Log in to MyACC
Meta-Analysis of TAVR vs. SAVR in Low-Risk Patients
Study Questions:
In this meta-analysis of randomized controlled trials (RCTs), what are the outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis (AS)?
Methods:
Four trials met entry criteria of: 1) published RCT (or post hoc analysis of RCT); 2) comparing TAVR vs. SAVR; 3) evaluating patients with Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) risk of <4%; and 4) reporting 1-year outcomes. Four studies analyzed included NOTION, SURTAVI, PARTNER 3, and Evolut Low Risk. The primary outcome of interest was all-cause death at 12 months and secondary outcomes evaluated were cardiovascular (CV) death, stroke, myocardial infarction, new/worsening atrial fibrillation, permanent pacemaker placement, major vascular or bleeding complications, acute kidney injury, acute valve re-intervention, moderate/severe paravalvular leak, and New York Heart Association class >II.
Results:
A total of 2,887 patients were analyzed. Within the TAVR arm, 67% of patients received a self-expanding valve. Mean age of patients was 75.4 years and STS-PROM was 2.3%. Compared with SAVR, TAVR was associated with a significantly lower risk of all-cause death (2.1% vs. 3.5%; relative risk [RR], 0.61; 95% confidence interval [CI], 0.39-0.96; p = 0.03) and cardiovascular death (1.6% vs. 2.9%; RR, 0.55; 95% CI, 0.33-0.90; p = 0.02) at 1 year. Patients receiving TAVR had lower rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3, but were more likely to need permanent pacemaker implantation (17.4% vs. 5.5%; RR, 3.85; 95% CI, 1.73-8.58; p = 0.001) and have moderate/severe paravalvular leak (3.6% vs. 1.7%; RR, 2.16; 95% CI, 1.03-4.54; p = 0.04).
Conclusions:
Data from this meta-analysis suggest that TAVR is associated with lower rates of all-cause and CV related mortality compared to SAVR at 12 months in low-risk patients with severe AS.
Perspective:
This meta-analysis included four recently published trials that studied TAVR versus SAVR in low-risk patients with AS. There is some variability in the trial design of the trials included (one post hoc analysis, one powered for superiority, one for inferiority, and one for superiority and inferiority). In addition, sensitivity analysis after excluding the less rigorous post hoc analysis of the SURTAVI trial, did not show a significant difference in all-cause death between TAVR and SAVR. Nevertheless, these data complement recent RCTs showing short-term (1-2 year) safety and efficacy of TAVR in low-risk AS patients, with a suggestion that TAVR may be associated with better short-term mortality. These findings re-affirm the recent Food and Drug Administration (FDA) approval of TAVR for low-risk patients, but longer follow-up regarding valve degeneration will be needed to confirm TAVR as the preferred treatment for low-risk patients with severe AS.
Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Atrial Fibrillation, Cardiac Surgical Procedures, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Myocardial Infarction, Pacemaker, Artificial, Risk, Stroke, Transcatheter Aortic Valve Replacement
< Back to Listings
