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Published in: BMC Cardiovascular Disorders 1/2020

Open Access 01-12-2020 | Arterial Occlusive Disease | Research article

Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis

Authors: Hai Feng, Xueming Chen, Xiaobo Guo, Zhe Zhang, Zhiwen Zhang, Bin Liu, Lishan Lian

Published in: BMC Cardiovascular Disorders | Issue 1/2020

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Abstract

Background

This quantitative meta-analysis was conducted to evaluate the efficacy and safety of drug-eluting balloon (DEB) vs. uncoated balloon (UCB) in patients with femoropopliteal arterial occlusive disease.

Methods

Electronic databases were searched to identify randomized controlled trials (RCTs) that compared DEB and UCB till November 2018. The random-effects model was used for conducting pooled analyses.

Results

Seventeen RCTs with 2706 patients were included in the final meta-analysis. Patients who received DEB had higher levels of minimal luminal diameter (MLD) at 6 (WMD: 0.77; 95%CI: 0.53 to 1.02; P < 0.001) and 12 months (WMD: 1.33; 95%CI: 0.93 to 1.73; P < 0.001) than those who received UCB. DEB reduced the late lumen loss (LLL) levels after 6 (WMD: -0.57; 95%CI: − 1.07 to − 0.06; P = 0.029) and 12 months (WMD: -0.95; 95%CI: − 1.28 to − 0.62; P < 0.001). DEB was found not superior over UCB on primary patency after 6 months (RR: 1.44; 95%CI: 0.88–2.35; P = 0.149), whereas DEB increased the primary patency after 12 (RR: 1.51; 95%CI: 1.25–1.83; P < 0.001) and 24 months (RR: 1.51; 95%CI: 1.30–1.77; P < 0.001). Patients who received DEB had reduced the risk of restenosis after 6 (RR: 0.47; 95%CI: 0.33–0.67; P < 0.001) and 12 months (RR: 0.55; 95%CI: 0.35–0.85; P = 0.008). DEB reduced the risk of major adverse events after 6 (RR: 0.30; 95%CI: 0.14–0.61; P = 0.001), 12 (RR: 0.49; 95%CI: 0.32–0.76; P = 0.001) and 24 months (RR: 0.62; 95%CI: 0.41–0.92; P = 0.018).

Conclusions

DEB yielded additional benefits on MLD, LLL, primary patency, restenosis, TLR, and major adverse events than UCB in patients with femoropopliteal arterial occlusive disease.
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Literature
8.
go back to reference Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.CrossRefPubMed Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.CrossRefPubMed
9.
11.
go back to reference Deeks JJ, Higgins JPT, Altman DG. Analyzing data and undertaking meta-analyses. In: Higgins JP, Green S, editors. Cochrane handbook for systematic reviews of interventions 501. edn. Oxford: The Cochrane Collaboration; 2008. Deeks JJ, Higgins JPT, Altman DG. Analyzing data and undertaking meta-analyses. In: Higgins JP, Green S, editors. Cochrane handbook for systematic reviews of interventions 501. edn. Oxford: The Cochrane Collaboration; 2008.
13.
go back to reference Tobias A. Assessing the influence of a single study in meta-analysis. Stata Tech Bull. 1999;47:15–7. Tobias A. Assessing the influence of a single study in meta-analysis. Stata Tech Bull. 1999;47:15–7.
16.
go back to reference Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994;50:1088–101.CrossRefPubMed Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994;50:1088–101.CrossRefPubMed
19.
go back to reference Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8:1614–22. https://doi.org/10.1016/j.jcin.2015.07.011.CrossRefPubMed Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8:1614–22. https://​doi.​org/​10.​1016/​j.​jcin.​2015.​07.​011.CrossRefPubMed
21.
24.
go back to reference Schroeder H, Werner M, Meyer DR, Reimer P, Kruger K, Jaff MR, et al. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation. 2017;135:2227–36. https://doi.org/10.1161/circulationaha.116.026493.CrossRefPubMedPubMedCentral Schroeder H, Werner M, Meyer DR, Reimer P, Kruger K, Jaff MR, et al. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation. 2017;135:2227–36. https://​doi.​org/​10.​1161/​circulationaha.​116.​026493.CrossRefPubMedPubMedCentral
28.
go back to reference Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7:10–9. https://doi.org/10.1016/j.jcin.2013.05.022.CrossRefPubMed Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7:10–9. https://​doi.​org/​10.​1016/​j.​jcin.​2013.​05.​022.CrossRefPubMed
31.
Metadata
Title
Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis
Authors
Hai Feng
Xueming Chen
Xiaobo Guo
Zhe Zhang
Zhiwen Zhang
Bin Liu
Lishan Lian
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2020
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-020-01667-y

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