The role of drug‐coated balloons (DCBs) in the treatment of de novo coronary lesions is not well established.

Electronic databases and major conference proceedings were searched for randomized controlled trials that compared DCBs with stents or angioplasty for de novo coronary lesions. The primary outcome was target lesion revascularization. Summary estimates were conducted using random‐effects analysis complemented by several subgroup and sensitivity analyses. A total of 14 randomized controlled trials with 2483 patients were included. At a mean follow up of 12 months, DCBs were associated with no difference in the incidence of target lesion revascularization as compared with alternative strategies (risk ratio [RR], 0.79; 95% CI, 0.35–1.76). There was no difference in treatment effect based on the indication (ie, small‐vessel disease, myocardial infarction, bifurcation, or high bleeding risk) (P_interaction=0.22). DCBs were associated with lower target lesion revascularization compared with bare metal stents and similar target lesion revascularization compared with drug‐eluting stents (P_interaction=0.03). There was no difference between DCBs and control in terms of major adverse cardiac events, vessel thrombosis, or cardiovascular mortality. However, DCBs were associated with a lower incidence of myocardial infarction (RR, 0.48; 95% CI, 0.25–0.90) and all‐cause mortality (RR, 0.45; 95% CI, 0.22–0.94).

In patients with de novo coronary lesions, use of DCBs was associated with comparable clinical outcomes irrespective of the indication or comparator device. DCBs had a similar rate of target lesion revascularization compared with drug‐eluting stents. A randomized trial powered for clinical outcomes and evaluating the role of DCBs for all‐comers is warranted.