"TAVR versus Surgery in Patients with Intermediate-Risk Aortic Stenosis".The New England Journal of Medicine. 2017. DOI: 10.1056/NEJMoa1615261.
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) a noninferior alternative to surgical aortic-valve replacement in patients with severe aortic stenosis who are at intermediate surgical risk?
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.
TAVR has emerged as an accepted treatment for severe aortic stenosis in patients at high or prohibitive surgical risk. Its role in patients at intermediate surgical risk remained less clear. The SURTAVI trial was designed to evaluate the safety and efficacy of TAVR versus surgical aortic-valve replacement in intermediate-risk patients.
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.
- 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.
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%
- 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.
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).
- 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.
The trial was funded by Medtronic.
The full trial results can be found at NEJM.org, DOI: 10.1056/NEJMoa1615261, and in the corresponding published article on transcatheter versus surgical aortic-valve replacement in patients at intermediate risk.