Basile Mattia, Salzillo Carmine, Bianchini Emiliano, Bianchini Francesco, Jurado-Román Alfonso, Gaspardone Achille, Burzotta Francesco, Sgueglia Gregory A
Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Cardiology Department, La Paz University Hospital, Madrid, Spain.
Catheter Cardiovasc Interv. 2025 Jun;105(7):1668-1676. doi: 10.1002/ccd.31512. Epub 2025 Mar 25.
Transradial access (TRA) is the preferred approach for percutaneous coronary intervention (PCI), associated with improved patient comfort, lower vascular complications and lower mortality compared to transfemoral access. However, TRA presents challenges such as radial artery spasm (RAS), radial artery occlusion (RAO), and anatomical variability that have driven the development of the sheathless approach.
This meta-analysis evaluates the efficacy and safety of a dedicated sheathless system strategy versus conventional sheath-based techniques in TRA PCI.
We conducted a systematic review and meta-analysis of studies comparing sheathless and sheath-based approaches in TRA PCI, with outcomes including RAS, access site crossover, access-related bleeding, RAO, procedural success, and procedural metrics. Primary analysis was stratified by study design-randomized controlled trials (RCTs) versus observational studies (OBS)-with additional subgroup analysis based on sheath type. Data were pooled using random-effects models, and heterogeneity assessed via the I² statistic.
Eight studies (3 RCTs, 5 OBS) comprising 6380 patients were included. The sheathless approach significantly reduced RAS (OR 0.31; 95% CI: 0.10-0.97) and access site crossover (OR 0.34; 95% CI: 0.16-0.69) compared to the sheath-based approach, particularly in the conventional sheath subgroup. No significant differences were found in access-related bleeding, RAO, procedural success, or procedural metrics.
This meta-analysis supports the sheathless system as a safe and effective alternative to sheath-based TRA PCI, reducing RAS, and crossover without increasing RAO or bleeding risk. These advantages may enhance procedural efficiency and patient comfort, especially in small radial arteries and extend its scope to newer applications.
经桡动脉入路（TRA）是经皮冠状动脉介入治疗（PCI）的首选方法，与经股动脉入路相比，患者舒适度更高，血管并发症更少，死亡率更低。然而，TRA存在诸如桡动脉痉挛（RAS）、桡动脉闭塞（RAO）和解剖变异等挑战，这些促使了无鞘入路方法的发展。
本荟萃分析评估在TRA PCI中，专用无鞘系统策略与传统基于鞘管的技术相比的疗效和安全性。
我们对比较TRA PCI中无鞘和基于鞘管方法的研究进行了系统评价和荟萃分析，结局包括RAS、穿刺部位转换、与穿刺相关的出血、RAO、手术成功率和手术指标。主要分析按研究设计分层——随机对照试验（RCT）与观察性研究（OBS）——并基于鞘管类型进行额外的亚组分析。使用随机效应模型汇总数据，并通过I²统计量评估异质性。
纳入了八项研究（3项RCT，5项OBS），共6380例患者。与基于鞘管的方法相比，无鞘方法显著降低了RAS（比值比0.31；95%置信区间：0.10 - 0.97）和穿刺部位转换（比值比0.34；95%置信区间：0.16 - 0.69），特别是在传统鞘管亚组中。在与穿刺相关的出血、RAO、手术成功率或手术指标方面未发现显著差异。
本荟萃分析支持无鞘系统作为基于鞘管的TRA PCI的一种安全有效的替代方法，可降低RAS和穿刺部位转换，而不增加RAO或出血风险。这些优势可能会提高手术效率和患者舒适度，特别是在桡动脉较细的情况下，并将其应用范围扩展到新的领域。
