Dedicated Sheathless System Versus Sheath-Based Approach for Transradial Percutaneous Coronary Intervention: Systematic Review and Meta-Analysis

Background: 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. Objectives: This meta-analysis evaluates the efficacy and safety of a dedicated sheathless system strategy versus conventional sheath-based techniques in TRA PCI. Methods: 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 I-2 statistic. Results: 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. Conclusions: 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.