合并糖尿病的冠状动脉原位病变患者应用药物涂层球囊的临床研究

Clinical Study on the Application of Drug-Coated Balloons in Patients with Denovo Coronary Artery Lesions in Combination with Diabetes Mellitus

摘要: 目的：探讨糖尿病血糖控制情况对有冠状动脉原位病变采用药物涂层球囊(DCB)治疗的患者临床预后的影响。方法：入选2019年8月~2021年11月于青岛市市立医院住院并采用DCB介入治疗的244例冠状动脉原位病变患者作为研究对象，根据患者是否有糖尿病以及糖尿病患者入院糖化血红蛋白(HbA1C)指标的高低分为无糖尿病组、糖尿病血糖控制良好组(HbA1C < 6.5%)和糖尿病血糖控制不佳组(HbA1C ≥ 6.5%)共三组。在出院后1年内的随访中，首要终点为主要心血管不良事件(MACE)和靶病变失败(TLF)。分析糖尿病以及其血糖控制情况对行DCB治疗的原位病变患者临床预后影响。结果：在244例使用DCB干预的冠状动脉原位病变患者中，无糖尿病组124例(50.82%)、糖尿病血糖控制良好组39例(15.98%)，糖尿病血糖控制不良组81例(33.20%)。1年随访结果显示在MACE发生率上糖尿病血糖控制不良组显著高于糖尿病血糖控制良好组和无糖尿病组(16.94% vs 15.38% vs 40.47%, P < 0.001)；在TLF发生率上糖尿病血糖控制不良组比无糖尿病组高(2.42% vs 9.88%, P = 0.032)。将有糖尿病史的患者根据术后服用双抗药物的种类分为阿司匹林 + 替格瑞洛组62例(52.10%)和阿司匹林 + 氯吡格雷组57例(47.90%)。将两组患者的临床预后指标对比分析，替格瑞洛组较氯吡格雷组心源性死亡(0.00% vs 7.02%, P = 0.044)和急性心力衰竭(0.00% vs 10.53%, P = 0.009)发生率更低。结论：1) 患有糖尿病以及血糖控制不良会对冠状动脉原位病变经由DCB治疗的预后造成消极影响。2) 强化血糖控制可以实现应用DCB治疗合并糖尿病的冠状动脉原位病变患者的不良事件发生率明显降低。3) 合并糖尿病的冠状动脉原位病变患者应用DCB治疗后通过强化血糖控制治疗外选择使用阿司匹林 + 替格瑞洛双联抗血小板治疗亦可改善患者预后。

Abstract: Objective: To investigate the impact of glycemic control in diabetes on the clinical prognosis of pa-tients treated with drug-coated balloons (DCB) for denovo coronary artery lesions. Methods: Two hundred and forty-four patients with denovo coronary artery lesions who were hospitalized and treated with DCB intervention in Qingdao Municipal Hospital from August 2019 to November 2021 were enrolled as study subjects, and patients were divided into the no-diabetes group, the diabetic well-controlled glycemic group (HbA1C < 6.5%) and the diabetic poorly controlled glycemic group (HbA1C ≥ 6.5%). The primary endpoints for the 1-year follow-up were major adverse cardiovascular events (MACE) and target lesion failure (TLF). The clinical prognostic impact of diabetes and its gly-cemic control on patients with denovo lesions treated with DCB was analyzed. Results: Among 244 patients with denovo coronary artery intervened with DCB, 124 (50.82%) were in the group with-out diabetes, 39 (15.98%) in the group with good diabetic glycemic control (HbA1C < 6.5%), and 81 (33.20%) in the group with poor diabetic glycemic control (HbA1C ≥ 6.5%). The 1-year follow-up results showed that the incidence of MACE in the diabetic poor glycemic control group was signifi-cantly higher than in the diabetic good glycemic control group and the no-diabetes group (16.94% vs. 15.38% vs. 40.47%, P < 0.001); the incidence of TLF in the diabetic poor glycemic control group was higher than in the no-diabetes group (2.42% vs. 9.88%, P = 0.032). Patients with a history of diabetes were divided into 62 patients (52.10%) in the aspirin + ticagrelor group and 57 patients (47.90%) in the aspirin + clopidogrel group according to the type of dual anti-drug they were taking postoperatively. Comparing the clinical prognostic indicators between the two groups, the incidence of cardiac death (0.00% vs. 7.02%, P = 0.044) and acute heart failure (0.00% vs. 10.53%, P = 0.009) in the ticagrelor group was lower than in the clopidogrel group. Conclusions: 1) The prognosis of denovocoronary artery disease treated with DCB is negatively affected by diabetes mellitus and poor glycemic control. 2) Intensive glycemic control significantly reduces the incidence of adverse events in patients with denovocoronary artery disease treated with DCB in combination with dia-betes mellitus. 3) The prognosis of patients with denovocoronary artery disease treated with DCB in combination with diabetes mellitus is improved by the use of aspirin + ticagrelor in addition to in-tensive glycemic control therapy.