Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, USA.
Non-invasive Cardiology, Jaipur National University Hospital and Medical College, Institute for Medical Sciences and Research Center, Jaipur, Rajasthan, India.
Indian Heart J. 2020 Sep-Oct;72(5):466-468. doi: 10.1016/j.ihj.2020.08.006. Epub 2020 Aug 13.
Despite the seminal trials on radial versus femoral access for percutaneous coronary intervention (PCI) in ST elevation myocardial infarction (STEMI) showing reduced bleeding, major adverse cardiovascular events and mortality; these outcomes were attributed by some to low usage of bivalirudin and an unnecessarily higher dose of Heparin, combined with high usage of GP IIb/IIIa inhibitors, as well as to the use of larger bore catheters in the femoral groups. To prove the point, a study comparing TF with TR access was mooted( Lee et al., 2013) 3; with bivalirudin instead of heparin, preferably with use of potent oral anti-platelets instead of GP IIb/IIIa inhibitors; and femoral vascular closure devices, ostensibly, to assess outcomes based on 'access-site alone'. With this intent, the SAFARI STEMI study was designed. In this article we discuss some of the major short-comings of this trial which raise significant questions on its results.
尽管经导管冠状动脉介入治疗（PCI）治疗 ST 段抬高型心肌梗死（STEMI）时，桡动脉入路与股动脉入路的开创性试验显示出血减少、主要心血管不良事件和死亡率降低；但一些人认为，这些结果归因于比伐卢定和肝素的使用率较低，以及与 GP IIb/IIIa 抑制剂的高使用率结合使用，以及股动脉组中使用更大口径的导管。为了证明这一点，有人提出了一项比较 TF 与 TR 入路的研究（Lee 等人，2013 年）3；使用比伐卢定代替肝素，最好使用强效口服抗血小板药物代替 GP IIb/IIIa 抑制剂；以及股血管闭合装置，显然是为了根据“仅入路部位”评估结果。出于这个目的，设计了 SAFARI STEMI 研究。在本文中，我们讨论了该试验的一些主要缺陷，这些缺陷对其结果提出了重大质疑。
