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 ( 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; ) and TLR (1.90% vs. 4.15%; OR, 2.233; 95% CI, 1.083 to 4.602; ). No significant differences were observed with regards to rates of MACE (OR: 1.580, 95% CI: 0.912-2.735; ), cardiac death (OR: 1.608, 95% CI: 0.523-4.946; ), MI (OR: 4.042, 95% CI: 0.855-19.117; ), and any revascularization (OR: 1.534, 95% CI: 0.983-2.393; ). 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.

中文翻译：

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药物涂层球囊在有或无糖尿病的冠心病患者中的临床结果：一项多中心倾向评分研究

背景。相对于非糖尿病患者，糖尿病 (DM) 患者的经皮冠状动脉介入治疗 (PCI) 与较差的临床结果相关。我们旨在评估药物涂层球囊 (DCB) 在糖尿病患者与非糖尿病患者中的疗效。方法和结果. 在这项观察性、前瞻性、多中心研究中，我们比较了有和无 DM 患者在接受 PCI 与 DCB 后的结果。目标病变失败（TLF）被分析为主要终点。次要终点是靶病变血运重建 (TLR)、主要不良心血管事件 (MACE)、心源性死亡、心肌梗死 (MI) 和任何血运重建的发生率。倾向得分匹配用于组装一组具有相似基线特征的患者。在 2,306 名符合条件的患者中，578 名糖尿病患者和 578 名非糖尿病患者具有相似的倾向评分并被纳入分析。随访期间（天），与 DM 患者相比，无 DM 患者的 TLF 年发生率较低（2.77% 对 5.36%；OR，1.991；95% CI，1.077 至 3.681；)和 TLR（1.90% 对 4.15%；OR，2.233；95% CI，1.083 至 4.602；）。MACE 发生率未观察到显着差异（OR：1.580，95% CI：0.912-2.735；)、心源性死亡 (OR: 1.608, 95% CI: 0.523-4.946;), MI (OR: 4.042, 95% CI: 0.855-19.117;)和任何血运重建 (OR: 1.534, 95% CI: 0.983-2.393;）。 结论。糖尿病患者在 DCB 血管成形术后经历更高的 TLF 和 TLR 率，而 MACE、心源性死亡、MI 或血运重建的风险没有显着增加。