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. 2018 Apr;8(2):121-136.
doi: 10.21037/cdt.2017.10.09.

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

Smit Patel  1 , Tatiana Svermova  1 , Anne Burke-Gaffney  1 , Richard G Bogle  2
Affiliations

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

Smit Patel et al. Cardiovasc Diagn Ther. 2018 Apr.

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.

Keywords: Bare-metal stents (BMS); de novo lesions; drug-eluting balloons (DEB); drug-eluting stents (DES); plain-old balloon angioplasty (POBA).

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Conflict of interest statement

Conflicts of Interest: The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Study selection process. EPC, endothelial progenitor cell-capturing stent.
Figure 2
Figure 2
Forest plot of mean differences for late lumen loss. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; POBA, plain-old balloon angioplasty.
Figure 3
Figure 3
Forest plot of risk ratios (RR) for binary restenosis. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; POBA, plain-old balloon angioplasty.
Figure 4
Figure 4
Forest plot of risk ratios (RR) for TLR. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; POBA, plain-old balloon angioplasty; TLR, target lesion revascularization.
Figure 5
Figure 5
Forest plot of risk ratios (RR) for MACE. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; MACE, major adverse cardiac events; POBA, plain-old balloon angioplasty.
Figure 6
Figure 6
Forest plot of risk ratios (RR) for MI. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; MI, myocardial infarction; POBA, plain-old balloon angioplasty.
Figure 7
Figure 7
Forest plot of risk ratios (RR) for death. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; POBA, plain-old balloon angioplasty.
Figure 8
Figure 8
Forest plot of risk ratios (RR) for stent thrombosis. BMS, bare-metal stents; CI, confidence interval; DEB, drug-eluting balloons; DES, drug-eluting stents; POBA, plain-old balloon angioplasty.
Figure 9
Figure 9
Funnel plot for publication bias using the primary angiographic endpoint of late lumen loss.
See this image and copyright information in PMC

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