Background: Studies examining the efficiency of drug-coated balloon (DCB) + bare metal stent (BMS) compared with stents alone for de novo lesions have reported inconsistent results. The present comprehensive meta-analysis of randomized controlled trials (RCTs) assessed and compared the clinical efficacy and safety of DCB + BMS with those of stents alone for de novo coronary artery disease.
Methods: We formally searched electronic databases before September 2016 to identify potential studies. All RCTs were eligible for inclusion if they compared DCB + BMS with a control treatment (drug-eluting stent [DES] alone or BMS alone) in patients with de novo coronary artery disease.
Results: Eleven RCTs with a total of 2196 patients met the inclusion criteria were included in our meta-analysis. Subgroup analysis indicated DCB plus BMS was associated with poorer outcomes when compared with DES alone in primary endpoint {(in-segment late lumen loss [LLL]: mean difference [MD], 0.19; 95% confidence interval [CI], 0.06-0.32; P = 0.0042) and (major adverse cardiovascular events [MACEs]: risk ratio [RR], 1.88; 95% CI, 1.44-2.45; P < 0.0001)}. However, DCB + BMS had nonsignificantly lower LLL than BMS alone (in-segment LLL: MD, -0.14; 95% CI, -0.33-0.04; P = 0.24), and was more advantageous in reducing MACE incidence, with borderline significance (MACEs: RR, 0.67; 95% CI, 0.45-0.99; P = 0.05).
Conclusions: In summary, the present results do not favor the DCB + BMS strategy as an alternative therapeutic method to DES implantation for de novo coronary artery lesions in percutaneous coronary intervention (PCI). Additional well-designed large RCTs with long-follow-up periods are required to clarify the inconsistent results.