"TAVR versus Surgery for Aortic Stenosis in Patients at Low Surgical Risk".The New England Journal of Medicine. 2019. 380:1695-1705.
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Funding 10 Further Reading
Is transcatheter aortic-valve replacement (TAVR) superior to surgical aortic-valve replacement in patients with severe aortic stenosis who are at low surgical risk?
Among patients with severe aortic stenosis at low risk for surgical complications, TAVR significantly reduced rates of death, stroke, or rehospitalization at 1 year compared to surgery.
Previous studies established TAVR as a beneficial alternative to surgery in higher-risk patients with severe aortic stenosis. This trial assessed TAVR versus surgery in lower-risk patients, finding lower rates of key outcomes like death, strokes, and rehospitalization for TAVR, favoring its use in a wider patient population.
As of the last update, guidelines did not include the results of this trial for recommending treatments in low-risk patients.
- Multicenter, randomized, nonblinded trial - N=1,000 patients with severe aortic stenosis at low surgical risk - Intervention: Transfemoral TAVR (n=503) - Comparator: Surgical aortic-valve replacement (n=497) - Primary outcome: Composite of death from any cause, stroke, or rehospitalization at 1 year - Follow-Up: 1 year
Inclusion Criteria - Severe, symptomatic aortic stenosis and low surgical risk - STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) score <4%
Exclusion Criteria - Clinical frailty, bicuspid aortic valves, or anatomy increasing the risk for both TAVR and surgery complications
Baseline Characteristics - Mean age: 73 years - Male: 69.3% - STS-PROM: 1.9%
- Transfemoral placement of a balloon-expandable SAPIEN 3 valve (TAVR group) - Surgical aortic-valve replacement with commercially available bioprosthetic valve (surgery group)
Primary Outcome - TAVR: 8.5% had composite events at 1 year - Surgery: 15.1% had composite events at 1 year - Absolute difference: -6.6 percentage points (P<0.001 for noninferiority and superiority)
- Lower rates of stroke at 30 days (P=0.02) - Shorter duration of the index hospitalization (P<0.001) - Lower rates of new-onset atrial fibrillation (P<0.001) - More rapid improvements in functional status and quality of life measures with TAVR
- The trial was funded by Edwards Lifesciences.
- For additional information on this trial, readers can refer to the full journal article in The New England Journal of Medicine or the trial registration at ClinicalTrials.gov (NCT02675114).