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).

中文翻译：

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严格的血糖控制（经手术前HbA1c <6.5％）在日本经药物治疗的糖尿病患者中经皮冠状动脉介入治疗后增加的心血管死亡风险：一项为期10年的随访研究。

在糖尿病患者的心血管（CV）疾病的二级预防中，HbA1c的最佳水平（最广泛使用的血糖控制指标）对于良好的临床效果尚待确定。这项研究评估了日本糖尿病患者经皮冠状动脉介入治疗（PCI）的术前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，涉及2000年至2016年间连续接受PCI的4542例患者。分析中包括在PCI时使用任何抗糖尿病药物（包括胰岛素）的患者（n = 1328）。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），和7.0％>和≤7.0％。主要结果是心血管死亡，包括猝死。中位随访时间为6。2年。在随访期间，分别有81例和23例患者发生了CV和猝死。尽管未经调整的Kaplan–Meier分析显示，术前HbA1c 7.0％二值化的患者之间的累积CV死亡率没有差异，但对5组HbA1c的分析显示，HbA1c <6.5％的患者的CV累积死亡率显着高于7.0–7.5的患者％（P ＝ 0.042）。多元Cox风险分析显示，术前HbA1c水平与CV死亡风险之间呈U型关系，最低风险发生在HbA1c 7.0–7.5％组中（HbA1c的危险比<6.5％，而7.0–7.5％：2.97， 95％置信区间：1.33–7.25，P = 0.007）。同样，单因素分析显示，猝死的最低风险是HbA1c 7.0–7.5％组。研究结果表明，在接受药物治疗的日本糖尿病患者的二级预防心血管疾病中，严格的血糖控制（HbA1c <6.5％）会增加心血管疾病死亡的风险。试验注册本研究报告了对在日本东京的Juntendo大学医院接受PCI的患者进行前瞻性注册数据库的回顾性分析（Juntendo医师临床试验联盟，J-PACT），该数据库已公开注册（日本大学医学信息网） -临床试验注册处（UMIN-CTR 000035587）。5％）用于日本糖尿病患者的心血管疾病的二级预防。试验注册本研究报告了对在日本东京的Juntendo大学医院接受PCI的患者进行前瞻性注册数据库的回顾性分析（Juntendo医师临床试验联盟，J-PACT），该数据库已公开注册（日本大学医学信息网） -临床试验注册处（UMIN-CTR 000035587）。5％）用于日本糖尿病患者的心血管疾病的二级预防。试验注册本研究报告了对在日本东京的Juntendo大学医院接受PCI的患者进行前瞻性注册数据库的回顾性分析（Juntendo医师临床试验联盟，J-PACT），该数据库已公开注册（日本大学医学信息网） -临床试验注册处（UMIN-CTR 000035587）。