Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.
Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
JACC Cardiovasc Interv. 2021 Jun 28;14(12):1293-1303. doi: 10.1016/j.jcin.2021.03.041. Epub 2021 May 18.
The aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site-related bleeding or vascular complications.
The femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.
An international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site-related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.
The primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.
In patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention [PCI] Trial [Color]; NCT03846752).
本研究旨在探讨在使用大腔导管进行复杂冠状动脉病变经皮冠状动脉介入治疗（PCI）时，与经股动脉（TF）入路相比，经桡动脉（TR）入路是否在与临床相关的血管入路部位出血或血管并发症方面更具优势。
目前，股动脉是进行复杂冠状动脉病变 PCI 的最常用入路，尤其是在需要使用大腔导管时。随着 TR 设备的缩小，TR PCI 可能会在这些患者中越来越多地应用，并且与 TF 方法相比可能是一种更安全的替代方法。
进行了一项国际性前瞻性多中心试验，将 388 例计划进行 PCI 治疗的复杂冠状动脉病变患者（包括慢性完全闭塞、左主干病变、严重钙化或复杂分叉病变）随机分为 7-F TR 入路（TRA）或 7-F TF 入路（TFA）。主要终点定义为血管入路部位相关的有临床意义的出血或需要在出院时进行干预的血管并发症。次要终点为手术成功率。
TRA 的主要终点事件发生率为 3.6%，而 TFA 的发生率为 19.1%（p<0.001）。从桡动脉到股动脉的交叉率为 3.6%，从股动脉到桡动脉的交叉率为 2.6%（p=0.558）。TFA 的手术成功率为 89.2%，TRA 的手术成功率为 86.0%（p=0.285）。TFA 和 TRA 之间在手术持续时间、造影剂用量或辐射剂量方面没有差异。
在接受大腔导管进行复杂冠状动脉病变 PCI 的患者中，与股动脉入路相比，桡动脉入路与临床相关的血管入路部位出血或血管并发症显著减少，而不影响手术成功率。（复杂大腔桡动脉经皮冠状动脉介入治疗试验[颜色]；NCT03846752）。
