【Abstract】
Background: Patients with type 2 diabetes are under substantially higher risk of in-stent restenosis (ISR) after coronary stent implantation. We sought to investigate whether visit-to-visit HbA1c variability is a potential predictor of ISR in diabetic patients after stent implantation.
Methods: We consecutively enrolled type 2 diabetic patients who underwent successful elective percutaneous coronary intervention and performed follow-up coronary angiography after around 12 months. The incidence of ISR and its relationship with visit-to-visit HbA1c variability, expressed as coefficient of variation (CV), standard deviation (SD) and variability independent of the mean (VIM), were studied. Multivariable Cox proportional hazards models were constructed to analyze the predictive value of HbA1c variability for ISR.
Results: From September 2014 to July 2018 in Ruijin Hospital, a total of 420 diabetic patients (688 lesions) after stent implantation were included in the final analysis. During a mean follow-up of 12.8±1.3 months, the incidence of ISR was 8.6%, which was significantly increased in patients with higher CV of HbA1c (P=0.001). The mean diameter stenosis (DS), net luminal loss and net luminal gain were 22.9±16.8%, 0.42±0.88 mm and 1.66±0.83 mm, respectively. Greater DS was observed in subjects with higher tertiles of CV of HbA1c (P<0.001), and this trend was more prominent in patients with optimal glycemic control (HbA1c≤7%) in the baseline. In multivariate analysis, HbA1c variability was independently associated with incidence of ISR after adjustment for traditional risk factors and mean HbA1c (HR: 3.00 [95% CI:1.14~7.92] for highest vs. lowest tertile). Inclusion of CV of HbA1c led to a better risk stratification accuracy. Assessing HbA1c variability by SD or VIM yielded similar findings.
Conclusions: This study suggests that visit-to-visit HbA1c variability is an independent predictor of incidence of ISR in patients with type 2 diabetes after stent implantation.
【中文摘要】
背景:2型糖尿病患者冠狀動脈支架植入術後支架內再狹窄(ISR)的發生風險明顯增高。本研究旨在探明糖尿病患者血糖變異度是否為ISR的潛在預測因子。
方法:本研究連續入組從2014年9月至2018年7月於瑞金醫院行經皮冠脈介入治療(PCI)的2型糖尿病患者,隨訪1年後複查造影。分析1年後ISR發生率及其與隨訪期間糖化血紅蛋白(HbA1c)變異度(包括變異係數[CV]、標準差[SD]、均值獨立性變異度[VIM])的相關性,並通過構建多變量Cox比例風險模型,分析血糖變異度對ISR的預測價值。
結果:本研究最終入組420例接受PCI術的糖尿病患者(共688支病變血管)。平均隨訪12.8±1.3月後ISR的發生率為8.6%,隨HbA1c變異度的增加而顯著升高(P=0.001)。平均管徑狹窄率(DS)為22.9±16.8%,管徑淨丟失為0.42±0.88 mm,管徑淨獲得為1.66±0.83 mm。HbA1c變異度越高,管徑狹窄率越大(P<0.001),且這種趨勢在基線血糖控制水平理想的患者中更為突出(HbA1c ≤ 7%)。多元分析顯示,校正了傳統危險因素及平均HbA1c後,HbA1c變異度與ISR發生率之間仍具有獨立相關性(HR:3.00 [95% CI:1.14~7.92]),且HbA1c 變異度可在傳統模型基礎上進一步提高危險分層的準確性。同時,應用多種血糖變異度的評價方法(CV、SD或VIM)分析均得到了類似結果。
結論:本研究提示,PCI術後長期HbA1c變異度是2型糖尿病合併冠心病患者支架術後再狹窄的獨立預測因子。