HealthDay News — There is no significant difference in the incidence of death or disabling stroke at five years among patients with aortic stenosis at intermediate surgical risk who undergo transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement, according to a study published online Jan. 29 in the New England Journal of Medicine.
Raj R. Makkar, M.D., from Cedars-Sinai Medical Center in Los Angeles, and colleagues enrolled 2,032 intermediate-risk patients with severe, symptomatic aortic stenosis and stratified them according to intended transfemoral or transthoracic access (76.3 and 23.7 percent, respectively). Patients were randomly assigned to undergo TAVR or surgical replacement.
The researchers observed no significant difference between the TAVR and surgery groups in the incidence of death from any cause or disabling stroke at five years (47.9 and 43.4 percent, respectively; hazard ratio, 1.09; 95 percent confidence interval, 0.95 to 1.25; P = 0.21). Similar results were seen in the transfemoral-access cohort (44.5 and 42.0 percent; hazard ratio, 1.02; 95 percent confidence interval, 0.87 to 1.20); in the transthoracic-access cohort, the incidence of death or disabling stroke was higher after TAVR than after surgery (59.3 versus 48.3 percent; hazard ratio, 1.32; 95 percent confidence interval, 1.02 to 1.71).
“The results of this study are encouraging because TAVR was comparable in terms of outcomes,” Makkar said in a statement. “These findings allow patients to have more peace of mind and undergo a less invasive procedure.”
Several authors disclosed financial ties to Edwards Lifesciences, which funded the study.