WASHINGTON, Sept. 23 /PRNewswire/ — One-year data from the
PARTNER clinical trial, published yesterday in the New England
Journal of Medicine, demonstrate that transcatheter aortic-valve
implantation, compared with standard therapy, resulted in
significantly lower rates of death among patients who cannot
undergo surgery for aortic stenosis. The results will be presented
today as a Late Breaking Trial at the 22nd annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium.
Transcatheter aortic-valve implantation (TAVI) is a new
procedure in which a bioprosthetic valve is inserted through a
catheter and implanted within the diseased native aortic valve. The
Placement of AoRtic TraNscathetER valves (PARTNER) trial is a
multicenter, randomized clinical trial comparing TAVI with standard
therapy in high-risk patients with severe aortic stenosis. The
co-principal investigators are Martin B. Leon, M.D., and Craig R.
Smith, M.D., at NewYork-Presbyterian Hospital/Columbia University
Medical Center. The data published today reflect a prespecified
cohort of patients who were considered to be unsuitable candidates
for surgery.
The primary end point was the rate of death from any cause over
the duration of the study. A total of 358 patients with aortic
stenosis who were considered to be unsuitable candidates for
surgery underwent randomization at 21 centers, including 17 in the
United States. Patients randomized for standard therapy received a
combination of watchful waiting, medications, and balloon aortic
valvuloplasty, which can provide transient clinical benefit but
does not alter long-term outcomes.
At one year, based on the Hazard Ratio of 0.55, patients
who underwent TAVI showed a reduction in mortality from 50.7
percent to 30.7 percent. In addition, there was a reduction in the
combined endpoint of death from any cause or repeat hospitalization
from 71.6 percent with standard therapy to 42.5 percent with
TAVI. Among
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