Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.
Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas (UNICAMP). Campinas, Brazil.
Atherosclerosis. 2020 Feb;295:45-53. doi: 10.1016/j.atherosclerosis.2020.01.002. Epub 2020 Jan 15.
Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status.
We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5.
A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes.
Diabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies.
糖尿病已被广泛认为是经皮冠状动脉介入治疗（PCI）后不良结局的强有力预测因素，但在药物洗脱支架和强效 P2Y12 抑制剂时代的研究结果却存在矛盾。本研究旨在评估根据糖尿病状态，在当代 PCI 后发生缺血和出血结局的情况。
我们研究了 GLOBAL LEADERS 研究中 15957 例接受稳定型或急性冠状动脉综合征 PCI 的患者，这些患者具有已知的基线糖尿病状态。主要终点是 2 年内全因死亡或新发 Q 波心肌梗死。次要安全性终点是定义为出血学术研究联合会（BARC）3 型或 5 型的主要出血。
研究队列中有四分之一（4038/15957）为糖尿病患者，与非糖尿病患者相比，这些患者在 2 年内发生主要终点的风险显著增加（调整后的危险比[HR] 1.38；95%置信区间[CI] 1.17-1.63）。差异主要是由于糖尿病患者在 2 年内全因死亡率的风险显著增加（调整后的 HR 1.47，95%CI 1.22-1.78）。两组间 BARC 3 型或 5 型出血的风险相当（调整后的 HR 1.09，95%CI 0.86-1.39）。在有和没有糖尿病的患者中，抗血小板策略（试验组与对照组）对 2 年内主要终点和次要安全性终点的发生率均无显著影响。
与非糖尿病患者相比，糖尿病患者 PCI 后发生缺血事件的风险更高，而出血风险相当。PCI 后糖尿病患者的结局不受两种不同抗血小板策略的影响。
