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《FREEDOM 试验后糖尿病患者的最佳血运重建:争议最终解决了吗?》

Optimal revascularization in diabetes after the FREEDOM trial: were the controversies finally settled?

机构信息

Cardiac Rehabilitation Institute, Sheba Medical Center, 52621 Tel-Hashomer, Israel.

出版信息

Cardiol J. 2013;20(4):331-6. doi: 10.5603/CJ.2013.0090.

Abstract

The prevalence of diabetes mellitus (DM) is growing worldwide. Prothrombotic and proinflammatory states, in adjunct to endothelial dysfunction and metabolic disorders, such as hyperglycemia, dyslipidemia, obesity, insulin resistance, and oxidative stress, are key features of the accelerated atherosclerotic progression observed in patients with DM. Moreover, drug-eluting stents (DES) thrombosis rate was higher in DM than in non-DM patients and DM itself was identifi ed as an independent predictor of stent thrombosis, particularly due to the impaired response to dual antiplatelet therapy. The accumulating data even before the FREEDOM trial provided strong evidence that in patients with DM and complex coronary artery disease, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) which was based on the first-generation DES. The FREEDOM trial enrolled 1900 patients with DM and multivessel coronary artery disease treated with CABG surgery or PCI with the first-generation DES. The patients were followed for a median 3.8 years; CABG was superior to PCI as it significantly reduced rates of death and myocardial infarction (MI), with a higher rate of stroke. The benefit of CABG was driven by differences in rates of both MI (p < 0.001) and death from any cause (p = 0.049). Following the FREEDOM results, patients with DM ought to be informed before coronary angiography about the potential survival benefit from CABG for the treatment of a complex disease. However, it should be noticed that the second generation DES were associated with better outcomes compared to the first-generation DES. New stent designs are continually being developed, with the aim of further improving the clinical effi cacy and the safety profile of these devices. Therefore, although the results of the FREEDOM trial clearly demonstrated that CABG was superior to PCI in DM, a comparative analysis of the new incoming stents warrants further investigation.

摘要

糖尿病(DM)的患病率在全球范围内不断上升。促血栓形成和促炎状态,以及内皮功能障碍和代谢紊乱,如高血糖、血脂异常、肥胖、胰岛素抵抗和氧化应激,是糖尿病患者加速动脉粥样硬化进展的关键特征。此外,糖尿病患者的药物洗脱支架(DES)血栓形成率高于非糖尿病患者,糖尿病本身被确定为支架血栓形成的独立预测因素,特别是由于对双联抗血小板治疗的反应受损。即使在 FREEDOM 试验之前,积累的数据也提供了强有力的证据,表明在患有糖尿病和复杂冠状动脉疾病的患者中,冠状动脉旁路移植术(CABG)优于基于第一代 DES 的经皮冠状动脉介入治疗(PCI)。FREEDOM 试验纳入了 1900 名患有糖尿病和多支冠状动脉疾病的患者,这些患者接受了 CABG 手术或第一代 DES 的 PCI 治疗。患者中位随访时间为 3.8 年;CABG 优于 PCI,因为它显著降低了死亡率和心肌梗死(MI)的发生率,而中风的发生率更高。CABG 的益处是由于 MI(p < 0.001)和任何原因导致的死亡率(p = 0.049)的差异驱动的。FREEDOM 结果公布后,在进行冠状动脉造影之前,应该告知患有糖尿病的患者,CABG 治疗复杂疾病可能带来生存获益。然而,应该注意的是,第二代 DES 与第一代 DES 相比,结果更好。新的支架设计不断得到开发,目的是进一步提高这些设备的临床疗效和安全性。因此,尽管 FREEDOM 试验的结果清楚地表明 CABG 在糖尿病患者中优于 PCI,但对新传入支架的比较分析需要进一步研究。

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