Self-expanding TAVR resulted in a 26.0% rate of all-cause mortality or major stroke at 12 months, significantly lower than the 43.0% objective performance goal (p < 0.0001).
Does TAVR with a self-expanding bioprosthesis reduce the composite of all-cause mortality or major stroke in patients with symptomatic severe aortic stenosis at extreme risk for surgery compared to an objective performance goal?
TAVR with a self-expanding bioprosthesis is safe and effective, significantly reducing the composite of all-cause mortality or major stroke at 12 months compared to a pre-specified objective performance goal in patients with severe aortic stenosis at extreme surgical risk.
Tasa de eventos absoluta: 26% vs 43%
valor p: p=< 0.0001
OBJECTIVES: This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND: Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS: We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS: A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS: TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
“The low rates of stroke and valve leakage with the CoreValve System — two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life — set a new standard for transcatheter valves.”
Popma et al. (Fri,) conducted a other in Symptomatic severe aortic stenosis (n=506). Self-expanding transcatheter aortic valve replacement (CoreValve THV) vs. Pre-specified objective performance goal (OPG) was evaluated on Composite of all-cause mortality or major stroke at 12 months (p=< 0.0001). Self-expanding TAVR resulted in a 26.0% rate of all-cause mortality or major stroke at 12 months, significantly lower than the 43.0% objective performance goal (p < 0.0001).