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Drug‐eluting balloons for De Novo coronary artery disease
Author(s) -
Zhang Tuo,
Sun Shiqun,
Shen Linghong,
He Ben
Publication year - 2013
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25022
Subject(s) - medicine , clinical endpoint , cardiology , coronary artery disease , confidence interval , stenosis , percutaneous coronary intervention , drug eluting stent , stent , incidence (geometry) , relative risk , randomized controlled trial , myocardial infarction , physics , optics
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, −2.59% [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. © 2013 Wiley Periodicals, Inc.