Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlu
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RESEARCH ARTICLE
Open Access
Comparison of efficacy and safety of drugeluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis Hai Feng* , Xueming Chen, Xiaobo Guo, Zhe Zhang, Zhiwen Zhang, Bin Liu and Lishan Lian
Abstract Background: This quantitative meta-analysis was conducted to evaluate the efficacy and safety of drug-eluting balloon (DEB) vs. uncoated balloon (UCB) in patients with femoropopliteal arterial occlusive disease. Methods: Electronic databases were searched to identify randomized controlled trials (RCTs) that compared DEB and UCB till November 2018. The random-effects model was used for conducting pooled analyses. Results: Seventeen RCTs with 2706 patients were included in the final meta-analysis. Patients who received DEB had higher levels of minimal luminal diameter (MLD) at 6 (WMD: 0.77; 95%CI: 0.53 to 1.02; P < 0.001) and 12 months (WMD: 1.33; 95%CI: 0.93 to 1.73; P < 0.001) than those who received UCB. DEB reduced the late lumen loss (LLL) levels after 6 (WMD: -0.57; 95%CI: − 1.07 to − 0.06; P = 0.029) and 12 months (WMD: -0.95; 95%CI: − 1.28 to − 0.62; P < 0.001). DEB was found not superior over UCB on primary patency after 6 months (RR: 1.44; 95%CI: 0.88–2.35; P = 0.149), whereas DEB increased the primary patency after 12 (RR: 1.51; 95%CI: 1.25–1.83; P < 0.001) and 24 months (RR: 1.51; 95%CI: 1.30–1.77; P < 0.001). Patients who received DEB had reduced the risk of restenosis after 6 (RR: 0.47; 95%CI: 0.33–0.67; P < 0.001) and 12 months (RR: 0.55; 95%CI: 0.35–0.85; P = 0.008). DEB reduced the risk of major adverse events after 6 (RR: 0.30; 95%CI: 0.14–0.61; P = 0.001), 12 (RR: 0.49; 95%CI: 0.32–0.76; P = 0.001) and 24 months (RR: 0.62; 95%CI: 0.41–0.92; P = 0.018). Conclusions: DEB yielded additional benefits on MLD, LLL, primary patency, restenosis, TLR, and major adverse events than UCB in patients with femoropopliteal arterial occlusive disease. Keywords: Drug-eluting balloon angioplasty, Uncoated balloon angioplasty, Femoropopliteal arterial occlusive disease, Meta-analysis, Randomized controlled trials
Background Peripheral artery disease (PAD) is predominantly caused by atherosclerosis and manifested as an obstructive disease of major arteries. It always occurs in lower extremities, causing significant disability, limb loss, and mortality, especially in elderly population [1]. According * Correspondence: [email protected] Department of Vascular Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
to a study, there are more than 200 million individuals affected by PAD and is considered as a serious global health problem [2]. The common type of PAD is femoropopliteal arterial occlusive disease, and is mainly managed by intermittent claudication and severe limb ischemia, lowering the quality of life of patients [3]. Currently, the treatment strategies for PAD included surgical approaches, conservative treatments, exercise training, or endovascular techniques, and these
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