Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained                    Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized                    EffPac Trial

Teichgräber, Ulf; Lehmann, Thomas; Aschenbach, René; Scheinert, Dierk; Zeller, Thomas; Brechtel, Klaus; Blessing, Erwin; Lichtenberg, Michael; Flotow, Peter von; Heilmeier, Britta; Sixt, Sebastian; Brucks, Steffen; Erbel, Christian; Beschorner, Ulrich; Werk, Michael; Riambau, Vicenç; Wienke, Andreas; Klumb, Christof; Thieme, Markus

doi:10.1148/radiol.2020191619

Cited by 30 publications

(20 citation statements)

References 16 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%

“…Twenty-seven studies 18,26,27,[29][30][31]34,[36][37][38][39][40][41][44][45][46][47][48][49][50][51][52][53][54][55]57,58 used paclitaxel-coated balloons. One study used a suboptimal design intentionally combining paclitaxel-coated balloons and stents, 43 and the remaining 6 studies 28,32,33,35,42,56 used paclitaxel eluting stents (Table 1).…”

Section: Device and Interventionmentioning

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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“…Results from the long lesion-and ISR subgroups were slightly worse. In comparison, earlier RCTs on femoropopliteal DCB angioplasty reported 24-month all-cause mortality and incidence of major amputation of 1-13% and 0-6%, respectively [1,4]. Thus, BIOLUX P-III safety outcomes were at upper end of range, probably attributed to advanced disease and comorbidities.…”

mentioning

confidence: 82%

“…Previous RCTs reported on 24-month primary patency of 57-90%, and on freedom from TLR of 64-97% after femoropopliteal DCB angioplasty [1,4]. However, in most cases, study populations differed considerably from the BIOLUX P-III registry, particularly regarding the share of CLI participants, and thus, direct comparison is not appropriate.…”

mentioning

confidence: 99%

Paclitaxel-Coated Balloon Angioplasty in the Real World: Jack-of-all-Trades?

Teichgräber

2020

Cardiovasc Intervent Radiol

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Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial

Cited by 30 publications

References 16 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

Paclitaxel-Coated Balloon Angioplasty in the Real World: Jack-of-all-Trades?

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