Ito Mitsuyo, Iijima Raisuke, Sato Manabu, Hara Hidehiko, Moroi Masao
Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, 2-22-36, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan.
Heart Vessels. 2025 Apr;40(4):302-311. doi: 10.1007/s00380-024-02470-x. Epub 2024 Oct 4.
We investigated whether drug-coated balloon (DCB) treatment is effective for all de novo cases of coronary artery disease (CAD) in patients with diabetes mellitus. Furthermore, we also investigated the relationship between the degree of diabetes mellitus and clinical outcomes after DCB treatment.
In this study, we included 516 consecutive patients with de novo CAD who were treated with DCB. The patients were divided into the diabetic and non-diabetic groups. Patients with diabetes mellitus were further classified into non-insulin-treated diabetes mellitus (NITDM) and insulin-treated diabetes mellitus (ITDM). The primary endpoints were major adverse cardiovascular ischemic events (MACE) and clinically driven target lesion revascularization (CD-TLR).
Within a mean clinical follow-up period of 2.5 years, the incidence of MACE among patients with diabetes mellitus (22.1%) was almost twice that of non-diabetic patients (11.9%) with a relative risk of 1.86 (95% CI 1.24-2.79, p = 0.002). The 3-year CD-TLR occurred in 28 patients with diabetes mellitus (10.6%) and 13 non-diabetic patients (5.1%, p = 0.02). ITDM patients had a significantly higher rate of MACE compared with non-diabetic patients with a relative risk of 2.86 (95% CI 1.76-4.63, p = 0.0002). ITDM remained an independent predictor of 3-year MACE with an odd ratio of 1.96 (95% CI 1.00-3.83, p = 0.05).
In patients undergoing DCB, the presence of DM was associated with a higher risk of MACE and CD-TLR. Particularly in DCB, treatment was still inadequately effective for ITDM patients.
我们研究了药物涂层球囊（DCB）治疗对糖尿病患者所有初发冠状动脉疾病（CAD）病例是否有效。此外，我们还研究了糖尿病程度与DCB治疗后临床结局之间的关系。
在本研究中，我们纳入了516例接受DCB治疗的连续性初发CAD患者。患者被分为糖尿病组和非糖尿病组。糖尿病患者进一步分为非胰岛素治疗糖尿病（NITDM）和胰岛素治疗糖尿病（ITDM）。主要终点是主要不良心血管缺血事件（MACE）和临床驱动的靶病变血运重建（CD-TLR）。
在平均2.5年的临床随访期内，糖尿病患者中MACE的发生率（22.1%）几乎是非糖尿病患者（11.9%）的两倍，相对风险为1.86（95%CI 1.24-2.79，p = 0.002）。28例糖尿病患者（10.6%）和13例非糖尿病患者（5.1%，p = 0.02）发生了3年CD-TLR。与非糖尿病患者相比，ITDM患者的MACE发生率显著更高，相对风险为2.86（95%CI 1.76-4.63，p = 0.0002）。ITDM仍然是3年MACE的独立预测因素，比值比为1.96（95%CI 1.00-3.83，p = 0.05）。
在接受DCB治疗的患者中，糖尿病的存在与MACE和CD-TLR的较高风险相关。特别是在DCB治疗中，对ITDM患者的治疗效果仍然不足。
