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Backgrounds: Although drug-eluting stents are the most common interventional devices for patients with coronary disease, drug-coated balloons (DCBs) represent a novel therapeutic alternative in certain scenarios. This prospective, observational all-comers study explored the clinical outcomes of DCB use in patients with coronary lesions., Methods and Results: All patients treated with DCBs were enrolled in this study, including patients with in-stent restenosis (ISR) or de novo lesions. The primary outcome was the target lesion revascularization (TLR) rate at one year. We enrolled 2306 patients with 2660 lesions and performed DCB angioplasty in 399 patients (17.3%) with ISR and 1907 patients (82.7%) with de novo lesions. During follow-up (366 ± 46 days), the TLR rate was lower in the de novo lesion group (1.31%) compared to the ISR group (7.02%) [odds ratio (OR) 0.176, 95% confidence interval (CI) 0.101-0.305, p < 0.001]. Patients with de novo lesions had a lower yearly incidence of MACE compared to ISR patients (2.73 vs. 9.27%, respectively, OR 0.274, 95% CI 0.177-0.424, p < 0.001) and a lower incidence of any revascularization (5.09 vs. 13.03%, OR 0.358, 95% CI 0.251-0.510, p < 0.001). No significant differences between groups were observed in the rates of cardiac death (OR 0.783, 95% CI 0.258-2.371, p = 0.655) or MI (OR 0.696, 95% CI 0.191-2.540, p = 0.573)., Conclusions: DCB angioplasty in this all-comers, real-world, prospective study was safe and efficient with low TLR and MACE rates. Thus, DCB appears to be an attractive alternative for the stent-less treatment of de novo coronary lesions. ISR in-stent restenosis; OR odds ratio; CI confidence interval; TLR target lesion revascularization; MACE major adverse cardiovascular events; MI myocardial infraction. MACE defined as the composite outcome of cardiac death, myocardial infarction, and target vessel revascularization. Any revascularization includes any percutaneous coronary intervention, and coronary artery bypass grafting., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The revascularization of small vessels using drug-eluting stents remains challenging. The use of the drug-coated balloon is an attractive therapeutic strategy in de novo lesions in small coronary vessels, particularly in the diabetic group. This study aimed to assess the outcomes of DCB-only angioplasty in small vessel disease., Methods: A total of 1198 patients with small vessel disease treated with DCB-only strategy were followed. Patients were divided into the diabetic and nondiabetic groups. Clinical and angiographical follow-up were organized at 12 months. The primary endpoints were target lesion failure and secondary major adverse cardiac events., Results: There was a significantly higher rate of target lesion failure among diabetic patients compared to nondiabetic [17 (3.9%) vs. 11 (1.4%), P =0.006], taken separately, the rate of target lesion revascularization significantly differed between groups with a higher rate observed in the diabetic group [9 (2%) vs. 4 (0.5%), P =0.014]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254-5.864, P =0.011) and target lesion revascularization (HR: 3.698, CI: 1.112-12.298, P =0.033) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, P =0.110) and MACE [19 (4.4%) vs. 21 (2.7%), P =0.120]., Conclusion: Drug-coated balloon-only treatment achieved lower incidence rates of TLF and MACE. Diabetes is an independent predictor for target lesion failure and target lesion revascularization at one year following DCB treatment in small coronary vessels. We observed no significant differences between groups regarding MACE in one year., Competing Interests: The authors declare that they have no known conflicts of financial interest or personal relationships that could have appeared to influence the work reported in this study., (Copyright © 2021 Botey Katamu Benjamin et al.)

Background: Relative to nondiabetic patients, percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) is associated with inferior clinical outcomes. We aimed to evaluate the outcomes of drug-coated balloon (DCB) in diabetic versus nondiabetic patients., Methods and Results: In this observational, prospective, multicenter study, we compared the outcomes of patients with and without DM after undergoing PCI with DCBs. Target lesion failure (TLF) was analyzed as primary endpoint. Secondary endpoints were the rates of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), and any revascularization. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics. Among 2,306 eligible patients, 578 with DM and 578 without DM had similar propensity scores and were included in the analyses. During follow-up (366 ± 46 days), compared with DM patients, patients without DM were associated with a lower yearly incidence of TLF (2.77% vs. 5.36%; OR, 1.991; 95% CI, 1.077 to 3.681; P = 0.025) and TLR (1.90% vs. 4.15%; OR, 2.233; 95% CI, 1.083 to 4.602; P = 0.026). No significant differences were observed with regards to rates of MACE (OR: 1.580, 95% CI: 0.912-2.735; P = 0.100), cardiac death (OR: 1.608, 95% CI: 0.523-4.946; P = 0.403), MI (OR: 4.042, 95% CI: 0.855-19.117; P = 0.057), and any revascularization (OR: 1.534, 95% CI: 0.983-2.393; P = 0.058)., Conclusions: Diabetic patients experience higher TLF and TLR rates following DCB angioplasty without substantial increase in the risk of MACE, cardiac death, MI, or revascularization., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (Copyright © 2021 Liang Pan et al.)

Background: A drug-coated balloon (DCB) has been designed as a new device for the treatment of coronary artery disease. The data regarding DCB-treated lesions in large coronary artery are limited. The purpose of our study was to explore the effectiveness and safety of DCB in large coronary artery., Methods: We prospectively analyzed all patients treated with DCB in de novo lesions consistent with inclusion criteria between May 2015 and April 2017. The observed outcomes included target lesion revascularization (TLR), myocardial infarction, cardiac death and non-cardiac death, and major adverse cardiac events (MACE)., Results: There were 92 patients including 94 coronary de novo lesions treated in all. The most often utilized DCB diameters were 3.0 mm (41.5%) and 3.5 mm (39.4%). Two acute closures occurred in hospital. Six bailout drug-eluting stents were used in the percutaneous coronary interventions (6.4%). Quantitative coronary angiography measurement at follow-up showed late lumen loss was -0.02 ± 0.49 mm. The TLR rate and overall MACE rates were 4.3% and 4.3% during the follow-up period in the whole patient population, respectively., Conclusions: Our study showed that the "DCB only" strategy is safe and efficient in large vessel lesions of patients whose predilation achieved an acceptable result., (Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)