Carl Magnus; Wallinder, Jonas; Öjersjö, Andreas; Falkenberg, Mårten

doi:10.1056/nejmoa2005206

Cited by 153 publications

(84 citation statements)

References 25 publications

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“…This association was later confirmed in a patient-level meta-analysis and a separate meta-analysis concerning amputation-free survival after below-the-knee treatment [2,3]. During this ongoing controversy, multiple studies that used either real-world data from large administrative and clinical registries [4][5][6][7][8][9] or interim analyses from a large RCT [10] were not able to replicate this unsettling safety signal. Strikingly, analyses using observational datasets found an opposite signal, with improved survival in patients exposed to paclitaxel when compared with those not exposed [5,6].…”

Section: Introductionmentioning

confidence: 99%

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study

Behrendt

Sedrakyan

Κατσάνος

et al. 2021

JCM

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Background: Randomized controlled trials have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, while observational studies have reported the opposite. This study aims to determine the underlying factors and cohort differences that may explain these opposite results, with specific focus on sex differences in treatment and outcomes. Methods: Multicenter health insurance claims data from a large insurance fund, BARMER, were studied. A homogeneous sample of patients with an index of endovascular revascularization for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. Adjusted logistic regression and Cox regression models were used to determine the factors predicting allocation to paclitaxel-coated devices and sex-specific 5-year all-cause mortality, respectively. Results: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years. Females were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with males. Mortality differences were mostly attributable to the female subgroup who were revascularized above the knee (hazard ratio, HR 0.78, 95% CI: 0.64–0.95), while no statistically significant differences were observed in males. Conclusions: This study found that females treated above the knee benefited from paclitaxel-coated devices, while no differences were found in males. Ongoing and future registries and trials should take sex disparities into account.

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Section: Introductionmentioning

confidence: 99%

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study

Behrendt

Sedrakyan

Κατσάνος

et al. 2021

JCM

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“… 13 A randomized controlled trial of paclitaxel-coated devices and a meta-analysis of their use in AV graft access showed no differences in mortality. 14 , 15 More clinical studies are needed to confirm the effects and safety of the use of FP-PESs.…”

Section: Discussionmentioning

confidence: 99%

Use of a fluoropolymer-based paclitaxel-eluting stent for arteriovenous graft outflow vein stenosis in hemodialysis patients

Matsuoka

Iida

Suemitsu

et al. 2021

Journal of Vascular Surgery Cases, Innovations and Techniques

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We implanted a fluoropolymer-based paclitaxel-eluting stent (FP-PES) in four hemodialysis patients with refractory outflow venous stenosis of their arteriovenous graft. The mean observation period after FP-PES implantation was 11.5 6 4.7 months (range, 7.0-18.0 months). After FP-PES implantation, the patients were evaluated by ultrasound every 3 months. No of the patients experienced neointimal hyperplasia in the stents during the observation period, and no reintervention was performed. FP-PESs could be an attractive alternative to percutaneous transluminal angioplasty for patients with refractory outflow venous stenosis of arteriovenous hemodialysis grafts.

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“…All identified studies relied on the high-quality level of clinical evidence to inform the respective economic evaluations of DCBs and DESs in PAD, but the quality of reporting in these economic evaluation studies was low. Nevertheless, it is worth mentioning the argument that currently exists about the safety of these devices: the divergent analyses conducted by Katsanos et al and Nordanstig et al merit consideration (11;27). It could be that the apparent increased mortality associated with these devices is actually connected to confounding factors unrelated to paclitaxel.…”

Section: Discussionmentioning

confidence: 99%

Quality of economic evaluations of drug-coated balloons and drug-eluting stents in peripheral artery disease: a systematic review

Etangsale

Nunno

Pineau

et al. 2021

Int J Technol Assess Health Care

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Objective We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings. Methods A systematic review was performed using four electronic databases to identify health economic evaluation studies reporting on the use of DCBs and DESs in PAD. The methodological and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists. Results Six articles were included in this review of the 1,728 publications identified. Four studies were cost-effectiveness analyses and two cost–utility analyses. According to the Cooper hierarchy scale, the studies used good-quality data sources. The level of evidence used for clinical effect sizes, safety data, baseline clinical data, and costs was of high quality in general. In contrast, an evaluation of the reporting quality suggested that essential information was lacking. Conclusion The present study demonstrates that clinical data used in economic evaluations of DCBs and DESs in PAD are from clinical studies of high quality in general. However, the quality of reporting represents a concern when interpreting the results provided by these economic studies.

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Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

Cited by 153 publications

References 25 publications

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study

Use of a fluoropolymer-based paclitaxel-eluting stent for arteriovenous graft outflow vein stenosis in hemodialysis patients

Quality of economic evaluations of drug-coated balloons and drug-eluting stents in peripheral artery disease: a systematic review

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