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TAVI vs. SAVR for Treatment of Severe Aortic Stenosis
Study Questions:
What is the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) across the spectrum of risk and in important subgroups?
Methods:
Trials comparing TAVI vs. SAVR were identified through Medline, Embase, and Cochrane databases. The primary outcome was death from any cause at 2 years. The investigators performed random-effects meta-analyses to combine the available evidence and to evaluate the effect in different subgroups. This systematic review and meta-analysis is registered with PROSPERO (CRD42016037273).
Results:
The investigators identified four eligible trials including 3,806 participants, who were randomly assigned to undergo TAVI (n = 1,898) or SAVR (n = 1,908). For the primary outcome of death from any cause, TAVI when compared with SAVR was associated with a significant 13% relative risk reduction [hazard ratio (95% confidence interval) 0.87 (0.76–0.99); p = 0.038] with homogeneity across all trials irrespective of TAVI device (Pinteraction = 0.306) and baseline risk (Pinteraction = 0.610). In subgroup analyses, TAVI showed a robust survival benefit over SAVR for patients undergoing transfemoral access [0.80 (0.69–0.93); p = 0.004], but not transthoracic access [1.17 (0.88–1.56); p = 0.293] (Pinteraction = 0.024) and in female [0.68 (0.50–0.91); p = 0.010], but not male patients [0.99 (0.77–1.28); p = 0.952] (Pinteraction = 0.050). Secondary outcomes of kidney injury, new-onset atrial fibrillation, and major bleeding favored TAVI, while major vascular complications, incidence of permanent pacemaker implantation, and paravalvular regurgitation favored SAVR.
Conclusions:
The authors concluded that compared with SAVR, TAVI is associated with a significant survival benefit throughout 2 years of follow-up.
Perspective:
This meta-analysis of the four landmark randomized controlled trials comparing TAVI with SAVR among patients with symptomatic, severe aortic stenosis showed a mortality benefit with TAVI when compared with SAVR at 2 years of follow-up. The effect appears to be consistent across high-risk and lower-risk categories, was independent of device type, and was driven by the subgroup of TAVI patients undergoing transfemoral access and the pronounced effect found in females. Given limitations of a relatively short follow-up of 2 years and lack of individual patient-level data for this analysis, prospective studies with longer-term follow-up are indicated to provide more definitive data.
Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Atrial Fibrillation, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Pacemaker, Artificial, Risk, Transcatheter Aortic Valve Replacement, Vascular Diseases
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