Drug-Coated Balloon Versus Drug-Eluting Stent In Patients With De Novo Small Coronary Vessel Lesions: A Systematic Review And Meta-Analysis

Background and Objectives: Drug-coated balloon as a novel therapeutic strategy has been used to treat restenosis in cases of bare metal and drug-eluting stents.However,evidence of its safety and efficacy is scarce in de novo small coronary artery vessel lesions.This meta-analysis aimed to compare the safety and efficacy of the drug-coated balloon and the drug-eluting stent.Methods: The PubMed,EMBASE,Web of Science,Cochrane library,China National Knowledge Infrastructure(CNKI),WanFang and SinoMed databases were searched for studies published up to March-13,2019.Studies comparing the drug-coated balloon with the drug-eluting stent strategy in patients with de novo small coronary artery vessel lesions(reference diameter,< 3 mm)were identified.The clinical outcomes were non-fatal myocardial infarction,cardiac death,all-cause death,target lesion revascularization,and target-vessel revascularization.Data were analyzed using the statistical software RevMan(version 5.3).Fixed effects models were performed to calculate the pooled odds ratios(OR)and 95% confidence intervals(95%CI).Sensitivity analyses were used to detect potential sources of heterogeneity,while subgroup analyses were implemented to assess the differential effects.Results: Three randomized controlled trials and three non-randomized controlled studies were identified.Six studies including a total of 1800 patients compared the differences between the drug-coated balloon and the drug-eluting stent strategies in patients with de novo small coronary artery vessel lesions.The results indicated that the drug-coated balloon strategy was associated with a significant reduction in non-fatal myocardial infarction(OR 0.53,95%CI 0.31-0.90,P=0.02)compared with the drug-eluting stent strategy,while insignificant inter-strategy differences were observed in cardiac death(OR 1.56,95% CI 0.73-3.33,P=0.25),all-cause death(OR 0.56,95% CI 0.25-1.23,P=0.15),target lesion revascularization(OR 1.24,95% CI 0.73-2.1,P=0.43),and target-vessel revascularization(OR 0.95,95% CI 0.59-1.52,P=0.84).Conclusions: This meta-analysis suggests that the drug-coated balloon strategy is non-inferior to the drug-eluting stent strategy,delivering a good outcome in non-fatal myocardial infarction,and can be recommended as an optimal treatment strategy in patients with de novo small coronary artery vessel lesions.Larger randomized controlled studies with longer follow-up periods are needed to further confirm the benefits of the drug-coated balloon strategy.