Mechanical Compression Versus Vascular Closure Devices for Femoral Artery Haemostasis After Peripheral Endovascular Procedures: A Randomised Controlled Trial

Background: Femoral arteriotomy closure after peripheral angiography and intervention is commonly achieved using vascular closure devices (VCDs) or compression-based strategies; however, comparative randomised data in contemporary peripheral endovascular practice remain limited. Methods: In this prospective randomised trial, adults undergoing femoral-access diagnostic angiography or peripheral endovascular intervention were assigned in a 1:1 ratio to haemostasis with the FemoStop™ II Gold pneumatic compression system or a contemporary VCD strategy. The primary endpoint was a composite of major or minor groin-site complications immediately after sheath removal. Secondary endpoints included composite complications at recovery, discharge, and 30 days, with separate analyses of major and minor complications. Patient-reported pain was assessed using the Verbal Numerical Rating Scale (VNRS). Efficacy and safety analyses were performed according to the intention-to-treat and as-treated principles, respectively. Risk ratios were estimated using modified Poisson regression with robust variance, with prespecified adjustment for sex, systolic blood pressure before sheath removal, and sheath size. Results: A total of 130 participants underwent randomisation, including 66 assigned to FemoStop™ II Gold and 64 assigned to VCDs. The primary composite endpoint occurred in 23/66 participants (34.9%) in the FemoStop™ II Gold group and 16/64 (25.0%) in the VCD group (absolute difference, 9.9 percentage points; 95% confidence interval CI, −6.1 to 25.7; p = 0.25), with the numerical difference driven predominantly by minor-only events (28.8% versus 15.6%; p = 0.09). At 30 days, the composite endpoint occurred in 17/66 participants (25.8%) and 12/64 participants (18.8%), respectively (absolute difference, 7.0 percentage points; 95% CI, −13.3 to 26.4; p = 0.40). Serious access-site events remained infrequent both immediately post-procedure (6.1% versus 9.4%; p = 0.53) and at 30 days (6.1% versus 4.7%; p = 0.72). The adjusted risk ratios were 1.28 (95% CI, 0.74 to 2.21) for the primary composite endpoint and 1.23 (95% CI, 0.63 to 2.40) for the 30-day composite endpoint. Ordinal VNRS pain distributions did not differ significantly at any timepoint, although “any pain” immediately post-procedure was less frequent with FemoStop™ II Gold (22.7% versus 40.6%; unadjusted risk ratio, 0.56; 95% CI, 0.33 to 0.93); this association was attenuated after adjustment (adjusted risk ratio, 0.63; 95% CI, 0.38 to 1.03). Prespecified interaction testing suggested that the effect of treatment on composite complications varied according to sheath size both immediately post-procedure and at 30 days (p < 0.001 for both interactions). Conclusions: In patients undergoing femoral-access diagnostic angiography or peripheral endovascular intervention, haemostasis with FemoStop™ II Gold resulted in 30-day groin-site complication rates that did not differ significantly from those observed with contemporary VCD strategies. Serious access-site events remained infrequent in both groups, and the apparent early reduction in patient-reported pain with FemoStop™ II Gold was not definitive after adjustment. Larger, adequately powered multicentre studies are warranted to clarify sheath size-dependent effects and uncommon clinically consequential vascular events.