article29

SURTAVI

"TAVR versus Surgery in Patients with Intermediate-Risk Aortic Stenosis".The New England Journal of Medicine. 2017. DOI: 10.1056/NEJMoa1615261.

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

Clinical Question

Is transcatheter aortic-valve replacement (TAVR) a noninferior alternative to surgical aortic-valve replacement in patients with severe aortic stenosis who are at intermediate surgical risk?

Bottom Line

In patients with severe aortic stenosis at intermediate surgical risk, TAVR was noninferior to surgery with respect to the primary composite endpoint of death from any cause or disabling stroke at 24 months. Each procedure had different adverse event profiles.

Major Points

Guidelines

As of the latest guidelines, there is no specific recommendation for TAVR in patients at intermediate risk for surgical aortic-valve replacement. The decision typically involves a case-by-case assessment by a heart team.

Design

- Multinational, randomized, noninferiority clinical trial
- N=1,746 patients
- TAVR with a self-expanding bioprosthesis (n=864)
- Surgical aortic-valve replacement (n=796)
- Setting: 87 centers in the United States, Europe, and Canada
- Enrollment: June 19, 2012, to June 30, 2016
- Follow-up: 24 months
- Primary outcome: A composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement.

Population

Inclusion Criteria
- Symptomatic, severe aortic stenosis
- Intermediate surgical risk (STS-PROM 3-15%)

Exclusion Criteria
- Severe illness with less than a 2-year life expectancy
- Contraindications to anticoagulation or antiplatelet therapy
- Other specific medical exclusions (reported in supplementary material)

Baseline Characteristics
- Mean age: 79.8±6.2 years
- 52.3% male
- STS-PROM score: 4.5±1.6%

Interventions

- Patients randomized to TAVR received a self-expanding bioprosthesis via transfemoral, subclavian, or direct aortic access.
- Patients randomized to surgery underwent traditional surgical aortic-valve replacement, with coronary revascularization as indicated.

Outcomes

Primary Outcome
- Incidence of death from any cause or disabling stroke at 24 months: 12.6% in TAVR group vs. 14.0% in surgery group (95% credible interval -5.2 to 2.3%; posterior probability of noninferiority, >0.999).

Secondary Outcomes
- Both TAVR and surgery significantly improved symptoms and quality of life, with TAVR showing early benefit at 1 month post-procedure.
- At 24 months, TAVR group had lower aortic-valve gradients and larger aortic-valve areas than surgery group.
- Surgery group had higher rates of acute kidney injury and atrial fibrillation; TAVR group had higher rates of residual aortic regurgitation and need for pacemaker implantation.

Funding

The trial was funded by Medtronic.