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Background: The use of drug-coated balloons (DCBs) in small-vessel coronary artery disease (SVD) remains controversial., Methods: We performed a meta-analysis of all randomized controlled trials (RCTs) reporting the outcomes of DCB vs. DES in de-novo SVD. We included a total of 5 RCTs (1459 patients), with (DCB n = 734 and DES n = 725)., Results: Over a median follow-up duration of 6 months, DCB was associated with smaller late lumen loss (LLL) compared with DES (mean difference -0.12 mm) (95% confidence intervals (CI) [-0.21, -0.03 mm], p = 0.01). Over a median follow-up of 12 months, both modalities had similar risk of major adverse cardiovascular events (MACE) (8.7% vs. 10.2%; odds ratio (OR): 0.94, 95% CI [0.49-1.79], p = 084), all-cause mortality (1.17% vs. 2.38%; OR: 0.53, 95% CI [0.16-1.75], p = 0.30), target lesion revascularization (TLR) (7.9% vs. 3.9%; OR: 1.26, 95% CI [0.51-3.14], p = 0.62), and target vessel revascularization (TVR) (8.2% vs. 7.8%; OR: 1.06, 95% CI [0.40-2.82], p = 0.91). DCBs were associated with lower risk of myocardial infarction (MI) compared with DES (1.55% vs. 3.31%; OR: 0.48, 95% CI [0.23-1.00], p = 0.05, I2 = 0%)., Conclusion: PCI of SVD with DCBs is associated with smaller LLL, lower risk of MI, and similar risk of MACE, death, TLR, and TVR compared with DES over one year. DCB appears as an attractive alternative to DES in patients with de-novo SVD, but long-term clinical data are still needed., Competing Interests: Declaration of competing interest Emmanouil Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens. Shareholder: MHI Ventures. Khaldoon Alaswad: consulting/speaker honoraria from Boston Scientific, Cardiovascular Systems Inc., Abbott Vascular, Teleflex. Mir Basir: Consulting/Speaker Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Zoll. Stéphane Rinfret: consulting/speaker honoraria from Abbott Vascular, Boston Scientific, Teleflex and Abiomed. All other authors have nothing to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study., Methods: We performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL)., Results: Three studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: -0.13 mm, 95% CI [-0.41, 0.14], p = 0.34) compared with DES., Conclusion: In diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting., (Copyright © 2019 Elsevier Inc. All rights reserved.)