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%), ], 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%), ]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254–5.864, ) and target lesion revascularization (HR: 3.698, CI: 1.112–12.298, ) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, ) and MACE [19 (4.4%) vs. 21 (2.7%), ]. 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.

中文翻译：

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新发小冠状血管疾病糖尿病和非糖尿病患者的仅药物涂层球囊血管成形术结果

背景。使用药物洗脱支架对小血管进行血运重建仍然具有挑战性。药物涂层球囊的使用是一种有吸引力的治疗策略，用于治疗冠状动脉小血管的新发病变，特别是在糖尿病组中。本研究旨在评估仅 DCB 血管成形术在小血管疾病中的结果。方法。共有 1198 名小血管疾病患者接受了 DCB-only 策略治疗。患者分为糖尿病组和非糖尿病组。在 12 个月时组织了临床和血管造影随访。主要终点是靶病变失败和次要主要不良心脏事件。结果. 与非糖尿病患者相比，糖尿病患者的靶病变失败率显着更高 [17 (3.9%) vs. 11 (1.4%)，]，单独来看，目标病变血运重建率在糖尿病组中观察到较高的组之间存在显着差异 [9 (2%) vs. 4 (0.5%)，]。糖尿病仍然是 TLF 的独立预测因子（HR：2.712，CI：1.254–5.864，)和靶病变血运重建 (HR: 3.698, CI: 1.112–12.298,)调整后。然而，在靶血管心肌梗死方面，两组之间没有观察到显着差异（0.6% vs. 0.1%，)和 MACE [19 (4.4%) 对 21 (2.7%)，]。结论。仅药物涂层球囊治疗可降低 TLF 和 MACE 的发生率。糖尿病是小冠状血管 DCB 治疗后一年靶病灶失败和靶病灶血运重建的独立预测因子。我们观察到一年内 MACE 组之间没有显着差异。