Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is non-inferior to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and low surgical risk, reported by a new study.
The multi-national, randomised trial enrolled 1,468 patients at 86 centres in Australia, Canada, France, Japan, the Netherlands, New Zealand and the United States. A total of 725 patients subsequently received TAVR with one of three types of self-expanding devices and 678 patients underwent SAVR with bioprosthetic surgical valves.
The study found that the incidence of death or disabling stroke at 24 months (the primary end point) was 5.3 per cent in the TAVR group (95% Bayesian credible interval [CI] 3.3-8.0) and 6.7 per cent in the surgery group (95% CI 4.4-9.6). TAVR was associated with a lower incidence of disabling stroke, acute kidney injury, bleeding events and atrial fibrillation than that of surgery but with a higher incidence of aortic regurgitation and pacemaker implantation.
The findings were presented at the American College of Cardiology’s 68th Annual Scientific Session and are published in the New England Journal of Medicine.