Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions-a systematic review and meta-analysis

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Title: Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions-a systematic review and meta-analysis
Authors: Patel, S
Svermova, T
Burke-Gaffney, A
Bogle, RG
Item Type: Journal Article
Abstract: Background: Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents (‘DEB-only’ strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES). Methods: A systematic literature search from January 2000 until May 2017 was conducted. Primary outcome measure, late lumen loss (LLL); and secondary outcomes; binary restenosis, major adverse cardiac events (MACE), target lesion revascularization (TLR), myocardial infarction (MI), cardiovascular death and stent thrombosis were analysed. Results: Seventeen RCTs were included with 2,616 patients. Several comparative groups showed significant differences. DEB with BMS were inferior to DES for LLL [mean difference (MD) =0.12 mm; 95% confidence interval (CI), 0.03 to 0.22; P=0.01]; and binary restenosis [risk ratio (RR) =1.89; (CI, 1.13 to 3.18); P=0.02]. DEB with BMS was superior to BMS for LLL [MD =−0.27 mm; (−0.45 to −0.10); P=0.002]; and MACE [RR =0.64; (0.46 to 0.90); P=0.010]. Finally, DEB alone was superior to POBA for LLL [MD =−0.39 mm; (−0.67 to −0.11); P=0.006] and binary restenosis [RR =0.20; (0.05 to 0.85); P=0.03] in bifurcation lesions. Conclusions: The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone, the combination is inferior to DES for treatment of de novo coronary lesions. Thus, DEB + BMS should not be applied in de novo lesions unless in patients who have absolute contraindications to DES. DEB alone, however, should be considered for relative contraindications to DES such as small vessel disease and bifurcation lesions.
Issue Date: 1-Apr-2018
Date of Acceptance: 28-Sep-2017
URI: http://hdl.handle.net/10044/1/60009
DOI: https://dx.doi.org/10.21037/cdt.2017.10.09
ISSN: 2223-3652
Publisher: AME PUBL CO
Start Page: 121
End Page: 136
Journal / Book Title: CARDIOVASCULAR DIAGNOSIS AND THERAPY
Volume: 8
Issue: 2
Copyright Statement: © 2018 Cardiovascular Diagnosis and Therapy. All rights reserved. This is an open access article.
Keywords: Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Bare-metal stents (BMS)
de novo lesions
drug-eluting balloons (DEB)
drug-eluting stents (DES)
plain-old balloon angioplasty (POBA)
BARE-METAL STENT
ELEVATION MYOCARDIAL-INFARCTION
OPTICAL COHERENCE TOMOGRAPHY
PACLITAXEL-COATED BALLOON
RANDOMIZED MULTICENTER
BIFURCATION LESIONS
CLINICAL-TRIAL
FOLLOW-UP
ANGIOPLASTY
RESTENOSIS
Publication Status: Published
Online Publication Date: 2018-04-01
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine



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