Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions-a systematic review and meta-analysis
File(s)
Published version
Author(s)
Patel, Smit
Svermova, Tatiana
Burke-Gaffney, Anne
Bogle, Richard G
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.
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.
Date Issued
2018-04-01
Date Acceptance
2017-09-28
Citation
CARDIOVASCULAR DIAGNOSIS AND THERAPY, 2018, 8 (2), pp.121-136
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.
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000430370000001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
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
Date Publish Online
2018-04-01