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

PLOS ONE, Dec 2019

Background 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. 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). 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.

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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. - 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)


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Kongyong Cui, Shuzheng Lyu, Xiantao Song, Fei Yuan, Feng Xu, Min Zhang, Wei Wang, Dongfeng Zhang, Jing Dai. 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, PLOS ONE, 2017, Volume 12, Issue 4, DOI: 10.1371/journal.pone.0176365