Many patients with severe aortic stenosis and coexisting conditions are not candidates
for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve
implantation (TAVI) has been suggested as a less invasive treatment for high-risk
patients with aortic stenosis.
We randomly assigned patients with severe aortic stenosis, whom surgeons considered
not to be suitable candidates for surgery, to standard therapy (including balloon
aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable
bovine pericardial valve. The primary end point was the rate of death from any cause.
A total of 358 patients with aortic stenosis who were not considered to be suitable
candidates for surgery underwent randomization at 21 centers (17 in the United States).
At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with
TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55;
95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end
point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared
with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001).
Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association
class III or IV) was lower among patients who had undergone TAVI than among those
who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as
compared with standard therapy, was associated with a higher incidence of major strokes
(5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001).
In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic
valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.
In patients with severe aortic stenosis who were not suitable candidates for surgery,
TAVI, as compared with standard therapy, significantly reduced the rates of death
from any cause, the composite end point of death from any cause or repeat hospitalization,
and cardiac symptoms, despite the higher incidence of major strokes and major vascular
events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).