Outcomes with Drug-Coated Balloons in Percutaneous Coronary Intervention in Diabetic Patients.

ABSTRACT

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 ±â€¯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.