Background Percutaneous coronary intervention (PCI) of small‐vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug‐coated balloons (DCBs) in SVD has received limited study. Objectives To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. Methods We performed a meta‐analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. Results Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow‐up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug‐eluting stents (DES). During a mean follow‐up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04–0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08–0.37, P = <0.00001) compared with noncoated balloon angioplasty. Conclusion The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

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