Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease: A PRISMA-compliant meta-analysis of randomized clinical trials.

backgroundStudies 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.

methodsWe 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.

resultsEleven 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).

conclusionsIn 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.