Key result
Combined suture- and plug-based closure cuts TF-TAVI access-site vascular complications ~45% vs. suture-only closure.
Why the study?
Does a combined suture-/plug-based vascular closure strategy reduce access site-related vascular complications compared to a suture-only strategy in patients undergoing transfemoral transcatheter aortic valve implantation?
RCT (n=454)
randomized
Yes
Does a combined suture-/plug-based vascular closure strategy reduce access site-related vascular complications compared to a suture-only strategy in patients undergoing transfemoral transcatheter aortic valve implantation?
Relative Risk: 0.55 (95% CI 0.44–0.68)
Absolute Event Rate: 27% vs 54%
p-value: p=<.001
A combined suture-/plug-based vascular closure strategy significantly reduces access site-related vascular complications and time to hemostasis compared to a suture-only strategy in patients undergoing TF-TAVI.
BACKGROUND AND AIMS: Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve haemostasis after TF-TAVI were compared. METHODS: The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicentre trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlide™/ProStyle™ (Abbott Vascular) and one Angio-Seal® (Terumo) vs. a suture-based VCD strategy (suture-only group) using two ProGlides™/ProStyles™. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium 3 criteria. Key secondary endpoints included time to haemostasis, bleeding type ≥ 2, and all-cause mortality over 30 days. RESULTS: Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group [relative risk .55 (95% confidence interval: .44, .68); P < .001]. Time to haemostasis was significantly shorter in the suture/plug group compared with the suture-only group (108 ± 208 s vs. 206 ± 171 s; P < .001). At 30 days, bleeding type ≥ 2 occurred less often in the suture/plug group compared with the suture-only group [6.2% vs. 12.1%, relative risk .66 (.43, 1.02); P = .032], with no significant difference in mortality. CONCLUSIONS: With regard to the composite of major or minor access site-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suture-based VCD strategy for vascular access closure in patients undergoing TF-TAVI.
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Rheude et al. (2024) conducted an RCT in Transfemoral transcatheter aortic valve implantation (TF-TAVI) (n=454). Combined suture-/plug-based vascular closure device strategy vs. Suture-based vascular closure device strategy was evaluated on Composite of major or minor access site-related vascular complications during index hospitalization (RR 0.55, 95% CI 0.44-0.68, p=<.001). A combined suture-/plug-based vascular closure strategy was superior to a suture-only strategy for reducing access site-related vascular complications after TF-TAVI (27% vs 54%; RR 0.55; P<.001).
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