Objectives Current evidence regarding the successof drug-eluting balloons (DEBs) for de novo coronary artery disease is insufficient for formulating formal recommendations. This study aimed to evaluate the effectiveness of DEBs by performing a meta-analysis of randomised controlled trials (RCTs).

Methods We searched MEDLINE, Ovid-EMBASE, and the Cochrane Library for RCTs comparing DEBs with stents for de novo coronary artery disease by intention-to-treat analysis. 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). The applicability of DEBs for different coronary de novo lesion subsets was further assessed by performing a subgroup analysis.

Results 9 RCTs wereultimately included. The trend favoured improved outcomes for DEB plus bare metal stent (BMS) versus BMS alone (in-segment diameter stenosis: WMD, -5.33% [95% confidence interval (CI): -10.32% to -0.34%]; MACEs: RR, 0.69 [95%CI: 0.44 to1.07]), but DEB with/without BMS was associated with worse outcomes compared with drug-eluting stent alone (in-segment diameter stenosis: WMD, 8.78% [95%CI:2.20% to 15.36%]; MACEs: RR, 1.53 [95%CI: 1.16 to 2.00]). Subgroup analysis showed that DEBs offer no advantage on simple coronary lesions, but seem to be non-inferior to DES intreating complex lesions, such as small coronary artery lesions or bifurcation lesions, on clinical findings.

Conclusions Current data do not support the useof DEBs for de novo coronary lesions,especially for simple coronary lesions.