A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions

Gouëffic, Yann; Sauguet, Antoine; Desgranges, Pascal; Feugier, Patrick; Rosset, Eugénio; Ducasse, Éric; Kaladji, Adrien; Mont, Lucie Salomon du; Pernès, J.; Commeau, Philippe; Lermusiaux, Patrick; Leclère, Brice; Guyomarch, Béatrice; Hoffmann, Clément; Maurel, Blandine

doi:10.1016/j.jcin.2019.12.028

Cited by 47 publications

(64 citation statements)

References 23 publications

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“…Our search identified 57 eligible RCTs from 69 articles enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel‐coated balloon vs. bypass surgery; Figure 1). 1,2,16‐82 Other drug eluting stents category included sirolimus/zotarolimus/everolimus eluting stent. Cochrane risk of bias is summarized in Figure S2a, b. Baseline characteristics are shown in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta‐analysis of randomized trials

Kuno

Ueyama

Mikami

et al. 2020

Cathet Cardio Intervent

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Objectives: We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses. Methods: PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization. Results: Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs.

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Section: Resultsmentioning

confidence: 99%

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta‐analysis of randomized trials

Kuno

Ueyama

Mikami

et al. 2020

Cathet Cardio Intervent

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“…Of the 34 studies deemed eligible for quantitative synthesis, 30 studies were multicenter RCTs 18, ; the remaining 4 were single-center trials [55][56][57][58] (Table 1). Twenty-five studies [26][27][28][29][30][31]33,[35][36][37]39,40,[43][44][45][46]48,50,51,[53][54][55][56][57][58] employed a 1:1 randomization process and conducted an intention to treat analysis, and 2 studies 42,52 compared a paclitaxel device to 2 nonpaclitaxel intervention groups implementing 1:1:1 randomization process. A further 6 studies 18,32,38,41,47,49 employed a 2:1 randomization process, and a single study 34 employed a 3:1 randomization process, paclitaxel to control.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

et al. 2021

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Purpose: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group. Materials and Methods: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality. Results: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I2=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I2=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I2=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I2=0%). Conclusion: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population. Systematic Review Registration: CRD42020216140.

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“…We chose Zilver PTX stent (Cook Medical) owing to its superior performance as the first generation drug-eluting stent in peripheral segments compared to conventional bare nitinol stents; however, Zilver PTX stent (Cook Medical) unfortunately failed to show durability superiority in subsequent reports. 5,6 Zeller et al 2 reported a 1-year clinical efficacy of Zilver PTX stent (Cook Medical) in use for in-stent restenosis; however, its efficacy over several years was uncertain. According to the reports, we speculated that it would be difficult to believe that Zilver PTX stent was a main factor for our case to keep patency over several years.…”

Section: Discussionmentioning

confidence: 99%

Possible effect of direct oral anti-coagulant for preventing long stenting lesion from in-stent restenosis in femoropopliteal segment: Case report with angioscopy findings

Tsuchiya

Akita

Oda

et al. 2020

SAGE Open Medical Case Reports

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A 64-year-old female underwent a successful first percutaneous intervention using MISAGO stents for a de novo femoropopliteal lesion. Subsequently, three more effective procedures were done using balloon catheters for in-stent restenosis. In May 2016, a fourth procedure using Zilver PTX stent for in-stent restenosis was carried out. For this final procedure, we added direct oral anti-coagulant as she had additional problem of popliteal vein thrombosis and her femoropopliteal segment remained clear. A Zilver PTX stent, a drug-eluting stent for a peripheral artery, was expected to bring superior outcomes compared to conventional bare nitinol stents (i.e. MISAGO stent). But subsequent studies reported that Zilver PTX stent was not more effective than conventional bare nitinol stents. In our above mentioned case, her angioscopy findings suggest that her successful outcome appears to be related to the added direct oral anti-coagulant.

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A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions

Cited by 47 publications

References 23 publications

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta‐analysis of randomized trials

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta‐analysis of randomized trials

Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Possible effect of direct oral anti-coagulant for preventing long stenting lesion from in-stent restenosis in femoropopliteal segment: Case report with angioscopy findings

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