BMC cardiovascular disorders · 2020
Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis.
СтатьяМетаанализСистематический обзорНазвание и аннотация: Перевод пока не подготовлен
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Feng Hai, Chen Xueming, Guo Xiaobo, Zhang Zhe, Zhang Zhiwen, Liu Bin, Lian Lishan
Аннотация
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.
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.