“沉默”糖尿病与当代药物洗脱支架治疗后临床结局：BIO-RESORT 沉默糖尿病研究。
"Silent" Diabetes and Clinical Outcome After Treatment With Contemporary Drug-Eluting Stents: The BIO-RESORT Silent Diabetes Study.
机构信息
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Health Technology and Services Research, MIRA-Institute of Technical Medicine and Biomedical Technology, University of Twente, Enschede, the Netherlands.
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
出版信息
JACC Cardiovasc Interv. 2018 Mar 12;11(5):448-459. doi: 10.1016/j.jcin.2017.10.038. Epub 2018 Feb 14.
OBJECTIVES
This study sought to assess the prevalence and clinical impact of silent diabetes and pre-diabetes in "nondiabetic" percutaneous coronary intervention (PCI) all-comers.
BACKGROUND
Patients with undetected and thus untreated (silent) diabetes may have higher event risks after PCI with contemporary drug-eluting stents (DES).
METHODS
The BIO-RESORT Silent Diabetes study, performed at Thoraxcentrum Twente, is a substudy of the randomized multicenter BIO-RESORT (BIOdegradable Polymer and DuRable Polymer Drug-eluting Stents in an All COmeRs PopulaTion) trial (NCT01674803). Patients underwent oral glucose tolerance testing (OGTT), and assessment of glycosylated hemoglobin with fasting plasma glucose. Primary endpoint was a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.
RESULTS
Of the 988 participants, OGTT detected silent diabetes in 68 (6.9%), pre-diabetes in 133 (13.3%), and normal glucose metabolism in 788 (79.8%). Patients with silent diabetes had higher primary endpoint rates (13.2% vs. 7.6% vs. 4.8%; p < 0.001; silent diabetes vs. normal: hazard ratio: 4.2; 95% confidence interval: 1.9 to 9.2). Differences were driven by myocardial infarction (p < 0.001) which occurred mostly <48 h. Based on glycosylated hemoglobin and fasting plasma glucose, silent diabetes was found in 33 (3.3%) patients, pre-diabetes in 217 (22.0%) patients, and normal glucose metabolism in 738 (74.7%) patients; primary endpoint rates were similar to OGTT-based analyses (12.1% vs. 5.5% vs. 3.1%; p = 0.01). Multivariate analyses demonstrated that abnormal glucose metabolism by either diagnostic approach, present in 330 (33.4%) patients, independently predicted adverse event risk (hazard ratio: 2.2; 95% confidence interval: 1.2 to 4.2).
CONCLUSIONS
Abnormal glucose metabolism was detected in 1 of 3 "nondiabetic" PCI patients and was independently associated with up to 4-fold higher event risks. Future intervention trials should determine whether meaningful benefits accrue from routine glycemia testing in such patients.
目的
本研究旨在评估“非糖尿病”经皮冠状动脉介入治疗（PCI）患者中无症状糖尿病和糖尿病前期的患病率及其临床影响。
背景
在使用当代药物洗脱支架（DES）后，未经检测和未经治疗（无症状）的糖尿病患者发生事件的风险可能更高。
方法
BIO-RESORT Silent Diabetes 研究在特温特胸科中心进行，是随机多中心 BIO-RESORT（生物可降解聚合物和耐用聚合物药物洗脱支架在所有患者人群中的研究）试验（NCT01674803）的子研究。患者接受口服葡萄糖耐量试验（OGTT）和空腹血浆葡萄糖测定糖化血红蛋白。主要终点为 1 年时心脏死亡、靶血管相关心肌梗死或靶血管血运重建的复合终点。
结果
在 988 名患者中，OGTT 检出无症状糖尿病 68 例（6.9%），糖尿病前期 133 例（13.3%），正常葡萄糖代谢 788 例（79.8%）。无症状糖尿病患者的主要终点发生率较高（13.2%比 7.6%比 4.8%；p<0.001；无症状糖尿病比正常：风险比 4.2；95%置信区间 1.9 至 9.2）。差异由心肌梗死驱动（p<0.001），大多数心肌梗死发生在 48 小时内。基于糖化血红蛋白和空腹血浆葡萄糖，33 例（3.3%）患者存在无症状糖尿病，217 例（22.0%）患者存在糖尿病前期，738 例（74.7%）患者存在正常葡萄糖代谢；主要终点发生率与基于 OGTT 的分析相似（12.1%比 5.5%比 3.1%；p=0.01）。多变量分析显示，两种诊断方法中存在异常葡萄糖代谢（330 例，33.4%）患者，独立预测不良事件风险（风险比 2.2；95%置信区间 1.2 至 4.2）。
结论
在 1/3 的“非糖尿病”PCI 患者中发现异常葡萄糖代谢，与高达 4 倍的更高事件风险独立相关。未来的干预试验应确定在这些患者中常规进行血糖检测是否会带来有意义的益处。
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