Valvular & structural heart diseaseSecondary analysis
Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement
- Secondary analysis of a randomised controlled trial
- ad hoc analysis
- multicentre
537 of 671 alive patients (80.0%) had echocardiographic analysis at 7 years
Authors' conclusion
In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years.
Study context
- Population
- Low-risk patients with symptomatic severe AS, 71 centres in the US and Canada, enrolled March 2016–October 2017randomised
- Participants
- 1,000 patients
- Comparison
- Transcatheter aortic valve replacement (TAVR) vs surgery
- TAVRn = 495
- Surgeryn = 453reference
- Primary endpoint
- Stage 2 or 3 BVD related to SVD, thrombosis or endocarditis; all-cause BVF; SVD-related BVF; aortic valve reintervention (cumulative incidence, death as competing risk)
- Follow-up
- 7 years
Primary result
As reported in the abstract
TAVR
7.3%
Stage 2 or 3 Structural Valve Deterioration (SVD)-related Bioprosthetic Valve Dysfunction (BVD) · All-cause Bioprosthetic Valve Failure (BVF) 6.9% · SVD-related BVF 3.9% · Valve reintervention 6.0% · Stage 2 or 3 thrombosis-related BVD 5.2% · Stage 2 or 3 endocarditis-related BVD 0.4%
Surgery
7.6%
Stage 2 or 3 SVD-related BVD · All-cause BVF 7.5% · SVD-related BVF 5.3% · Valve reintervention 5.5% · Stage 2 or 3 thrombosis-related BVD 0.9% · Stage 2 or 3 endocarditis-related BVD 0.5%
Further findings
Alive and free of all-cause BVF · 7 years
P = 0.69
Original publication
Summarised from the published abstract; every number is checked against it