Valvular & structural heart diseaseRandomised controlled trial
Comparison of strategies for vascular ACCESS closure after Transcatheter Aortic Valve Implantation: the ACCESS-TAVI randomized trial
- Randomised controlled trial
- prospective
- multicentre
Authors' conclusion
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.
Study context
- Population
- Patients undergoing transfemoral TAVI
- Participants
- 454 patients
- Comparison
- Combined suture-/plug-based vascular closure device (VCD) vs suture-based VCD strategy
- Suture/plugn = 230
- Suture-onlyn = 224reference
- Primary endpoint
- Composite of:
- Major
- Minor access site-related vascular complications (VARC-3)
- Follow-up
- During index hospitalization
Primary result
As reported in the abstract
Relative risk
.55
95% CI .44, .68
P < 0.001
Events by treatment group
Secondary outcomes
Time to haemostasis · significantly shorter with suture/plug
P < 0.001
All-cause mortality · 30 days
- No significant difference in mortality
Safety
Bleeding type ≥ 2 · 30 days
RR .66 (.43, 1.02) · P = 0.032
Original publication
Comparison of strategies for vascular ACCESS closure after Transcatheter Aortic Valve Implantation: the ACCESS-TAVI randomized trial. Eur Heart J. Published 30 October 2024. doi:10.1093/eurheartj/ehae784
Summarised from the published abstract; every number is checked against it