Suture closure AFtEr large bore vein access (SAFE‐VEIN): A randomized, prospective study of the efficacy and safety of venous closure device

Abstract Background Perclose ProGlide (PPG) Suture‐Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). Methods In this physician‐initiated, randomized, single‐center study clinicaltrials.gov ID: NCT04632641, single‐stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG ( n = 47) or figure of 8 suture ( n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular‐related complications and mortality. Wilcoxon rank‐sum test was used to compare TTH, TTA, and TTD. Results TTH (minutes) was significantly lower in PPG versus figure of 8 suture median, (Q1, Q3) 7 (2,10) vs. 11 (10,15) respectively, p < 0.001. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture 322 (246,452) vs. 403 (353, 633) respectively, p = 0.005. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms 1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. Conclusion PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same‐day discharge in these patients.