WEDNESDAY, Sept. 22 (HealthDay News) -- Transcatheter aortic-valve implantation (TAVI) appears to be more effective in reducing the rates of death, repeat hospitalization, and cardiac symptoms than standard therapy in patients with aortic stenosis who are not suitable candidates for surgery despite a higher risk of major stroke and vascular complications, according to a study published online Sept. 22 in the New England Journal of Medicine.
Martin B. Leon, M.D., of the Columbia University Medical Center/New York-Presbyterian Hospital in New York City, and colleagues randomly assigned 358 patients with severe aortic stenosis who were considered unsuitable for surgery to standard therapy (including balloon aortic valvuloplasty) or transfemoral TAVI of a balloon-expandable bovine pericardial valve.
At one year, the researchers found that the rate of death from any cause was 30.7 percent with TAVI compared to 50.7 percent with standard therapy. The rate of the composite end point of death from any cause or repeat hospitalization was 42.5 percent with TAVI and 71.6 percent with standard therapy (hazard ratio, 0.46). Among survivors at one year, the rate of cardiac symptoms (New York Heart Association class III or IV) was 25.2 percent with TAVI versus 58 percent with standard therapy. The incidence of major strokes at 30 days was 5.0 percent with TAVI and 1.1 percent with standard therapy (P = 0.06). The incidence of major vascular complications at 30 days was 16.2 percent with TAVI and 1.1 percent with standard therapy.
"On the basis of a rate of death from any cause at one year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery (like the patients enrolled in this study). These results cannot be extrapolated to other patients with aortic stenosis," the authors write.
The research was funded by Edwards Lifesciences, and several authors disclosed financial relationships with various pharmaceutical and medical device companies, including Edwards Lifesciences.
Full Text
