Valvular & structural heart disease
Single vs Double ProGlide Devices for Access Site Closure after Transfemoral Aortic Valve Replacement: The SINGLE-CLOSURE Trial
Primary resultResult — go to the resultRisk difference −2.2% 95% CI −7.0% to 2.6%Authors' conclusion
A single-ProGlide strategy was noninferior to conventional double-ProGlide closure for the composite of VARC-3-defined access-site or access-related vascular complications after transfemoral TAVR. Primary endpoint events were predominantly minor vascular complications.
Study context
- Population
- Patients aged ≥65 years scheduled for transfemoral transcatheter aortic valve replacement (TAVR)randomized, modified intention-to-treat population analysed: 436 single-ProGlide, 430 double-ProGlide
- Participants
- 876 patients
- Comparison
- single-ProGlide or double-ProGlide closure for the main access site
- single-ProGliden = 436
- double-ProGliden = 430
- Primary endpoint
- Composite of Valve Academic Research Consortium (VARC)-3-defined access-site or access-related major and minor vascular complications
- Follow-up
- In-hospital
Methodological details25 centers in China
- 25 centers in China
Primary result
As reported in the abstract
Risk difference
−2.2%
95% CI −7.0% to 2.6%
P = 0.013
Events by treatment group
Non-inferiority margin 3.19 as printed, not drawn
Secondary outcomes
Additional closure devices · might be used more often with the single-ProGlide strategy
Individual components of the primary endpoint, access-related bleeding, time to hemostasis, and all-cause mortality (secondary endpoints)
- Similar between groups
Safety
Access-related major vascular complications
Access-site stenosis · numerically less frequent with the single-ProGlide strategy
Original publication
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