USA: Major clinical outcomes (disabling stroke and death) were similar 5 years after TAVR and surgical aortic valve replacement among intermediate-risk patients with symptomatic severe aortic stenosis, researchers state in a recent study published in JAMA Cardiology.
Findings from the SURTAVI trial further showed that TAVR was associated with superior hemodynamic valve performance but also with valve interventions and paravalvular leak.
Previous studies have shown transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve to be noninferior to surgery for disabling stroke and mortality at 2 years among patients with severe aortic valve stenosis at intermediate surgical risk. There is a lack of comparisons of longer-term hemodynamic and clinical outcomes are limited.
Against the above background, Nicolas M. Van Mieghem, Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues reported prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. -- a prospective randomized, unblinded clinical trial.
Randomization was stratified by the need for revascularization determined by the local heart teams and investigational sites. The researchers enrolled patients with severe aortic valve stenosis at intermediate risk of 30-day surgical mortality at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. The analysis took place between August and October 2021. The main outcomes were prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years.
1660 patients were randomized to TAVR with a self-expanding, supra-annular transcatheter (n = 864) or a surgical bioprosthesis (n = 796). The mean age was 79.8 years, 43.6% were female, and the mean Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5%.
The key findings of the study were as follows:
At 5 years, the death or disabling stroke rates were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02).
Transprosthetic gradients remained lower (mean, 8.6 mm Hg vs 11.2 mm Hg) and aortic valve areas were higher (mean 2.2 cm2 vs 1.8 cm2) with TAVR vs surgery.
More patients had moderate/severe paravalvular leak with TAVR than surgery (3.0% vs 0.7%).
New pacemaker implantation rates were higher for TAVR than surgery at 5 years 39.1% vs 15.1%; hazard ratio, 3.30), as were valve reintervention rates (3.5% vs 1.9%; hazard ratio, 2.21), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention.
The researchers conclude, "clinical outcomes at 5 years were similar and bioprosthetic valve performance remained stable after TAVR and surgery among patients with symptomatic severe aortic stenosis at intermediate surgical risk."
Reference:
Van Mieghem NM, Deeb GM, Søndergaard L, et al. Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. Published online August 24, 2022. doi:10.1001/jamacardio.2022.2695