Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials
April
Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta- analysis of 14 randomized controlled trials
Kongyong Cui 0 1
Shuzheng Lyu 0 1
Xiantao Song 0 1
Fei Yuan 0 1
Feng Xu 0 1
Min Zhang 0 1
Wei Wang 0 1
Dongfeng Zhang 0 1
Jing Dai 0 1
0 Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University and Beijing Institute of Heart, Lung and Blood Vessel Diseases , Beijing , China
1 Editor: Raffaele Bugiardini, University of Bologna , ITALY
Drug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.
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Data Availability Statement: All relevant data are
within the paper and its Supporting Information
files.
Funding: This study is supported by ``Twelve Five''
National Key Technology R&D Program of China
(Grant No. 2011BAI11B05) (http://www.most.gov.
cn/eng/programmes1/200610/t20061009_36224.
htm). The funders had no role in study design, data
collection and analysis, decision to publish, or
preparation of the manuscript.
Background
Methods
Randomized controlled trials (RCTs) assessing the efficacy of DEB+BMS in comparison
with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library
databases through January 2016. Primary endpoints were major adverse cardiac events
(MACEs) and late lumen loss (LLL). Secondary endpoints included death, myocardial
infarction (MI), target lesion revascularization (TLR), stent thrombosis (ST), binary restenosis,
and minimum lumen diameter (MLD). Dichotomous and continuous data were presented as
odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs),
respectively, and analyzed using a random-effects model.
Results
A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS
showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04) and reduced LLL
(MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS. Meanwhile,
treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%
CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003),
TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and MLD (MD: -0.25 mm, 95%CI: -0.42
mm to -0.09 mm, P = 0.003).
Competing interests: The authors have declared that no competing interests exist.
Conclusions
This limited evidence demonstrated that treatment with DEB+BMS appears to be effective
in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to
DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation
DES) should be recommended for patients with de novo CAD.
Introduction
First-generation drug-eluting stents (DESs) reduce restenosis after percutaneous coronary
intervention (PCI) by preventing vessel wall recoil and late negative remodeling, as well as
restraining neointimal hyperplasia [
1,2
]. However, they are associated with many potential
serious complications such as late stent thrombosis, non-homogenous drug delivery,
and delayed vascularization, which makes bare-mental stent (BMS) preferred with shorter
dual antiplatelet therapy in patients at high bleeding risk [
3,4
]. Recently, network
metaanalyses has demonstrated new generation DES was associated with significantly lower
rates of stent thrombosis in comparison to BMS [
5,6
]. Furthermore, randomized controlled
trials (RCTs) with new generation DES have shown lower rate of stent thrombosis and
similar risk of bleeding compared with BMS in patients with contraindications to
first-generation DES [
7,8
]. Obviously, new generation DES might be an appropriate choice for the
treatment of de novo coronary disease among patients at high risk of bleeding or
thrombosis.
Local drug delivery by drug-eluting balloon (DEB) has emerged as an effective and safe
treatment option for in-stent restenosis (ISR) in both BMS [
9
] and DES [
10,11
], delivering
active drugs homogeneously to inhibit neointimal hyperplasia without remaining in the
arteries permanently. To date, DEB is considered an important method for treating
BMS-ISR and DES-ISR in the updated European Society of Cardiology guidelines with a
class I recommendation (level of evidence A) [12]. Furthermore, DEB can also deliver
drugs to de novo coronary lesions. Indeed, it is usually used in combination with BMS,
especially for lesions without local flow-limiting vessel dissections and high-grade elastic
recoil. Although previous meta-analyses demonstrated that DEB+BMS was not superior to
BMS, while DEB with/without BMS tended to be inferior to DES without statistical
differences, the effec (...truncated)