Drug-Eluting Balloons for De Novo Coronary Artery Disease: A Meta-Analysis of Angiographic and Clinical Data

作者：Zhang, Tuo; Sun, Shiqun; Shen, Linghong; He, Ben^*

来源：Catheterization and Cardiovascular Interventions, 2013, 82(7): 1021-1030.

DOI：10.1002/ccd.25022

• drug-eluting balloon
• percutaneous coronary intervention
• de novo coronary artery disease

Objectives: To evaluate the effectiveness of drug-eluting balloons (DEBs) in the treatment of de novo coronary artery disease by performing a meta-analysis of randomized controlled trials (RCTs). Backgrounds: Current evidence regarding the success of DEBs is insufficient to formulate formal recommendations. Methods: Seven RCTs were ultimately included. The primary angiographic endpoint was in-segment diameter stenosis, compared by measuring weighted mean difference (WMD). The primary clinical endpoint was incidence of major adverse cardiovascular events (MACEs) during a 1-year follow-up, compared by measuring pooled risk ratio (RR). Results: For de novo native coronary lesions intervention, DEB plus bare metal stent (BMS) was not superior to BMS alone in both primary angiographic and clinical endpoints (in-segment diameter stenosis: WMD, 22.59% [95% confidence interval (CI): -9.13% to 3.94%]; MACEs: RR, 0.83 [95% CI: 0.48-1.46]), and DEB with/without BMS was associated with worse outcomes when compared with DES alone (in-segment diameter stenosis: WMD, 10.64% [95% CI: 2.41-18.87%]; MACEs: RR, 1.54 [95% CI: 0.91-2.61]). Subgroup analysis showed that DEB plus BMS significantly increased the risk of MACEs for simple de novo coronary lesions intervention when compared with DES alone (RR, 1.87 [95% CI: 1.33-2.63]). Conclusions: Current data does not support the use of DEBs for de novo coronary lesions, especially for simple coronary lesions.

• 出版日期2013-12-1
• 单位上海交通大学