Comparing efficacy of drug-coated balloon-only approach and stent approach in treating de novo coronary artery lesions: A meta-analysis of randomized controlled trials. A protocol for systematic review and meta-analysis

BACKGROUND: Drug-coated balloons (DCB) have been a novel alternative therapeutic strategy in de novo coronary artery diseases. However, the clinical feasibility of the DCB-only approach in treating small vessel disease remains controversial, while study aimed to assess the efficacy and safety of the DCB-only approach versus stent approaches in treating large vessel disease is limited. METHODS: From February 2020 to May 2020, we will search Cochrane Library, PubMed, EMBASE, ScienceDirect, Scopus, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, and Chongqing VIP Database for eligible trials comparing DCB with drug-eluting stents for treatment of de novo lesions in both small vessel disease and large vessel disease. The primary endpoint is major adverse cardiac events (MACE); the secondary endpoints include in-lesion late lumen loss, binary restenosis, myocardial infarction, target lesion revascularization (TLR), mortality and target vessel thrombosis. Meta-analysis will be conducted using Review Manager software (V.5.3). RESULTS: The results will be presented as risk ratios for dichotomous data, and weighted mean differences for continuous data. CONCLUSION: We will assess outcomes of the DCB-only approach in the treatment of de novo lesions compared with the stent approach. PROSPERO REGISTRATION NUMBER: CRD42020164484.