Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Cardiovasc Diabetol. 2020 Feb 18;19(1):21. doi: 10.1186/s12933-020-00996-8.
In the secondary prevention of cardiovascular (CV) disease in patients with diabetes, an optimal level of HbA1c, the most widely-used glycemic control indicator, for favorable clinical consequences still remains to be established. This study assessed the association between preprocedural HbA1c level and CV mortality in Japanese diabetic patients undergoing percutaneous coronary intervention (PCI).
This is a retrospective observational study using a single-center prospective PCI database involving consecutive 4542 patients who underwent PCI between 2000 and 2016. Patients with any antidiabetic medication including insulin at PCI were included in the analysis (n = 1328). We divided the patients into 5 and 2 groups according to HbA1c level; HbA1c: < 6.5% (n = 267), 6.5-7.0% (n = 268), 7.0-7.5% (n = 262), 7.5-8.5% (n = 287) and ≥ 8.5% (n = 244), and 7.0% > and ≤ 7.0%, respectively. The primary outcome was CV mortality including sudden death. The median follow-up duration was 6.2 years.
In the follow-up period, CV and sudden death occurred in 81 and 23 patients, respectively. While unadjusted Kaplan-Meier analysis showed no difference in cumulative CV mortality rate between patients binarized by preprocedural HbA1c 7.0%, analysis of the 5 groups of HbA1c showed significantly higher cumulative CV death in patients with HbA1c < 6.5% compared with those with 7.0-7.5% (P = 0.042). Multivariate Cox hazard analysis revealed a U-shaped relationship between preprocedural HbA1c level and risk of CV death, and the lowest risk was in the HbA1c 7.0-7.5% group (Hazard ratio of HbA1c < 6.5% compared to 7.0-7.5%: 2.97, 95% confidence interval: 1.33-7.25, P = 0.007). Similarly, univariate analysis revealed the lowest risk of sudden death was in the HbA1c 7.0-7.5% group.
The findings indicate an increased risk of CV mortality by strict glycemic control (HbA1c < 6.5%) in the secondary prevention of CV disease in Japanese patients with medically-treated diabetes. Trial registration This study reports the retrospective analysis of a prospective registry database of patients who underwent PCI at Juntendo University Hospital, Tokyo, Japan (Juntendo Physicians' Alliance for Clinical Trials, J-PACT), which is publicly registered (University Medical Information Network Japan-Clinical Trials Registry UMIN-CTR 000035587).
在糖尿病患者的心血管（CV）疾病二级预防中，最广泛使用的血糖控制指标——糖化血红蛋白（HbA1c）的最佳水平仍有待确定，以获得有利的临床结果。本研究评估了日本接受经皮冠状动脉介入治疗（PCI）的糖尿病患者术前 HbA1c 水平与 CV 死亡率之间的关系。
这是一项使用单中心前瞻性 PCI 数据库的回顾性观察性研究，共纳入 2000 年至 2016 年间接受 PCI 的 4542 例连续患者。包括接受任何降糖药物治疗（包括胰岛素）的患者（n=1328）。我们根据 HbA1c 水平将患者分为 5 组和 2 组；HbA1c：<6.5%（n=267）、6.5-7.0%（n=268）、7.0-7.5%（n=262）、7.5-8.5%（n=287）和≥8.5%（n=244），分别为 7.0%>和≤7.0%。主要结局为包括猝死在内的 CV 死亡率。中位随访时间为 6.2 年。
在随访期间，81 例患者发生 CV 死亡，23 例患者发生猝死。尽管未经调整的 Kaplan-Meier 分析显示术前 HbA1c 7.0% 二分位患者的累积 CV 死亡率无差异，但 HbA1c 5 组分析显示，HbA1c<6.5%的患者累积 CV 死亡明显高于 7.0-7.5%的患者（P=0.042）。多变量 Cox 风险分析显示，术前 HbA1c 水平与 CV 死亡风险呈 U 型关系，HbA1c 7.0-7.5%组风险最低（HbA1c<6.5%与 7.0-7.5%相比的风险比：2.97，95%置信区间：1.33-7.25，P=0.007）。同样，单变量分析显示，HbA1c 7.0-7.5%组猝死风险最低。
研究结果表明，在日本接受药物治疗的糖尿病患者的 CV 疾病二级预防中，严格的血糖控制（HbA1c<6.5%）可能增加 CV 死亡风险。试验注册本研究报告了日本顺天堂大学医院接受 PCI 治疗的患者前瞻性登记数据库的回顾性分析（顺天堂医师临床研究联盟，J-PACT），该研究已在日本医学信息网络-临床试验注册（UMIN-CTR 000035587）上公开注册。
